Trials (Ospedale San Raffaele)
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NCTID: NCT02170090
Title: Adjuvant Chemotherapy With Gemcitabine and Cisplatin Compared to Standard of Care After Curative Intent Resection of Biliary Tract Cancer Study Summary: This is a multicenter, prospective, randomized, controlled phase III trial designed to assess the clinical performance of gemcitabine with cisplatin and observation vs. standard of care (observation alone in stage 1 and capecitabine and observation in stage 2) in patients after curative intent resection of BTC. Sponsor: Universitätsklinikum Hamburg-Eppendorf Intervention: Gemcitabine Start Date: 2014-04 Last Updated: 2023-01-25 Number of Patients: 789 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Cholangiocarcinoma
NCTID: NCT00002990
Title: Surgery and BCG in Treating Patients With Bladder Cancer Study Summary: RATIONALE: Biological therapies such as BCG use different ways to stimulate the immune system and stop cancer cells from growing. PURPOSE: This randomized phase III trial is studying four different regimens of BCG and comparing how well they work in treating patients who have undergone surgery for bladder cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: BCG vaccine Start Date: 1997-03 Last Updated: 2013-06-12 Number of Patients: 1288 Recruitment Status: COMPLETED Condition: Bladder Cancer
NCTID: NCT00795756
Title: Intrathecal DepoCyte and Lineage-targeted Minimal Residual Disease-oriented Therapy of Acute Lymphoblastic Leukemia Study Summary: The aim of this clinical study in adult ALL is to compare by risk category (1) the feasibility of two different CNS prophylaxis regimens and (2) the overall disease-free survival in relation to the achievement of an early MRD negative status and following consolidation with lineage-targeted methotrexate infusions and other disease-specific therapeutic elements, with or without the application of allogeneic or autologous SCT depending on risk class and MRD study results. In this multicentric prospective pilot randomized phase II trial on CNS prophylaxis, all patients receive induction/consolidation therapy incorporating lineage-targeted high-dose methotrexate plus other drugs (with additional imatinib in Ph/BCR-ABL+ ALL), for the achievement of an early negative MRD status. The MRD study supports a risk/MRD-oriented final consolidation phase. Sponsor: Northern Italy Leukemia Group Intervention: liposome-encapsulated cytarabine (DepoCyte) Start Date: 2008-01 Last Updated: 2014-10-22 Number of Patients: 145 Recruitment Status: COMPLETED Condition: Acute Lymphoblastic Leukemia
NCTID: NCT00002903
Title: Docetaxel in Treating Patients With Recurrent or Refractory Germ Cell Cancer Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients with recurrent or refractory germ cell cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: docetaxel Start Date: 1995-07 Last Updated: 2012-07-02 Number of Patients: 25 Recruitment Status: COMPLETED Condition: Extragonadal Germ Cell Tumor
NCTID: NCT05802290
Title: NIVolumab in Subjects With Recurrent or Metastatic Platinum-refrACTORy SCCHN Study Summary: Subjects will receive treatment with nivolumab monotherapy at 240mg flat dose as a 30 minute IV infusion on Day 1 of a treatment cycle every 2 weeks (14 days) until confirmed progression of disease, unacceptable toxicity, death or withdrawal of consent. This study is designed to better evaluate the safety profile of nivolumab in a large series of patients with Recurrent or Metastatic (R/M) Squamous Cell Carcinoma of the Head and Neck. The primary endpoint of this study is the incidence of high-grade (CTCAE v 4.03 Grade 3 or higher), treatment-related, select adverse events. Sponsor: Gruppo Oncologico del Nord-Ovest Intervention: Nivolumab 240 MG in 24 ML Injection Start Date: 2017-11-27 Last Updated: 2023-04-06 Number of Patients: 124 Recruitment Status: COMPLETED Condition: Squamous Cell Carcinoma of Head and Neck
NCTID: NCT04576156
Title: A Study Comparing Imetelstat Versus Best Available Therapy for the Treatment of Intermediate-2 or High-risk Myelofibrosis (MF) Who Have Not Responded to Janus Kinase (JAK)-Inhibitor Treatment Study Summary: The purpose of the study is to evaluate the overall survival of participants treated with imetelstat compared to best available therapy with intermediate-2 or high-risk Myelofibrosis (MF) who are relapsed/refractory to Janus Kinase (JAK)-Inhibitor treatment. Sponsor: Geron Corporation Intervention: Imetelstat Start Date: 2021-04-12 Last Updated: 2023-11-28 Number of Patients: 320 Recruitment Status: RECRUITING Condition: Myelofibrosis
NCTID: NCT04034056
Title: Untreated FolliculaR Lymphoma Treated With OBinituzumAb in a Non-interventional Study (URBAN) Study Summary: To evaluate the effectiveness and safety of obinutuzumab in clinical routine in 1L FL measured by the % of relapse within 24 months from start of therapy. Sponsor: Hoffmann-La Roche Intervention: Obinutuzumab Start Date: 2019-09-02 Last Updated: 2023-10-04 Number of Patients: 299 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Follicular Lymphoma
NCTID: NCT03552003
Title: Study for Elderly (≥ 65 Years) Patients With Classical Hodgkin Lymphoma Undergoing CGA at Diagnosis Study Summary: The aim of the study is to develop a prognostic index for elderly patients with newly diagnosed cHL starting from a prospective observational study of consecutive cases registered after the completion of the Comprehensive Geriatric Assessment (CGA) Sponsor: Fondazione Italiana Linfomi - ETS Intervention: Treatment for clinical practise Start Date: 2018-08-10 Last Updated: 2022-08-26 Number of Patients: 400 Recruitment Status: RECRUITING Condition: Classical Hodgkin Lymphoma
NCTID: NCT01940497
Title: A Study of the Safety of Subcutaneously Administered Trastuzumab (Herceptin) in Participants With Early and Locally Advanced Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer Study Summary: This non-randomized, multicenter, open-label study will assess the safety and efficacy of subcutaneously administered trastuzumab in participants with early and locally advanced HER2-positive breast cancer in two sequential cohorts. First 120 participants will be treated with subcutaneous (SC) trastuzumab 600 milligrams (mg) vial (Cohort A) and the subsequent 120 participants will be treated with SC trastuzumab prefilled single use injection device (SID) (Cohort B). Participants from each cohort will receive neoadjuvant or adjuvant chemotherapy consisting of doxorubicin every 3 weeks (q3w) (1 cycle) for 4 cycles followed by paclitaxel weekly or docetaxel every 3 weeks (q3w) in combination with SC trastuzumab (600 mg) q3w for 4 cycles and a further 14 cycles of SC trastuzumab (600 mg) q3w alone. All participants will be followed up for 24 months after the last participant has received the last dose of study treatment, or earlier in case of withdrawal from the study, loss to follow-up or death. Sponsor: Hoffmann-La Roche Intervention: Doxorubicin Start Date: 2013-11-15 Last Updated: 2020-11-03 Number of Patients: 240 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT02810990
Title: Bosutinib in Elderly Chronic Myeloid Leukemia Study Summary: The objective of the present study is to evaluate a new drug called bosutinib as it is believed that this agent may be able to predict an excellent prognosis in patients that did not obtain any benefit with other drugs before. Still, this needs to be proved and we hope this study is able to do so. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: Bosutinib Start Date: 2016-11-17 Last Updated: 2023-02-03 Number of Patients: 65 Recruitment Status: COMPLETED Condition: Chronic Myeloid Leukemia
NCTID: NCT03981497
Title: Microwave Ablation for Treatment of Small Renal Tumors and Primary and Secondary Liver Neoplasms Study Summary: The goal of this observational study is to collect data on efficacy and safety of microwave ablation (MWA) used to treat subjects with primary and secondary liver malignancies and renal malignancies. The main question it aims to evaluate the short, medium and long-term clinical course of patients treated with MWA. Participants will not alter their normal clinical and therapeutic practice, due to the observational nature of the study, and all data regarding microwave treatments will be collected (including demographic data). follow their normal clinical and therapeutic path Sponsor: Francesco De Cobelli Intervention: Microwave ablation (MWA) Start Date: 2018-02-28 Last Updated: 2023-01-26 Number of Patients: 500 Recruitment Status: RECRUITING Condition: Liver Cancer
NCTID: NCT01530503
Title: Second Line Therapy in Advanced Biliary Tract Cancer Study Summary: The purpose of this study is to assess the therapeutic activity of capecitabine alone or in combination with mitomycin C as second-line therapy in patients with advanced/metastatic biliary adenocarcinoma in progression after gemcitabine and platinum compounds Sponsor: IRCCS San Raffaele Intervention: capecitabine and mitomycin Start Date: 2011-11 Last Updated: 2016-02-25 Number of Patients: 52 Recruitment Status: COMPLETED Condition: Biliary Tract Cancer
NCTID: NCT05375903
Title: A Phase 1 Dose-escalation Study of UGN-301 in Patients With Recurrent Non-muscle Invasive Bladder Cancer (NMIBC) Study Summary: This study is being conducted to evaluate the safety and determine the recommended Phase 2 dose (RP2D) of UGN-301 (zalifrelimab) administered intravesically as monotherapy and in combination with other agents in patients with recurrent NMIBC. Sponsor: UroGen Pharma Ltd. Intervention: UGN-301 Start Date: 2022-06-01 Last Updated: 2023-08-21 Number of Patients: 60 Recruitment Status: RECRUITING Condition: Non-muscle Invasive Bladder Cancer
NCTID: NCT00002503
Title: Strontium Compared With Radiation Therapy in Treating Patients With Hormone-Refractory Prostate Cancer With Painful Bone Metastases Study Summary: RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. This may be an effective treatment for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of strontium or radiation therapy in treating patients with prostate cancer that is refractory to hormone therapy who have painful bone metastases. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: strontium chloride Sr 89 Start Date: 1992-10 Last Updated: 2012-09-24 Number of Patients: 204 Recruitment Status: COMPLETED Condition: Metastatic Cancer
NCTID: NCT00774345
Title: A Study to Evaluate the Efficacy and Safety of Lenalidomide as Maintenance Therapy for Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Following Second Line Therapy Study Summary: The purpose of this study is to determine if lenalidomide (Revlimid®) is safe and effective as a maintenance therapy at improving further the quality of the response you achieved with your last therapy and at prolonging the duration of your response. This study will compare the effects (good and bad) of lenalidomide with the dummy drug. Sponsor: Celgene Intervention: Lenalidomide Start Date: 2009-01-27 Last Updated: 2021-12-02 Number of Patients: 317 Recruitment Status: COMPLETED Condition: B-cell Chronic Lymphocytic Leukemia
NCTID: NCT04221945
Title: Study of Chemoradiotherapy With or Without Pembrolizumab (MK-3475) For The Treatment of Locally Advanced Cervical Cancer (MK-3475-A18/KEYNOTE-A18/ENGOT-cx11/GOG-3047) Study Summary: The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus concurrent chemoradiotherapy compared to placebo plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer. The primary hypotheses are that pembrolizumab plus concurrent chemoradiotherapy is superior to placebo plus concurrent chemoradiotherapy with respect to progression-free survival and overall survival. Once the study objectives have been met or the study has ended, participants will be discontinued from this study and will be enrolled in an extension study to continue protocol-defined assessments and treatment. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2020-05-12 Last Updated: 2023-07-20 Number of Patients: 980 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Uterine Cervical Neoplasms
NCTID: NCT04038359
Title: A Phase 2 Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Subjects With Indolent Non-Hodgkin Lymphoma. (TEMPO) Study Summary: This study will examine the effects of predefined 2 week duvelisib dose holidays on tumor responses and safety/tolerability. Sponsor: SecuraBio Intervention: Duvelisib Start Date: 2019-09-24 Last Updated: 2023-08-14 Number of Patients: 102 Recruitment Status: COMPLETED Condition: Indolent Non-hodgkin Lymphoma
NCTID: NCT04557059
Title: A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer Study Summary: The main purpose of this study is to determine if the addition of apalutamide to radiotherapy (RT) plus luteinizing hormone-releasing hormone agonist (LHRHa) delays metastatic progression as assessed by prostate specific membrane antigen-positron emission tomography (PSMA-PET) or death compared with RT plus LHRHa alone. Sponsor: Janssen Pharmaceutica N.V., Belgium Intervention: Radiotherapy Start Date: 2020-11-12 Last Updated: 2023-11-09 Number of Patients: 412 Recruitment Status: RECRUITING Condition: Prostatic Neoplasms
NCTID: NCT05916703
Title: Smart Optical and Ultrasound Diagnostic of Breast Cancer Study Summary: SOLUS is a trans-disciplinary 48-month project bringing together 9 partners: industries (4), academic and clinical institutions from 5 countries (engineers, physicists and radiologists) representing cutting-edge expertise in their fields, to develop an innovative non-invasive, point-of-care, low-cost, easy-to-operate, multi-modal imaging system (diffuse optics and ultrasounds/shear wave elastography) for high-specificity diagnosis of breast cancer, the most common female cancer in Europe. Mammographic screening is effective in reducing mortality, however the 10-year cumulative false-positive risk is 50-60%, leading to needless additional invasive procedures (e.g. biopsy). The project addresses the unmet clinical need for higher specificity in breast cancer imaging following screening by fully combining photonics with non-photonics techniques, developing and clinically validating innovative and previously unthinkable photonics concepts and components: time-domain small source-detector distance optical tomography, miniaturized picosecond pulsed laser sources, high-dynamic-range time-gated single-photons detectors to achieve unprecedented sensitivity and depth penetration. For the first time, this allows a comprehensive quantitative characterization of breast tissue including composition (water, lipids, collagen), functional blood parameters, morphologic information and mechanical parameters (stiffness). This innovative multi-parametric characterization will significantly improve the specificity of breast screening, with great impact on the quality of life of millions of European women every year, and huge savings for the healthcare systems. The strong involvement of leading industrial players at all levels in the value chain will push the European innovation process and make a significant contribution to ensuring Europe’s industrial leadership in the biophotonics healthcare market, while addressing one of the largest societal challenges in health and well-being. Sponsor: IRCCS San Raffaele Intervention: SOLUS examination Start Date: 2021-11-11 Last Updated: 2023-06-23 Number of Patients: 40 Recruitment Status: RECRUITING Condition: Breast Disease
NCTID: NCT04949256
Title: Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Plus Chemotherapy in Participants With Metastatic Esophageal Carcinoma (MK-7902-014/E7080-G000-320/LEAP-014) Study Summary: The purpose of this study is to assess the efficacy and safety of pembrolizumab plus lenvatinib plus chemotherapy compared with pembrolizumab plus chemotherapy as first-line intervention in participants with metastatic esophageal carcinoma The primary hypotheses are that pembrolizumab plus lenvatinib plus chemotherapy is superior to pembrolizumab plus chemotherapy with respect to overall survival (OS) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2021-07-28 Last Updated: 2023-11-24 Number of Patients: 862 Recruitment Status: RECRUITING Condition: Metastatic Esophageal Squamous Cell Carcinoma
NCTID: NCT04767659
Title: Monitoring Response to NAC and Prediction of pCR in Breast Cancer Patients Using Optical Imaging Study Summary: Neoadjuvant chemotherapy (NAC) is the first line treatment for locally advanced breast cancer (BC). Besides making breast conserving surgery feasible, its main aim is to achieve a pathological complete response (pCR). Previous studies demonstrated that a pCR correlated with a higher disease-free survival. Tumor response may vary among different BC subtypes and only 30% of BC respond completely to NAC. Treating chemo-resistant disease with NAC may cause patient harm due to drug toxicity and surgery delay. It is therefore very important to promptly identify those women who will not benefit from NAC. Mammography and ultrasound proved ineffective in monitoring changes in lesion size due to therapy-induced fibrosis. MRI is the most accurate imaging technique for assessing early clinical response by measuring tumor size, however its accuracy is lower post NAC. This necessitates the need for a new technique able to non invasively assess the effectiveness of NAC. Optical techniques are sensitive to the biological changes that occur within the tumor after NAC administration. These changes occur prior to tumor size reduction. Optically estimated total hemoglobin concentration correlates with the histological analysis of vasculature as well as with tumor-associated angiogenesis which can affect tumor changes during NAC. Other promising biomarkers related to tissue composition (water, lipid, collagen content) and structure (scattering) may also be evaluated by optical techniques. The aim of the study is to monitor the effectiveness of NAC in BC patients with a near infrared spectroscopic imaging platform which allows to non-invasively detect changes in vascularization and size of BC and to characterize the presence of temporal changes in regional concentrations of relevant biomarkers (oxy- and deoxyhemoglobin, water, lipid and collagen concentration, scattering) within tissue during NAC. This optical imaging technique will provide a non-invasive, safe and relatively inexpensive tool to monitor patients’ response to NAC and to predict their outcome. Sponsor: IRCCS San Raffaele Intervention: MAMMOT2 Start Date: 2020-01-27 Last Updated: 2021-02-23 Number of Patients: 20 Recruitment Status: UNKNOWN Condition: Breast Cancer Female
NCTID: NCT04172675
Title: A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) Study Summary: The purpose of this study is to evaluate recurrence-free survival (RFS) in participants treated with erdafitinib vs Investigator’s Choice, for participants with high-risk non-muscle-invasive bladder cancer (NMIBC) who harbor fibroblast growth factor receptor (FGFR) mutations or fusions, and who recurred after bacillus calmette-guerin (BCG) therapy. Sponsor: Janssen Research & Development, LLC Intervention: Erdafitinib Start Date: 2020-02-28 Last Updated: 2023-11-13 Number of Patients: 107 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Urinary Bladder Neoplasms
NCTID: NCT01599559
Title: Randomized, Open-label, Two-arms, Phase III Comparative Study Assessing the Role of Involved Mediastinal Radiotherapy After Rituximab Containing Chemotherapy Regimens to Patients With Newly Diagnosed Primary Mediastinal Large B-Cell Lymphoma Study Summary: Primary mediastinal large B cell lymphoma is treated with a combination of chemotherapy and the monoclonal antibody rituximab (chemoimmunotherapy). Following chemoimmunotherapy patients receive radiation therapy if they have residues which may be active tumour. However at the end of chemoimmunotherapy the majority of patients show tissue scarring that is not necessarily active tumor. In recent years, PET/CT has proved to be a good tool to accurately identify active tumor from scar tissue in patients treated for mediastinal lymphoma.The purpose of this trial is to test whether radiation therapy is really necessary in patients where PET/CT has shown that the tumor is no longer active. Therefore we will compare radiation treatment with careful observation. Patients that at the end of conventional treatment of chemoimmunotherapy have a negative PET/CT (i.e., without residues suspected to contain active tumor), will randomly assigned to two different treatment groups: one treatment group will receive the radiation treatment, and the other treatment group will receive careful observation. The trial is planned according to a non-inferiority design aimed at demonstrating that progression free survival after the experimental treatment (observation) is not worse than after the standard comparator (mediastinal irradiation.Participation in this study could spare patients with complete remission at the end of chemo immunotherapy (PET/CT negative) radiation therapy that may be unnecessary. Sponsor: International Extranodal Lymphoma Study Group (IELSG) Intervention: observation Start Date: 2012-10 Last Updated: 2023-10-19 Number of Patients: 540 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Primary Mediastinal B-cell Lymphoma
NCTID: NCT05876754
Title: An Early Access Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma Study Summary: A Phase 3b research study to consolidate the data that ivosidenib is safe and effective in adult patients with previously treated, locally advanced, or metastatic cholangiocarcinoma (CCA). All patients who meet inclusion criteria will be enrolled to receive ivosidenib tablets orally once daily for 28 day cycles, continuing as long as clinical benefit and consent for participation is maintained. There will be a minimum of 6 study visits from screening until the final follow-up, if one cycle of treatment is completed and consent is maintained through 18 months of follow-up. Each additional cycle completed will add one study visit, on the first day of each cycle. Sponsor: Servier Affaires Médicales Intervention: Ivosidenib Oral Tablet Start Date: 2023-05-03 Last Updated: 2023-09-06 Number of Patients: 220 Recruitment Status: RECRUITING Condition: Cholangiocarcinoma
NCTID: NCT03596866
Title: A Study of Brigatinib Compared to Alectinib in Adults With Non-Small-Cell Lung Cancer Study Summary: Brigatinib is a medicine that binds to the surface of tumor cells in some cancers and delivers a dose of chemotherapy directly to the tumor. In this study, participants will be people with non-small-cell lung cancer (NSCLC for short). The main aim of the study is to learn if brigatinib stops the tumors from growing, or if the tumors have shrunk or disappeared, compared to a medicine called alectinib. At the first visit, the study doctor will check who can take part. Participants who can take part will be picked for 1 of 2 treatments by chance: * Brigatinib tablets * Alectinib capsules All participants will take brigatinib or alectinib at about the same time every day. They will continue with treatment throughout the study unless their cancer gets worse, they have side effects from the treatment, they leave the study for certain reasons, or the study is stopped. After stopping treatment, participants will visit the study clinic for a check-up 30 days later. Sponsor: Takeda Intervention: Brigatinib Start Date: 2019-04-19 Last Updated: 2023-05-18 Number of Patients: 248 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: ALK+ Advanced NSCLC
NCTID: NCT04622319
Title: A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DESTINY-Breast05) Study Summary: Patients with HER2-positive primary breast cancer (BC) who do not achieve complete response after appropriate neoadjuvant therapy are at higher risk of disease recurrence. More effective treatment options are needed for this patient population. This study will examine the efficacy and safety of trastuzumab deruxtecan (T-DXd) compared with trastuzumab emtansine (T-DM1) in high-risk patients with residual invasive breast cancer following neoadjuvant therapy. Sponsor: Daiichi Sankyo, Inc. Intervention: DS-8201a Start Date: 2020-12-04 Last Updated: 2023-11-07 Number of Patients: 1600 Recruitment Status: RECRUITING Condition: HER2-Positive Primary Breast Cancer
NCTID: NCT00210366
Title: Salvage Therapy With Idarubicin in Relapsing CNS Lymphoma Study Summary: The main objective of the trial is to assess the therapeutic activity of idarubicin as salvage treatment in patients with recurrent or progressive lymphoma in the central nervous system. Sponsor: International Extranodal Lymphoma Study Group (IELSG) Intervention: Idarubicin Start Date: 2004-11 Last Updated: 2010-07-30 Number of Patients: 25 Recruitment Status: TERMINATED Condition: Lymphoma, B-Cell
NCTID: NCT04844866
Title: Efficacy and Safety of MB-CART2019.1 vs. SoC in Lymphoma Patients Study Summary: This is a pivotal Phase II randomised, multi-centre, open-label study to evaluate the efficacy and safety of MB-CART2019.1 compared to standard of care therapy in participants with relapsed/refractory diffuse large B-cell lymphoma, who are not eligible for high-dose chemotherapy and autologous stem cell transplantation. Sponsor: Miltenyi Biomedicine GmbH Intervention: MB-CART2019.1 Start Date: 2021-08-18 Last Updated: 2023-11-07 Number of Patients: 168 Recruitment Status: RECRUITING Condition: Diffuse Large B-cell Lymphoma
NCTID: NCT02638467
Title: Allogeneic Stem Cell Transplantation in Chronic Myeloid Leukemia Failing TKIs Therapy Study Summary: Patients newly diagnosed with chronic phase chronic myeloid leukemia undergo treatment with TK inhibitors (TKI). A possible cause of TK failure is represented by the insufficient recovery of normal Ph- hematopoiesis during TKI treatment, with consequent severe cytopenias that limit TKI adequate administration. Although rare, this event happens in a proportion of 4-5% of CML patients. Our hypothesis is to circumvent this peculiar condition by providing a normal hematopoiesis from a HLA-matched donor (Human Leukocyte Antigen). The transplant procedure is therefore intended in providing a sustained hematopoiesis that will allow an early treatment with an adequate dosing of TKI. The transplant procedure planned in our study is built on all available evidences to provide the lowest incidence of acute and chronic GvHD (Graft-versus-host disease). Therefore, a bone marrow will be the preferential source and a GvHD prophylaxis based on Anti-thrombocyte globulin (ATG) and Cyclosporine/Methotrexate will be used according to standard current experience in the field of family and unrelated donors. The pre-transplant TKI will be continued until aplasia will develop, in order to decrease the tumor load as much as possible.The use of TKIs shortly after transplant carries the risk of inhibiting the newly transplanted hematopoietic cells, as Kit, an important kinase in normal bone marrow cells, is frequently blocked by Abl inhibitors. The use of bosutinib as post-transplant therapy is justified by the lack of Kit inhibition that distinguishes bosutinib from all other TKIs, and which could allow a minimal inhibitory activity against the transplanted normal bone marrow. Sponsor: University of Milano Bicocca Intervention: Bosutinib Start Date: 2015-11 Last Updated: 2020-11-05 Number of Patients: 2 Recruitment Status: COMPLETED Condition: Leukemia
NCTID: NCT05725343
Title: A Prevention Trial of Canakinumab in Subjects at High Risk for Lung Cancer Study Summary: Randomized phase III, double-blind, placebo-controlled, multicenter clinical trial. Sponsor: Mario Negri Institute for Pharmacological Research Intervention: Canakinumab Start Date: 2022-02-03 Last Updated: 2023-02-13 Number of Patients: 350 Recruitment Status: TERMINATED Condition: Lung Cancer
NCTID: NCT03473743
Title: A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer Study Summary: The purpose of this study is to: (a) characterize the safety and tolerability of and to identify the recommended Phase 2 dose (RP2D) and schedule for erdafitinib in combination with cetrelimab, and for erdafitinib in combination with cetrelimab and platinum (cisplatin and carboplatin) chemotherapy and; (b) to evaluate the safety and clinical activity of erdafitinib alone and in combination with cetrelimab in cisplatin-ineligible participants with metastatic or locally advanced urothelial cancer (UC) with select fibroblast growth factor receptor (FGFR) gene alterations and no prior systemic therapy for metastatic disease. Sponsor: Janssen Research & Development, LLC Intervention: Erdafitinib Start Date: 2018-04-05 Last Updated: 2023-10-25 Number of Patients: 125 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Urothelial Carcinoma
NCTID: NCT05254743
Title: A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Study Summary: The purpose of this study is to compare the efficacy and safety of pirtobruitinib (LOXO-305) to ibrutinib in participants with CLL/SLL. Participants may or may not have already had treatment for their cancer. Participation could last up to six years. Sponsor: Loxo Oncology, Inc. Intervention: Pirtobrutinib Start Date: 2022-07-22 Last Updated: 2023-10-12 Number of Patients: 650 Recruitment Status: RECRUITING Condition: Chronic Lymphocytic Leukemia
NCTID: NCT01383707
Title: A Study of Bevacizumab and Modified FOLFOX-6 (mFOLFOX-6) in Participants With Metastatic Colorectal Cancer Study Summary: The multicenter, open-label, single-arm, non-randomized, two-stage Simon’s design, phase II study (The CLMO-001 Trial) will evaluate the efficacy and safety of bevacizumab in combination with mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil <math display="block">5-FU</math> and oxaliplatin) in participants with colorectal cancer and liver metastases. Participants will receive combination therapy of bevacizumab 5 milligrams per kilogram (mg/kg) intravenous (IV) dose and mFOLFOX-6 every 2 weeks during Cycles 1-5 and Cycles 7-12. Participants will receive mFOLFOX-6 alone (without bevacizumab) on Cycle 6. In between Cycle 6 and 7, participants will undergo liver surgery if operable. Thereafter participants will receive bevacizumab (5 mg/kg IV every 2 weeks) alone for 52 weeks (26 cycles) after the end of the post-operative phase (maintenance therapy). At the end of the preoperative treatment phase (Cycles 1-6), participants showing different alternative conditions admitted by the protocol will undergo different management (alternative study designs 1 to 3). Sponsor: Hoffmann-La Roche Intervention: 5-Fluorouracil (5-FU) Start Date: 2011-08-12 Last Updated: 2017-06-14 Number of Patients: 77 Recruitment Status: COMPLETED Condition: Colorectal Cancer
NCTID: NCT02067143
Title: MRD/Risk-oriented Therapy of Adult Ph- ALL Including Pegylated Asparaginase and Lineage-targeted Methotrexate Study Summary: This study will be conducted in different centres and will study adult patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL). The study treatment will include a induction/consolidation therapy incorporating pegylated Asparaginase (Peg-ASP) and lineage-targeted high-dose methotrexate plus other antileukemic drugs, for the achievement of an early negative minimal residual disease (MRD) status. The MRD study supports a risk/MRD-oriented final consolidation phase. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: Prephase PDN + CY Start Date: 2014-05-20 Last Updated: 2021-09-08 Number of Patients: 204 Recruitment Status: COMPLETED Condition: Untreated Philadelphia Positive Acute Lymphoblastic Leukemia
NCTID: NCT01307267
Title: A Study Of PF-05082566 As A Single Agent And In Combination With Rituximab Study Summary: A study of PF-05082566, a 4-1BB agonist monoclonal antibody (mAb), in patients with solid tumors or b-cell lymphomas, and in combination with rituximab in patients with CD20 positive Non-Hodgkin’s Lymphoma (NHL). Sponsor: Pfizer Intervention: PF-05082566 Start Date: 2011-06-21 Last Updated: 2020-03-17 Number of Patients: 190 Recruitment Status: COMPLETED Condition: Lymphoma, Non-Hodgkin
NCTID: NCT03503786
Title: Carboplatin, Paclitaxel With or Without Avelumab in Advanced or Recurrent Endometrial Cancer Study Summary: This study aims to evaluate the safety and activity of the Avelumab in combination with Carboplatin-Paclitaxel in advanced or recurrent endometrial cancer Sponsor: National Cancer Institute, Naples Intervention: Carboplatin Start Date: 2018-04-01 Last Updated: 2023-11-13 Number of Patients: 125 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Endometrial Cancer
NCTID: NCT02947347
Title: Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma Study Summary: The purpose of this study is to evaluate whether the addition of ibrutinib will result in prolongation of progression-free survival (PFS) when compared with rituximab alone in treatment naïve participants with follicular lymphoma. Sponsor: Pharmacyclics LLC. Intervention: ibrutinib Start Date: 2017-01 Last Updated: 2023-05-03 Number of Patients: 445 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Follicular Lymphoma
NCTID: NCT02834247
Title: A Study of TAK-659 in Combination With Nivolumab in Participants With Advanced Solid Tumors Study Summary: The purpose of this study is to evaluate the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D), safety and efficacy of TAK-659 in combination with nivolumab in participants with advanced solid tumors. Sponsor: Calithera Biosciences, Inc Intervention: TAK-659 Start Date: 2016-08-12 Last Updated: 2023-02-08 Number of Patients: 41 Recruitment Status: TERMINATED Condition: Triple-Negative Breast Neoplasms
NCTID: NCT04404283
Title: Brentuximab Vedotin Plus Lenalidomide and Rituximab for the Treatment of Relapsed/Refractory DLBCL Study Summary: Participants in this study will have diffuse large B-cell lymphoma (DLBCL) that has come back or not gotten better with treatment. The trial will study whether brentuximab vedotin plus two drugs works better to treat this type of cancer than the two drugs alone. Participants will be randomly assigned to get either brentuximab vedotin or placebo. The placebo will look like brentuximab vedotin, but has no medicine in it. Since the study is “blinded,” participants and their doctors will not know whether a participant gets brentuximab vedotin or placebo. All participants in the study will get rituximab and lenalidomide. These are drugs that can be used to treat DLBCL. Sponsor: Seagen Inc. Intervention: Brentuximab vedotin Start Date: 2020-08-20 Last Updated: 2023-11-29 Number of Patients: 225 Recruitment Status: RECRUITING Condition: Diffuse Large B-cell Lymphoma
NCTID: NCT04165083
Title: KEYMAKER-U01 Substudy 2: Efficacy and Safety Study of Pembrolizumab (MK-3475) When Used With Investigational Agents in Treatment-naïve Participants With Anti-programmed Cell Death Receptor Ligand 1 (PD-L1) Positive Advanced Non-small Cell Lung Cancer (NSCLC) (MK-3475-01B/KEYMAKER-U01B) Study Summary: The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) in combination with MK-4830 in treatment-naïve participants with advanced squamous or non-squamous NSCLC that is PD-L1 positive. This study is one of three pembrolizumab substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01/KEYMAKER-U01). The pembrolizumab+MK-0482 arm was added with Amendment 6. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2020-12-22 Last Updated: 2023-11-13 Number of Patients: 120 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT06059547
Title: Neoadjuvant Immunotherapy in Combination With the Anti-GDF-15 Antibody Visugromab (CTL-002) for Treatment of Muscle Invasive Bladder Cancer Study Summary: This is a multi-center, stratified and single-blinded Phase 2 study of neoadjuvant immunotherapy in combination with the antiGDF15 antibody visugromab (CTL-002) for the treatment of subjects with MIBC set to undergo radical Cystectomy (RC) who cannot receive or refuse to receive cisplatin-based chemotherapy. Sponsor: CatalYm GmbH Intervention: Nivolumab Start Date: 2023-09-06 Last Updated: 2023-09-28 Number of Patients: 30 Recruitment Status: RECRUITING Condition: Bladder Cancer
NCTID: NCT02647047
Title: Spinal Versus Epidural Analgesia in Laparotomic Liver Surgery Study Summary: The purpose of this study is to evaluate the efficacy of spinal analgesia for minor laparotomic hepatectomy compared with epidural analgesia, monitoring visual analog scale (VAS). The investigators expect at least the same post-operative pain control in the two groups (non inferiority of pain control with spinal analgesia compared to epidural analgesia). Second endpoint is to verify whether after spinal analgesia there is a decrease in patient’s length of hospitalization according to enhanced recovery after surgery (ERAS) principles. Sponsor: Ospedale San Raffaele Intervention: Spinal analgesia Start Date: 2016-01 Last Updated: 2016-01-06 Number of Patients: 40 Recruitment Status: UNKNOWN Condition: Secondary Malignant Neoplasm of Liver
NCTID: NCT05382286
Title: Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician’s Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer Study Summary: The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician’s choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (PD-L1). Sponsor: Gilead Sciences Intervention: Sacituzumab Govitecan-hziy Start Date: 2022-07-25 Last Updated: 2023-11-15 Number of Patients: 440 Recruitment Status: RECRUITING Condition: Triple Negative Breast Cancer
NCTID: NCT01774786
Title: A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Gastroesophageal Junction or Gastric Cancer Study Summary: This double-blind, placebo-controlled, randomized, multicenter, international, parallel arm study will evaluate the efficacy and safety of pertuzumab in combination with trastuzumab, fluoropyrimidine and cisplatin as first-line treatment in participants with HER2-positive metastatic gastroesophageal junction (GEJ) or gastric cancer (GC). Participants will be randomized to receive pertuzumab 840 milligrams (mg) or placebo intravenously every 3 weeks (q3w) in combination with trastuzumab (initial dose of 8 milligrams per kilogram <math display="block">mg/kg</math> intravenously <math display="block">IV</math> followed by 6 mg/kg IV q3w) and cisplatin and fluoropyrimidine (capecitabine or 5-fluorouracil) for the first 6 treatment cycles. Participants will continue to receive pertuzumab or placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason. Sponsor: Hoffmann-La Roche Intervention: 5-Fluorouracil Start Date: 2013-06-10 Last Updated: 2020-12-30 Number of Patients: 780 Recruitment Status: COMPLETED Condition: Gastric Cancer
NCTID: NCT05063786
Title: Trastuzumab + Alpelisib +/- Fulvestrant vs Trastuzumab + CT in Patients With PIK3CA Mutated Previously Treated HER2+ Advanced BrEasT Cancer (ALPHABET) Study Summary: Randomized phase III trial of trastuzumab + Alpelisib +/- fulvestrant versus trastuzumab + chemotherapy in patients with PIK3CA mutated previously treated HER2+ Advanced Breast cancer. Sponsor: Spanish Breast Cancer Research Group Intervention: Trastuzumab Start Date: 2021-09-14 Last Updated: 2023-03-24 Number of Patients: 300 Recruitment Status: RECRUITING Condition: Advanced Breast Cancer
NCTID: NCT03625037
Title: First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma Study Summary: The trial is a global, multi-center safety and efficacy trial of epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20). The trial consists of 3 parts: * a dose-escalation part (Phase 1, first-in-human (FIH)) * an expansion part (Phase 2a) * a dose-optimization part (Phase 2a) Sponsor: Genmab Intervention: Epcoritamab Start Date: 2018-06-26 Last Updated: 2023-08-08 Number of Patients: 786 Recruitment Status: RECRUITING Condition: Diffuse Large B-cell Lymphoma (DLBCL)
NCTID: NCT05502237
Title: Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer Study Summary: The primary objective of this study is to compare the effect of zimberelimab (ZIM) and domvanalimab (DOM) in combination with chemotherapy relative to pembrolizumab (PEMBRO) in combination with chemotherapy on progression-free survival (PFS) and overall survival (OS) in patients with untreated metastatic non-small cell lung cancer with no actionable genomic alteration. Sponsor: Gilead Sciences Intervention: Zimberelimab Start Date: 2022-10-12 Last Updated: 2023-11-07 Number of Patients: 720 Recruitment Status: RECRUITING Condition: Non-small Cell Lung Cancer
NCTID: NCT05966233
Title: R-DHAP vs POLA-R-DHAP Followed by Autologous Transplant as First Salvage Treatment in Patient With Relapsed or Refractory Diffuse Large B Cell Lymphoma Study Summary: Prospective, multicenter, open label, phase II randomized clinical trial in DLBCL patients relapsed or refractory to first line R-chemo, aged 18-70 years and candidate to autologous transplant. Patients will be randomized 1:1 to received 4 cycles of R-DHAP or R-DHAP plus Polatuzumab Vedotin as induction treatment plus autologous transplant. Sponsor: Fondazione Italiana Linfomi - ETS Intervention: R-DHAP Start Date: 2023-10 Last Updated: 2023-08-01 Number of Patients: 150 Recruitment Status: NOT_YET_RECRUITING Condition: Diffuse Large B Cell Lymphoma Refractory
NCTID: NCT03336333
Title: A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL Study Summary: To compare efficacy between zanubrutinib versus bendamustine and rituximab in patients with previously untreated CLL/SLL, as measured by progression free survival assess by Independent Central Review. Sponsor: BeiGene Intervention: Zanubrutinib Start Date: 2017-10-31 Last Updated: 2023-11-09 Number of Patients: 590 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Chronic Lymphocytic Leukemia
NCTID: NCT05929222
Title: Comparison Between Local Radiotherapy Alone or Combined With Obinutuzumab in Early Stage Follicular Lymphoma: the GAZEBO Trial From the Fondazione Italiana Linfomi Study Summary: Prospective, multicenter, open label, phase III randomized clinical trial in previously untreated Follicular Lymphoma in early stage. Patients will be randomized to receive Radiotherapy or Radiotherapy plus Obinotuzumab. Sponsor: Fondazione Italiana Linfomi - ETS Intervention: Radiotherapy Start Date: 2024-01 Last Updated: 2023-09-08 Number of Patients: 190 Recruitment Status: NOT_YET_RECRUITING Condition: Follicular Lymphoma
NCTID: NCT05552222
Title: A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma Study Summary: The purpose of this study is to compare the efficacy of teclistamab in combination with daratumumab and lenalidomide (Tec-DR) and talquetamab in combination with daratumumab and lenalidomide (Tal-DR) versus daratumumab, lenalidomide, dexamethasone (DRd). Sponsor: Janssen Research & Development, LLC Intervention: Teclistamab Start Date: 2022-10-25 Last Updated: 2023-11-24 Number of Patients: 1590 Recruitment Status: RECRUITING Condition: Multiple Myeloma
NCTID: NCT01287585
Title: Ph 3 ADI-PEG 20 Versus Placebo in Subjects With Advanced Hepatocellular Carcinoma Who Have Failed Prior Systemic Therapy Study Summary: This is a study of ADI-PEG 20 (pegylated arginine deiminase), an arginine degrading enzyme versus placebo in patients with hepatocellular carcinoma who have failed prior systemic treatment (chemotherapy). Hepatocellular carcinomas have been found to require arginine, an amino acid. Thus the hypothesis is that by restricting arginine with ADI-PEG 20, the hepatocellular carcinoma cells will starve and die. Sponsor: Polaris Group Intervention: ADI-PEG 20 (arginine deiminase formulated with polyethylene glycol) Start Date: 2011-07 Last Updated: 2019-09-06 Number of Patients: 636 Recruitment Status: COMPLETED Condition: Hepatocellular Carcinoma
NCTID: NCT05152147
Title: A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers Study Summary: This study is being done to find out if zanidatamab, when given with chemotherapy plus or minus tislelizumab, is safe and works better than trastuzumab given with chemotherapy. The patients in this study will have advanced human epidermal growth factor 2 (HER2)-positive stomach and esophageal cancers that are no longer treatable with surgery (unresectable) or chemoradiation, and/or have grown or spread to other parts of the body (metastatic). Sponsor: Jazz Pharmaceuticals Intervention: Zanidatamab Start Date: 2021-12-02 Last Updated: 2023-11-18 Number of Patients: 714 Recruitment Status: RECRUITING Condition: Gastric Neoplasms
NCTID: NCT04161885
Title: A Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine Versus Standard of Care After Allogeneic Stem Cell Transplantation (SCT) in Participants With Acute Myeloid Leukemia (AML) Study Summary: The main objective of this study is to evaluate the efficacy of venetoclax in combination with azacitidine to improve Overall Survival (OS) in Acute Myeloid Leukemia (AML) participants compared to Best Supportive Care (BSC) when given as maintenance therapy following allogeneic stem cell transplantation (SCT). This study will have 2 parts: Part 1 (Dose Confirmation), which may include participants who are greater than or equal to 18 years old; Part 2 (Randomization) which may include participants who are greater than or equal to 12 years old. During Part 1, recommended Phase 3 dose of venetoclax in combination with azacitidine will be determined and during Part 2, the efficacy and safety of venetoclax with azacitidine (Part 2 Arm A) will be compared with BSC (Part 2 Arm B). Sponsor: AbbVie Intervention: Venetoclax Start Date: 2020-02-26 Last Updated: 2023-11-14 Number of Patients: 424 Recruitment Status: RECRUITING Condition: Acute Myeloid Leukemia (AML)
NCTID: NCT01856283
Title: Nilotinib 300 mg BID in Newly Diagnosed CP-CML Patients to Verify Disappearance of CD34+/Lin-Ph+ Cells Study Summary: This is a multicentre, single-arm study of nilotinib 300 mg BID in newly diagnosed patients with CP-CML. This study is designed to establish the disappearance of Ph+ stem cells (CD34+/lin-) in BM during nilotinib treatment. In addition, in this study the investigators aim to perform Gene Expression Profiling (GEP) of CML enrolled patients using Affymetrix GeneChip Instruments and Software Systems, and Affymetrix GeneChip Human Genome U133 Plus 2.0 (whole human transcriptome analysis) at diagnosis and at 3 different time points during treatment with Nilotinib (after 3, 6, 12 months). Sponsor: Niguarda Hospital Intervention: Nilotinib 300mg BID Start Date: 2013-03 Last Updated: 2021-01-13 Number of Patients: 87 Recruitment Status: COMPLETED Condition: Leukemia, Myeloid, Chronic-Phase
NCTID: NCT01966471
Title: A Study of Trastuzumab Emtansine (Kadcyla) Plus Pertuzumab (Perjeta) Following Anthracyclines in Comparison With Trastuzumab (Herceptin) Plus Pertuzumab and a Taxane Following Anthracyclines as Adjuvant Therapy in Participants With Operable HER2-Positive Primary Breast Cancer Study Summary: This two-arm, randomized, open-label, multicenter study will evaluate the efficacy and safety of trastuzumab emtansine in combination with pertuzumab versus trastuzumab in combination with pertuzumab and a taxane as adjuvant therapy in participants with human epidermal growth (HER) factor 2 (HER2)-positive primary invasive breast cancer. Following surgery and anthracycline-based chemotherapy, participants will receive either trastuzumab emtansine at a dose of 3.6 milligrams per kilogram (mg/kg) and pertuzumab at a dose of 420 milligrams (mg) intravenously (IV) every 3 weeks (q3w) or trastuzumab at a dose of 6 mg/kg and pertuzumab at a dose of 420 mg IV q3w in combination with a taxane. Sponsor: Hoffmann-La Roche Intervention: Trastuzumab Emtansine Start Date: 2014-01-31 Last Updated: 2022-06-14 Number of Patients: 1846 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT01358071
Title: Phase II Study of NGR-hTNF in Combination With Doxorubicin in Platinum-resistant Ovarian Cancer Study Summary: The primary objective of this randomized phase II trial is to compare progression-free survival (PFS) in patients randomized to NGR-hTNF plus an anthracycline versus patients randomized to an anthracycline alone Sponsor: AGC Biologics S.p.A. Intervention: NGR-hTNF Start Date: 2011-06 Last Updated: 2018-09-27 Number of Patients: 119 Recruitment Status: COMPLETED Condition: Ovarian Cancer
NCTID: NCT00509379
Title: Non-randomized Safety Study With Bortezomib/Rituximab in Relapsed/Refractory Indolent Lymphoma Study Summary: The promising activity of Bortezomib as single agent in low grade lymphoma patients in small studies has led to a number of larger multicenter trials with Bortezomib in combination with Rituximab in mantle-cell lymphoma, follicular lymphoma and marginal zone lymphoma. Sponsor: Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie Intervention: Rituximab Start Date: 2006-09 Last Updated: 2011-01-28 Number of Patients: 48 Recruitment Status: COMPLETED Condition: Lymphoma
NCTID: NCT01539291
Title: Extension Study of Idelalisib in Participants With Chronic Lymphocytic Leukemia (CLL) Who Participated in GS-US-312-0116 (NCT01539512) Study Summary: The primary objective of this extension study (GS-US-312-0117) that is a companion study to Study GS-US-312-0116 (NCT01539512), is to evaluate the effect of idelalisib on the onset, magnitude, and duration of tumor control. Randomization was done in study GS-US-312-0116, and carried forward to study GS-US-312-117. Sponsor: Gilead Sciences Intervention: Idelalisib Start Date: 2012-10-03 Last Updated: 2019-08-20 Number of Patients: 161 Recruitment Status: TERMINATED Condition: Chronic Lymphocytic Leukemia
NCTID: NCT00809575
Title: Quality of Life and Symptoms in Patients With Newly Diagnosed Myelodysplastic Syndromes Study Summary: RATIONALE: Gathering information about quality of life, fatigue, and other symptoms from patients with myelodysplastic syndromes may help doctors learn more about the disease and may help plan treatment. PURPOSE: This clinical trial is studying quality of life and symptoms in patients with newly diagnosed myelodysplastic syndromes. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: questionnaire administration Start Date: 2008-10-02 Last Updated: 2020-12-22 Number of Patients: 927 Recruitment Status: UNKNOWN Condition: Adult
NCTID: NCT05155254
Title: IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18) Study Summary: Phase 3, multicenter, international, open-label, randomized, 2-arm trial investigating the safety and efficacy of IO102-IO103 in combination with pembrolizumab as first-line treatment for patients with previously untreated unresectable or metastatic (advanced) melanoma. Patients will be stratified on the basis of the following factors; Disease stage: Stage III (unresectable) and IV M1a-b versus stage IV M1c-d and BRAFV600 mutation status: mutated vs wild type. All patients will receive pembrolizumab 200 mg intravenously every 3 weeks for a maximum of 35 cycles (up to 2 years treatment). Patients randomized to IO102-IO103 dual-antigen, immunotherapeutic arm will also be given IO102-IO103 Q3W with an additional dose given during the induction period on Day 8 of cycles 1 and 2. IO102 IO103 will thereafter be administered subcutaneous every 3 weeks during the maintenance period. Each patient can be treated for a maximum of 37 administrations in total (up to 2 years of treatment). The primary objective is to investigate the efficacy of IO102-IO103 in combination with pembrolizumab (compared with pembrolizumab alone) in terms of progression free survival. Sponsor: IO Biotech Intervention: IO102-IO103 Start Date: 2022-05-17 Last Updated: 2023-09-13 Number of Patients: 380 Recruitment Status: RECRUITING Condition: Metastatic Melanoma
NCTID: NCT02545283
Title: A Study of Idasanutlin With Cytarabine Versus Cytarabine Plus Placebo in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) Study Summary: This is a multicenter, double-blind, randomized, placebo-controlled study designed to compare overall survival in participants with relapsed or refractory AML treated with idasanutlin in combination with cytarabine versus participants treated with placebo and cytarabine. Participants will receive induction treatment with idasanutlin/placebo and cytarabine (Cycle 1). Responding participants may continue to receive a maximum of further two cycles of consolidation (Cycle 2 and Cycle 3). Complete remission (CR), CR with incomplete platelet count recovery (CRp), overall remission rate (ORR), event-free survival (EFS) and percentage of participants with an allogeneic hematopoietic stem cell transplant (HSCT) will also be compared between treatment arms. This study will include participants with and without TP53 wild type (TP53 WT) mutations. Sponsor: Hoffmann-La Roche Intervention: Cytarabine Start Date: 2015-12-30 Last Updated: 2022-01-11 Number of Patients: 447 Recruitment Status: TERMINATED Condition: Leukemia, Myeloid, Acute
NCTID: NCT05005442
Title: A Study of Pembrolizumab/Vibostolimab (MK-7684A) in Relapsed/Refractory Hematological Malignancies (MK-7684A-004, KEYVIBE-004) Study Summary: The purpose of the study is to determine the safety and tolerability of pembrolizumab/vibostolimab (MK-7684A) in hematological malignancies. This study will also evaluate the overall response rate (ORR), the duration of response (DOR), and disease control rate (DCR) following administration of pembrolizumab/vibostolimab. In addition, this study will characterize pharmacokinetic (PK) profile of vibostolimab (MK-7684). Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab/vibostolimab coformuation Start Date: 2021-09-28 Last Updated: 2023-09-01 Number of Patients: 180 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Hematological Malignancies
NCTID: NCT02999672
Title: A Study to Determine Best Tumor Response With Trastuzumab Emtansine in Human Epidermal Growth Factor Receptor 2 (HER2) Overexpressing Solid Tumors Study Summary: This multicenter, non-randomized, Phase II study will assess the efficacy, safety, and pharmacokinetics of trastuzumab emtansine in participants with HER2 overexpressing locally advanced (unresectable and not treatable with curative intent) or metastatic urothelial bladder cancer (UBC), locally advanced (unresectable and not treatable with curative intent) or metastatic pancreatic cancer/cholangiocarcinoma with advanced disease where cure is no longer possible and where no other treatment options are available anymore. Participants will receive intravenous (IV) infusion of trastuzumab emtansine as Regimen A (2.4 milligrams per kilogram <math display="block">mg/kg</math>, weekly <math display="block">qw</math>) or Regimen B (3.6 mg/kg, every 3 weeks <math display="block">q3w</math>) until unacceptable toxicity, withdrawal of consent, disease progression (PD), or death, whichever occurs first. Based on tolerability and safety aspects, steering committee and Independent Data Monitoring Committee (iDMC) will decide on expansion of the study to include more participants with other carcinoma types. Sponsor: Hoffmann-La Roche Intervention: Trastuzumab Emtansine Start Date: 2016-12-23 Last Updated: 2019-08-28 Number of Patients: 20 Recruitment Status: COMPLETED Condition: Bladder Cancer
NCTID: NCT04662710
Title: Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) Plus Chemotherapy in Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-7902-015/E7080-G000-321/LEAP-015) Study Summary: The purpose of this study is to assess the efficacy and safety of lenvatinib (E7080/MK-7902) plus pembrolizumab (MK-3475) plus chemotherapy compared with chemotherapy alone in participants with advanced/metastatic gastroesophageal cancer. The primary study hypotheses are that lenvatinib plus pembrolizumab plus chemotherapy is superior to chemotherapy alone for both overall survival (OS) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR), in participants with programmed cell death-ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 and in all participants. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2020-12-30 Last Updated: 2023-09-08 Number of Patients: 890 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Advanced/Metastatic Gastroesophageal Adenocarcinoma
NCTID: NCT00358072
Title: Treatment of Adult ALL With an MRD-directed Programme. Study Summary: The study aims to optimize the concept of risk-oriented postremission consolidation therapy, by offering (i) standard consolidation-maintenance to patients at lowest risk of relapse as defined by MRD(Minimal Residual Disease) negative status, and (ii) allogeneic stem cell transplantation (related/unrelated donor available) or multicycle high-dose therapy with autologous blood stem cell transplant (no donor) to patients at highest risk of relapse as defined by MRD+ status. The prognostic role of MRD evaluation in unselected patients will be evaluated. Sponsor: Northern Italy Leukemia Group Intervention: Postremission consolidation based on MRD status Start Date: 2000-05 Last Updated: 2010-12-29 Number of Patients: 280 Recruitment Status: COMPLETED Condition: Acute Lymphoblastic Leukemia
NCTID: NCT02336672
Title: EUS-Guided Cryothermal Ablation in Patients With Stage III Pancreatic Adenocarcinoma (HybridTherm Study) Study Summary: In patients with locally advanced tumour, neoadjuvant treatment has been proposed in various modalities as a way to decrease size and downstage the tumour leading to a re-sectable disease. The HybridTherm probe (HTP), (ERBE Elektromedizin GmbH, Tübingen, Germany) combines bipolar RF-ablation with cryogenic induced cooling. A bipolar radiofrequency system creates ablation with less collateral thermal damage than standard monopolar systems but with the trade-off to lose overall efficiency. Sponsor: IRCCS San Raffaele Intervention: Cryothermal ablation Start Date: 2014-11-11 Last Updated: 2023-09-28 Number of Patients: 66 Recruitment Status: COMPLETED Condition: Pancreatic Adenocarcinoma Non-resectable
NCTID: NCT05580562
Title: ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study) Study Summary: This is a randomized, double-blind, placebo-controlled, parallel-group, international, Phase 3 study in patients with newly diagnosed H3 K27M-mutant diffuse glioma to assess whether treatment with ONC201 following frontline radiotherapy will extend overall survival and progression-free survival in this population. Eligible participants will have histologically diagnosed H3 K27M-mutant diffuse glioma and have completed standard frontline radiotherapy. Sponsor: Chimerix Intervention: ONC201 Start Date: 2023-01-23 Last Updated: 2023-11-28 Number of Patients: 450 Recruitment Status: RECRUITING Condition: H3 K27M
NCTID: NCT04362072
Title: Study of Lorlatinib In People With ALK-positive Non-small Cell Lung Cancer Study Summary: The purpose of this clinical trial is to learn whether the study medicine (called lorlatinib) is safe and effective for the treatment of non-small cell lung cancer that is caused by an abnormal anaplastic lymphoma kinase (ALK) gene. This study is seeking participants whose lung cancer has progressed after receiving either alectinib or ceritinib as their first treatment. Participants will take part in this study for up to approximately 4 years, depending on when the study is completed and how their cancer responds to the study treatment. They will take lorlatinib orally (by mouth) once daily. Participants will visit the study site about every six weeks to meet with the study team. During these visits, the study team will monitor the safety and effects of lorlatinib. Sponsor: Pfizer Intervention: Lorlatinib Start Date: 2020-09-29 Last Updated: 2023-07-07 Number of Patients: 71 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Carcinoma
NCTID: NCT04666038
Title: Study of LOXO-305 Versus Investigator’s Choice (IdelaR or BR) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Study Summary: This is a study for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) who have previously received treatment with at least a BTK inhibitor. The main purpose is to compare LOXO-305 to idelalisib plus rituximab or bendamustine plus rituximab. Participation could last up to four years, and possibly longer, if the disease does not progress. Sponsor: Loxo Oncology, Inc. Intervention: LOXO-305 Start Date: 2021-03-09 Last Updated: 2023-11-01 Number of Patients: 250 Recruitment Status: RECRUITING Condition: Chronic Lymphocytic Leukemia
NCTID: NCT04561362
Title: Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies Study Summary: This study is a Phase I/II, multicenter, first-in-human, open-label dose-escalation study of BT8009 given as a single agent and in combination with pembrolizumab in participants with advanced solid tumors associated with Nectin-4 expression or in participants with advanced solid tumor malignancies having renal insufficiency. The primary endpoints are Dose limiting toxicities (Parts A-1 and A-2), Overall response rate per RECIST v1.1 (Part B) and Safety and tolerability (Part C). Sponsor: BicycleTx Limited Intervention: BT8009 Start Date: 2020-07-17 Last Updated: 2023-11-14 Number of Patients: 329 Recruitment Status: RECRUITING Condition: Advanced Solid Tumor
NCTID: NCT05062889
Title: Exploiting Circulating Tumour DNA to Intensify the Postoperative Treatment Resected Colon Cancer Patients Study Summary: The aims of this study are to evaluate if an intensified adjuvant treatment with FOLFOXIRI could increase the rate of cases with undetectable ct-DNA after chemotherapy and to evaluate if a further adjuvant treatment with Trifluridine/Tipiracil could increase the rate of cases with undetectable ct-DNA and therefore improve DFS in a population at high-risk of relapse. Sponsor: Gruppo Oncologico del Nord-Ovest Intervention: 5-Fluorouracil continuous infusion FOLFOXIRI schedule Start Date: 2023-05-17 Last Updated: 2023-06-29 Number of Patients: 300 Recruitment Status: RECRUITING Condition: Stage II Colon Cancer
NCTID: NCT01980888
Title: Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab in Adults With Previously Untreated Chronic Lymphocytic Leukemia Study Summary: The primary objective of this study is to evaluate the progression-free survival in participants with previously untreated chronic lymphocytic leukemia (CLL) who would otherwise be suitable for bendamustine and rituximab treatment as standard of care. An increased rate of deaths and serious adverse events (SAEs) among participants with front-line CLL and early-line indolent non-Hodgkin lymphoma (iNHL) treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). Sponsor: Gilead Sciences Intervention: Idelalisib Start Date: 2014-02-05 Last Updated: 2018-11-19 Number of Patients: 311 Recruitment Status: TERMINATED Condition: Chronic Lymphocytic Leukemia
NCTID: NCT01516593
Title: Short Term Intensified Chemo-immunotherapy in HIV-positive Patients With Burkitt Lymphoma Study Summary: This is a multicenter,open-label trial to evaluate activity and safety of the investigational intensive in HIV+ patients with Burkitt’s lymphoma. Experimental treatment consists of an induction phase followed by a consolidation or intensified phase according to tumor response. Until recently, the immuno-compromised state of patients with concomitant HIV/AIDS and BL was thought to limit the ability to administer intensive chemotherapeutic regimens due to infection rate. However, the advent of highly active antiretroviral therapy (HAART) and evidence in diffuse large B-cell lymphomas that HIV-positive patients can tolerate standard chemotherapeutic regimens with improved outcomes have led investigators to treat HIV-positive patients with the same intensive chemotherapy regimens used to treat immuno-competent patients. Data suggest that these current approaches, along with supportive care, may result in improved patient outcomes, similar to those in the immuno-competent patient population. Sponsor: Andres J. M. Ferreri Intervention: Induction Phase Start Date: 2011-11 Last Updated: 2022-08-04 Number of Patients: 19 Recruitment Status: COMPLETED Condition: HIV
NCTID: NCT04077463
Title: A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer Study Summary: The purpose of this study is to confirm the tolerability of recommended Phase 2 dose (RP2D) of Lazertinib (Phase 1), to determine the tolerability and identify the recommended Phase 2 combination dose of Lazertinib when combined with Amivantamab (JNJ-61186372) (Phase 1b), to characterize the safety and tolerability of Lazertinib and Amivantamab combinations at the RP2CD in participants with advanced non-small cell lung cancer (NSCLC) with documented advanced or metastatic epidermal growth factor receptor (EGFR) mutation (Phase 1b expansion cohorts A, B, C, D and E), to estimate the antitumor activity of Lazertinib and Amivantamab combinations at the RP2CD in participants with advanced NSCLC with documented advanced or metastatic EGFR mutation (Phase 1b expansion cohorts A, B, C, and D), to validate the biomarker identified in Phase 1b expansion Cohort D as a predictor of antitumor activity of Lazertinib and Amivantamab combination (Cohort E) or Amivantamab monotherapy (Cohort F) in participants with osimertinib-relapsed, chemotherapy-naïve, EGFR Exon19del or L858R mutated NSCLC, to identify the recommended Phase 2 dose (RP2ChD) of Lazertinib when combined with Amivantamab and standard of care chemotherapy and to determine the tolerability of the Lazertinib, Amivantamab, and platinum-doublet chemotherapy (LACP) combination (Phase 1b LACP combination cohort) and to characterize the safety and tolerability of Lazertinib at the RP2ChD and Amivantamab and standard of care chemotherapy in participants with advanced or metastatic EGFR-mutated NSCLC (Phase 1b LACP combination cohort), to assess 2 potential biomarker strategies to identify participants at increased, or decreased, probability of tumor response with JNJ-61186372 and lazertinib combination in participants with EGFR Exon19del or L858R mutated NSCLC progressed on or after osimertinib (Phase 1b expansion Cohort D). Sponsor: Janssen Research & Development, LLC Intervention: Lazertinib Start Date: 2019-09-04 Last Updated: 2023-11-08 Number of Patients: 460 Recruitment Status: RECRUITING Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT02912949
Title: A Study of Zenocutuzumab (MCLA-128) in Patients With Solid Tumors Harboring an NRG1 Fusion (eNRGy) Study Summary: This is a Phase I/II, open-label, multi-center, multi-national, dose escalation, single agent study to assess the safety, tolerability, PK, PD, immunogenicity and anti-tumor activity of zenocutuzumab (MCLA-128) in patients with solid tumors harboring an NRG1 fusion (eNRGy) Sponsor: Merus N.V. Intervention: zenocutuzumab (MCLA-128) Start Date: 2015-01 Last Updated: 2022-12-27 Number of Patients: 250 Recruitment Status: RECRUITING Condition: Solid Tumours Harboring NRG1 Fusion
NCTID: NCT04728893
Title: Efficacy and Safety of Nemtabrutinib (MK-1026) in Participants With Hematologic Malignancies (MK-1026-003) Study Summary: The purpose of this study is to evaluate the safety and efficacy of nemtabrutinib (formerly ARQ 531) in participants with hematologic malignancies of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), Richter’s transformation, marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), follicular lymphoma (FL), and Waldenström’s macroglobulinemia (WM). Sponsor: Merck Sharp & Dohme LLC Intervention: Nemtabrutinib Start Date: 2021-04-05 Last Updated: 2023-11-24 Number of Patients: 450 Recruitment Status: RECRUITING Condition: Hematologic Malignancies
NCTID: NCT03517449
Title: Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician’s Choice in Participants With Advanced Endometrial Cancer (MK-3475-775/E7080-G000-309 Per Merck Standard Convention [KEYNOTE-775]) Study Summary: This is a study of pembrolizumab (MK-3475, KEYTRUDA®) in combination with lenvatinib (E7080) versus treatment of physician’s choice (doxorubicin or paclitaxel) for the treatment of advanced endometrial cancer. Participants will be randomly assigned to receive either pembrolizumab and lenvatinib or treatment of physician’s choice. The primary study hypothesis is that pembrolizumab in combination with lenvatinib prolongs progression free survival (PFS) and overall survival (OS) when compared to treatment of physician’s choice. Sponsor: Eisai Inc. Intervention: Pembrolizumab Start Date: 2018-06-11 Last Updated: 2023-10-18 Number of Patients: 827 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Endometrial Neoplasms
NCTID: NCT02665416
Title: Study Evaluating the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD), and Therapeutic Activity of Selicrelumab (RO7009789) With Vanucizumab or Bevacizumab in Participants With Metastatic Solid Tumors Study Summary: This open-label, two-part study is designed to assess the safety, PK, PD, and therapeutic activity of Selicrelumab in combination with vanucizumab or bevacizumab in participants with metastatic solid tumors not amenable to standard treatment. Part I (dose escalation) is designed to establish the maximum tolerated dose (MTD) of Selicrelumab in this combination. Part II (expansion) is intended to characterize the safety and tolerability of Selicrelumab in combination with bevacizumab among indication-specific cohorts and to confirm the recommended dose. Sponsor: Hoffmann-La Roche Intervention: Selicrelumab Start Date: 2016-01-25 Last Updated: 2020-04-07 Number of Patients: 94 Recruitment Status: COMPLETED Condition: Advanced/Metastatic Solid Tumors
NCTID: NCT04770545
Title: An Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan (APL-2) in Subjects With Geographic Atrophy Secondary to AMD Study Summary: This is a phase 3, open-label, multicenter, extension study to evaluate the long-term safety and efficacy of pegcetacoplan (APL-2) in subjects with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) who participated in Study APL2-103 (NCT03777332) or completed the treatment at Month 24 of either Study APL2-303 (Derby, NCT03525613) or Study APL2-304 (Oaks, NCT03525600). Sponsor: Apellis Pharmaceuticals, Inc. Intervention: PEGCETACOPLAN (APL-2) Start Date: 2021-03-04 Last Updated: 2023-08-31 Number of Patients: 1200 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Geographic Atrophy Secondary to Age-related Macular Degeneration
NCTID: NCT01755182
Title: Systemic Therapy With or Without Upfront Transarterial Embolization for Inoperable Liver Metastasis of Neuroendocrine Tumors Study Summary: The purpose of this study is to verify if adding a locoregional treatment of liver metastasis (with trans-arterial embolization-TAE) to medical treatments of proven efficacy can prolong the progression free survival of patients affected by neuroendocrine tumors (NET) with inoperable liver metastases Sponsor: National Cancer Institute, Naples Intervention: approved pharmacologic therapy Start Date: 2013-07 Last Updated: 2016-05-06 Number of Patients: 1 Recruitment Status: TERMINATED Condition: Neuroendocrine Tumors
NCTID: NCT05006716
Title: A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies Study Summary: Study consists of two main parts to explore BGB-16673 recommended dosing, a Part 1 monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety expansion of selected doses, and a part 2 (dose expansion cohorts) Sponsor: BeiGene Intervention: BGB-16673 Start Date: 2021-09-13 Last Updated: 2023-11-13 Number of Patients: 291 Recruitment Status: RECRUITING Condition: B-cell Malignancy
NCTID: NCT03941093
Title: Evaluation of Efficacy and Safety of Neoadjuvant Treatment With Pamrevlumab in Combination With Chemotherapy (Either Gemcitabine Plus Nab-paclitaxel or FOLFIRINOX) in Participants With Locally Advanced Pancreatic Cancer Study Summary: This is a Phase 3, randomized, double-blind trial to evaluate the efficacy and safety of neoadjuvant treatment with pamrevlumab or placebo in combination with either gemcitabine plus nab-paclitaxel (G
P) or FOLFIRINOX in the treatment of participants with locally advanced, unresectable pancreatic cancer.
Sponsor: FibroGen Intervention: Pamrevlumab + Gemcitabine + Nab-paclitaxel or Pamrevlumab + FOLFIRINOX Start Date: 2019-05-10 Last Updated: 2022-12-27 Number of Patients: 284 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Pancreatic Cancer Non-resectable
NCTID: NCT04848493
Title: National Project on Vaccines, COVID-19 and Frail Patients Study Summary: This is a multicentre observational study with the aim of evaluating the antibody and cellular response after vaccination for SARS-CoV-2 with Pfizer-BioNTech or Moderna vaccines in frail subjects with impaired immuno-competence, due to their underlying diseases or ongoing therapies. Sponsor: Azienda Unità Sanitaria Locale Reggio Emilia Intervention: COVID-19 vaccines Start Date: 2021-04-19 Last Updated: 2021-04-22 Number of Patients: 1300 Recruitment Status: UNKNOWN Condition: COVID-19
NCTID: NCT00072293
Title: Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases Study Summary: RATIONALE: Surgery to remove lymph nodes in the armpit in patients with sentinel lymph node micrometastases may remove cancer cells that have spread from tumors in the breast. It is not yet known whether surgery to remove the primary tumor is more effective with or without axillary lymph node dissection. PURPOSE: This randomized phase III trial is studying surgery and axillary lymph node dissection to see how well they work compared to surgery alone in treating women with node-negative breast cancer and sentinel lymph node micrometastases. Sponsor: ETOP IBCSG Partners Foundation Intervention: Axillary lymph node dissection Start Date: 2001-12 Last Updated: 2018-01-23 Number of Patients: 931 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT00844649
Title: Phase III Study of ABI-007(Albumin-bound Paclitaxel) Plus Gemcitabine Versus Gemcitabine in Metastatic Adenocarcinoma of the Pancreas Study Summary: Phase III Metastatic Pancreatic Cancer Sponsor: Celgene Intervention: Albumin-bound paclitaxel (ABI-007) Start Date: 2009-03-01 Last Updated: 2019-11-25 Number of Patients: 861 Recruitment Status: COMPLETED Condition: Metastatic Pancreatic Cancer
NCTID: NCT05371093
Title: Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma Study Summary: The goal of this clinical study is test how well the study drug, axicabtagene ciloleucel, works in participants with relapsed/refractory follicular lymphoma Sponsor: Kite, A Gilead Company Intervention: Axicabtagene Ciloleucel Start Date: 2022-09-12 Last Updated: 2023-09-08 Number of Patients: 230 Recruitment Status: RECRUITING Condition: Relapsed/Refractory Follicular Lymphoma
NCTID: NCT03465982
Title: Timing to Minimally Invasive Surgery After Neoadjuvant Chemoradiotherapy for Rectal Cancer Study Summary: The trial is a multicenter, prospective, randomized controlled, unblinded, parallel-group trial comparing standard and delayed surgery after neoadjuvant chemoradiotherapy for the curative treatment of rectal cancer. Three-hundred and thirty-two patients will be randomized on an equal basis to either robotic-assisted/standard laparoscopic rectal cancer surgery after 8 weeks or robotic-assisted/standard laparoscopic rectal cancer surgery after 12 weeks. The recruiting interval will be of 5 years and the follow-up period will end 5 years after the last patient is randomized. Sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria Intervention: Surgery after 8 weeks from chemoradiation treatment Start Date: 2018-06-05 Last Updated: 2021-10-22 Number of Patients: 340 Recruitment Status: RECRUITING Condition: Rectal Cancer
NCTID: NCT02109016
Title: A Study to Assess the Efficacy and Safety of the VEGFR-FGFR Inhibitor, Lucitanib, Given to Patients With Advanced/Metastatic Lung Cancer and FGF, VEGF, or PDGF Related Genetic Alterations Study Summary: The purpose of this study is to determine whether lucitanib is safe and effective in the treatment of patients with advanced/metastatic lung cancer and fibroblast growth factor (FGF), vascular endothelial growth factor receptor (VEGF), or platelet derived growth factor (PDGF) related genetic alterations. Sponsor: Clovis Oncology, Inc. Intervention: Lucitanib Start Date: 2014-04 Last Updated: 2019-07-29 Number of Patients: 18 Recruitment Status: TERMINATED Condition: Non-Small Cell Lung Cancer
NCTID: NCT02239120
Title: Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source (RE-SPECT ESUS) Study Summary: This trial will enroll approximately 6,000 patients with recent embolic stroke of unknown source (ESUS). Patients will be randomized to dabigatran or acetylsalicyclic acid (ASA) (1:1 ratio) and have visits every three months. The study doctor may prescribe blinded concomitant ASA for pts with coronary artery disease but this is not mandatory. All Adverse Events (AEs), Serious Adverse Events (SAEs), outcome events will be recorded. The trial will conclude when the required number of stroke events are positively adjudicated which is estimated to take 3 years (including 2.5 years of enrollment). Sponsor: Boehringer Ingelheim Intervention: optional ASA as comedication Start Date: 2014-11-27 Last Updated: 2019-09-06 Number of Patients: 5390 Recruitment Status: COMPLETED Condition: Stroke
NCTID: NCT05850520
Title: A Study to Learn How Well a Higher Amount of Aflibercept Given as an Injection Into the Eye Works and How Safe it is in People With Reduced Vision Due to Swelling in the Macula, Central Part of the Retina Caused by a Blocked Vein in the Retina (Macula Edema Secondary to Retinal Vein Occlusion) Study Summary: Researchers are looking for a better way to treat people who have macular edema secondary to retinal vein occlusion (RVO). In people with RVO, a blood vessel that carries blood away from the retina (vein) becomes blocked. The retina is the very back part of the eye. The blocked vein causes fluid and blood to leak into the retina and thereby causes a swelling of the macula (the center of the retina responsible for fine vision). This swelling is called macular edema. When a vein in the retina is blocked, the levels of a protein called vascular endothelial growth factor (VEGF) rises. VEGF helps the growth of new blood vessels. This can lead to macular edema and may cause the vision to become blurry. The study treatment intravitreal (IVT) aflibercept is given as an injection into the eye. It works by blocking VEGF and this can help repair vision problems related to RVO. IVT aflibercept is already available and is prescribed by doctors as the standard of care treatment for macula edema secondary to RVO. Standard of care is a treatment that medical experts consider most appropriate for a disease. Standard of care is given every 4 weeks in people with macula edema secondary to RVO. While repeated injections of aflibercept may prevent worsening of vision, it may place a burden on the patient. However, a higher amount (8 mg) compared to the standard of care (2 mg) of IVT aflibercept is being tested in studies. This higher amount could be given less often. The amount of IVT aflibercept given is measured in milligrams, also known as mg. The main purpose of this study is to learn how well a higher amount of the study treatment aflibercept works in people with macular edema secondary to RVO. To answer this, researchers will measure changes in vision called best corrected visual acuity (BCVA) in the study participants between study start and after 36 weeks of treatment. Changes will then be compared between those participants who received the higher amount of IVT aflibercept and those that received standard of care. To learn how safe the study treatment is in the participants, the researchers will count the number of participants from study start and up to 64 weeks later that have: * adverse events * serious adverse events “Adverse events” are any medical problems that the participants have during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think they might be related to the study treatments. An adverse event is considered “serious” when it leads to death, puts the participants’ lives at risk, requires hospitalization, causes disability, causes a baby being born with medical problems or is otherwise medically important. Dependent on the treatment group, the participants will either receive the higher amount of aflibercept or standard of care as an intravitreal injection for up to 60 weeks. The study will consist of a test (screening) phase, a treatment phase and an end of study phase. Each participant will be in the study for up to 64 weeks. One visit to the study site is planned during the screening phase, followed by visits approximately every 4 weeks (16 in total) during treatment and one visit at the end of the study. During the study, the study doctors and their team will: * check patients’ eye health using various eye examination techniques * measure patients’ eye vision (BCVA) * take blood and urine samples * do physical examinations * check vital signs * examine heart health using electrocardiogram (ECG) * do pregnancy tests in women of childbearing age In addition, participants will be asked to fill a questionnaire on vision-related quality of life. Sponsor: Bayer Intervention: Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_higher dose Start Date: 2023-05-15 Last Updated: 2023-11-28 Number of Patients: 822 Recruitment Status: RECRUITING Condition: Macular Edema Secondary to Retinal Vein Occlusion
NCTID: NCT02582320
Title: Clinical-biological Characteristics and Outcome of Chronic Lymphocytic Leukemia Under Ibrutinib-named Patient Program Study Summary: This is a retrospective observational study aimed at describing the characteristics and outcome of CLL patients included in the NPP in Italy in a period of time ranging from the start of the NPP until November, 30th 2014. A longitudinal survey will be carried out by collecting data of patients who received at least 1 dose of Ibrutinib. All patients will be observed for at least 12 months from the treatment start. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: Ibrutinib Start Date: 2016-03 Last Updated: 2021-09-13 Number of Patients: 264 Recruitment Status: COMPLETED Condition: Chronic Lymphocytic Leukemia
NCTID: NCT01903993
Title: A Randomized Phase 2 Study of Atezolizumab (an Engineered Anti-PDL1 Antibody) Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum Therapy - “POPLAR” Study Summary: This multicenter, open-label, randomized study will evaluate the efficacy and safety of Atezolizumab compared with docetaxel in participants with advanced or metastatic non-small cell lung cancer after platinum failure. Participants will be randomized to receive either Atezolizumab 1200 milligram (mg) intravenously every 3 weeks or docetaxel 75 milligram per meter square (mg/m^2) intravenously every 3 weeks. Treatment with Atezolizumab may be continued as long as participants are experiencing clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression. Sponsor: Hoffmann-La Roche Intervention: Docetaxel Start Date: 2013-08-06 Last Updated: 2019-10-02 Number of Patients: 287 Recruitment Status: COMPLETED Condition: Non-Small Cell Lung Cancer
NCTID: NCT04965493
Title: A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Study Summary: The purpose of this study is to compare the efficacy and safety of fixed duration pirtobruitinib (LOXO-305) with VR (Arm A) compared to VR alone (Arm B) in patients with CLL/SLL who have been previously treated with at least one prior line of therapy. Participation could last up to five years. Sponsor: Loxo Oncology, Inc. Intervention: Pirtobrutinib Start Date: 2021-09-20 Last Updated: 2023-10-12 Number of Patients: 600 Recruitment Status: RECRUITING Condition: Chronic Lymphocytic Leukemia
NCTID: NCT01290120
Title: Chemotherapy Plus Rituximab Combination for Adult Lymphoblastic Leukemia (B-ALL) and Burkitt’s Non-Hodgkin Lymphoma Study Summary: The study was set up to assess the efficacy and tolerability of a chemotherapy-immunotherapy combination programme originally introduced by GMALL (the German cooperative group for adult acute lymphoblastic leukemia)in 2002, to improve remission rate, overall and disease-free survival rates of adult patients with Burkitt’s leukemia and lymphoma. The therapy includes a maximum of six chemotherapy courses (two with high doses of methotrexate and cytarabine) plus anti-CD20 antibody (Rituximab, up to 8 total doses), supplemented by local radiation therapy in the case of initial mediastinal or central nervous system (CNS) involvement or a residual tumor after chemotherapy. Sponsor: Northern Italy Leukemia Group Intervention: Chemotherapy-Rituximab combination Start Date: 2002-11 Last Updated: 2014-09-16 Number of Patients: 182 Recruitment Status: COMPLETED Condition: Burkitt Lymphoma
NCTID: NCT03158220
Title: Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004) Study Summary: This study will assess the safety and immunogenicity of GARDASIL®9 (V503) in 16- to 45-year-old women. The primary hypothesis of the study states that anti-HPV 16, 18, 31, 33, 45, 52, and 58 geometric mean titers (GMTs) at 4 weeks postdose 3 are non-inferior in adult women as compared with GMTs in young adult women. Sponsor: Merck Sharp & Dohme LLC Intervention: V503 Start Date: 2017-09-20 Last Updated: 2019-11-21 Number of Patients: 1212 Recruitment Status: COMPLETED Condition: Cervical Cancer
NCTID: NCT01640782
Title: Intergroup Trial of Adjuvant Chemotherapy in Adenocarcinoma of the Stomach Study Summary: Open label, randomised, multicenter, superiority study for efficacy. Patients with histologically proven adenocarcinoma of the stomach or gastroesophageal junction without gross or microscopic evidence of residual disease after surgery with curative intent and fulfilling all the inclusion/exclusion criteria are eligible for this study. Sponsor: Mario Negri Institute for Pharmacological Research Intervention: Irinotecan, Leucovorin, 5-Fluorouracil, Docetaxel, Cisplatin Start Date: 2005-02 Last Updated: 2014-07-18 Number of Patients: 1100 Recruitment Status: COMPLETED Condition: Adenocarcinoma of the Stomach
NCTID: NCT06147349
Title: Kidney Cancer Observational Protocol Study Summary: The aim of this observational study is to gather pre and post surgery clinical data belonging to patients who underwent radical or partial nephrectomy and to evaluate the impact of the surgery on the quality of life of the patients, as well as possible relapses within a 10 year period. Sponsor: IRCCS San Raffaele Intervention: Radical or partial nephrectomy Start Date: 2010-01-27 Last Updated: 2023-11-27 Number of Patients: 2500 Recruitment Status: RECRUITING Condition: Renal Cancer
NCTID: NCT00963105
Title: Study of Lenalidomide to Evaluate Safety and Efficacy in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia Study Summary: The purpose of this study is to determine the safety and effectiveness of different dose regimens of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). Sponsor: Celgene Intervention: lenalidomide Start Date: 2009-10-19 Last Updated: 2018-10-31 Number of Patients: 104 Recruitment Status: COMPLETED Condition: Relapsed or Refractory Chronic Lymphocytic Leukemia
NCTID: NCT00054626
Title: Cisplatin and Gemcitabine Compared With Observation in Treating Patients Who Have Undergone Surgery for Bladder Cancer Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known if combination chemotherapy is effective in preventing relapse in patients who have undergone radical cystectomy for bladder cancer. PURPOSE: Phase III trial to compare the effectiveness of cisplatin combined with gemcitabine with that of observation in treating patients with bladder cancer who have undergone surgery to remove the bladder. Sponsor: Fondazione C.N.R./Regione Toscana “G. Monasterio”, Pisa, Italy Intervention: cisplatin Start Date: 2001-09 Last Updated: 2013-12-18 Number of Patients: 700 Recruitment Status: UNKNOWN Condition: Bladder Cancer
NCTID: NCT01827605
Title: A Phase III Multicenter, Randomized Study Comparing RIT Vs ASCT in Patients With Relapsed/Refractory (FL) Study Summary: This is a Phase III, multicenter, open-label, randomized and controlled study to compare the efficacy of a consolidation therapy with RIT versus ASCT in patients with FL in CR or PR after second or third line chemotherapy supplemented with rituximab. Sponsor: Fondazione Italiana Linfomi - ETS Intervention: ZEVALIN Start Date: 2012-01 Last Updated: 2023-09-14 Number of Patients: 159 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Relapsed Follicular Lymphoma
NCTID: NCT01853826
Title: An Open Label Trial of Afatinib (Giotrif) in Treatment-naive (1st Line) or Chemotherapy Pre-treated Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s) Study Summary: To evaluate the safety and tolerability of afatinib (Giotrif) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR mutation(s) and have never been treated with an EGFR-TKI Sponsor: Boehringer Ingelheim Intervention: afatinib Start Date: 2013-07-17 Last Updated: 2023-07-12 Number of Patients: 481 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT04534205
Title: A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1 Study Summary: An open-label, controlled, multi-site, interventional, 2-arm, Phase II trial of BNT113 in combination with pembrolizumab vs pembrolizumab monotherapy as first line treatment in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing programmed cell death ligand -1 (PD-L1) with combined positive score (CPS) ≥1. This trial has two parts. Part A, an initial non-randomized Safety Run-In Phase to confirm the safety and tolerability at the selected dose range level of BNT113 in combination with pembrolizumab. Part B, the Randomized part of the trial to generate pivotal efficacy and safety data of BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy in the first line setting in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing PD-L1 with CPS ≥1. For Part B, an optional pre-screening phase is available for all patients where patients’ tumor samples may be submitted for central HPV16 DNA and central PD-L1 expression testing prior to screening into the main trial. Sponsor: BioNTech SE Intervention: BNT113 Start Date: 2021-01-07 Last Updated: 2023-11-15 Number of Patients: 285 Recruitment Status: RECRUITING Condition: Unresectable Head and Neck Squamous Cell Carcinoma
NCTID: NCT02545504
Title: Andecaliximab With mFOLFOX6 as First Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Study Summary: The primary objective of this study is to compare the efficacy of andecaliximab (GS-5745) versus placebo in combination with modified fluorouracil (5-FU), leucovorin (LV), and oxaliplatin (OXA) (mFOLFOX6) as measured by overall survival. Sponsor: Gilead Sciences Intervention: Andecaliximab Start Date: 2015-10-13 Last Updated: 2020-05-26 Number of Patients: 432 Recruitment Status: COMPLETED Condition: Gastric Adenocarcinoma
NCTID: NCT03434704
Title: Peripheral Blood Stem Cell Transplantation From Family Haploidentical Donors in Patients With Myelodysplastic Syndrome and Acute Leukemia Under Primary Prophylaxis With Posaconazole Study Summary: SIR-POSA is a phase II trial of peripheral blood stem cell (PBSC) transplantation from a partially compatible family (Haplo) donor in patients with a blood tumor (myelodysplastic syndrome (MDS) and acute leukemia) treated for the prevention of primary fungal infections with posaconazole. The aim is evaluate the composite end-point graft-versus-host disease-free, relapse-free survival (GRFS) in these patients and evaluate the feasibility and efficacy of posaconazole oral tablets as primary antifungal prophylaxis. Sponsor: Ciceri Fabio Intervention: Conditioning treatment “Thiotepa-Treosulfan-Fludarabine” Start Date: 2018-06-18 Last Updated: 2022-07-19 Number of Patients: 10 Recruitment Status: COMPLETED Condition: Transplant-Related Hematologic Malignancy
NCTID: NCT04624204
Title: Placebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013/KEYLYNK-013) Study Summary: The purpose of this study is to compare overall survival (OS) and progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR). Hypothesis (H1): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib is superior to concurrent chemoradiation therapy alone with respect to PFS per RECIST 1.1 by BICR. Hypothesis (H2): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab is superior to concurrent chemoradiation therapy alone with respect to PFS per RECIST 1.1 by BICR. Hypothesis (H3): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib is superior to concurrent chemoradiation therapy alone with respect to OS. Hypothesis (H4): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab is superior to concurrent chemoradiation therapy alone with respect to OS. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab 200 mg Start Date: 2020-12-08 Last Updated: 2023-11-28 Number of Patients: 672 Recruitment Status: RECRUITING Condition: Small Cell Lung Cancer
NCTID: NCT05058404
Title: Shortened vs Standard Chemotherapy Combined With Immunotherapy for the Initial Treatment of Patients With High Tumor Burden Follicular Lymphoma Study Summary: FIL_FOLL19 is an open-label, multicenter, randomized phase III trial. The sponsor of this clinical trial is Fondazione Italiana Linfomi (FIL). The Primary Objective of the study is to demonstrate that, in patients with newly diagnosed, advanced stage Follicular Lymphoma (FL) with high tumor burden according to the Groupe d’Etude des Lymphomes Folliculaires (GELF) criteria, a treatment strategy that reduces the number of chemotherapy cycles in case of early response to immunochemotherapy is not inferior compared to standard therapy at full dose in terms of Progression-Free Survival (PFS). Sponsor: Fondazione Italiana Linfomi - ETS Intervention: Immunochemotherapy regimen: Rituximab-bendamustine (Arm A) Start Date: 2021-12-01 Last Updated: 2023-03-09 Number of Patients: 602 Recruitment Status: RECRUITING Condition: Follicular Lymphoma
NCTID: NCT03786926
Title: Trial to Evaluate the Safety and Pharmacokinetics of HMPL-689 in Patients With Lymphomas Study Summary: An open-label, dose escalation and expansion clinical trial to evaluate the safety, tolerability and PK of HMPL-689 in patients with relapsed or refractory lymphomas Sponsor: Hutchmed Intervention: HMPL-689 Start Date: 2019-08-26 Last Updated: 2023-01-13 Number of Patients: 53 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Lymphoma
NCTID: NCT03052608
Title: A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC Study Summary: A phase 3 study to demonstrate whether lorlatinib given as monotherapy is superior to crizotinib alone in prolonging the progression-free survival in advanced ALK-positive NSCLC patients who are treatment naïve and to compare lorlatinib to crizotinib with respect to overall survival in the same population Sponsor: Pfizer Intervention: Lorlatinib Start Date: 2017-04-27 Last Updated: 2023-06-07 Number of Patients: 296 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT02654379
Title: Observational Study Evaluating Rituximab Use and Use of the Patient Alert Card in Participants Receiving Rituximab Infusion for a Non-Oncology Indication at Infusion Centers in Europe Study Summary: This study is to characterize the indications for which rituximab is being used and to evaluate the use of the Patient Alert Card (PAC) in participants receiving the medication for non-oncology conditions at infusion centers. The study involves the retrospective chart review of rituximab users’ medical records in non-oncology indications as well as a survey to collect information on participant characteristics, and will include questions about participant knowledge on the risk of infections, participant receipt and review of the PAC, and any actions the participant has taken as a result of receiving the PAC. Sponsor: Hoffmann-La Roche Intervention: Rituximab Start Date: 2015-12-18 Last Updated: 2018-04-09 Number of Patients: 1408 Recruitment Status: COMPLETED Condition: Off-Label Use
NCTID: NCT04181827
Title: A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma Study Summary: The purpose of this study is to compare the efficacy of JNJ-68284528 (ciltacabtagene autoleucel <math display="block">cilta-cel</math>) with standard therapy, either Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd). Sponsor: Janssen Research & Development, LLC Intervention: JNJ-68284528 Start Date: 2020-06-12 Last Updated: 2023-11-09 Number of Patients: 419 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Multiple Myeloma
NCTID: NCT00002904
Title: Ecteinascidin 743 in Treating Adults With Advanced Solid Tumors Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of ecteinascidin 743 in treating adults with advanced solid tumors. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: trabectedin Start Date: 1996-02 Last Updated: 2012-07-02 Number of Patients: 40 Recruitment Status: COMPLETED Condition: Unspecified Adult Solid Tumor, Protocol Specific
NCTID: NCT02008227
Title: A Study of Atezolizumab Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum-Containing Therapy Study Summary: This global, multicenter, open-label, randomized, controlled study evaluated the efficacy and safety of atezolizumab (an anti-programmed death-ligand 1 <math display="block">anti-PD-L1</math> antibody)compared with docetaxel in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure with platinum-containing chemotherapy. Participants were randomized 1:1 to receive either docetaxel or atezolizumab. Treatment may continue as long as participants experienced clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2014-03-11 Last Updated: 2019-12-20 Number of Patients: 1225 Recruitment Status: COMPLETED Condition: Non-Squamous Non-Small Cell Lung Cancer
NCTID: NCT03390504
Title: A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations Study Summary: The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which includes an anti-programmed death ligand 1(PD-<math display="block">L</math>1) agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2). Sponsor: Janssen Research & Development, LLC Intervention: Erdafitinib Start Date: 2018-03-23 Last Updated: 2023-11-13 Number of Patients: 629 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Urothelial Cancer
NCTID: NCT03371017
Title: A Study of the Efficacy and Safety of Atezolizumab Plus Chemotherapy for Patients With Early Relapsing Recurrent Triple-Negative Breast Cancer Study Summary: This study will evaluate the efficacy and safety of atezolizumab plus chemotherapy compared with placebo plus chemotherapy in patients with inoperable recurrent triple-negative breast cancer (TNBC). Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2018-01-11 Last Updated: 2023-11-07 Number of Patients: 572 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Triple Negative Breast Neoplasms
NCTID: NCT05226117
Title: Sacituzumab Govitecan, Preceding Radical Cystectomy, in Treating Patients With Muscle-invasive Bladder Cancer Study Summary: SURE-01 is a neoadjuvant phase 2, open-label, non-randomized, singlecohort study in patients with urothelial carcinoma of the bladder. Patients will be consecutively enrolled and treated. The primary objective of the study is to assess whether sacituzumab govitecan results in pathological complete response (in patients with Muscle-invasive Bladder Cancer who cannot receive or refuse cisplatin-based chemotherapy). Secondary objectives were to evaluate the radiological response of those patients with measurable disease; to evaluate the surgical and medical safety of neoadjuvant therapy; to assess survival outcomes (event-free survival and overall survival). Sponsor: IRCCS San Raffaele Intervention: Sacituzumab govitecan Start Date: 2021-11-29 Last Updated: 2022-02-23 Number of Patients: 56 Recruitment Status: RECRUITING Condition: Urothelial Carcinoma
NCTID: NCT00774826
Title: Multicentric Study, Three Randomized Arms (R-CVP vs R-CHOP vs R-FM),for Patients With Stage II-IV Follicular Lymphoma Study Summary: The purpose of this study is to define an improvement and theassessment of the Time to Treatment Failure in patients randomized in three different arms: R-CVP vs R-CHOP vs R-FM. Sponsor: Fondazione Italiana Linfomi - ETS Intervention: R-CVP Start Date: 2005-12 Last Updated: 2011-02-15 Number of Patients: 534 Recruitment Status: UNKNOWN Condition: Follicular Lymphoma
NCTID: NCT04938817
Title: Safety and Efficacy Study of Pembrolizumab (MK-3475) in Combination With Investigational Agents for the Treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC) in Need of Second-Line Therapy (MK-3475-B98/KEYNOTE-B98) Study Summary: This study is a rolling arm study of pembrolizumab in combination with investigational agents in participants with anti-programmed cell death 1 (PD-1)/ programmed cell death ligand 1 (PD-L1) refractory ES-SCLC in need of second-line treatment. This study will have 2 parts: an initial safety lead-in to determine safety and tolerability for experimental combinations of investigational agents without an established recommended phase 2 dose (RP2D) followed by an efficacy evaluation. Investigational agents will initiate directly in or be added to the efficacy evaluation after an initial evaluation of safety and tolerability of the investigational agent has been completed in a separate study or in the safety lead-in of this study. If an RP2D for a combination being evaluated in the safety lead-in is established from another study, then the efficacy evaluation may begin at the determined RP2D. There will be no hypothesis testing in this study. Sponsor: Merck Sharp & Dohme LLC Intervention: coformulation pembrolizumab/quavonlimab Start Date: 2021-08-19 Last Updated: 2023-01-04 Number of Patients: 80 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Small Cell Lung Carcinoma
NCTID: NCT02827617
Title: Identification of Biomarkers That Are Predictive of Early Ibrutinib Treatment Failure in High Risk TP53 Mutated Chronic Lymphocytic Leukemia Study Summary: The general aim of the project is the identification of dynamic molecular markers that can help the early and real time prediction of sustained benefit or no benefit from ibrutinib treatment in CLL harboring TP53 mutations. Specific aims of the project include: 1) Assess whether clearance of TP53 mutated clones translates into a predictive biomarker of long term benefit from ibrutinib treatment in CLL. 2) Assess whether plasma cell free DNA represents a sensitive tool that can early and dynamically inform on the development of ibrutinib resistant mutations in CLL. Sponsor: Oncology Institute of Southern Switzerland Intervention: Ibrutinib Start Date: 2016-06-01 Last Updated: 2023-04-03 Number of Patients: 56 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Chronic Lymphocytic Leukemia
NCTID: NCT04165317
Title: A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer Study Summary: The purpose of this study is to learn about the safety and effects of the study medicine (sasanlimab) in people with non-muscle invasive bladder cancer. This study is seeking participants whose bladder cancer is still in early stages, has not spread outside of the bladder, has been removed with surgery, and is high risk (Part A) or was previously treated with BCG (Bacillus Calmette Guerin), a standard treatment for bladder cancer (Part B). In Part A (enrollment closed), each participant was assigned to one of three study treatment groups. * One group is given sasanlimab and BCG at the study clinic. * The second group is given sasanlimab and BCG at the study clinic. This group will receive BCG for the first six weeks only. * The third group is given BCG only and will not receive sasanlimab. In Part B of the study, each new participant will be assigned to a study treatment group based on the type of their bladder tumor. * Both groups will be given sasanlimab at the study clinic. On August 31, 2022, the Sponsor announced the discontinuation of enrollment to Part B. The decision to discontinue enrollment to Part B was not made for safety reasons. Sponsor: Pfizer Intervention: PF-06801591 Start Date: 2019-12-30 Last Updated: 2023-09-01 Number of Patients: 1070 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-muscle Invasive Bladder Cancer
NCTID: NCT03589326
Title: A Study of Ponatinib Versus Imatinib in Adults With Acute Lymphoblastic Leukemia Study Summary: In this study, adults with newly-diagnosed Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) will receive first-line therapy of ponatinib or imatinib. The main aim of this study is to compare the number of participants on each treatment that show no signs of disease. Participants will take tablets of either ponatinib or imatinib at the same time each day combined with reduced-intensity chemotherapy for up to 20 months. Then, they will continue with single-agent therapy (ponatinib or imatinib) until they meet the discontinuation criteria from the study. Sponsor: Takeda Intervention: Ponatinib Start Date: 2018-10-04 Last Updated: 2023-10-27 Number of Patients: 245 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL)
NCTID: NCT02039726
Title: (QuANTUM-R): An Open-label Study of Quizartinib Monotherapy vs. Salvage Chemotherapy in Acute Myeloid Leukemia (AML) Subjects Who Are FLT3-ITD Positive Study Summary: The primary objective of the study is to determine whether quizartinib monotherapy prolongs overall survival (OS) compared to salvage chemotherapy in subjects with FMS-like tyrosine kinase 3 - Internal Tandem Duplication (FLT3-ITD) positive AML who are refractory to or have relapsed within 6 months, after first-line AML therapy. Sponsor: Daiichi Sankyo, Inc. Intervention: Quizartinib Start Date: 2014-05 Last Updated: 2021-02-24 Number of Patients: 367 Recruitment Status: COMPLETED Condition: AML
NCTID: NCT05111626
Title: Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer Study Summary: The main objective of Part 1 is to evaluate the safety and tolerability of bemarituzumab plus 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) and nivolumab. The main objective Part 2 is to compare efficacy of bemarituzumab plus chemotherapy (mFOLFOX6 or capecitabine combined with oxaliplatin (CAPOX)) and nivolumab to placebo plus chemotherapy (mFOLFOX6 or CAPOX) and nivolumab as assessed by overall survival. Sponsor: Amgen Intervention: Bemarituzumab Start Date: 2022-03-14 Last Updated: 2023-11-27 Number of Patients: 528 Recruitment Status: RECRUITING Condition: Gastric Cancer
NCTID: NCT01732926
Title: Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas Study Summary: The primary objective of this study is to evaluate the addition of idelalisib to bendamustine/rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL). An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line iNHL treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). Sponsor: Gilead Sciences Intervention: Idelalisib Start Date: 2013-01-02 Last Updated: 2018-11-16 Number of Patients: 475 Recruitment Status: TERMINATED Condition: Indolent Non-Hodgkin’s Lymphomas
NCTID: NCT00388726
Title: E7389 Versus Treatment of Physician’s Choice in Patients With Locally Recurrent or Metastatic Breast Cancer Study Summary: The purpose of this study is to compare Overall Survival (OS), Progression Free Survival (PFS), objective tumor response rate, duration of response, and safety in patients treated with E7389 versus the Treatment of Physician’s Choice (TPC) in patients with locally recurrent or metastatic breast cancer. Sponsor: Eisai Inc. Intervention: E7389 Start Date: 2006-11 Last Updated: 2020-01-07 Number of Patients: 762 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT03332017
Title: A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma Study Summary: The purpose of the study is to evaluate the efficacy, safety and tolerability and of BGB-3111 plus obinutuzumab versus obinutuzumab alone in participants with relapsed/refractory non-Hodgkin follicular lymphoma. Sponsor: BeiGene Intervention: Zanubrutinib Start Date: 2017-11-15 Last Updated: 2023-11-13 Number of Patients: 217 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Relapsed/Refractory Follicular Non-Hodgkin Lymphoma
NCTID: NCT04736706
Title: A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012) Study Summary: The goal of this study is to evaluate the efficacy and safety of pembrolizumab plus belzutifan plus lenvatinib or pembrolizumab/quavonlimab plus lenvatinib versus pembrolizumab plus lenvatinib as first-line treatment in participants with advanced clear cell renal cell carcinoma (ccRCC). The primary hypotheses are (1) pembrolizumab plus belzutifan plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to progression-free survival (PFS) and overall survival (OS), in advanced ccRCC participants; and (2) pembrolizumab/quavonlimab plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to PFS and OS, in advanced ccRCC participants. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2021-04-14 Last Updated: 2023-11-24 Number of Patients: 1653 Recruitment Status: RECRUITING Condition: Carcinoma, Renal Cell
NCTID: NCT05267106
Title: Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Glioblastoma or Other Primary Central Nervous System Tumors Harboring Activating FGFR1-3 Alterations Study Summary: This is an open-label, monotherapy study of pemigatinib in participants with recurrent glioblastoma (GBM) or other recurrent gliomas, circumscribed astrocytic gliomas, and glioneuronal and neuronal tumors with an activating FGFR1-3 mutation or fusion/rearrangement. This study consists of 2 cohorts, Cohorts A, and B, and will enroll approximately 82 participants into each cohort. Participants will receive pemigatinib 13.5 mg QD on a 2-week on-therapy and 1-week off-therapy schedule as long as they are receiving benefit and have not met any criteria for study withdrawal. Sponsor: Incyte Corporation Intervention: Pemigatinib Start Date: 2022-05-20 Last Updated: 2023-11-15 Number of Patients: 164 Recruitment Status: RECRUITING Condition: Glioblastoma
NCTID: NCT04629508
Title: To Assess the Safety, Tolerability and Efficacy of Itacitinib Immediate Release Tablets in Participants With Primary or Secondary Myelofibrosis Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy (LIMBER-213) Study Summary: This is a 2-part study. In Part 1, participants will be dosed at 2 different dose levels in order to select the RP2D for Part 2 of the study. Sponsor: Incyte Corporation Intervention: itacitinib Start Date: 2021-07-12 Last Updated: 2023-08-30 Number of Patients: 4 Recruitment Status: COMPLETED Condition: Myelofibrosis
NCTID: NCT03151408
Title: An Efficacy and Safety Study Of Pracinostat In Combination With Azacitidine In Adults With Acute Myeloid Leukemia Study Summary: This is a Phase III, multicenter, double-blind, randomized study of pracinostat vs. placebo with azacitidine (AZA) as background therapy in patients ≥ 18 years of age with newly diagnosed acute myeloid leukemia (AML), excluding acute promyelocytic leukemia and cytogenetic low-risk AML, who are unfit to receive intensive remission induction chemotherapy due to age ≥ 75 years or comorbidities. Patients will be randomized in a 1:1 ratio to one of two groups: Group A (experimental group) to receive pracinostat plus AZA and Group B (control group) to receive placebo plus AZA. Randomization will be stratified by cytogenetic risk category (intermediate vs. unfavorable-risk, according to SWOG Cytogenetic Risk Category Definitions) and ECOG performance status (0-1 vs. 2). Treatments will be administered based on 28-day cycles, with pracinostat/placebo administered orally once every other day, 3 times a week for 3 weeks, followed by one week of no treatment and AZA administered for 7 days of each cycle. Study treatment should continue until there is documented disease progression, relapse from complete remission (CR), or non-manageable toxicity. A minimum of 6 cycles may be required to achieve a complete remission. Once permanently discontinued from study treatment, patients will enter the Long-term Follow-up phase of the study and will be followed for assessment of disease progression, if applicable, and survival every 3 months (±1 month) until death. The end of this study is defined when 390 events (deaths) have occurred and the study is unblinded for final overall survival analysis. Patients who are receiving study treatment at the end of the study may have the opportunity to continue to receive the study drugs to which they were randomized to (Post- Study Observation Period), until the Sponsor informs the Investigators of the appropriate course of action based on the study results. The Post-Study Observation Period is defined as the period starting from the end of the study for a maximum of 12 months. Sponsor: Helsinn Healthcare SA Intervention: Pracinostat Start Date: 2017-06-23 Last Updated: 2022-03-10 Number of Patients: 406 Recruitment Status: TERMINATED Condition: Acute Myeloid Leukemia
NCTID: NCT01535391
Title: Nilotinib in PH+, BCR-, ABL+ CML Patients Study Summary: This study is an open-label, multicentric, phase IIIb study of NILOTINIB administered orally twice daily for 24 months and indefinitely if it is in the interest of the patient. The primary objective of the trial is to evaluate the efficacy of nilotinib, 300 mg twice daily with dose increase to 400 mg twice daily in case of suboptimal response or failure (excluding patients who will fail for progression to ABP), in a population of patients with Ph-positive, BCR-ABL positive CML in early CP. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: Nilotinib Start Date: 2012-01 Last Updated: 2018-08-06 Number of Patients: 109 Recruitment Status: COMPLETED Condition: Chronic Myeloid Leukemia
NCTID: NCT03866109
Title: A Study Evaluating Temferon in Patients With Glioblastoma & Unmethylated MGMT Study Summary: This is a non-randomized, open label, phase I/IIa, dose-escalation study, involving a single injection of Temferon, an investigational advanced therapy consisting of autologous CD34+-enriched hematopoietic stem and progenitor cells exposed to transduction with a lentiviral vector driving myeloid specific interferon-alpha2 expression, which will be administered to up to 27 patients affected by GBM who have an unmethylated MGMT promoter. Part A will evaluate the safety and tolerability of 5 escalating doses of Temferon and 3 different conditioning regimens in up to 27 patients, following first line treatment. Sponsor: Genenta Science Intervention: Temferon Start Date: 2019-03-05 Last Updated: 2023-01-20 Number of Patients: 27 Recruitment Status: RECRUITING Condition: Glioblastoma Multiforme
NCTID: NCT01809106
Title: RCT Comparing the Analgesic Efficacy of 4 Therapeutic Strategies Based on 4 Different Major Opioids (Fentanyl, Oxycodone, Buprenorphine vs Morphine) in Cancer Patients With Moderate/Severe Pain, at the Moment of Starting 3rd Step of WHO Analgesic Ladder. Study Summary: Pain, in neoplastic disease, is a symptom with severe negative impact on the quality of life of patients and a high incidence, with values around 70-90% in advanced and metastatic stages. Than 20 years the main reference for the pharmacological treatment of cancer pain are the guidelines produced by the World Health Organization (WHO). This document shows that the use of opioid drugs is the mainstay of treatment, with particular reference to opioids “major” (3 rd step of the analgesic ladder). The 4 opioids more most commonly prescribed in Italy (oral morphine and oxycodone, fentanyl and buprenorphine transdermal), based on the data currently available, have an analgesic effect would partly overlap but with different percentages of non-responders (NR), a different need to increase the dose over time to maintain adequate analgesia, a different action to the switch to another molecule for ineffectiveness analgesic. The observations described suggest that opioids, although they belong to the same family drug may not be fully comparable with regard to the clinical effects products. Important differences are known on the pharmacokinetic and pharmacodynamic and, more recently, also in terms of pharmacogenomics. This is a comparative study of analgesic strategies based on the use of the 4 mentioned opioids, going to look for possible differences in terms of analgesic efficacy, changes in dose over time, use of switch or permanent abandonment of treatment, parallel to the contour of the side effects. The associated sub-project will link the structure gene of patients and clinical results have emerged. Sponsor: Mario Negri Institute for Pharmacological Research Intervention: Morphine Start Date: 2011-04 Last Updated: 2015-12-24 Number of Patients: 518 Recruitment Status: COMPLETED Condition: Cancer
NCTID: NCT03455504
Title: Venetoclax Add in Combination With Fludarabine, Cyratabine and Idarubicine in Induction for Acute Myelid Leukemia Study Summary: This study will test the effectiveness and safety of Venetoclax in combination with standard induction regimen for patients with acute leukemia and poor prognosis. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: Venetoclax Start Date: 2018-10-26 Last Updated: 2023-01-10 Number of Patients: 124 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Acute Myeloid Leukemia
NCTID: NCT00911027
Title: SonoVue Guided Prostate Biopsy Study Summary: This is a phase III European multicenter, open label, prospective study to assess the diagnostic accuracy of the use of SonoVue contrast agent to guide prostate biopsies in comparison with the current practice of ultrasound guided systematic biopsy. The trial will involve 15-20 European Centers. Sponsor: Bracco Diagnostics, Inc Intervention: Contrast-enhanced ultrasound guided biopsy Start Date: 2009-02 Last Updated: 2012-04-25 Number of Patients: 282 Recruitment Status: TERMINATED Condition: Prostate Cancer
NCTID: NCT01663727
Title: Study To Evaluate the Efficacy and Safety Of Bevacizumab, and Associated Biomarkers, In Combination With Paclitaxel Compared With Paclitaxel Plus Placebo as First-line Treatment Of Patients With Her2-Negative Metastatic Breast Cancer Study Summary: This is a Phase III, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of bevacizumab administered in combination with paclitaxel in patients with previously untreated, locally recurrent, or metastatic HER2-negative breast cancer. Patients will be randomized to one of two treatment arms: bevacizumab or placebo. All patients will be given an intravenous (IV) infusion of of paclitaxel (90 mg/m2) for 3 weeks during each 28-day cycle. bevacizumab or placebo (10 mg/kg) will be administered by IV infusion on Days 1 and 15 of each 28-day cycle. Patients will be treated until disease progression, unacceptable toxicity or death from any cause occurs. Sponsor: Hoffmann-La Roche Intervention: Bevacizumab [Avastin] Start Date: 2012-08-27 Last Updated: 2019-01-22 Number of Patients: 481 Recruitment Status: COMPLETED Condition: Metastatic Breast Cancer
NCTID: NCT04527991
Title: Study of Sacituzumab Govitecan-hziy (IMMU-132) Versus Treatment of Physician’s Choice in Participants With Metastatic or Locally Advanced Unresectable Urothelial Cancer Study Summary: The primary objective of this study is to assess overall survival (OS) with sacituzumab govitecan-hziy in comparison with treatment of physician’s choice (TPC) in participants with metastatic or locally advanced unresectable urothelial cancer (UC). Sponsor: Gilead Sciences Intervention: Sacituzumab Govitecan-hziy Start Date: 2021-01-13 Last Updated: 2023-06-22 Number of Patients: 696 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Locally Advanced or Metastatic Unresectable Urothelial Cancer
NCTID: NCT06008691
Title: A Prospective, Observational Cohort Study on the Clinical Impact of Novel Monoclonal Antibodies in B-cell Non-Hodgkin Lymphoma in Italian Clinical Practice Study Summary: This is a prospective, observational cohort study to evaluate the clinical impact of novel Monoclonal AntiBodies (MAB) in B-cell Non-Hodgkin Lymphoma (NHL) in Italian clinical practice. Sponsor: Fondazione Italiana Linfomi - ETS Intervention: “novel” MAB (alone or in combination) Start Date: 2023-10 Last Updated: 2023-08-23 Number of Patients: 1500 Recruitment Status: NOT_YET_RECRUITING Condition: Non-Hodgkin Lymphoma, B-cell
NCTID: NCT00022191
Title: Cisplatin Plus Gemcitabine With or Without Paclitaxel in Treating Patients With Stage IV Urinary Tract Cancer Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective for urinary tract cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin plus gemcitabine with or without paclitaxel in treating patients who have stage IV urinary tract cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: cisplatin Start Date: 2001-05 Last Updated: 2013-06-12 Number of Patients: 608 Recruitment Status: COMPLETED Condition: Bladder Cancer
NCTID: NCT02920008
Title: Phase 3 Randomized, Open-Label Study of Guadecitabine vs Treatment Choice in Previously Treated Acute Myeloid Leukemia Study Summary: Multicenter, randomized, open-label, parallel-group study of guadecitabine vs treatment choice (TC). Participants will be randomly assigned in a 1:1 ratio to either guadecitabine or TC. TC options include the 8 high or low intensity, locally available regimens below; or Best supportive Care (BSC) alone: * High intensity (intermediate or high dose cytarabine <math display="block">HiDAC</math>; mitoxantrone, etoposide, and cytarabine <math display="block">MEC</math>; or fludarabine, cytarabine, granulocyte colony stimulating factor <math display="block">G-CSF</math>, +/- idarubicin <math display="block">FLAG/FLAG-Ida</math>). * Low intensity (low dose cytarabine <math display="block">LDAC</math>, decitabine, or azacitidine). * BSC. Sponsor: Astex Pharmaceuticals, Inc. Intervention: guadecitabine Start Date: 2017-03-16 Last Updated: 2023-05-25 Number of Patients: 302 Recruitment Status: COMPLETED Condition: Acute Myeloid Leukemia
NCTID: NCT04463771
Title: Safety and Efficacy of Retifanlimab (INCMGA00012) Alone or in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-based Chemotherapy. Study Summary: This is a multicenter, open-label, nonrandomized, Phase 2 umbrella study of retifanlimab in participants who have advanced or metastatic endometrial cancer that has progressed on or after platinum-based chemotherapy. retifanlimab will be administered as monotherapy or in combination with other immunotherapy or targeted agents. Sponsor: Incyte Corporation Intervention: retifanlimab Start Date: 2021-01-26 Last Updated: 2023-10-26 Number of Patients: 300 Recruitment Status: RECRUITING Condition: Endometrial Cancer
NCTID: NCT01702571
Title: A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer Who Have Received Prior Anti-HER2 And Chemotherapy-based Treatment Study Summary: This two-cohort, open-label, multicenter study will assess the safety, efficacy and tolerability of trastuzumab emtansine in participants with HER2-positive locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) who have received prior anti-HER2 and chemotherapy-based treatment. Participants in Cohort 1 will be drawn from the general participant population; Cohort 2 will include only Asian participants. Sponsor: Hoffmann-La Roche Intervention: Trastuzumab Emtansine Start Date: 2012-11-27 Last Updated: 2022-04-04 Number of Patients: 2185 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT03536039
Title: RCHOP Chemoimmunotherapy Preceded BY BBB Permeabilization by t-NGR Necrosis Factor Study Summary: Patients with primary central nervous system lymphoma (PCNSL) are treated with high-dose-methotrexate-based chemotherapy, which requires hospitalization and extensive expertise to manage related toxicity. Treatment with R-CHOP, the most commonly used combination against aggressive lymphomas, could overcome these difficulties, but CNS bioavailability of related drugs is poor due to their limited capability to cross the blood-brain barrier (BBB). Tumor necrosis factor (TNF) induces selective BBB permeabilization and enhances CNS access of anticancer drugs in animal models. The addition of NGR peptide improves biological properties of TNF, resulting in increased drug availability and antitumor synergistic effect, without increased toxicity. Thus, the addition of NGR-hTNF to R-CHOP may result in improved CNS drug availability and activity in patients with relapsed/refractory PCNSL; this hypothesis is being tested in this ongoing phase II trial called “INGRID”. This trial will consider HIV-negative patients (age 18-80 ys; ECOG PS ≤3) with relapsed/refractory PCNSL previously treated with high-dose-methotrexate-based chemotherapy± radiotherapy, and with measurable disease. Sponsor: Andres J. M. Ferreri Intervention: NGR-hTNF Start Date: 2016-01-27 Last Updated: 2022-08-03 Number of Patients: 28 Recruitment Status: COMPLETED Condition: Lymphoma, Large B-Cell, Diffuse
NCTID: NCT05254171
Title: Study of Nab-Paclitaxel and Gemcitabine With or Without SBP-101 in Pancreatic Cancer Study Summary: The study is a randomized, double-blind, placebo-controlled, multicenter study of standard treatment with nab-paclitaxel and gemcitabine with or without SBP-101 in subjects previously untreated for metastatic pancreatic ductal adenocarcinoma (PDA), including subjects who have received prior neoadjuvant or adjuvant treatment. Sponsor: Panbela Therapeutics, Inc. Intervention: SBP-101 Start Date: 2022-08-08 Last Updated: 2023-11-13 Number of Patients: 150 Recruitment Status: RECRUITING Condition: Pancreatic Cancer Metastatic
NCTID: NCT02005471
Title: A Study to Evaluate the Benefit of Venetoclax Plus Rituximab Compared With Bendamustine Plus Rituximab in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) Study Summary: The purpose of this open-label, multicenter, randomized, Phase III study is to evaluate the benefit of venetoclax in combination with rituximab compared with bendamustine in combination with rituximab in participants with relapsed or refractory CLL. Participants will be randomly assigned in 1:1 ratio to receive either venetoclax + rituximab (Arm A) or bendamustine + rituximab (Arm B). Sponsor: Hoffmann-La Roche Intervention: Bendamustine Start Date: 2014-03-17 Last Updated: 2023-10-17 Number of Patients: 389 Recruitment Status: COMPLETED Condition: Chronic Lymphocytic Leukemia
NCTID: NCT04031339
Title: Study of Clinical Outcomes of Thyroid Cancer Study Summary: The Italian Thyroid Cancer Observatory (ITCO) repository was established to collect data on thyroid cancer management in a prospective and consecutive series of newly-diagnosed patients, enrolled in centers uniformly distributed across the nation. Sponsor: University of Roma La Sapienza Intervention: Standard treatment Start Date: 2013-01-01 Last Updated: 2023-05-10 Number of Patients: 15000 Recruitment Status: RECRUITING Condition: Thyroid Neoplasms
NCTID: NCT03901339
Title: Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician’s Choice in Participants With HR+/HER2- Metastatic Breast Cancer Study Summary: The primary objective of this study is to assess and compare the efficacy and safety of sacituzumab govitecan-hzi versus treatment of physician’s choice (TPC) in participants with hormonal receptor-positive (HR+) human epidermal growth factor receptor 2 (HER2-) negative metastatic breast cancer (MBC). Sponsor: Gilead Sciences Intervention: Sacituzumab Govitecan-hziy Start Date: 2019-05-08 Last Updated: 2023-11-18 Number of Patients: 543 Recruitment Status: COMPLETED Condition: Metastatic Breast Cancer
NCTID: NCT05259839
Title: A Study to Assess Adverse Events and Change in Disease Activity of Intravenously (IV) Infused ABBV-383 in Combination With Anti-Cancer Regimens for the Treatment of Adult Participants With Relapsed/Refractory Multiple Myeloma Study Summary: Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the safety and toxicity of ABBV-383 when co-administered with pomalidomide-dexamethasone (Pd), lenalidomide-dexamethasone (Rd), daratumumab-dexamethasone (Dd), or nirogacestat (Niro) in adult participants with relapsed/refractory (R/R) multiple myeloma (MM). Adverse events and change in disease activity will be assessed. ABBV-383 is an investigational drug being developed for the treatment of R/R MM. Study doctors put the participants in groups called treatment arms. ABBV-383 co-administered with Pd, Rd, Dd, or Niro will be explored. Each treatment arm receives a different treatment combination depending on stage of the study and eligibility. This study will include a dose escalation phase to determine the best dose of ABBV-383, followed by a dose expansion phase to confirm the dose. Approximately 270 adult participants with R/R MM will be enrolled in the study in approximately 45 sites worldwide. Participants will receive intravenous (IV) ABBV-383 co-administered with oral/IV Pd, oral/IV Rd, oral/IV/subcutaneous (SC) Dd, or oral/IV Niro in 28-day cycles. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects. Sponsor: TeneoOne Inc. Intervention: ABBV-383 Start Date: 2022-10-20 Last Updated: 2023-10-23 Number of Patients: 270 Recruitment Status: RECRUITING Condition: Relapsed/Refractory Multiple Myeloma
NCTID: NCT01011920
Title: Trial for Patients With Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma Study Summary: This is a multicenter open label randomized phase II trial. Enrolled Primary Central Nervous System Lymphoma (PCNSL) patients will be stratified according to the IELSG score and randomized to receive one of the follows as primary chemotherapy: * Arm A: Methotrexate (MTX) + Cytarabine (Ara-C) * Arm B: MTX + Ara-C + rituximab * Arm C: MTX + Ara-C + rituximab + thiotepa. Chemotherapy will be administered every three weeks. The maximum number of chemotherapy induction courses will be 4. Patients in Stable Disease (SD) or better after two courses will receive two more courses of the same primary chemotherapy regimen. Stem-cells harvest will be performed in the three arms after the second course. After 4 courses response assessment will be performed. Patients who will not achieve SD or better after the 4th course, as well as those who will experience Progressive Disease (PD) at any time and those who will not achieve a sufficient stem cell harvest, will receive Whole Brain Radiation Therapy (WBRT) 36-40 Gy +/- tumor bed boost of 9 Gy. Patients who will achieve SD or better after the 4th course will be stratified according to objective response to primary chemotherapy and to primary chemotherapy regimen and randomly allocated to receive as consolidation therapy one of the follows: * Arm D: WBRT 36 Gy +/- boost 9 Gy * Arm E: Carmustine (BCNU) + Thiotepa + Autologous Peripheral Blood Stem Cell Transplant (APBSCT) Patients in Complete Response (CR) after WBRT or APBSCT will remain in follow-up. Patients who will not achieve a CR after WBRT will be managed according to physician’s preferences. Patients who will not achieve a CR after APBSCT will be referred to WBRT. Sponsor: International Extranodal Lymphoma Study Group (IELSG) Intervention: Methotrexate Start Date: 2009-11 Last Updated: 2017-08-23 Number of Patients: 126 Recruitment Status: COMPLETED Condition: Central Nervous System Lymphoma
NCTID: NCT04758975
Title: Venetoclax, Rituximab and Ibrutinib in TN Patients With CLL Undetectable Minimal Residual Disease (uMRD) in Treatment-naïve Patients With Chronic Lymphocytic Leukemia (CLL) Study Summary: This is a Phase 2, multicenter, open-label uncontrolled interventional study aimed a determining therapeutic benefits of the addition of ibrutinib to 12 months of venetoclax (single-agent for 6 months then combined with rituximab for additional 6 months) in patients with treatment-naïve CLL based on a MRD-guided approach. Study treatment will be administered according to the following scheme: VENETOCLAX: Cycle 1 Day 1-Cycle 1 Day 28 Ramp-up with weekly dose escalation; Cycles 2-12: 400 mg QD RITUXIMAB: Cycle 7 Day 1 375 mg/m2; Cycles 8-12 Day 1 500 mg/m2 At the end of Cycle 12 the MRD status is checked: 3 consecutive uMRD in PB + 1 uMRD in BM at last assessment treatment discontinuation and follow-up At least 1 MRD+ sample in the last 3 assessments. Venetoclax 400 mg QD until uMRD or up to 24 months or unacceptable toxicity (whichever occurs first) in combination with IBRUTINIB 420 mg QD until uMRD or PD or unacceptable toxicity. Venetoclax will be administered orally once daily (QD) beginning with a dose-titration phase (Ramp-up Period). At Cycle 7 Day 1 rituximab will be added for up to 6 monthly cycles (Cycle 7 Day 1 rituximab 375 mg/m2, Cycles 8-12 Day 1 rituximab 500 mg/m2). At Cycle 12 Day 1, disease status, renal function and risk of bleeding will be assessed. Minimal residual disease (MRD) will be evaluated serially in both PB and, after 3 consecutive uMRD in PB, in BM. All subjects with uMRD (defined as those with MRD level <10-4 in the PB in 3 consecutive assessments and in a BM aspirate) will discontinue venetoclax at the end of Cycle 12 (i.e. Cycle 12 Day 28). All subjects with detectable MRD (defined as those with MRD level in the PB and/or BM >10-4) and patients with stable disease without any contraindications to ibrutinib will start treatment with ibrutinib. Ibrutinib will be administered at the standard dose in CLL (i.e. 420 mg QD). Venetoclax will be administered until confirmed uMRD (3 consecutive uMRD in PB, the last one with concomitant uMRD in BM), unacceptable toxicity or disease progression or for a maximum of 2 years and ibrutinib will be continued until unacceptable toxicity, confirmed uMRD or disease progression. Sponsor: Paolo Ghia Intervention: Venetoclax Start Date: 2022-09-19 Last Updated: 2023-10-04 Number of Patients: 55 Recruitment Status: RECRUITING Condition: Chronic Lymphocytic Leukemia (CLL)
NCTID: NCT01706120
Title: Study of Clinical and Biological Prognostic Factors in Patients With Ovarian Cancer Receiving Carboplatin +Paclitaxel With Bevacizumab Study Summary: The addition of bevacizumab to first-line chemotherapy has been shown to improve progression free survival for patients with ovarian cancer. The purpose of this study is to explore the potential role of clinical and biologic factors in identifying those patients who benefit most from this combined therapy in terms of progression free and overall survival. Sponsor: National Cancer Institute, Naples Intervention: Bevacizumab Start Date: 2012-10 Last Updated: 2023-03-24 Number of Patients: 400 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Ovarian Cancer
NCTID: NCT02234050
Title: Trabectedin for Recurrent Grade II/III Meningioma Study Summary: The aim of this study is to collect data on activity, toxicity and quality of life of trabectedin therapy in patients with recurrent high-grade meningioma. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Trabectedin Start Date: 2015-07 Last Updated: 2019-02-28 Number of Patients: 90 Recruitment Status: COMPLETED Condition: Recurrent High Grade Meningioma
NCTID: NCT04924075
Title: Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015) Study Summary: This is a study to evaluate the efficacy and safety of belzutifan monotherapy in participants with advanced pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumor (pNET), von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Advanced Solid Tumors With hypoxia inducible factor-2 alpha (HIF-2α) related genetic alterations. The primary objective of the study is to evaluate the objective response rate (ORR) of belzutifan per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). Sponsor: Merck Sharp & Dohme LLC Intervention: Belzutifan Start Date: 2021-08-12 Last Updated: 2023-11-27 Number of Patients: 322 Recruitment Status: RECRUITING Condition: Pheochromocytoma/Paraganglioma
NCTID: NCT05794906
Title: A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies Study Summary: Researchers are looking for a better way to treat men at high-risk of biochemical recurrence (BCR) of prostate cancer. BCR means that in men who had prostate cancer and were treated by either surgery and/ or radiation therapy, the blood level of a specific protein called PSA rises. PSA is a marker of prostate cancer cells activity. The PSA increase means that the cancer has come back even though conventional imaging such as computed tomography (CT) scans, magnetic resonance imaging (MRI) and bone scans does not show any lesion of prostate cancer. Recently a more sensitive imaging method called prostate-specific membrane antigen <math display="block">PSMA</math> positron emission tomography <math display="block">PET</math>) /computed tomography <math display="block">CT</math>) scan may identify prostate cancer lesions not detectable by conventional imaging. Men with BCR have a higher risk of their cancer spreading to other parts of the body, particularly when PSA levels raised to a certain limit within a short period of time after local therapies. Once the cancer spreads to other parts of the body, it can become even harder to treat. In men with prostate cancer, male sex hormones (also called androgens) like testosterone can help the cancer grow and spread. To reduce androgens levels in these patients, there are treatments that block androgens production in the body called androgen deprivation therapy (ADT). ADT is often used to stop prostate cancer. Another way to stop prostate cancer growth and spread is to block the action of androgen receptors on prostate cancer cells called androgen receptor inhibitors (ARIs). The new generation ARIs including darolutamide can block the action of androgens receptors and are available for the treatment of prostate cancer in addition to ADT. It is already known that men with prostate cancer benefit from these treatments. The main objective of this study is to learn if the combination of darolutamide and ADT prolongs the time that the participants live without their cancer getting worse, or to death due to any cause, compared to placebo (which is a treatment that looks like a medicine but does not have any medicine in it) and ADT given for a pre-specified duration of 24 months. To do this, the study team will measure the time from the date of treatment allocation to the finding of new cancer spread in the participants by using PSMA PET/CT, or death due to any cause. The PSMA PET/CT scans is performed using a radioactive substance called a “tracer” that specifically binds to the prostate-specific membrane antigen (PSMA) which is a protein often found in large amounts on prostate cancer cells. To avoid bias in treatment, the study participants will be randomly (by chance) allocated to one of two treatment groups. Based on the allocated treatment group, the participants will either take darolutamide plus ADT or placebo plus ADT twice daily as tablets by mouth. The study will consist of a test (screening) phase, a treatment phase and a follow-up phase. The treatment duration is pre-specified to be 24 months unless the cancer gets worse, the participants have medical problems, or they leave the study for any reason. In addition, image guided radiotherapy (IGRT) or surgery is allowed and your doctor will explain the benefits and risks of this type of therapy. During the study, the study team will: * take blood and urine samples. * measure PSA and testosterone levels in the blood samples * do physical examinations * check the participants’ overall health * examine heart health using electrocardiogram (ECG) * check vital signs * check cancer status using PSMA PET/CT scans, CT, MRI and bone scans * take tumor samples (if required) * ask the participants if they have medical problems About 30 days after the participants have taken their last treatment, the study doctors and their team will check the participants’ health and if their cancer worsened. The study team will continue to check this and regularly ask the participants questions about medical problems and subsequent therapies until they leave the study for any reason or until they leave the study for any reason or until the end of the study, whatever comes first. Sponsor: Bayer Intervention: Darolutamide (BAY1841788, Nubeqa) Start Date: 2023-04-03 Last Updated: 2023-11-28 Number of Patients: 750 Recruitment Status: RECRUITING Condition: Biochemically Recurrent Prostate Cancer
NCTID: NCT05007106
Title: MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005) Study Summary: The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of pembrolizumab/vibostolimab co-formulation (MK-7684A) with or without other anticancer therapies in participants with selected advanced solid tumors. The primary hypothesis is that pembrolizumab/vibostolimab co-formulation is superior to pembrolizumab alone in terms of objective response rate or progression-free survival in participants with cervical cancer. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab/Vibostolimab Co-Formulation Start Date: 2021-09-16 Last Updated: 2023-11-24 Number of Patients: 610 Recruitment Status: RECRUITING Condition: Uterine Cervical Neoplasms
NCTID: NCT05733806
Title: Study on Gynecological Rare Cancers Study Summary: This is a prospective, observational, multicenter study on gynecological rare tumors. Sponsor: National Cancer Institute, Naples Intervention: chemotherapy, surgery Start Date: 2019-10-14 Last Updated: 2023-02-23 Number of Patients: 500 Recruitment Status: RECRUITING Condition: Gynecologic Cancer
NCTID: NCT03215706
Title: A Study of Nivolumab and Ipilimumab Combined With Chemotherapy Compared to Chemotherapy Alone in First Line NSCLC Study Summary: The purpose of this study is to determine whether Nivolumab, Ipilimumab combined with chemotherapy is more effective than chemotherapy by itself when treating stage IV NSCLC as the first treatment given for the disease Sponsor: Bristol-Myers Squibb Intervention: Ipilimumab Start Date: 2017-08-24 Last Updated: 2023-11-01 Number of Patients: 719 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-Small Cell Lung Cancer
NCTID: NCT04901806
Title: Study of PBI-200 in Subjects With NTRK-Fusion-Positive Solid Tumors Study Summary: This is a first-in-human, Phase 1/2 open-label, multicenter, dose-escalation, safety, PK, and biomarker study of PBI-200 in subjects with NTRK-fusion-positive advanced or metastatic solid tumors. Sponsor: Pyramid Biosciences Intervention: PBI-200 Start Date: 2021-07-20 Last Updated: 2023-05-11 Number of Patients: 74 Recruitment Status: RECRUITING Condition: Solid Tumor, Adult
NCTID: NCT02077868
Title: Evaluation of MGN1703 Maintenance Treatment in Patients With mCRC With Tumor Reduction During Induction Treatment Study Summary: The purpose of this this trial is to prove the efficacy and safety of MGN1703 as a maintenance therapy after first-line chemotherapeutic treatment of metastatic colorectal cancer. Sponsor: Mologen AG Intervention: Usual Maintenance Start Date: 2014-09 Last Updated: 2019-09-10 Number of Patients: 540 Recruitment Status: UNKNOWN Condition: Metastatic Colorectal Cancer
NCTID: NCT02436668
Title: Study of Ibrutinib vs Placebo, in Combination With Nab-paclitaxel and Gemcitabine, in the First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma (RESOLVE) Study Summary: This is a phase 3 study to evaluate the efficacy of ibrutinib in combination with nab-paclitaxel and gemcitabine for the first line treatment of patients with metastatic pancreatic adenocarcinoma. Sponsor: Pharmacyclics LLC. Intervention: Ibrutinib Start Date: 2015-05 Last Updated: 2020-12-30 Number of Patients: 430 Recruitment Status: COMPLETED Condition: Metastatic Pancreatic Adenocarcinoma
NCTID: NCT04028050
Title: A Study of Atezolizumab in Combination With Carboplatin Plus Etoposide to Investigate Safety and Efficacy in Patients With Untreated Extensive-Stage Small Cell Lung Cancer Study Summary: This is a phase IIIB, single-arm, single-country, multicenter study of the safety and efficacy of atezolizumab in combination with carboplatin plus etoposide in patients who have ES-SCLC and are chemotherapy-naive for their extensive-stage disease. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2019-08-12 Last Updated: 2023-07-24 Number of Patients: 155 Recruitment Status: COMPLETED Condition: Small Cell Lung Carcinoma
NCTID: NCT06057168
Title: Performance of Elucirem® in DSC-MRI Perfusion of Brain Gliomas Study Summary: This trial aims to study the performance of Elucirem® (gadopiclenol) in Dynamic Susceptibility Contrast Magnetic Resonance Imaging (DSC-MRI) perfusion of brain gliomas. Sponsor: Guerbet Intervention: Elucirem Start Date: 2023-09-07 Last Updated: 2023-09-28 Number of Patients: 138 Recruitment Status: RECRUITING Condition: Brain Tumor, Primary
NCTID: NCT04480268
Title: PAXG Out in the Country Study Summary: The objective of this study is to assess the reproducibility of PAXG regimen as first-line/primary chemotherapy in daily clinical practice in Pancreatic Ductal Adenocarcinoma (PDAC) borderline resectable, locally advanced or metastatic patients out of a large volume center. Sponsor: IRCCS San Raffaele Intervention: PAXG regimen (cisplatin, nab-paclitaxel, capecitabine, gemcitabine) chemotherapy Start Date: 2020-07-08 Last Updated: 2021-02-10 Number of Patients: 175 Recruitment Status: RECRUITING Condition: Pancreatic Ductal Adenocarcinoma
NCTID: NCT02293707
Title: A Phase II Randomised Trial of Three Regimens of GX301 Vaccination in Castration-resistant Prostate Cancer Study Summary: GX301 is an experimental therapeutic vaccine directed against human telomerase, an enzyme playing an essential role in cancer cell proliferation. This clinical trial will test three different GX301 administration regimens in castration-resistant prostate cancer patients who have achieved response or disease stability with first-line docetaxel treatment. This is aimed at identifying an optimal vaccination regimen. The three regimens will primarily be compared for their efficacy and safety in inducing vaccine-specific immunological responses over a period of 6 months following treatment initiation. In addition, patients will be observed for the occurrence of disease progression and for their vital status up to 24 months. Sponsor: Laboratoires Leurquin Mediolanum Intervention: GX301 Start Date: 2014-11 Last Updated: 2020-07-22 Number of Patients: 99 Recruitment Status: COMPLETED Condition: Prostate Cancer
NCTID: NCT00849667
Title: Efficacy and Safety of Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Participants With Platinum-sensitive Ovarian Cancer in First Relapse Study Summary: This research is being done to find out if Carboplatin and Taxane works better alone or when given with an experimental drug called MORAb-003(farletuzumab) in subjects with first platinum sensitive relapsed ovarian cancer. Sponsor: Morphotek Intervention: Farletuzumab Start Date: 2009-04-16 Last Updated: 2022-12-30 Number of Patients: 1100 Recruitment Status: TERMINATED Condition: Ovarian Cancer
NCTID: NCT04740307
Title: Safety and Efficacy of Coformulated Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib (E7080/MK-7902) in Advanced Hepatocellular Carcinoma (MK-1308A-004) Study Summary: The purpose of this study is to evaluate the safety and efficacy of fixed dose coformulated pembrolizumab/quavonlimab (MK-1308A) plus lenvatinib in a first line (1L) hepatocellular carcinoma (HCC) setting. No hypothesis testing will be performed. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab/Quavonlimab Start Date: 2021-03-16 Last Updated: 2023-11-13 Number of Patients: 110 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Advanced Hepatocellular Carcinoma
NCTID: NCT00875667
Title: A Study to Determine the Efficacy of Lenalidomide Versus Investigator’s Choice in Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL) Study Summary: To evaluate the safety and efficacy of lenalidomide versus investigator choice in patients with relapsed or refractory mantle cell lymphoma. Sponsor: Celgene Intervention: Lenalidomide Start Date: 2009-04-30 Last Updated: 2019-09-16 Number of Patients: 254 Recruitment Status: COMPLETED Condition: Mantle Cell Lymphoma
NCTID: NCT03425643
Title: Efficacy and Safety of Pembrolizumab (MK-3475) With Platinum Doublet Chemotherapy as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (MK-3475-671/KEYNOTE-671) Study Summary: This trial will evaluate the safety and efficacy of pembrolizumab (MK-3475) in combination with platinum doublet neoadjuvant chemotherapy (NAC) before surgery <math display="block">neoadjuvant phase</math>, followed by pembrolizumab alone after surgery <math display="block">adjuvant phase</math> in participants with resectable stage II, IIIA, and resectable IIIB (T3-4N2) non-small cell lung cancer (NSCLC). The primary hypotheses of this study are that neoadjuvant pembrolizumab (vs. placebo) in combination with NAC, followed by surgery and adjuvant pembrolizumab (vs. placebo) will improve: 1) event free survival (EFS) by biopsy assessed by local pathologist or by investigator-assessed imaging using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1); and 2) overall survival (OS). Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2018-04-24 Last Updated: 2023-11-13 Number of Patients: 797 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-small Cell Lung Cancer
NCTID: NCT01307397
Title: A Study of Vemurafenib in Participants With Metastatic Melanoma Study Summary: This multi-center study evaluates the safety and efficacy of vemurafenib in participants with BRAF V600 mutation-positive, surgically incurable, and unresectable Stage IIIC or IV (American Joint Committee on Cancer <math display="block">AJCC</math>) metastatic melanoma. Sponsor: Hoffmann-La Roche Intervention: Vemurafenib Start Date: 2011-03-01 Last Updated: 2017-12-18 Number of Patients: 3219 Recruitment Status: COMPLETED Condition: Malignant Melanoma
NCTID: NCT02544633
Title: Phase 2 Study of MGCD265 in Patients With Non-Small Cell Lung Cancer With Activating Genetic Alterations in MET Study Summary: MGCD265 is an orally administered receptor tyrosine kinase inhibitor that targets MET and other receptors. This study is a Phase 2 trial of MGCD265 in patients with locally advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) that has activating genetic changes of the MET gene (mutation or amplification <math display="block">increase number of gene copies</math>). Testing for tumor gene changes can be performed in tumor tissue or blood samples. Patients must have previously received treatment with chemotherapy. The number of patients to be enrolled will depend on how many enrolled patients experience tumor size reduction. MGCD265 will be administered orally, twice daily. The study is designed to evaluate whether the number of patients experiencing tumor size reduction is substantially higher than would be expected with other available treatments. Sponsor: Mirati Therapeutics Inc. Intervention: MGCD265 Start Date: 2015-10 Last Updated: 2020-03-04 Number of Patients: 68 Recruitment Status: COMPLETED Condition: Non-Small Cell Lung Cancer
NCTID: NCT01010295
Title: A Clinico-Pathological Study to Investigate the Possible Infective Causes of Non-Hodgkin Lymphoma of the Ocular Adnexae Study Summary: Patients with mucosa-associated lymphoid tissue (MALT) lymphoma of the ocular adnexae (MLOA) will be eligible for treatment with doxycycline (part A: clinico-pathological study); patients with other types of ocular lymphoma, inflammatory lesions or those ineligible/unwilling for treatment with doxycycline can participate in the only pathologic study (part B). Sponsor: International Extranodal Lymphoma Study Group (IELSG) Intervention: doxycycline (tetracycline) Start Date: 2006-09 Last Updated: 2013-11-25 Number of Patients: 54 Recruitment Status: COMPLETED Condition: Non-Hodgkin Lymphoma
NCTID: NCT01569295
Title: Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) (Tugela ) Study Summary: The primary objective of this study is to evaluate the effect of the addition of idelalisib (formerly GS-1101) to bendamustine + rituximab (BR) on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL) Sponsor: Gilead Sciences Intervention: Idelalisib Start Date: 2012-06-15 Last Updated: 2020-03-10 Number of Patients: 416 Recruitment Status: COMPLETED Condition: Chronic Lymphocytic Leukemia
NCTID: NCT04277637
Title: Study of Bcl-2 Inhibitor BGB-11417 in Participants With Mature B-Cell Malignancies Study Summary: The purpose of this study is to determine the safety, tolerability; and to define the maximum tolerated dose (MTD) and Recommended Phase 2 Dose (RP2D); and to evaluate the safety and tolerability of the ramp-up dosing schedule and at the RP2D of BGB-11417 monotherapy, and when given in combination with zanubrutinib and obinutuzumab. Sponsor: BeiGene Intervention: BGB-11417 Start Date: 2020-03-24 Last Updated: 2023-11-09 Number of Patients: 537 Recruitment Status: RECRUITING Condition: Mature B-Cell Malignancies
NCTID: NCT02785900
Title: Vadastuximab Talirine (SGN-CD33A; 33A) Combined With Azacitidine or Decitabine in Older Patients With Newly Diagnosed Acute Myeloid Leukemia Study Summary: The purpose of this study in AML patients is to test whether vadastuximab talirine (SGN-CD33A; 33A) combined with either azacitidine or decitabine improves remission rates and extends overall survival as compared to placebo combined with either azacitidine or decitabine. Sponsor: Seagen Inc. Intervention: 33A Start Date: 2016-05 Last Updated: 2018-12-12 Number of Patients: 240 Recruitment Status: TERMINATED Condition: Acute Myeloid Leukemia
NCTID: NCT01389414
Title: Panitumumab Plus Gemcitabine and Oxaliplatin (GEMOX)Versus GEMOX Alone to Treat Advanced Biliary Tract Adenocarcinoma Study Summary: This is a multi-centre phase II, open-label, randomized (1:1), parallel-arm, study of panitumumab in combination with chemotherapy (P-GEMOX) versus chemotherapy alone (GEMOX). Eligible subjects will be enrolled and randomized to receive first-line combination therapy consisting of panitumumab and GEMOX (experimental arm) or GEMOX alone (control arm).The ame of the Stuy is to evaluate the clinical activity of the P-GEMOX (Panitumumab and GEMOX) combination compared to GEMOX alone in patients with previously untreated surgically unresectable or metastatic biliary tract carcinoma (KRAS wild-type)and To evaluate the safety profile of the P-GEMOX combination; to assess the objective response rate; to assess overall survival; to study the correlation between biomarkers with activity and efficacy. Sponsor: Prof. Massimo Aglietta Intervention: Panitumumab plus GEMOX chemotherapy Start Date: 2010-05 Last Updated: 2015-05-28 Number of Patients: 89 Recruitment Status: COMPLETED Condition: Biliary Carcinoma
NCTID: NCT03403725
Title: MEN1309 I.v. Infusion in Pts With CD205-positive Metastatic Solid Tumors and Relapsed or Refractory NHL Ph I Study Study Summary: The purpose of this clinical trial is to identify the highest dose of MEN1309 drug with acceptable safety profile and that can be used in patients affected by CD205-positive solid tumors and Non-Hodgkin Lymphoma Sponsor: Menarini Group Intervention: MEN1309 Start Date: 2017-08-28 Last Updated: 2021-09-28 Number of Patients: 28 Recruitment Status: TERMINATED Condition: Metastatic Solid Tumors
NCTID: NCT04332822
Title: A Randomized, Multicenter, Phase III Trial Comparing Treatment With R-mini-CHOP With R-mini-CHP + Polatuzumab Vedotin in Patients With Diffuse Large Cell B Cell Lymphoma Study Summary: This is a phase III, randomized, open-label, multicenter trial, conducted in Sweden, Norway, Finland, Denmark, Italy and Switzerland, in elderly patients with untreated diffuse large B-cell lymphoma. Elderly is defined as either ≥80 years of age, or ≥75 years and frail, according to a simplified Comprehensive Geriatric Assessment. Patients will be randomized 1:1 to either the standard treatment for this population, R-miniCHOP, or an experimental regimen, R-pola-miniCHP, where vincristine is substituted by an immunoconjugate, polatuzumab vedotin. The duration of the screening period is up to 4 weeks. The duration of active treatment is 18 weeks in both arms, and patients will be followed up to 36 months after end of treatment. Start of enrollment is planned in Q1 2020, and the last visit of the last patient included (end of trial) is estimated in Q1 2026. Sponsor: Nordic Lymphoma Group Intervention: R-pola-mini-CHP Start Date: 2020-08-19 Last Updated: 2021-07-09 Number of Patients: 200 Recruitment Status: RECRUITING Condition: DLBCL
NCTID: NCT04053231
Title: Hepatocarcinoma Recurrence on the Liver Study - Part2 Study Summary: Rationale for the trial. To evaluate the impact of surgery on hepatocarcinoma recurrence. Thus, to evaluate the impact of different clinical, radiological, histopathological variables on recurrence after surgical treatment. The nature of this study will allow to observe, over time, the distribution of the considered collection variables, allowing a strictly observational monitoring of possible associations able to suggest models or interpretations, which can then be the basis for the construction of prospective and randomized studies. Sponsor: University of Milano Bicocca Intervention: liver resection Start Date: 2019-09 Last Updated: 2019-08-12 Number of Patients: 3000 Recruitment Status: NOT_YET_RECRUITING Condition: Liver Cancer
NCTID: NCT01000025
Title: PF-00299804 in Stage IIIB or Stage IV Non-Small Cell Lung Cancer Not Responding to Standard Therapy for Advanced or Metastatic Cancer Study Summary: RATIONALE: PF-00299804 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether PF-00299804 is more effective than a placebo in treating patients with advanced non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying PF-00299804 to see how well it works compared with a placebo in treating patients with stage IIIB or stage IV non-small cell lung cancer that has not responded to standard therapy for advanced or metastatic cancer. Sponsor: NCIC Clinical Trials Group Intervention: PF-00299804 Start Date: 2009-12-23 Last Updated: 2023-08-22 Number of Patients: 720 Recruitment Status: COMPLETED Condition: Lung Cancer
NCTID: NCT03595592
Title: Neoadjuvant Treatment of HER2 Positive Early High-risk and Locally Advanced Breast Cancer Study Summary: n the present study the neoadjuvant approach with the anti-HER2 trastuzumab and pertuzumab combined with carboplatin and paclitaxel will be used to compare the Event-Free Survival (EFS) in regimens with and without atezolizumab. Following the neoadjuvant part of the study, after surgery all patients will continue to receive trastuzumab and pertuzumab to complete one year of anti-HER2 therapy. Similarly, patients allocated to receive atezolizumab will continue atezolizumab to complete one year In addition, several IHC and molecular assays will be performed before and during the period of chemotherapy administration and at surgery with the goal of defining a marker of efficacy to be later validated in a larger adjuvant setting. Sponsor: Fondazione Michelangelo Intervention: Trastuzumab Start Date: 2018-09-07 Last Updated: 2023-02-15 Number of Patients: 650 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Invasive Breast Cancer
NCTID: NCT02420821
Title: A Study of Atezolizumab in Combination With Bevacizumab Versus Sunitinib in Participants With Untreated Advanced Renal Cell Carcinoma (RCC) Study Summary: This multi-center, randomized, open-label study will evaluate the efficacy and safety of atezolizumab plus bevacizumab versus sunitinib in participants with inoperable, locally advanced, or metastatic RCC who have not received prior systemic active or experimental therapy, either in the adjuvant or metastatic setting. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody Start Date: 2015-05-20 Last Updated: 2023-01-30 Number of Patients: 915 Recruitment Status: COMPLETED Condition: Renal Cell Carcinoma
NCTID: NCT01539512
Title: A Randomized, Double-Blind, Placebo-Controlled Study of Idelalisib in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) Study Summary: This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effect of idelalisib in combination with rituximab on the onset, magnitude, and duration of tumor control in participants previously treated for chronic lymphocytic leukemia (CLL). Eligible patients will be randomized with a 1:1 ratio into 1 of the 2 treatment arms to receive either idelalisib plus rituximab or placebo plus rituximab. Participants who are tolerating primary study therapy but experience definitive CLL progression are eligible to receive active idelalisib therapy in the extension study, GS-US-312-0117. Sponsor: Gilead Sciences Intervention: Idelalisib Start Date: 2012-04 Last Updated: 2019-05-14 Number of Patients: 220 Recruitment Status: COMPLETED Condition: Chronic Lymphocytic Leukemia
NCTID: NCT05327530
Title: A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley) Study Summary: The purpose of this study is to assess the safety and efficacy of avelumab in combination with other anti-tumor agents as a maintenance treatment in participants with bladder cancer. Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: Avelumab Start Date: 2022-08-17 Last Updated: 2023-10-23 Number of Patients: 252 Recruitment Status: RECRUITING Condition: Locally Advanced or Metastatic Urothelial Carcinoma
NCTID: NCT03697512
Title: MALIBU Trial - Combination of Ibrutinib and Rituximab in Untreated Marginal Zone Lymphomas Study Summary: Single-arm, phase II clinical trial of patients with Extranodal Marginal Zone Lymphoma (EMZL). It is planned to recruit 130 patients. Additional patients with Splenic Marginal Zone Lymphoma (SMZL), up to 30, and Nodal Marginal Zone Lymphoma (NMZL), up to 15, will be included in the trial in order to preliminary explore the clinical activity and safety of the combination treatment proposed. The study primary endpoints will be analysed on the EMZL population. Outcome of patients with SMZL and NMZL will be analysed and reported separately Sponsor: International Extranodal Lymphoma Study Group (IELSG) Intervention: Ibrutinib Start Date: 2019-09-27 Last Updated: 2023-05-10 Number of Patients: 175 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Marginal Zone Lymphoma
NCTID: NCT02409355
Title: A Study of Atezolizumab Compared With Gemcitabine Plus (+) Cisplatin or Carboplatin for PD-L1-Selected Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower111) Study Summary: This randomized, open-label study was designed to evaluate and compare the safety and efficacy of atezolizumab with gemcitabine + cisplatin or carboplatin in PD-L1 selected participants with chemotherapy-naive, Stage IV squamous NSCLC. The study was closed due to low patient enrollment and the Sponsor’s decision to include patients with squamous NSCLC into the GO29431 study, NCT02409342. Therefore the planned objectives of this study are no longer applicable and formal analyses of efficacy or safety have not been performed. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2015-05-07 Last Updated: 2019-02-15 Number of Patients: 8 Recruitment Status: TERMINATED Condition: Non-Small Cell Lung Cancer
NCTID: NCT04915248
Title: Study to Evaluate Combined Treatment of Daratumumab, Bortezomib and Dexamethasone in PBL Patients. Study Summary: It is an open-label, multicenter, phase II, single arm trial to Evaluate Activity and Safety of Daratumumab in combination with Bortezomib and Dexamethasone in patients about 28 patients with Relapsed or Refractory Plasmablastic lymphoma. Sponsor: Fondazione Italiana Linfomi - ETS Intervention: Daratumumab Start Date: 2022-07-11 Last Updated: 2023-10-11 Number of Patients: 28 Recruitment Status: RECRUITING Condition: Plasmablastic Lymphoma
NCTID: NCT04919512
Title: A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder Study Summary: The purpose of this study is to evaluate the anti-tumor effects of TAR-200 in combination with intravenous (IV) cetrelimab and IV cetrelimab alone. Sponsor: Janssen Research & Development, LLC Intervention: TAR-200 Start Date: 2022-07-07 Last Updated: 2023-11-08 Number of Patients: 160 Recruitment Status: RECRUITING Condition: Urinary Bladder Neoplasms
NCTID: NCT00786851
Title: Salvage Treatment With Lenalidomide and Dexamethaosne (LEN-DEX) in Patients With Relapsed/Refractory Mantle Cell Lymphoma (MCL) Study Summary: This is a prospective, multicenter phase II trial designed to evaluate the safety and activity of the combination of Lenalidomide (Len) and Dexamethasone (Dex) in patients with relapsed/refractory mantle cell lymphoma (MCL). Sponsor: Fondazione Italiana Linfomi - ETS Intervention: Lenalidomide and Dexametasone Start Date: 2008-07 Last Updated: 2016-08-17 Number of Patients: 33 Recruitment Status: COMPLETED Condition: MANTLE CELL LYMPHOMA
NCTID: NCT03493451
Title: Study of BGB-A317 in Participants With Relapsed or Refractory Mature T- and NK-cell Neoplasms Study Summary: This was a multi-center, prospective, non-randomized, open-label, Phase 2 clinical study to evaluate the safety and efficacy of BGB-A317 in participants with relapsed or refractory mature T- and natural killer (NK)-cell neoplasms. There were three cohorts: * Cohort 1: Relapsed or refractory (R/R) extranodal NK/T cell lymphoma (ENKTL; nasal or non-nasal type) * Cohort 2: Other R/R mature T-cell neoplasms, limited to the following histologies: peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), or anaplastic large-cell lymphoma (ALCL) * Cohort 3: R/R cutaneous T-cell lymphoma, limited to mycosis fungoides (MF) or Sèzary syndrome (SS) Study procedures included a Screening phase (up to 35 days); Treatment phase (until disease progression, intolerable toxicity, or withdrawal of informed consent, whichever occurs first); Safety Follow-up phase (up to 90 days following last study treatment for all adverse events (AEs) and serious adverse events (SAEs)); and Survival follow-up phase (duration varying by participant). Sponsor: BeiGene Intervention: Tislelizumab Start Date: 2018-04-13 Last Updated: 2022-05-04 Number of Patients: 77 Recruitment Status: COMPLETED Condition: Peripheral T Cell Lymphoma
NCTID: NCT01358812
Title: FOLFOXIRI Plus Panitumumab In Kras and Braf Wild-Type Metastatic Colorectal Cancer Study Summary: The GONO-FOLFOXIRI regimen demonstrated higher activity and efficacy compared to FOLFIRI in a phase III trial. Panitumumab with oxaliplatin- or irinotecan-based doublets is feasible and associated with improved activity in KRAS codon 12-13 wild-type patients. BRAF and other RAS rare mutations have been suggested as additional potential biomarkers for anti-EGFR agents in metastatic colo-rectal cancer. The present study aims to demonstrate the feasibility and the activity of the first-line combination of the GONO-FOLFOXIRI regimen and Panitumumab in molecularly selected metastatic colo-rectal cancer patients. Sponsor: Gruppo Oncologico del Nord-Ovest Intervention: FOLFOXIRI + Panitumumab Start Date: 2010-03 Last Updated: 2015-03-11 Number of Patients: 37 Recruitment Status: COMPLETED Condition: Metastatic Colo-rectal Cancer
NCTID: NCT03915951
Title: An Open-label Study of Encorafenib + Binimetinib in Patients With BRAFV600-mutant Non-small Cell Lung Cancer Study Summary: This is an open-label, multicenter, non-randomized, Phase 2 study to determine the safety, tolerability and efficacy of encorafenib given in combination with binimetinib in patients with BRAFV600E-mutant metastatic non-small cell lung cancer (NSCLC). Patients who are either treatment-naïve, OR who have received 1) first-line treatment with standard platinum-based chemotherapy, OR 2) first-line treatment with an anti-programmed cell death protein 1 (PD-1)/programmed cell death protein ligand 1 (PD-L1) inhibitor given alone or in combination with platinum-based chemotherapy will be enrolled. Sponsor: Pfizer Intervention: encorafenib Start Date: 2019-06-04 Last Updated: 2023-10-30 Number of Patients: 98 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-small Cell Lung Cancer
NCTID: NCT01347866
Title: Clinical Study Of PI3K/mTOR Inhibitors In Combination With An Oral MEK Inhibitor Or Irinotecan In Patients With Advanced Cancer Study Summary: After the fourth protocol amendment two study arms are evaluated in this clinical protocol: PD-0325901 (oral MEK inhibitor) plus PF-05212384 (intravenous PI3K/mTOR inhibitor) and PF-05212384 plus irinotecan. The study will assess safety, pharmacokinetics and pharmacodynamics of these combinations in patients with advanced cancer. Once the maximum tolerated doses are identified, further assessment of these combinations will be done in patients with previously treated metastatic colorectal or pancreatic cancer for the PF-05212384 plus irinotecan arm and in patients with ovarian cancer or KRAS mutated non small cell lung cancer for the combination of PF-05212384 plus PD-0325901. Sponsor: Pfizer Intervention: PF-05212384 Start Date: 2011-10 Last Updated: 2018-10-29 Number of Patients: 105 Recruitment Status: TERMINATED Condition: Advanced Cancer
NCTID: NCT03126019
Title: A Study of INCB050465 in Relapsed or Refractory Follicular Lymphoma Study Summary: The purpose of this study is to assess the objective response rate of parsaclisib treatment in participants with relapsed or refractory follicular lymphoma. Sponsor: Incyte Corporation Intervention: Parsaclisib Start Date: 2018-03-14 Last Updated: 2023-07-27 Number of Patients: 126 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Lymphoma
NCTID: NCT04551066
Title: To Evaluate the Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis (LIMBER-313) Study Summary: The purpose of the study is to compare the efficacy of parsaclisib when combined with ruxolitinb versus placebo combined with ruxolitinib in participants with myelofibrosis. Sponsor: Incyte Corporation Intervention: parsaclisib Start Date: 2021-05-27 Last Updated: 2023-10-06 Number of Patients: 252 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Myelofibrosis
NCTID: NCT01098266
Title: NGR015: Study in Second Line for Patient With Advanced Malignant Pleural Mesothelioma Pretreated With Pemetrexed Study Summary: The main objective of the trial is to document the efficacy of NGR-hTNF administered at low dose weekly in advanced Malignant Pleural Mesothelioma patients previously treated with a pemetrexed-based chemotherapy regimen. Sponsor: AGC Biologics S.p.A. Intervention: NGR-hTNF plus Best Investigator’s Choice (BIC) Start Date: 2010-04-12 Last Updated: 2019-09-17 Number of Patients: 400 Recruitment Status: COMPLETED Condition: Malignant Pleural Mesothelioma
NCTID: NCT01667419
Title: A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma Study Summary: This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of vemurafenib in participants with completely resected, cutaneous BRAF mutation-positive melanoma at high risk for recurrence. Participants will be enrolled in two separate cohorts: Cohort 1 will include participants with completely resected Stage IIC, IIIA (participants with one or more nodal metastasis greater than <math display="block">\></math> 1 millimeter <math display="block">mm</math> in diameter), or IIIB cutaneous melanoma, as defined by the American Joint Committee on Cancer (AJCC) Classification, Version 7; Cohort 2 will include participants with Stage IIIC cutaneous melanoma, as defined by this classification scheme. Within each cohort, participants will be randomized (1:1 ratio) to receive vemurafenib or matching placebo over a 52-week period. Sponsor: Hoffmann-La Roche Intervention: Vemurafenib Start Date: 2012-09-24 Last Updated: 2019-07-23 Number of Patients: 498 Recruitment Status: COMPLETED Condition: Melanoma
NCTID: NCT03961919
Title: Phase II Trial in Elderly Patients With AML or MDS in Complete Remission Not Eligible for Allogenic Transplant Study Summary: FLAT-Auto is a phase II trial. fludarabine and ARA-C will be combined with the alkylating agent treosulfan (FLAT), to investigate the feasibility and the efficacy of a new regimen, supported with autologous peripheral blood SCT (PBSCT), as final postremission consolidation in AML/MDS elderly patients. Sponsor: Ciceri Fabio Intervention: Fludarabine Start Date: 2009-02-10 Last Updated: 2023-11-18 Number of Patients: 15 Recruitment Status: COMPLETED Condition: Acute Myeloid Leukemia
NCTID: NCT00182819
Title: Radiation Therapy or Temozolomide in Treating Patients With Gliomas Study Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective than temozolomide in treating gliomas. PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to temozolomide in treating patients with gliomas. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: temozolomide Start Date: 2005-07 Last Updated: 2016-10-12 Number of Patients: 709 Recruitment Status: COMPLETED Condition: Brain and Central Nervous System Tumors
NCTID: NCT03988114
Title: A Study of Abemaciclib (LY2835219) in Participants With HR+, HER2- Advanced Breast Cancer Study Summary: The reason for this study is to see if the drug abemaciclib in combination with nonsteroidal aromatase inhibitors (anastrozole or letrozole) is effective in participants with Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) advanced breast cancer that have certain disease characteristics. Sponsor: Eli Lilly and Company Intervention: Abemaciclib Start Date: 2019-09-16 Last Updated: 2019-09-06 Number of Patients: 0 Recruitment Status: WITHDRAWN Condition: Metastatic Breast Cancer
NCTID: NCT02903914
Title: Arginase Inhibitor INCB001158 as a Single Agent and in Combination With Immune Checkpoint Therapy in Patients With Advanced/Metastatic Solid Tumors Study Summary: This study is an open-label Phase 1/Phase 2 evaluation of INCB001158 as a single agent and in combination with immune checkpoint therapy in patients with advanced/metastatic solid tumors. Sponsor: Incyte Corporation Intervention: INCB001158 Start Date: 2016-09-14 Last Updated: 2023-02-24 Number of Patients: 260 Recruitment Status: COMPLETED Condition: Metastatic Cancer
NCTID: NCT01964430
Title: Nab-paclitaxel and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer (the “Apact” Study) Study Summary: The purpose of this study is to compare whether there is a delay or prevention of recurrence or death in participants with surgically removed pancreatic cancer who then take nab-Paclitaxel in combination with gemcitabine compared to those who take gemcitabine alone. Sponsor: Celgene Intervention: nab-Paclitaxel Start Date: 2014-03-28 Last Updated: 2023-06-28 Number of Patients: 866 Recruitment Status: COMPLETED Condition: Pancreatic Neoplasms
NCTID: NCT05645692
Title: A Study Evaluating Different Immunotherapies (LAG-3 and PD-1 With or Without TIGIT, Compared to PD-L1 Alone) in Participants With Untreated Locally Advanced Metastatic Urothelial Cancer Study Summary: This study will evaluate the efficacy, safety, and pharmacokinetics of tobemstomig alone or in combination with tiragolumab compared with atezolizumab in participants with previously untreated, locally advanced or metastatic urothelial cancer (mUC) who are ineligible to receive a platinum containing chemotherapy. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2023-04-13 Last Updated: 2023-11-07 Number of Patients: 240 Recruitment Status: RECRUITING Condition: Urothelial Cancer
NCTID: NCT03552692
Title: Use of Venetoclax as Single Agent in Patients With Relapsed/Refractory BCL-2 Positive Peripheral T Cell Lymphoma Study Summary: The FIL_VERT study is a phase II, open label, multicenter clinical trial. The primary of objective of the Study is to evaluate the efficacy of Venetoclax ABT-199/GDC-0199) in terms of overall response rate (ORR) in patients with relapsed/refractory BCL-2 positive peripheral T cell lymphoma not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL) and other nodal T-cell lymphomas of T-follicular helper origin (TFH) Sponsor: Fondazione Italiana Linfomi - ETS Intervention: Venetoclax Start Date: 2018-09-25 Last Updated: 2023-07-06 Number of Patients: 22 Recruitment Status: TERMINATED Condition: T-Cell Lymphoma Relapsed
NCTID: NCT04227951
Title: Gastrectomy With or Without Drainage (ADiGe)? Study Summary: Prophylactic use of anastomotic drain in upper gastrointestinal surgery has been questioned in the last 15 years but only small studies have been conducted. In 2015 a Cochrane meta analysis on four Randomized Controlled Trials (RCT) concluded that there was no convincing evidence to the routine drain placement in gastrectomy. Nevertheless the Authors evidenced the moderate/low methodological quality of the included studies and highlighted how 3 out of four came from Eastern countries. Despite the above mentioned limits, Enhanced Recovery After Surgery (ERAS) society published the guidelines for gastrectomy that strongly recommend, with high evidence level, to avoid routine use of drain in gastric surgery. After 2015 some other retrospective studies have been published, all with inconsistent results. Our objective is to perform a multicentre prospective trial in a large western cohort of patients to establish wether avoid routine use of anastomotic drain does not led to an increasing of postoperative invasive procedure. Sponsor: Azienda Ospedaliera Universitaria Integrata Verona Intervention: Avoid drain placement Start Date: 2019-12-17 Last Updated: 2023-07-20 Number of Patients: 404 Recruitment Status: COMPLETED Condition: Gastric Cancer
NCTID: NCT05943951
Title: Italian Study on the Right Hemicolectomy: How the Lymphadenectomy is Performed Study Summary: The objective of the study is the analysis of lymphadenectomy in the course of right hemicolectomy, in relation to the radicality of the surgical resection that is performed. In particular, the investigators wants to inquire how according to precise standards regarding surgical radicalness and consequently the anatomical piece that is obtained it is possible to correlate a certain number of lymph nodes and their possible positivity. The lead center is the General and Thoracic Surgery Department of the University of Ferrara. Prof. Anania is the responsible for the enrollment of patients and the coordination with the collaborating centers in the six month-study Sponsor: Gabriele Anania Intervention: Right hemicolectomy Start Date: 2022-04-01 Last Updated: 2023-07-13 Number of Patients: 788 Recruitment Status: COMPLETED Condition: Colon Cancer
NCTID: NCT03967951
Title: CT Radiomic Features of Pancreatic Neuroendocrine Neoplasms Study Summary: The aim of this study is to quantify inter-observer variability in delineating pancreatic neuroendocrine neoplasm (PanNEN) on Computerized Tomography (CT) images and its impact on radiomic features (RF), subsequently to this determination, to use CT texture analysis to predict, histological characteristics of PanNEN on CT scans. Sponsor: Francesco De Cobelli Intervention: CT radiomic feature evaluation Start Date: 2019-03-23 Last Updated: 2019-12-26 Number of Patients: 70 Recruitment Status: COMPLETED Condition: Pancreatic Neuroendocrine Tumor
NCTID: NCT02411448
Title: A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY) Study Summary: The main purpose of this study is to evaluate the efficacy and safety of ramucirumab in combination with erlotinib as compared to placebo in combination with erlotinib in previously untreated participants with stage IV non-small cell lung cancer (NSCLC) harboring an activating epidermal growth factor receptor (EGFR) mutation (Exon 19-Del and Exon 21 L858R). Safety and tolerability of ramucirumab in combination with erlotinib will be assessed in Part A before proceeding to Part B. The purpose of Part C is to determine the efficacy and safety of ramucirumab in combination with gefitinib in previously untreated East Asian participants with EGFR mutation-positive metastatic NSCLC and of ramucirumab in combination with osimertinib in those participants whose disease progressed on ramucirumab and gefitinib and that have T790M - positive metastatic NSCLC. Sponsor: Eli Lilly and Company Intervention: Ramucirumab Start Date: 2015-05-06 Last Updated: 2023-06-02 Number of Patients: 545 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Non-Small Cell Lung Cancer
NCTID: NCT03173248
Title: Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Participants With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation Study Summary: Study AG120-C-009 is a global, Phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of AG-120 (ivosidenib) + azacitidine vs placebo + azacitidine in adult participants with previously untreated IDH1m AML who are considered appropriate candidates for non-intensive therapy. The primary endpoint is event-free survival (EFS). The key secondary efficacy endpoints are overall survival (OS), rate of complete remission (CR), rate of CR and complete remission with partial hematologic recovery (CRh), and overall response rate (ORR). Participants eligible for study treatment based on Screening assessments will be randomized 1:1 to receive oral AG-120 or matched placebo, both administered in combination with subcutaneous (SC) or intravenous (IV) azacitidine. An estimated 200 participants will take part in the study. Sponsor: Institut de Recherches Internationales Servier Intervention: AG-120 Start Date: 2017-06-26 Last Updated: 2023-07-12 Number of Patients: 146 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Newly Diagnosed Acute Myeloid Leukemia (AML)
NCTID: NCT02779751
Title: A Study of Abemaciclib (LY2835219) in Participants With Non-Small Cell Lung Cancer or Breast Cancer Study Summary: The main purpose of this study is to evaluate the safety and efficacy of abemaciclib in combination with pembrolizumab in participants with advanced non-small cell lung cancer (NSCLC) or hormone receptor positive (HR+), human epidermal growth factor receptor negative (HER2-) breast cancer. Sponsor: Eli Lilly and Company Intervention: Abemaciclib Start Date: 2016-11-14 Last Updated: 2023-09-29 Number of Patients: 100 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non Small Cell Lung Cancer
NCTID: NCT02604342
Title: Alectinib Versus Pemetrexed or Docetaxel in Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) Participants Previously Treated With Platinum-Based Chemotherapy and Crizotinib Study Summary: This randomized active-controlled multicenter Phase III open-label study will evaluate and compare between treatment groups the efficacy of alectinib versus chemotherapy in participants with ALK-positive advanced NSCLC who were previously treated with chemotherapy and crizotinib, as measured by investigator-assessed progression-free survival (PFS) and to evaluate and compare between treatment groups the central nervous system (CNS) objective response rate (C-ORR) in participants with measurable CNS metastases at baseline, as assessed by an Independent Review Committee (IRC). Sponsor: Hoffmann-La Roche Intervention: Alectinib Start Date: 2015-11-03 Last Updated: 2019-10-29 Number of Patients: 119 Recruitment Status: COMPLETED Condition: Non-small Cell Lung Cancer
NCTID: NCT05967689
Title: A Study of Zipalertinib in Patients With Advanced Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions or Other Uncommon Mutation. Study Summary: The purpose of this study is to evaluate the safety and efficacy of zipalertinib in patients with locally advanced or metastatic NSCLC harboring EGFR ex20ins mutations and other mutations. Sponsor: Taiho Oncology, Inc. Intervention: TAS6417 Start Date: 2023-07-27 Last Updated: 2023-11-29 Number of Patients: 160 Recruitment Status: RECRUITING Condition: Advanced or Metastatic NSCLC Harboring Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion (ex20ins) Mutations
NCTID: NCT02242942
Title: Comparison of the Treatments of Obinutuzumab + Venetoclax Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia Study Summary: This open-label, multicenter, randomized Phase III study is designed to compare the efficacy and safety of a combined regimen of obinutuzumab and venetoclax versus obinutuzumab + chlorambucil in participants with chronic lymphocytic leukemia (CLL) and coexisting medical conditions. The time on study treatment was approximately one year and the follow-up period will be up to 9 years. Sponsor: Hoffmann-La Roche Intervention: Chlorambucil Start Date: 2014-12-31 Last Updated: 2023-09-21 Number of Patients: 445 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Lymphocytic Leukemia, Chronic
NCTID: NCT02409342
Title: A Study of Atezolizumab (MPDL3280A) Compared With a Platinum Agent (Cisplatin or Carboplatin) + (Pemetrexed or Gemcitabine) in Participants With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower110] Study Summary: This randomized, open-label study will evaluate the efficacy and safety of atezolizumab compared with chemotherapy consisting of a platinum agent (cisplatin or carboplatin per investigator discretion) combined with either pemetrexed (non-squamous disease) or gemcitabine (squamous disease) in programmed death-ligand 1 (PD-L1)-selected, chemotherapy-naive participants with Stage IV Non-Squamous or Squamous NSCLC. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody Start Date: 2015-07-20 Last Updated: 2023-03-15 Number of Patients: 572 Recruitment Status: COMPLETED Condition: Non-Squamous Non-Small Cell Lung Cancer, Squamous Non-Small Cell Lung Cancer
NCTID: NCT05319730
Title: A Study to Evaluate Investigational Agents With or Without Pembrolizumab (MK-3475) in Participants With Advanced Esophageal Cancer Previously Exposed to Programmed Cell Death 1 Protein (PD-1)/ Programmed Cell Death Ligand 1 (PD-L1) Treatment (MK-3475-06B) Study Summary: This is a Phase 1/2, multicenter, randomized, open-label umbrella platform study to evaluate the safety and efficacy of investigational agents with or without pembrolizumab and/or chemotherapy, for the treatment of participants with second line (2L) esophageal squamous cell carcinoma (ESCC) who have previously been exposed to PD-1/PD-L1 based treatment. Sponsor: Merck Sharp & Dohme LLC Intervention: Paclitaxel Start Date: 2023-05-16 Last Updated: 2023-11-27 Number of Patients: 200 Recruitment Status: RECRUITING Condition: Esophageal Squamous Cell Carcinoma
NCTID: NCT05153330
Title: Study of BMF-219, a Covalent Menin Inhibitor, in Adult Patients With AML, ALL (With KMT2A/ MLL1r, NPM1 Mutations), DLBCL, MM, and CLL/SLL Study Summary: A Phase 1 first-in-human dose-escalation and dose-expansion study of BMF-219, an oral covalent menin inhibitor, in adult patients with AML, ALL (with KMT2A/ MLL1r, NPM1 mutations), DLBCL, MM, and CLL/SLL. Sponsor: Biomea Fusion Inc. Intervention: BMF-219 Start Date: 2022-01-24 Last Updated: 2023-10-06 Number of Patients: 177 Recruitment Status: RECRUITING Condition: Acute Myeloid Leukemia
NCTID: NCT03420742
Title: A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate, Midazolam, in Participants With ALK-Positive or ROS1-Positive Solid Tumors Study Summary: The purpose of this study is to characterize the effect of repeat-dose administration of brigatinib 180 milligram (mg) once daily (QD) on the single-dose pharmacokinetics (PK) of midazolam. Sponsor: Takeda Intervention: Midazolam Start Date: 2019-06-26 Last Updated: 2023-01-27 Number of Patients: 24 Recruitment Status: COMPLETED Condition: Carcinoma, Advanced ALK+ or ROS1+Non-Small-Cell Lung, Neoplasm, Advanced ALK+ or ROS1+Solid Tumors
NCTID: NCT02406742
Title: A Phase 1/2, Open-label, Dose Finding Study to Evaluate CC-122 in Combination With Ibrutinib and Obinutuzumab in Subjects With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Study Summary: Safety, pharmacokinetics, and preliminary efficacy of CC-122 alone and in combination with ibrutinib and obinuzutumab. CC-122 has multiple activities, including immune modulation of several immune cell subsets and antiproliferative activity in CLL. CC-122 has also been shown to have a tolerable safety profile with some preliminary signs of efficacy with early human experience. Sponsor: Celgene Intervention: CC-122 Start Date: 2015-07-27 Last Updated: 2021-09-20 Number of Patients: 47 Recruitment Status: COMPLETED Condition: Leukemia, Lymphocytic, Chronic, B-Cell
NCTID: NCT04521231
Title: A Study of Subcutaneous Blinatumomab Administration in Acute Lymphoblastic Leukemia (ALL) Patients Study Summary: The study aims to evaluate the safety, efficacy, and tolerability of subcutaneous (SC) blinatumomab for treatment of Acute Lymphoblastic Leukemia (ALL), to determine the maximum tolerated dose (MTD), and recommended phase 2 dose(s) (RP2D) of SC administered blinatumomab. It will also conduct a clinical PK evaluation of SC1 and SC2 blinatumomab formulations. Sponsor: Amgen Intervention: Blinatumomab Start Date: 2021-01-04 Last Updated: 2023-11-18 Number of Patients: 125 Recruitment Status: RECRUITING Condition: B Cell Precursor Acute Lymphoblastic Leukemia
NCTID: NCT04586231
Title: A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011) Study Summary: This study will compare the efficacy and safety of belzutifan + lenvatinib versus cabozantinib in participants with advanced renal cell carcinoma (RCC) with clear cell component after prior therapy. The primary hypothesis is that belzutifan + lenvatinib is superior to cabozantinib in terms of progression-free survival or overall survival. Sponsor: Merck Sharp & Dohme LLC Intervention: Belzutifan Start Date: 2021-02-25 Last Updated: 2023-08-14 Number of Patients: 708 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Carcinoma, Renal Cell
NCTID: NCT05124288
Title: Analysis of the Immunobiology of Acute Myeloid Leukemia Relapses After Allogeneic Hematopoietic Stem Cell Transplant (HSCT) for the Generation of Guidelines and Personalized Therapeutic Pathways Study Summary: This is a retrospective and prospective non-interventional multicenter observational study. Neither diagnostic approaches nor experimental drugs/procedure will be applied and the samples will take place at the same time as the samples will be taken during routinary clinical practice. The aim of this study is to analyze the immunobiology of Acute Myeloid Leukemia (AML) relapses after allogeneic HSCT for the generation of guidelines and personalized therapeutic pathways. Sponsor: Ciceri Fabio Intervention: Observations on Relapsed AML Allogeneic Transplanted patients Start Date: 2022-07-18 Last Updated: 2022-07-21 Number of Patients: 500 Recruitment Status: RECRUITING Condition: Acute Myeloid Leukemia, in Relapse
NCTID: NCT00545688
Title: A Study of Pertuzumab in Combination With Herceptin in Patients With HER2 Positive Breast Cancer. Study Summary: This 4 arm study will evaluate the efficacy and safety of 4 neoadjuvant treatment regimens in female patients with locally advanced, inflammatory or early stage HER2 positive breast cancer. Before surgery, patients will be randomized to one of 4 treatment arms, to receive 4 cycles of a)Herceptin + docetaxel b)Herceptin + docetaxel + pertuzumab c)Herceptin + pertuzumab or 4)pertuzumab + docetaxel. Pertuzumab will be administered at a loading dose of 840mg iv, then 420mg iv 3-weekly, Herceptin at a loading dose of 8mg/kg iv then 6mg/kg 3-weekly, and docetaxel at a dose of 75mg/m2 escalating to 100mg/m2 3-weekly. During the entire pre- and post-surgery period all patients will receive adequate chemotherapy as per standard of care, as well as any surgery and/or radiotherapy as required. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Sponsor: Hoffmann-La Roche Intervention: Herceptin Start Date: 2006-06-26 Last Updated: 2017-08-15 Number of Patients: 417 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT01822314
Title: Neoadjuvant Chemotherapy With Nab-paclitaxel in Women With HER2-negative High-risk Breast Cancer Study Summary: The purpose of this study is to assess the efficacy of neoadjuvant weekly nab-paclitaxel followed by Adriamycin, Cyclophosphamide (AC) or Epirubicin, Cyclophosphamide (EC) or Fluorouracil,Epirubicin,Cyclophosphamide (FEC)compared with neoadjuvant weekly solvent-based paclitaxel followed by AC or EC or FEC in terms of rate of pathological complete remissions at surgery. Sponsor: Fondazione Michelangelo Intervention: Abraxane Start Date: 2013-04 Last Updated: 2023-02-15 Number of Patients: 632 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT03031483
Title: Clarithromycin + Lenalidomide Combination: a Full Oral Treatment for Patients With Relapsed/Refractory Extranodal Marginal Zone Lymphoma Study Summary: Patients with lymphoid tissue lymphoma mucosa-associated (MALT) for which the standard treatments with radiotherapy, chemotherapy and / or immunotherapy show lack of efficacy Sponsor: International Extranodal Lymphoma Study Group (IELSG) Intervention: clarithromycin and lenalidomide Start Date: 2017-04-03 Last Updated: 2022-11-07 Number of Patients: 44 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Mucosa Associated Lymphoid Tissue (MALT) Lymphoma
NCTID: NCT03229200
Title: Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib. Study Summary: Multicenter, open-label, prospective treatment protocol that provides continued access to ibrutinib to subjects who have completed parent ibrutinib studies, are still benefitting from treatment with ibrutinib, and have no access to commercial ibrutinib for their underlying disease within their region. Sponsor: Pharmacyclics Switzerland GmbH Intervention: Ibrutinib Start Date: 2017-05-22 Last Updated: 2023-11-24 Number of Patients: 600 Recruitment Status: ENROLLING_BY_INVITATION Condition: Lymphoma, B-Cell
NCTID: NCT02536300
Title: Dose Optimization Study of Idelalisib in Follicular Lymphoma Study Summary: The primary objective of this study is to establish a safe and effective dosing regimen of idelalisib in participants with relapsed or refractory follicular lymphoma (FL) who have no other therapeutic options. Sponsor: Gilead Sciences Intervention: Idelalisib Start Date: 2016-01-14 Last Updated: 2023-08-14 Number of Patients: 96 Recruitment Status: TERMINATED Condition: Follicular Lymphoma
NCTID: NCT02910583
Title: Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CLL/SLL) Study Summary: This is a multicenter, 2-cohort Phase 2 study assessing both minimal residual disease (MRD)-guided discontinuation and fixed duration therapy with the combination of ibrutinib + venetoclax in subjects with treatment-naïve CLL or SLL. Sponsor: Pharmacyclics LLC. Intervention: ibrutinib Start Date: 2016-09-28 Last Updated: 2023-04-18 Number of Patients: 323 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Leukemia
NCTID: NCT04241185
Title: Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Muscle-invasive Bladder Cancer (MIBC) (MK-3475-992/KEYNOTE-992) Study Summary: This study is designed to assess the antitumor efficacy and safety of pembrolizumab in combination with chemoradiotherapy (CRT) versus CRT alone in participants with muscle-invasive bladder cancer (MIBC). The primary hypothesis is that pembrolizumab + chemoradiotherapy is superior to placebo + chemoradiotherapy with respect to bladder intact event-free survival. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2020-05-19 Last Updated: 2023-11-27 Number of Patients: 636 Recruitment Status: RECRUITING Condition: Urinary Bladder Neoplasms
NCTID: NCT02947685
Title: Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer Study Summary: The primary objective of this study is to demonstrate that the combination of palbociclib with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus endocrine therapy alone in improving the outcomes of subjects with hormone receptor-positive, HER2+ metastatic breast cancer. Sponsor: Alliance Foundation Trials, LLC. Intervention: palbociclib Start Date: 2017-06-21 Last Updated: 2023-05-30 Number of Patients: 496 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: HER-2 Positive Breast Cancer
NCTID: NCT02923921
Title: Study of Pegilodecakin (LY3500518) With FOLFOX Compared to FOLFOX Alone Second-line Tx in Participants With Metastatic Pancreatic Cancer Study Summary: To compare the efficacy of pegilodecakin in combination with FOLFOX versus FOLFOX alone in participants with metastatic pancreatic cancer as measured by overall survival. Sponsor: Eli Lilly and Company Intervention: Pegilodecakin Start Date: 2017-03-01 Last Updated: 2020-10-19 Number of Patients: 567 Recruitment Status: COMPLETED Condition: Pancreatic Cancer
NCTID: NCT02993731
Title: A Study of Napabucasin Plus Nab-Paclitaxel With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma Study Summary: This is a randomized, open-label, multi-center, phase 3 study of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine for adult patients with Metastatic Pancreatic Ductal Adenocarcinoma. Sponsor: Sumitomo Pharma America, Inc. Intervention: Napabucasin Start Date: 2016-12 Last Updated: 2023-11-15 Number of Patients: 1134 Recruitment Status: COMPLETED Condition: Carcinoma, Pancreatic Ductal
NCTID: NCT02450331
Title: A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection Study Summary: This Phase III, open-label, randomized, multicenter study is to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with observation in participants with muscle-invasive UC who are at high risk for recurrence following resection. Eligible participants were randomized by a 1:1 ratio into atezolizumab group or control group. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2015-10-05 Last Updated: 2023-06-18 Number of Patients: 809 Recruitment Status: TERMINATED Condition: Carcinoma, Transitional Cell
NCTID: NCT02164955
Title: A Post Authorisation Registry of IMNOVID (Pomalidomide) for Patients With Relapsed and Refractory Multiple Myeloma. Study Summary: This registry is a prospective, multi-center, observational study and will collect safety data on multiple myeloma adult patients who have received at least two prior therapies and take IMNOVID (pomalidomide) as part of standard care. The registry will remain open until 500 patients will have received at least 3 cycles of pomalidomide. All patients registered will be followed for up to 3 years after the informed consent date or until death or withdrawal of consent. During this time the incidence of second primary malignancies (SPM), overall survival and any occurrence of a pregnancy will be assessed. Sponsor: Celgene Intervention: IMNOVID Start Date: 2014-06-26 Last Updated: 2022-10-20 Number of Patients: 775 Recruitment Status: COMPLETED Condition: Multiple Myeloma
NCTID: NCT04662255
Title: Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL) Study Summary: This is a study for participants with a type of blood cancer called mantle cell lymphoma (MCL). The main purpose is to compare pirtobrutinib (LOXO-305) to other drugs that work in a similar way that have already been approved by the United States Food and Drug Administration (US FDA). Participation could last up to two years, and possibly longer, if the disease does not progress. Sponsor: Loxo Oncology, Inc. Intervention: Pirtobrutinib Start Date: 2021-04-08 Last Updated: 2023-10-04 Number of Patients: 500 Recruitment Status: RECRUITING Condition: Lymphoma, Mantle-Cell
NCTID: NCT00637325
Title: Trastuzumab Optimization Trial in Breast Cancer Study Summary: This is an open-label, randomised phase III, multicentre, Italian study designed to investigate the role of trastuzumab in patients with locally advanced and/or metastatic breast cancer over expressing HER2 who received a first line chemotherapy containing trastuzumab. The trial in divided in two studies: 1. The maintenance study will be conducted in patients not progressing to a first line chemotherapy plus trastuzumab. 2. The 2nd line study will be conducted in patients progressing to a first line chemotherapy plus trastuzumab. Sponsor: Regione Lombardia Intervention: trastuzumab Start Date: 2007-11 Last Updated: 2008-03-17 Number of Patients: 500 Recruitment Status: UNKNOWN Condition: Metastatic or Locally Advanced Breast Cancer
NCTID: NCT02293785
Title: GREAT - Good Response With Appropriate Treatment Study Summary: The symptoms associated in advanced cancer patients and adverse events due to use of opioids have major influence on the state of health and quality of life of patients. The pain, in particular, is a symptom with severe negative impact and with a prevalence ranging between 33% and 64%, according to the stage of the disease, with values around 70-90% in advanced stages and metastatic. The use of opioids, however, is usually associated with the appearance of common adverse events as drowsiness/sedation, constipation, nausea/vomiting, and dizziness. Some effects are self-limiting in the time for the appearance of tolerance while others, as constipation persist. Several clinical studies have demonstrated that the association oxycodone-naloxone (OXN), which consists in the union between a molecule agonist and an antagonist of opioid receptors, reduced the constipation in the presence of unchanged analgesic efficacy compared to oxycodone alone. Sponsor: Mario Negri Institute for Pharmacological Research Intervention: Oxycodone-Naloxone Start Date: 2014-11 Last Updated: 2016-03-21 Number of Patients: 200 Recruitment Status: COMPLETED Condition: Cancer Pain
NCTID: NCT00495287
Title: A Remission Induction Therapy and Risk-oriented Postremission Strategy for Adult Acute Myelogenous Leukemia (AML) Study Summary: The study was set up to assess: # Standard-dose versus high-dose remission induction therapy. A standard ICE chemotherapy vs sequential high-dose cytarabine, with appropriate supportive/prophylactic measures, followed by morphological, cytogenetic and molecular monitoring of remission. # A risk-oriented postremission therapy: HR patients will be electively submitted to allogeneic stem cell transplantation (allo-SCT), whenever possible (related/unrelated donor/cord blood; ablative
on-ablative conditioning according to national and local protocols and guidelines). Provided sufficient blood stem cells were previously collected (>2x10e6/kg Cluster of Differentiation 34 cells), SR patients and HR patients excluded from allo-SCT and aged 65 years or less will be randomized to: myeloablative autologous blood stem cell transplantation vs non-myeloablative, multicycle, autologous blood stem cell-supported high-dose cytarabine-based therapy. #* HR/SR patients unable to be randomized because of inadequate blood stem cell yield will receive intermediate-dose consolidation; patients aged >65 years will be treated with age-adapted therapy.
Sponsor: Northern Italy Leukemia Group Intervention: cytosine arabinoside Start Date: 2006-11 Last Updated: 2016-03-31 Number of Patients: 573 Recruitment Status: COMPLETED Condition: Acute Myelogenous Leukemia
NCTID: NCT03523585
Title: DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02] Study Summary: This study will compare DS 8201a to standard treatment. Participants must have HER2 breast cancer that has been treated before. Their cancer: * cannot be removed by an operation * has spread to other parts of the body Sponsor: Daiichi Sankyo, Inc. Intervention: Trastuzumab deruxtecan Start Date: 2018-08-01 Last Updated: 2023-06-26 Number of Patients: 608 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT03804866
Title: NGR-hTNF in Combination With an Anthracycline in Platinum-resistant Ovarian Cancer (NGR018) Study Summary: The primary objective of this extension protocol is to evaluate the early safety of a new schedule of NGR-hTNF given weekly, instead of every 3 or 4 weeks, in a cohort of 12 patients randomized to the experimental arm A, as compared to a reference cohort of 12 patients randomized to an anthracycline alone Sponsor: AGC Biologics S.p.A. Intervention: NGR-hTNF Start Date: 2013-03 Last Updated: 2019-01-15 Number of Patients: 14 Recruitment Status: COMPLETED Condition: Ovarian Cancer
NCTID: NCT03391466
Title: Study of Effectiveness of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma Study Summary: The goal of this clinical study is to assess whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Sponsor: Kite, A Gilead Company Intervention: Axicabtagene Ciloleucel Start Date: 2018-01-25 Last Updated: 2023-07-06 Number of Patients: 359 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
NCTID: NCT03003325
Title: The Benefit/Risk Profile of AOP2014 in Low-risk Patients With PV Study Summary: The Low-PV study is a multicenter, phase II, randomized trial aimed to assess whether the addition of Pegylated Proline-interferon-alpha-2b to the best therapeutic current strategy available based on phlebotomies and low dose acetylsalicylic acid (ASA) could improve the efficacy of treatment of patients with PV at low risk of thrombosis (younger than 60 years and without prior vascular events), in term of control of recommended level of hematocrit < 45%, over a period of 12 months. Sponsor: Fondazione per la Ricerca Ospedale Maggiore Intervention: AOP2014 Start Date: 2017-02-02 Last Updated: 2023-08-03 Number of Patients: 127 Recruitment Status: COMPLETED Condition: Polycythemia Vera
NCTID: NCT03720561
Title: A Study to Evaluate Ibrutinib Retention in Chronic Lymphocytic Leukemia Participants Treated in a Real World Setting Study Summary: The purpose of this study is to describe the 2-year retention rate of ibrutinib treatment for chronic lymphocytic leukemia (CLL) in Italian routine clinical practice. Sponsor: Janssen-Cilag S.p.A. Intervention: Ibrutinib Start Date: 2018-10-30 Last Updated: 2022-01-03 Number of Patients: 312 Recruitment Status: COMPLETED Condition: Leukemia, Lymphocytic, Chronic, B-Cell
NCTID: NCT05806853
Title: PET/MR for Prostate Cancer Restaging: a Phase II Prospective Monocentric Study Study Summary: The overall goal is to provide an innovative approach to restage patients with biochemical recurrence of prostate cancer by using hybrid PET/MR with innovative radiotracers (68Ga-PSMA and 68Ga-RM2) Sponsor: IRCCS San Raffaele Intervention: 68Ga-PSMA Start Date: 2020-06-03 Last Updated: 2023-04-10 Number of Patients: 60 Recruitment Status: COMPLETED Condition: Prostate Cancer
NCTID: NCT04538664
Title: A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions Study Summary: The purpose of this study is to compare the efficacy, as demonstrated by progression-free survival (PFS), in participants treated with amivantamab in combination with chemotherapy, versus chemotherapy alone in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) characterized by EGFR Exon 20ins mutations. Sponsor: Janssen Research & Development, LLC Intervention: Amivantamab Start Date: 2020-10-13 Last Updated: 2023-10-11 Number of Patients: 308 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT01679860
Title: Intensive Chemo-immunotherapy as First Line Treatment in Adult Patients With Peripheral T- Cell Lymphoma Study Summary: Peripheral T cell lymphomas (PTCL) are a rare hematologic disease. Five-year overall survival (OS) of PTCL patients (pts) ranges between 20 and 30%. Allogeneic stem cell transplantation (allo-STC) may have a curative role for these pts but its toxicity is high when myeloablative conditioning is used. Reduced intensity conditionings (RIC) can decrease transplant related toxicity and mortality. The investigators have recently proved feasibility and potential efficacy of a RIC regimen in relapsed PTCL patients. We want to investigate whether it is possible to improve the outcome of alk negative PTCL pts, stage II-IV at diagnosis, by intensifying the therapeutic approach. The intensification will be obtained by combining intensive chemotherapy, alemtuzumab (anti-CD52 humanised antibody) and auto- or allo-SCT in pts aged between 18 and 60 years (Clinical Study A) or adding alemtuzumab to standard chemotherapy (CHOP) in pts aged between 61 and 70 years(Clinical Study B). Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Intervention: Clin A. CHOP-CAMPATH (Chemo-immunotherapy) + SCT Start Date: 2006-11 Last Updated: 2012-09-06 Number of Patients: 92 Recruitment Status: COMPLETED Condition: Lymphoma, T-Cell, Peripheral
NCTID: NCT02668653
Title: Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML) Study Summary: Quizartinib is an experimental drug. It is not approved for regular use. It can only be used in medical research. Adults might be able to join this study after bone marrow tests show they have a certain kind of blood cancer (FLT3-ITD AML). Participants will have an equal chance of receiving quizartinib or placebo along with their chemotherapy. Sponsor: Daiichi Sankyo, Inc. Intervention: Chemotherapy Start Date: 2016-09-01 Last Updated: 2023-11-18 Number of Patients: 539 Recruitment Status: COMPLETED Condition: Acute Myeloid Leukemia
NCTID: NCT03495960
Title: Study on Tailored Treatment in Elderly Patients With Newly Diagnosed Primary Lymphoma of Central Nervous System Study Summary: Primary central nervous system lymphomas are rare aggressive malignancies, usually treated in two steps: an induction phase (where a combination of chemotherapy is given) followed by a consolidation phase (where patients usually receive one of the following: whole-brain irradiation, chemotherapy supported by autologous stem-cell transplantation, other type of chemotherapy, or are just observed). The feasibility of this overall strategy, for several reasons, is limited in elderly patients . This study involves patients aged ≥70 years. The more fit patients will receive the standard chemotherapy combination (high-dose methotrexate, procarbazine and rituximab) as induction. Responding patients will receive either procarbazine or lenalidomide as maintenance therapy; the aim is to evaluate the efficacy of these two drugs. The more fragile patients will receive a less aggressive therapy consisting of concomitant whole-brain radiotherapy, temozolomide and rituximab as induction therapy, followed by temozolomide as maintenance treatment; the aim is to evaluate the efficacy of this combination of treatment. Sponsor: International Extranodal Lymphoma Study Group (IELSG) Intervention: Rituximab Start Date: 2019-06-15 Last Updated: 2023-05-18 Number of Patients: 208 Recruitment Status: RECRUITING Condition: Primary Central Nervous System Lymphoma
NCTID: NCT01477060
Title: Modulation of Response to Hormonal Therapy With Lapatinib and/or Metformin in Patients With Metastatic Breast Cancer Study Summary: Target Population: female patients with HER2-negative, ER and/or PgR positive breast cancer in progression after first-line hormonal therapy. The study rationale is based on the potentiality of reversing endocrine-resistance by Lapatinib * Activity on compensatory-adaptive mechanisms of hyperactivity of signals generated by HER2 family * Modulation of energy balance and signals associated to survival through AMPK activation (via Calmodulin) Metformin * Indirect mechanism, through reduced insulin receptors and IGFR stimulation, with reduces proliferative effects downstream * Direct mechanism, through AMPK activation (via LKB1), with reduced protein synthesis (mTOR inhibition) and increased availability of intracellular energy Lapatinib and Metformin * AMPK “Double”activation, through different potentially additional mechanisms. * Inhibition of proliferative mechanisms for interference on various intracellular target ** IR (A e/o B); IGFR ** EGFR; HER2 Primary objectives : # To assess the rate of patients free from disease progression at 3 months from randomization Secondary objectives : # To assess the overall response rate # To assess the duration of response # To assess 3-years overall survival rate # To assess tolerability of each proposed treatment Female patients with HER2-negative, ER and/or PgR positive breast cancer in progression after first-line hormonal therapy will randomized to receive: hormonal therapy + lapatinib or hormonal therapy + metformin or hormonal therapy + metformin + lapatinib with a ratio 1:1:1. For each arm of the study the following sample size is required: * First step: 23 patients, for a total of 69 patients in all 3 arms * Second step: further 33 patients, for a total of 168 patients in all 3 arms. Sponsor: Fondazione Michelangelo Intervention: Lapatinib Start Date: 2011-11 Last Updated: 2014-02-20 Number of Patients: 32 Recruitment Status: TERMINATED Condition: Metastatic Breast Cancer
NCTID: NCT02625610
Title: Avelumab in First-Line Maintenance Gastric Cancer (JAVELIN Gastric 100) Study Summary: The purpose of this study was to demonstrate superiority of treatment with avelumab versus continuation of first-line chemotherapy. Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: Avelumab Start Date: 2015-12-24 Last Updated: 2022-06-09 Number of Patients: 499 Recruitment Status: COMPLETED Condition: Unresectable, Locally Advanced or Metastatic, Adenocarcinoma of the Stomach, or of the Gastro Esophageal Junction
NCTID: NCT05091567
Title: A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer Study Summary: Study GO43104 is a Phase III, randomized, open-label, multicenter study of lurbinectedin in combination with atezolizumab compared with atezolizumab alone administered as maintenance therapy in participants with extensive-stage small-cell lung cancer (ES-SCLC) after first-line induction therapy with carboplatin, etoposide, and atezolizumab. The study consists of 2 phases: an induction phase and a maintenance phase. Participants need to have an ongoing response or stable disease per the Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 criteria after completion of 4 cycles of carboplatin, etoposide, and atezolizumab induction treatment in order to be considered for eligibility screening for the maintenance phase. Eligible participants will be randomized in a 1:1 ratio to receive either lurbinectedin plus atezolizumab or atezolizumab in the maintenance phase. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2021-11-18 Last Updated: 2023-11-13 Number of Patients: 690 Recruitment Status: RECRUITING Condition: Small-Cell Lung Cancer
NCTID: NCT03568929
Title: Safety Profile of Idelalisib in Patients With Refractory Follicular Lymphoma Study Summary: The primary objective of this study is to assess the overall safety profile of idelalisib monotherapy in patients with refractory follicular lymphoma (FL). Sponsor: Gilead Sciences Intervention: Idelalisib Start Date: 2018-05-25 Last Updated: 2021-11-19 Number of Patients: 257 Recruitment Status: COMPLETED Condition: Follicular Non-Hodgkin’s Lymphoma Refractory
NCTID: NCT00003053
Title: Combination Chemotherapy in Treating Patients With Stage I, II, or IIIA Non-small Cell Lung Cancer That Has Been Surgically Removed Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Randomized phase III trial to compare cisplatin and etoposide with no chemotherapy in treating patients who have stage I, stage II, or stage IIIA non-small cell lung cancer that has been surgically removed. Sponsor: European Institute of Oncology Intervention: cisplatin Start Date: 1994-01 Last Updated: 2013-09-20 Number of Patients: 750 Recruitment Status: UNKNOWN Condition: Lung Cancer
NCTID: NCT00210353
Title: Randomized Trial of Chlorambucil Versus Chlorambucil Plus Rituximab Versus Rituximab in MALT Lymphoma Study Summary: Assess the therapeutic activity and safety of the combination of Chlorambucil and Rituximab in MALT lymphomas and determine whether the addition of Rituximab to Chlorambucil will improve the outcome of MALT lymphoma in comparison to treatment with Chlorambucil alone. In April 2006, a third arm of treatment was added to compare the antitumor activity and safety of rituximab alone vs chlorambucil alone Sponsor: International Extranodal Lymphoma Study Group (IELSG) Intervention: chlorambucil (drug) Start Date: 2003-01 Last Updated: 2019-06-06 Number of Patients: 454 Recruitment Status: COMPLETED Condition: Lymphoma, Mucosa-Associated Lymphoid Tissue
NCTID: NCT01462253
Title: Clofarabine-cyclophosphamide as Salvage Therapy for Refractory and Relapsed Acute Lymphoblastic Leukemia (ALL) Adults Study Summary: This is a multicentric, prospective pilot trial testing a Clofarabine-Cyclophosphamide combination to treat refractory and first bone marrow relapse adult ALL, for the achievement of a complete remission (CR) and the concurrent evaluation of biological response in ALL cells (minimal residual disease, apoptosis and DNA cell damage, pharmacogenomics). Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: Clofarabine, Cyclophosphamide Start Date: 2012-10 Last Updated: 2019-01-25 Number of Patients: 35 Recruitment Status: COMPLETED Condition: Acute Lymphoblastic Leukemia
NCTID: NCT03547973
Title: Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread Study Summary: The objective of this study is to evaluate the efficacy and safety of sacituzumab govitecan-hziy monotherapy and with novel combinations in participants with metastatic urothelial cancer (mUC). Sponsor: Gilead Sciences Intervention: Sacituzumab Govitecan-hziy Start Date: 2018-08-13 Last Updated: 2023-11-13 Number of Patients: 643 Recruitment Status: RECRUITING Condition: Metastatic Urothelial Cancer
NCTID: NCT01485861
Title: Study of Ipatasertib or Apitolisib With Abiraterone Acetate Versus Abiraterone Acetate in Participants With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel Chemotherapy Study Summary: This multicenter, international, Phase Ib/II trial consists of three stages: a Phase Ib, open-label stage in which the recommended Phase II dose was determined for ipataseritib administrated in combination with abiraterone and of apitolisib administrated in combination with abiraterone (this phase is no longer active), a Phase II, 3-arm, double-blind, randomized comparison of ipatasertib with abiraterone and prednisone/prednisolone versus placebo with abiraterone and prednisone/prednisolone and a safety single-arm, open-label cohort of ipatasertib 400 mg daily alone or in combination with prednisone/prednisolone or prednisone/prednisolone plus abiraterone. Sponsor: Genentech, Inc. Intervention: Abiraterone Start Date: 2012-01-11 Last Updated: 2023-09-14 Number of Patients: 298 Recruitment Status: COMPLETED Condition: Prostate Cancer
NCTID: NCT02163694
Title: A Phase 3 Randomized, Placebo-controlled Trial of Carboplatin and Paclitaxel With or Without Veliparib (ABT-888) in HER2-negative Metastatic or Locally Advanced Unresectable BRCA-associated Breast Cancer Study Summary: The primary objective of the study is to assess the progression-free survival (PFS) of veliparib in combination with carboplatin and paclitaxel (C/P) compared to placebo plus C/P in participants with a Breast Cancer Gene 1 or 2 (BRCA1; BRCA2) mutation in Human Epidermal Growth Factor Receptor 2 (HER2)-negative metastatic or locally advanced unresectable breast cancer. The secondary objectives of the study are to assess overall survival (OS), clinical benefit rate (CBR) through the end of Week 24, objective response rate (ORR) and PFS on subsequent therapy (PFS2) in participants treated with veliparib in combination with C/P versus placebo in combination with C/P. Sponsor: AbbVie Intervention: Veliparib Placebo Start Date: 2014-07-17 Last Updated: 2023-02-16 Number of Patients: 509 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Breast Cancer
NCTID: NCT05028660
Title: AURORAX-0093A: Glycosaminoglycan Profiling for Prognostication of Muscle-invasive Bladder Cancer - a Pilot Study Study Summary: AURORAX-0093A (AUR93A) is a pilot cohort observational study that will explore the use of urine and plasma glycosaminoglycans (GAGs) to prognosticate muscle-invasive bladder cancer (MIBC) patients elected for neo-adjuvant chemotherapy (NAC). Sponsor: Elypta Intervention: GAG score Start Date: 2021-07-21 Last Updated: 2023-05-11 Number of Patients: 76 Recruitment Status: RECRUITING Condition: Muscle-Invasive Bladder Carcinoma
NCTID: NCT03740529
Title: A Study of Oral LOXO-305 in Patients With Previously Treated CLL/SLL or NHL Study Summary: This is an open-label, multi-center Phase 1/2 study of oral LOXO-305 (pirtobrutinib) in patients with CLL/SLL and NHL who have failed or are intolerant to standard of care. Sponsor: Loxo Oncology, Inc. Intervention: Pirtobrutinib Start Date: 2018-11-16 Last Updated: 2023-03-08 Number of Patients: 860 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Chronic Lymphocytic Leukemia
NCTID: NCT02904577
Title: Indolent Non Follicular Lymphomas Prognostic Project Study Summary: Prospective collection of data of possible prognostic relevance in patients with indolent non - follicular B-CELL Lymphomas. Sponsor: Fondazione Italiana Linfomi - ETS Intervention: Any treatment, watch and wait policy included Start Date: 2011-09 Last Updated: 2023-09-14 Number of Patients: 370 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Indolent B-Cell Lymphomas
NCTID: NCT04634877
Title: Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053) Study Summary: The purpose of this study is to compare pembrolizumab + adjuvant chemotherapy with placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to disease-free survival (DFS) as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to overall survival (OS). The primary hypotheses are that pembrolizumab + adjuvant chemotherapy is superior to placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to DFS as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to OS. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2021-01-10 Last Updated: 2023-11-21 Number of Patients: 990 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Endometrial Neoplasms
NCTID: NCT00400673
Title: A Risk-Oriented Therapeutic Strategy for Adult Acute Myelogenous Leukemia Study Summary: The study was set up to assess: # A two-step, increasing-intensity remission induction phase. A conventional chemotherapy course (ICE, plus G-CSF) was followed, in unresponsive patients, by sequential high-dose cytarabine (plus G-CSF), aiming to provide an early effective rescue to as many refractory cases as possible. # A risk-oriented postremission consolidation phase. The objective was to adopt allogeneic stem cell transplantation (alloSCT) in high-risk (HR) cases, while standard-risk (SR) ones were consolidated with a multicycle high-dose cytarabine-containing program, which included the use of autologous stem cells plus G-CSF to limit drug-related toxicity and intercycle treatment delays. Sponsor: Northern Italy Leukemia Group Intervention: Two-step remission induction and risk-oriented consolidation Start Date: 2000-05 Last Updated: 2011-04-01 Number of Patients: 581 Recruitment Status: COMPLETED Condition: Acute Myelogenous Leukemia
NCTID: NCT04082364
Title: Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer Study Summary: This is a Phase 2/3, randomized, open-label study for the treatment of patients with HER2-positive Gastric cancer (GC) or Gastroesophageal Junction (GEJ) cancer conducted in two parts. Part A is a single-arm cohort (Cohort A, 40 to 110 patients) will evaluate safety and efficacy of margetuximab plus retifanlimab. Part B has 2 subparts. Cohort B1 has 4 arms (50 patients/arm). Patients will be randomized to margetuximab plus retifanlimab plus chemotherapy, margetuximab plus tebotelimab, plus chemotherapy, margetuximab plus chemotherapy, or trastuzumab plus chemotherapy. The most effective combination with margetuximab from Cohort B1 will be used in Cohort B2. Cohort B2 has 2 arms (250 patients/arm). Patients will be randomized to margetuximab plus retifanlimab or tebotelimab plus chemotherapy, or to trastuzumab plus chemotherapy. Sponsor: MacroGenics Intervention: margetuximab Start Date: 2019-09-30 Last Updated: 2023-09-11 Number of Patients: 82 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Gastric Cancer
NCTID: NCT04725188
Title: Pembrolizumab/Vibostolimab Coformulation (MK-7684A) or Pembrolizumab/Vibostolimab Coformulation Plus Docetaxel Versus Docetaxel for Metastatic Non Small Cell Lung Cancer (NSCLC) With Progressive Disease After Platinum Doublet Chemotherapy and Immunotherapy (MK-7684A-002, KEYVIBE-002) Study Summary: The main purpose of this study is to compare pembrolizumab/vibostolimab coformulation (MK-7684A) plus docetaxel or pembrolizumab/vibostolimab coformulation to normal saline placebo plus docetaxel. Participants with metastatic non-small cell lung cancer (NSCLC) and progressive disease (PD) after platinum doublet chemotherapy and treatment with one prior anti- programmed cell death 1 (PD-1)/ programmed cell death ligand 1(PD-L1) monoclonal antibody (mAb). MK-7684A is a coformulation product of pembrolizumab/vibostolimab. The dual primary hypotheses of the study are pembrolizumab/vibostolimab coformulation plus docetaxel and pembrolizumab/vibostolimab coformulation is superior to normal saline placebo plus docetaxel with respect to progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab/Vibostolimab coformuation Start Date: 2021-04-20 Last Updated: 2023-07-06 Number of Patients: 255 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Non Small Cell Lung Cancer
NCTID: NCT03523572
Title: Trastuzumab Deruxtecan With Nivolumab in Advanced Breast and Urothelial Cancer Study Summary: This is a study of trastuzumab deruxtecan, which was approved by the FDA (in December 2019) for the treatment of HER2-positive unresectable or metastatic breast cancer following two or more prior anti-HER2 based regimens. Participants will receive this study drug along with a cancer drug, an immune checkpoint inhibitor, anti-PD1, called nivolumab. The study will be done in two parts: * Part 1 is to identify the recommended dose to use for treatment. * Part 2 is to find out how well the combination works, and how safe and tolerable it is. Sponsor: Daiichi Sankyo, Inc. Intervention: Trastuzumab deruxtecan Start Date: 2018-06-20 Last Updated: 2021-08-12 Number of Patients: 99 Recruitment Status: UNKNOWN Condition: Breast Cancer
NCTID: NCT04609410
Title: Bleeding in Laparoscopic Liver Surgery Study Summary: Blood loss during liver resection surgery affects patients morbidity, short and long-term mortality. Among non-surgical interventions to minimize intraoperative blood loss and perioperative blood products transfusion, maintaining conditions of low central venous pressure is considered as standard of care. In animals undergoing laparoscopic hepatectomy, reducing airway pressures represents a minimally invasive measure to reduce central venous pressure and therefore bleeding from the hepatic vein. Neuromuscular blocking agents are usually administered during anesthesia to facilitate endotracheal intubation and to improve surgical conditions: a deep level of neuromuscular blockade has already been shown to reduce peak airway pressures and plateau airway pressures in non-abdominal procedures. Such airway pressures reduction can potentially limit bleeding from hepatic veins during transection phase in liver surgery. The aim of the present study is to evaluate the impact of deep neuromuscular blockade on bleeding (as a consequence of reduced airway peak pressure and plateau pressure) in hepatic laparoscopic resections. Patients undergoing laparoscopic liver resection will be randomized to achieve, using intravenous Rocuronium, either a deep neuromuscular blockade (post-tetanic count = 0 and/or = 1 and train of four count = 0) or moderate neuromuscular blockade (train of four count ≥ 1 and/or post-tetanic count > 5) during surgery. Neuromuscular blockade measurements will be performed every 15 minutes. The primary endpoint is to assess the total blood loss at the end of the resection phase. Sponsor: Università Vita-Salute San Raffaele Intervention: Neuromuscular blockade Start Date: 2020-10-30 Last Updated: 2022-06-23 Number of Patients: 200 Recruitment Status: RECRUITING Condition: Neuromuscular Blockade
NCTID: NCT01475110
Title: Observational Study in Adults With Imatinib-resistant/Intolerant Chronic Myeloid Leukemia Treated With Nilotinib Study Summary: The GIMEMA CML Working Party promotes an observational (retrospective and perspective) study of Imatinib-resistant or intolerant CML patients treated with Nilotinib in Italy. Enrollment will include all patients who started Nilotinib between January 2005 and December 2012. Patients will be followed for 4 years since treatment start. After this time, survival data, disease status and treatment will be recorded at 6-months-interval. This study will help the definition of guidelines for a proper management of Nilotinib in any-phase CML patients. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: Imatinib Start Date: 2012-09-13 Last Updated: 2022-10-25 Number of Patients: 19 Recruitment Status: COMPLETED Condition: Chronic Myeloid Leukaemia
NCTID: NCT04873362
Title: A Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy Study Summary: This is a Phase III, two-arm, randomized, double-blind placebo-controlled study in participants with HER2-positive primary breast cancer who have received preoperative chemotherapy and HER2-directed therapy, including trastuzumab followed by surgery, with a finding of residual invasive disease in the breast and/or axillary lymph nodes. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2021-05-04 Last Updated: 2023-11-13 Number of Patients: 1700 Recruitment Status: RECRUITING Condition: Breast Cancer
NCTID: NCT05036564
Title: Diagnosis; Objective RespOnse; THErApy Study Summary: Thi is a prospective and low-intervention clinical trial. We propose to design a panel of “core” genetic alterations by sequencing Cerebral Spinal Fluid (CSF) DNA in patients with confirmed or suspicious Primary Central Neurvous System Lymphoma (PCNSL) with the aim to improve diagnostic sensitivity, response assessment and monitoring early CNS relapse in routine practice. Enrolled patients will receive conventional treatments according to well-established international guidelines, DNA assessments will not influence the treatment choices. Sponsor: IRCCS San Raffaele Intervention: Lumbar puncture Start Date: 2020-10-16 Last Updated: 2021-09-13 Number of Patients: 70 Recruitment Status: RECRUITING Condition: Primary CNS Lymphoma
NCTID: NCT03924895
Title: Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303) Study Summary: This is a study of perioperative pembrolizumab or enfortumab vedotin in combination with pembrolizumab in participants who are cisplatin-ineligible or decline cisplatin with muscle-invasive bladder cancer (MIBC). The primary hypothesis is that perioperative pembrolizumab plus radical cystectomy (RC) plus pelvic lymph node dissection (PLND) and perioperative enfortumab vedotin in combination with pembrolizumab plus RC+PLND will achieve superior event-free survival (EFS) compared with RC+PLND alone. With Amendment 5, outcome measures for programmed cell death ligand 1 (PD-L1) combined positive score (CPS) were removed. With Amendment 8, the primary outcome measure of pathologic complete response (pCR) rates was changed to a secondary outcome measure. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2019-07-24 Last Updated: 2023-11-27 Number of Patients: 857 Recruitment Status: RECRUITING Condition: Urinary Bladder Cancer, Muscle-invasive
NCTID: NCT00813696
Title: Gemcitabine or Gemcitabine and Cisplatin in the Treatment of Advanced Pancreatic Cancer Study Summary: The purpose of this study is to evaluate the impact of the addition of cisplatin to gemcitabine in the treatment of patients with inoperable advanced pancreatic cancer. Sponsor: Istituti Tumori Giovanni Paolo II Intervention: gemcitabine Start Date: 2002-04 Last Updated: 2008-12-23 Number of Patients: 400 Recruitment Status: UNKNOWN Condition: Pancreatic Cancer
NCTID: NCT04165096
Title: KEYMAKER-U01 Substudy 3: Efficacy and Safety Study of Pembrolizumab (MK-3475) When Used With Investigational Agents in Participants With Advanced Non-small Cell Lung Cancer (NSCLC), Previously Treated With Anti-programmed Cell Death Receptor Ligand 1 (PD-L1) Therapy (MK-3475-01C/KEYMAKER-U01C) Study Summary: The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) in combination with boserolimab (MK-5890), MK-4830, MK-0482 in participants with advanced squamous or non-squamous NSCLC that have been previously treated with anti-PD-L1 therapy. This study is one of three pembrolizumab substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01/KEYMAKER-U01). Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2020-01-21 Last Updated: 2023-04-10 Number of Patients: 135 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT01303796
Title: A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia Study Summary: This Phase 3 study assesses two drug regimens as the initial treatment of patients who are at least 70 years of age and have newly diagnosed acute myeloid leukemia (AML) for whom the doctor does not recommend the use of standard intensive treatment or the patient has decided not to receive standard intensive treatment after being fully informed about its benefits and risks by his/her doctor. The two drug regimens are sapacitabine administered in alternating cycles with decitabine or decitabine alone. The purpose of the study is to learn which drug regimen is more likely to keep AML in check as long as possible. Sponsor: Cyclacel Pharmaceuticals, Inc. Intervention: Sapacitabine Start Date: 2011-10-01 Last Updated: 2022-06-22 Number of Patients: 482 Recruitment Status: COMPLETED Condition: Acute Myeloid Leukemia
NCTID: NCT04565496
Title: Phase 2 Study of Neoadjuvant PEMbrolizumab Before Radical PROstatectomy in High-risk Prostate Cancer Patients Study Summary: This is a phase 2, open-label, non-randomized, single-arm study in patients with high-risk PCa diagnosed with prostate biopsy and undergoing RP and ePLND. Pembrolizumab will be administered at the dose of 200 mg intravenously, every 3 weeks, for a total of 3 cycles prior to RP and ePLND. Local, nodal and systemic staging with prostate mpMRI, abdominal and chest CT, PSMA-PET/CT and bone scans will be performed before the administration of pembrolizumab. Surgery will be planned at the time of study inclusion to be done within 3 weeks of the last dose of study drug (screening: 3 weeks; cycle 1 followed by 3 weeks; cycle 2 followed by 3 weeks; cycle 3 followed by 3 weeks to surgery = 12 weeks from inclusion to surgery). Patients will receive 3 cycles of pembrolizumab at 200mg 3 weekly prior to RP and ePLND. Surgery will take place within 3 weeks after the last dose of the study drug. After surgery, patients with the evidence of aggressive disease features (namely, pathologic grade group 4-5; pT3b-4 and/or LNI) will be managed according to local guidelines (adjuvant radiotherapy with or without ADT will be allowed). Further Anti PD-1 therapy will not be given post-operatively. PD-L1 status will be retrospectively assessed on both tumour cells and immune cells in tissue specimens from for all patients enrolled in the study. Sponsor: IRCCS San Raffaele Intervention: Pembrolizumab Start Date: 2021-01-01 Last Updated: 2020-09-25 Number of Patients: 59 Recruitment Status: NOT_YET_RECRUITING Condition: Prostate Cancer
NCTID: NCT01814488
Title: A Phase II Study on Allogeneic Stem Cell Transplantation in Patients With Active Acute Leukemia Study Summary: The experimental treatment consists in the application of a therapeutic strategy of allogeneic transplantation as a potential curative procedure in a population of patients with chemoresistant acute leukemias. Therapeutic intervention, namely the conditioning regimen as well as GVHD prophylaxis, are based on regimens currently in standard use in the context of allogeneic transplantation. Sponsor: Gruppo Italiano Trapianto di Midollo Osseo Intervention: allogeneic transplant Start Date: 2013-07 Last Updated: 2023-03-10 Number of Patients: 101 Recruitment Status: COMPLETED Condition: Acute Leukemia
NCTID: NCT05298423
Title: Study of Pembrolizumab/Vibostolimab (MK-7684A) in Combination With Concurrent Chemoradiotherapy Followed by Pembrolizumab/Vibostolimab Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Stage III Non-small Cell Lung Cancer (MK-7684A-006/KEYVIBE-006) Study Summary: This study is to evaluate the safety and efficacy of pembrolizumab/vibostolimab (MK-7684A) in combination with concurrent chemoradiotherapy (cCRT) followed by pembrolizumab/vibostolimab versus cCRT followed by durvalumab in participants with unresectable, locally advanced, stage III Non-small Cell Lung Cancer (NSCLC). The primary hypotheses are that pembrolizumab/vibostolimab with cCRT followed by pembrolizumab/vibostolimab is superior to cCRT followed by durvalumab with respect to the following: * progression free survival (PFS) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 by blinded independent central review (BICR) in participants with programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥1% and PD-L1 all comer participants. * overall survival (OS) in participants with PD-L1 TPS ≥1% and PD-L1 all comer participants. Sponsor: Merck Sharp & Dohme LLC Intervention: pembrolizumab/vibostolimab Start Date: 2022-05-03 Last Updated: 2023-11-24 Number of Patients: 784 Recruitment Status: RECRUITING Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT04832958
Title: Imaging Guided Surgery to Improve the Detection of Lymph Node Metastases in Prostate Cancer Patients Study Summary: The project aims at assessing the role of radio-guided surgery in the detection of lymph node invasion (LNI) in prostate cancer (PCa) patients undergoing radical prostatectomy (RP) by using an intraoperative gamma probe and a radioactive labelled PSMA ligand (99mTc-PSMA-I&S). We hypothesize that 99mTc-PSMA-I&S radio-guided surgery (99mTc-PSMA-RGS) might assist physicians in the identification of patients with LNI candidate for an extended pelvic lymph node dissection (ePLND). Overall, 100 men with a LNI risk >5% according to the Briganti nomogram will be submitted to 68Ga-PSMA PET/MRI followed by 99mTc-PSMA-RGS and ePLND. The aims are 1) to assess the safety and tolerability of 99mTc-PSMA-I&S; 2) to assess the accuracy of 99mTc-PSMA-RGS in the identification of LNI compared to available clinical tools and to molecular imaging (i.e., 68Ga-PSMA PET/MRI); 3) to assess whether 99mTc-PSMA-RGS would allow for the identification of positive nodes outside the standard ePLND template. Sponsor: IRCCS San Raffaele Intervention: 99m-TC-PSMA-I&S Start Date: 2021-05-15 Last Updated: 2023-01-25 Number of Patients: 100 Recruitment Status: RECRUITING Condition: Prostate Cancer
NCTID: NCT01021423
Title: A Study to Evaluate the Efficacy of Lenalidomide as Maintenance Therapy After Completion of First-line Combination Chemotherapy in Patients With Mantle Cell Lymphoma (MCL). Study Summary: A study to evaluate the efficacy of lenalidomide as maintenance therapy after completion of first-line combination chemotherapy in patients with mantle cell lymphoma (MCL) who are not candidates for transplantation and have achieved partial response (PR) or complete response (CR). This study was prematurely terminated by the sponsor in light of new unpublished data that rendered the current design of the study no longer clinically relevant. A study design with the control arm of no active treatment was no longer appropriate. The termination of the trial was not based on any safety concerns in the study. Sponsor: Celgene Intervention: Lenalidomide Start Date: 2010-04-01 Last Updated: 2019-11-19 Number of Patients: 9 Recruitment Status: TERMINATED Condition: Mantle Cell Lymphoma
NCTID: NCT00910910
Title: Study Of The Effectiveness & Safety Of Lenalidomide Versus Chlorambucil As First Line Therapy For Elderly Patients With B-Cell CLL (The ORIGIN Trial) Study Summary: The purpose of this study is to determine the safety and efficacy of lenalidomide as a first line therapy in treating patients with B-cell Chronic Lymphocytic Leukemia. This study will compare the effects (good and bad) of lenalidomide with chlorambucil. Sponsor: Celgene Intervention: Lenalidomide Start Date: 2009-10-13 Last Updated: 2019-07-09 Number of Patients: 450 Recruitment Status: COMPLETED Condition: B-Cell Chronic Lymphocytic Leukemia
NCTID: NCT03786094
Title: Pivotal Study in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer Study Summary: This is a phase 3, multicenter, open-label, randomized active-controlled, parallel group to investigate the efficacy, safety and tolerability of intravenous balixafortide given with eribulin versus eribulin alone in the treatment of HER2 negative, Locally Recurrent or Metastatic Breast Cancer. Sponsor: Spexis AG Intervention: Eribulin Start Date: 2019-05-30 Last Updated: 2023-11-01 Number of Patients: 432 Recruitment Status: TERMINATED Condition: Metastatic Breast Cancer
NCTID: NCT00657878
Title: Efficacy Study of Chemotherapy to Treat Ovarian Cancer Recurrence by Prolonging the Platinum Free Interval Study Summary: This study aims to test the hypothesis that the artificial prolongation of the platinum-free interval with a non-platinum treatment will improve the effectiveness of overall therapy in patients with ovarian cancer progression occurring 6-12 months after first-line treatment with a platinum-derivative. Sponsor: National Cancer Institute, Naples Intervention: stealth liposomal doxorubicin Start Date: 2008-11 Last Updated: 2023-11-13 Number of Patients: 215 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Ovarian Cancer
NCTID: NCT05495295
Title: First-in-human Trial of PhOx430, a First-in-class Acetylglucosaminyltransferase V Inhibitor, in Advanced Solid Tumours Study Summary: The PhAST Trial is an adaptive first-in-human clinical trial of the acetylglucosaminyltransferase V inhibitor PhOx430 in patients with advanced solid tumours conceived and designed with the contribution of the Gianni Bonadonna Foundation, a non-profit academic research institution aimed at promoting therapeutic innovation in oncology.. The trial includes two parts, a dose escalation phase which will enroll patients with non-selected tumour types, followed by a cohort expansion phase in selected tumour types. Sponsor: Phost’In Therapeutics Intervention: PhOx430 Start Date: 2022-07-18 Last Updated: 2022-08-10 Number of Patients: 146 Recruitment Status: RECRUITING Condition: Malignant Tumor
NCTID: NCT04754035
Title: Clinical Study With Ibrutinib and Venetoclax for Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia Study Summary: This is a Phase 2a, multicenter, open-label uncontrolled study aimed at determining therapeutic benefits of the addition of ibrutinib to venetoclax in patients with relapsed/refractory CLL based on a MRD-guided approach. Sponsor: Paolo Ghia Intervention: Venetoclax Start Date: 2017-11-08 Last Updated: 2023-10-03 Number of Patients: 31 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Chronic Lymphocytic Leukemia
NCTID: NCT04961996
Title: A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician’s Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer) Study Summary: This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with endocrine therapy of physician’s choice in participants with medium- and high-risk Stage I-III histologically confirmed estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative early breast cancer. In addition, an open-label exploratory substudy will explore the safety and efficacy of giredestrant in combination with abemaciclib in a subset of the primary study population. Sponsor: Hoffmann-La Roche Intervention: Giredestrant Start Date: 2021-08-27 Last Updated: 2023-11-18 Number of Patients: 4200 Recruitment Status: RECRUITING Condition: Early Breast Cancer
NCTID: NCT05568095
Title: A Clinical Trial of a New Combination Treatment, Domvanalimab and Zimberelimab, Plus Chemotherapy, for People With an Upper Gastrointestinal Tract Cancer That Cannot be Removed With Surgery That Has Spread to Other Parts of the Body Study Summary: This randomized Phase 3 open-label study will compare the efficacy of the T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif (ITIM) domain (TIGIT) monoclonal antibody domvanalimab, the anti programmed cell death protein 1 (PD-1) monoclonal antibody zimberelimab, and multiagent chemotherapy versus the anti PD-1 monoclonal antibody nivolumab and multiagent chemotherapy in the first-line treatment of participants with locally advanced unresectable or metastatic gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma. Sponsor: Arcus Biosciences, Inc. Intervention: Domvanalimab Start Date: 2022-11-21 Last Updated: 2023-11-15 Number of Patients: 970 Recruitment Status: RECRUITING Condition: Advanced Upper Gastrointestinal Tract Adenocarcinoma
NCTID: NCT03096496
Title: Long-term QoL in Acute Promyelocytic Leukemia Treated With ATO or Standard Chemotherapy Study Summary: This is a prospective and international observational study run by the GIMEMA. All data will be centrally collected and analyzed at the GIMEMA Data Center in Rome (Italy). Patients reported outcomes will be collected using internationally validated questionnaires. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: QoL questionnaires Start Date: 2017-03-27 Last Updated: 2021-02-08 Number of Patients: 161 Recruitment Status: UNKNOWN Condition: Acute Promyelocytic Leukemia
NCTID: NCT03875495
Title: A Phase I/II Study Evaluating Temferon in Multiple Myeloma Patients With Early Relapse After Front Line Therapy (TEM-MM) Study Summary: This is a non-randomized, open label, phase I/II, dose-escalation study, involving a single injection of Temferon, an investigational advanced therapy consisting of autologous CD34+-enriched hematopoietic stem and progenitor cells exposed to transduction with a lentiviral vector driving myeloid-specific interferon-ɑ2 expression, which will be administered to up to 9 patients affected by multiple myeloma in early relapse after intensive front line treatment. Sponsor: Genenta Science Intervention: Temferon Start Date: 2019-03-06 Last Updated: 2022-01-28 Number of Patients: 9 Recruitment Status: TERMINATED Condition: Multiple Myeloma
NCTID: NCT03397394
Title: Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Study Summary: The purpose of the ATLAS study is to determine how patients with locally advanced unresectable or metastatic urothelial carcinoma respond to treatment with rucaparib. Sponsor: pharmaand GmbH Intervention: Rucaparib Start Date: 2018-06-01 Last Updated: 2023-06-09 Number of Patients: 97 Recruitment Status: TERMINATED Condition: Bladder Cancer
NCTID: NCT04628494
Title: A Phase 3 Trial of Epcoritamab vs Investigator’s Choice Chemotherapy in R/R DLBCL Study Summary: The drug that will be investigated in the study is an antibody, epcoritamab, also known as EPKINLY™ and GEN3013. Since the safety and tolerability of epcoritamab has already been studied in previous studies in humans, the main purpose of this study is to evaluate efficacy. To evaluate this, half of the participants who are eligible will receive epcoritamab and the other half will receive a pre-specified investigator’s choice of chemotherapy. Epcoritamab will be studied in R/R DLBCL participants who did not respond to a previous autologous stem cell transplant (ASCT) or do not meet the criteria for ASCT Sponsor: Genmab Intervention: Epcoritamab Start Date: 2021-01-13 Last Updated: 2023-08-07 Number of Patients: 552 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Diffuse Large B-cell Lymphoma
NCTID: NCT03711032
Title: Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676) Study Summary: This study is designed to assess the antitumor efficacy and safety of pembrolizumab in combination with BCG, compared to BCG monotherapy, in participants with HR NMIBC that is either persistent or recurrent following adequate BCG induction (Cohort A), or that is naïve to BCG treatment (Cohort B). The primary hypothesis for Cohort A is that the combination of pembrolizumab plus BCG has a superior complete response rate (CRR) as assessed by central pathology review compared to BCG in participants with carcinoma in situ (CIS). The primary hypothesis for Cohort B is that the combination of pembrolizumab plus BCG (either reduced maintenance or full maintenance) has a superior Event Free Survival (EFS) compared to BCG. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2018-12-24 Last Updated: 2023-11-27 Number of Patients: 1405 Recruitment Status: RECRUITING Condition: High-risk Non-muscle Invasive Bladder Cancer
NCTID: NCT02513394
Title: PALbociclib CoLlaborative Adjuvant Study Study Summary: This is a prospective, two arm, international, multicenter, randomized, open-label Phase III study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ / HER2- early breast cancer (EBC). The purpose of the PALLAS study is to determine whether the addition of palbociclib to adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HR+/HER2- early breast cancer. Assessment of a variety of correlative analysis, including evaluation of the effect of palbociclib in genomically defined tumor subgroups, is planned. Sponsor: Alliance Foundation Trials, LLC. Intervention: Palbociclib Start Date: 2015-08 Last Updated: 2023-06-15 Number of Patients: 5796 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT01820910
Title: Phase II Trial of First-line Doxycycline for Ocular Adnexal Marginal Zone Lymphoma Treatment Study Summary: Objective of this trial is to establish the efficacy of an upfront targeted therapy consisting of Chlamydophila psittaci (Cp)-eradicating therapy with prolonged administration of doxycycline followed by eradication monitoring and antibiotic re-treatment at infection re-occurrence in patients with newly diagnosed ocular adnexae marginal zone lymphoma The primary endpoint is the 2-year progression-free survival (PFS) of patients with newly diagnosed stage-IE lymphoma treated with the experimental strategy. Sponsor: International Extranodal Lymphoma Study Group (IELSG) Intervention: Doxycycline Start Date: 2013-03 Last Updated: 2023-05-18 Number of Patients: 34 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Marginal Zone Lymphoma of Ocular Adnexal
NCTID: NCT04416984
Title: Safety and Efficacy of ALLO-501A Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell Lymphoma (ALPHA2) Study Summary: The purpose of the ALPHA-2 study is to assess the safety, efficacy, and cell kinetics of ALLO-501A in adults with relapsed or refractory large B-cell lymphoma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647 Sponsor: Allogene Therapeutics Intervention: ALLO-501A Start Date: 2020-05-21 Last Updated: 2023-11-07 Number of Patients: 160 Recruitment Status: RECRUITING Condition: Relapsed/Refractory Large B Cell Lymphoma
NCTID: NCT02281084
Title: Safety and Efficacy Study of CC-486 in Subjects With Myelodysplastic Syndromes Study Summary: Evaluate the safety and efficacy of oral azacitidne (CC-486) twice daily (BID) in subjects with myelodysplastic syndromes who failed to achieve an objective response post injectable hypomethylating agent (iHMA) treatment Reason for removing the combination arm: Due to difficulties with dose-finding, the durvalumab plus CC-486 combination arm was closed to enrollment. Extension: An Extension Phase (EP) has been added to allow subjects who are currently receiving oral azacitidine BID and who are demonstrating clinical benefit as assessed by the Investigator, to continue receiving oral azacitidine until the subject meets the criteria for study discontinuation. Sponsor: Celgene Intervention: Oral Azacitidine Start Date: 2015-07-06 Last Updated: 2023-07-28 Number of Patients: 65 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Myelodysplastic Syndromes
NCTID: NCT02625623
Title: Avelumab in Third-Line Gastric Cancer (JAVELIN Gastric 300) Study Summary: The purpose of this study was to demonstrate superiority of treatment with avelumab plus best supportive care (BSC) versus physician’s choice (chosen from a pre-specified list of therapeutic options) plus BSC. Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: Avelumab Start Date: 2015-12-28 Last Updated: 2020-11-24 Number of Patients: 371 Recruitment Status: COMPLETED Condition: Unresectable, Recurrent, Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
NCTID: NCT01772472
Title: A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE) Study Summary: This 2-arm, randomized, open-label study will evaluate the efficacy and safety of trastuzumab emtansine versus trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer who have residual tumor present in the breast or axillary lymph nodes following preoperative therapy. Eligible patients will be randomized to receive either trastuzumab emtansine 3.6 mg/kg or trastuzumab 6 mg/kg intravenously every 3 weeks for 14 cycles. Radiotherapy and/or hormone therapy will be given in addition if indicated. Sponsor: Hoffmann-La Roche Intervention: trastuzumab Start Date: 2013-04-03 Last Updated: 2023-11-13 Number of Patients: 1487 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT03250338
Title: Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R/R FLT3 Mutated AML Study Summary: This is a randomized, multi-center, double-blind, placebo-controlled study designed to evaluate the efficacy of crenolanib administered following salvage chemotherapy, consolidation chemotherapy, post bone marrow transplantation and as maintenance in relapsed/refractory AML subjects with FLT3 activating mutation. Sponsor: Arog Pharmaceuticals, Inc. Intervention: Crenolanib Start Date: 2018-06-05 Last Updated: 2021-04-30 Number of Patients: 322 Recruitment Status: RECRUITING Condition: Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations
NCTID: NCT01572038
Title: A Study of Pertuzumab in Combination With Trastuzumab (Herceptin) and a Taxane in First-Line Treatment in Participants With Human Epidermal Growth Factor 2 (HER2)-Positive Advanced Breast Cancer Study Summary: This multicenter, open-label, single-arm, Phase IIIb study will evaluate the safety and tolerability of pertuzumab in combination with trastuzumab (Herceptin) and a taxane (docetaxel, paclitaxel or nab-paclitaxel) in first-line treatment in participants with metastatic or locally recurrent HER2-positive breast cancer. Participants will receive pertuzumab intravenously (IV) and trastuzumab (Herceptin) IV plus a taxane in cycles of 3 weeks each until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurs first. Sponsor: Hoffmann-La Roche Intervention: Docetaxel Start Date: 2012-06-01 Last Updated: 2020-09-25 Number of Patients: 1436 Recruitment Status: COMPLETED Condition: Breast Neoplasms
NCTID: NCT04385992
Title: Neoadjuvant PRRT With 177Lu-DOTATATE Followed by Surgery for Resectable PanNET Study Summary: Peptide Receptor Radionuclide Therapy (PRRT) is based on specific somatostatin receptor targeting with radiolabelled analogues 90Y-DOTATOC and 177Lu-DOTATATE. These two most commonly used radiopeptides, 90Y-DOTATOC and 177Lu-DOTATATE, produce overall objective response rates of 15-35%. PRRT is generally well tolerated with mild toxicity, if the necessary precautions, such as the co-administration of nephroprotective amino acids or the adjustment of the administered activity, are taken. The main aim of this study is to evaluate the safety and the efficacy of neoadjuvant PRRT with 177Lu-DOTATATE followed by surgical resection for resectable non-functioning PanNETs at high risk of recurrence. The primary endpoint is the Rate of postoperative 90-day morbidity and mortality after neoadjuvant PRRT with 177Lu-DOTATATE followed by pancreatic resection and the secondary endpoints are: # Rate of objective radiological response to PRRT with 177Lu-DOTATATE according to RECIST criteria (version 1.1), for primary lesions’ assessment, and modified RECIST criteria (mRECIST), for liver metastases’ assessment, if detected # Quality of life (QoL) after neoadjuvant PRRT followed by pancreatic surgical resection. The study is designed as a prospective phase II single-arm trial. 8 Italian centers will participate to the study (6 surgical sites, 2 nuclear medicine sites). Patients will be recruited for 12 months. The study will end 2 months after operation of the last patient enrolled and the total duration of the study will be 24 months. Sample size estimation: 30 patients Sponsor: IRCCS San Raffaele Intervention: 177Lu-Dotatate Start Date: 2020-03-09 Last Updated: 2023-06-27 Number of Patients: 31 Recruitment Status: COMPLETED Condition: Neuroendocrine Tumors
NCTID: NCT02836925
Title: Ledipasvir+Sofosbuvir and Sofosbuvir+Velpatasvir for Pts With Indolent Bcell Lymphoma Associated With HCV Infection Study Summary: This is a non-randomized, a single arm, phase II multicentre study of sofosbuvir plus ledipasvir (genotype 1 and 4) or sofosbuvir plus velpatasvir (genotype 2 and 3) for patients with hepatitis C virus-associated indolent B-cell lymphomas (HCV-RNA positive). Sponsor: Fondazione Italiana Linfomi - ETS Intervention: Ledipasvir+Sofosbuvir Start Date: 2016-03 Last Updated: 2023-03-31 Number of Patients: 40 Recruitment Status: COMPLETED Condition: Indolent B-cell Lymphoma
NCTID: NCT03248492
Title: A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1) Study Summary: Some human epidermal growth factor receptor 2 (HER-2) breast cancer patients do not respond or become resistant to current treatment. DS-8201a is a new experimental product that is a combination of an antibody and a drug. It has not yet been approved for use. DS-8201a may slow down tumor growth. This might improve outcomes for these patients. Sponsor: Daiichi Sankyo, Inc. Intervention: DS-8201a Start Date: 2017-08-25 Last Updated: 2023-11-15 Number of Patients: 253 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT04712292
Title: Effects of COVID-19 Pandemic on the Outcomes of Colorectal Cancer Study Summary: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has been identified as the cause of the Coronavirus disease 19 (COVID-19), which was initially reported in December 2019 in China and has since rapidly spread worldwide. Since then, the COVID-19 pandemic has caused a detrimental effect of the national health care system, causing a drastic reduction of the screening programs for colorectal cancer and requiring the redistribution of the hospital resources from elective surgery to the care of patients with SARS-Cov_2 infection requiring admission. Sponsor: University of Bologna Intervention: Surgical procedure for confirmed or suspected colorectal cancer Start Date: 2020-09-08 Last Updated: 2022-02-28 Number of Patients: 15000 Recruitment Status: RECRUITING Condition: Colorectal Neoplasms Malignant
NCTID: NCT02007512
Title: Efficacy and Safety Study of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer Study Summary: The purpose of this study is to determine if enzalutamide given in combination with exemestane is safe and effective in patients with advanced breast cancer. Sponsor: Pfizer Intervention: Enzalutamide Start Date: 2013-12-13 Last Updated: 2023-04-27 Number of Patients: 247 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT05977673
Title: Efficacy and Safety of Frontline Tislelizumab in Patients With de Novo Hodgkin Lymphoma Unsuitable for Standard Frontline Chemotherapy Study Summary: This is a multicenter, prospective, non-randomized, open-label, phase 2 clinical study to evaluate the efficacy and safety of tislelizumab in patients with de novo Hodgkin Lymphoma deemed ineligible to frontline chemotherapy. Sponsor: Fondazione Italiana Linfomi - ETS Intervention: Tislelizumab Start Date: 2023-12 Last Updated: 2023-11-24 Number of Patients: 28 Recruitment Status: NOT_YET_RECRUITING Condition: Hodgkin Lymphoma
NCTID: NCT02021500
Title: A Study to Collect Survival Data on Patients Previously Enrolled in Abraxane Pancreatic Cancer Study CA046. Study Summary: A study to collect survival data on patients previously enrolled in Abraxane pancreatic cancer study CA046. Sponsor: Celgene Intervention: ABI-007 Start Date: 2014-01-02 Last Updated: 2019-11-01 Number of Patients: 40 Recruitment Status: COMPLETED Condition: Pancreatic Cancer
NCTID: NCT04658862
Title: A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder Study Summary: The purpose of study is to compare bladder intact-event free survival (BI-EFS) in participants receiving TAR-200 in combination with intravenous (IV) cetrelimab versus concurrent chemoradiotherapy. Sponsor: Janssen Research & Development, LLC Intervention: Cetrelimab Start Date: 2020-12-07 Last Updated: 2023-11-07 Number of Patients: 550 Recruitment Status: RECRUITING Condition: Urinary Bladder Neoplasms
NCTID: NCT04416672
Title: Validation of the Italian Version of the PRO-CTCAE Study Summary: The aim of this study is to complete the validation process by testing the remaining two psychometric properties (validity and responsiveness) of the Italian version of the PRO-CTCAE in a large group of patients. In particular, for the first time this study will validate the tool for individual types of cancer and will provide information on psychometric properties based on the type of treatment used in clinical practice. Sponsor: National Cancer Institute, Naples Intervention: PRO-CTCAE items Start Date: 2018-07-01 Last Updated: 2023-03-24 Number of Patients: 3675 Recruitment Status: RECRUITING Condition: Malignant Neoplasms
NCTID: NCT04222972
Title: A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) Study Summary: This is an international, randomized, open-label, Phase 3 study designed to evaluate whether the potent and selective RET inhibitor, pralsetinib, improves outcomes when compared to a platinum chemotherapy-based regimen chosen by the Investigator from a list of standard of care treatments, as measured primarily by progression free survival (PFS), for participants with RET fusion-positive metastatic NSCLC who have not previously received systemic anticancer therapy for metastatic disease. Participants who have centrally confirmed progressive disease on the control arm have the option to crossover to pralsetinib. Sponsor: Hoffmann-La Roche Intervention: Pralsetinib Start Date: 2020-07-24 Last Updated: 2023-11-13 Number of Patients: 226 Recruitment Status: RECRUITING Condition: RET-fusion Non Small Cell Lung Cancer
NCTID: NCT03368378
Title: Early DVC Ligation and Urinary Continence Recovery After RARP Study Summary: The aim of the study is to evaluate the impact of early deep venous complex ligation (eDVCL) in patients affected by clinically localized prostate cancer (PCa) undergoing robot-assisted radical prostatectomy with or without pelvic lymph node dissection. Overall, 312 patients will be randomized to the standard technique vs. eDVCL. The primary endpoint is represented by early urinary continence recovery. The secondary endpoints are perioperative outcomes, erectile function recovery and positive surgical margins. Sponsor: IRCCS San Raffaele Intervention: Early DVC ligation Start Date: 2017-11-28 Last Updated: 2020-09-23 Number of Patients: 312 Recruitment Status: COMPLETED Condition: Prostate Cancer
NCTID: NCT04895358
Title: Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49) Study Summary: The safety and efficacy of pembrolizumab plus the investigator’s choice of chemotherapy will be assessed compared to placebo plus the investigator’s choice of chemotherapy in the treatment of chemotherapy-candidate hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally recurrent inoperable or metastatic breast cancer. The primary hypotheses are that the combination of pembrolizumab and chemotherapy is superior to placebo and chemotherapy in regards to Progression-Free Survival (PFS) or overall survival (OS) in participants with programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) ≥1 and ≥10. Sponsor: Merck Sharp & Dohme LLC Intervention: pembrolizumab Start Date: 2021-06-18 Last Updated: 2023-11-27 Number of Patients: 800 Recruitment Status: RECRUITING Condition: Breast Neoplasms
NCTID: NCT05671510
Title: ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors Study Summary: The goal of this Phase 3 clinical trial is study the safety and efficacy of the nextgen anti-CTLA-4 antibody, gotistobart (ONC-392/BNT316), in patients with metastatic non-small cell lung cancer who have disease progressed on anti-PD-1/PD-L1 antibody based therapy. The study will test whether gotistobart, in comparison with chemotherapy agent docetaxel, could prolong the life for NSCLC patients. Patients will be randomized to be treated with either gotistobart or docetaxel, IV infusion, once every 21 days, for up to 17 cycles in approximately one year. Sponsor: OncoC4, Inc. Intervention: Gotistobart Start Date: 2023-06-28 Last Updated: 2023-10-12 Number of Patients: 600 Recruitment Status: RECRUITING Condition: Non Small Cell Lung Cancer
NCTID: NCT03539536
Title: Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer Study Summary: This study is designed to identify the target Non-Small Cell Lung Cancer (NSCLC) population(s) that overexpress c-Met (c-Met+) best suited for telisotuzumab vedotin therapy in the second line or third line setting (Stage 1) and then to expand the group(s) to further evaluate efficacy in the selected population(s) (Stage 2). After the Stage 2 global enrollment is completed, an additional cohort at an alternate dose level will evaluate the safety and efficacy of telisotuzumab vedotin (Stage 3). Sponsor: AbbVie Intervention: Telisotuzumab vedotin Start Date: 2018-10-10 Last Updated: 2023-07-14 Number of Patients: 270 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-small Cell Lung Cancer
NCTID: NCT02620280
Title: Neoadjuvant Therapy in TRIPle Negative Breast Cancer With antiPDL1 Study Summary: This study that aims to evaluate the addition of MPDL3280A (atezolizumab) to carboplatin and nab-paclitaxel in patients with early high-risk and locally advanced triple negative breast cancer. compared to the control arm of carboplatin and abraxane. Half of participants will receive MPDL3280A in combination with carboplatin and abraxane, while the other half will receive only carboplatin and abraxane. Sponsor: Fondazione Michelangelo Intervention: Carboplatin Start Date: 2016-04 Last Updated: 2023-02-15 Number of Patients: 278 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Invasive Ductal Breast Carcinoma
NCTID: NCT06037980
Title: CisPlatin plUs Gemcitabine and Nabpaclitaxel (GAP) as pReoperative Chemotherapy Versus Immediate Resection in patIents With resecTable BiliarY Tract Cancers (BTC) at High Risk for Recurrence Study Summary: PURITY is a multicentre, randomized adaptive phase II/III trial aimed at comparing the triplet combination of gemcitabine, cisplatin and nabpaclitaxel as neoadjuvant treatment (ARM A) versus standard upfront surgery (ARM B) in terms of 12-month PFS rate (phase II part) and PFS (phase III part) in patients with resectable BTC at high risk for recurrence. Sponsor: Gruppo Oncologico del Nord-Ovest Intervention: Gemcitabine Start Date: 2023-11-07 Last Updated: 2023-11-15 Number of Patients: 300 Recruitment Status: RECRUITING Condition: Biliary Tract Cancer
NCTID: NCT03963024
Title: Treosulfan-TMI Conditioning and Rapamycin GvHD Prophylaxis Before Allo-HSCT Study Summary: TrRaMM-TMI is a phase I trial to evaluate the feasibility and efficacy of an original sequential TMI/TrRaMM (Total Marrow Irradiation/Treosulfan-Rapamycin-Mycophenolate Mofetil) schedule in patients with hematological malignancies in advanced stage of disease undergoing an allogenic Stem Cell Transplant (SCT). The aim is to determine the maximum tolerated dose of TMI when combined with conditioning chemotherapy to transplant according to TrRaMM schedule. Sponsor: IRCCS San Raffaele Intervention: Conditioning treatment “Treosulfan-TMI” Start Date: 2014-02-12 Last Updated: 2020-10-19 Number of Patients: 9 Recruitment Status: TERMINATED Condition: Irradiated Bone Marrow
NCTID: NCT03175224
Title: APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Study Summary: To assess: * efficacy of APL-101 as monotherapy for the treatment of NSCLC harboring MET Exon 14 skipping mutations, NSCLC harboring MET amplification, solid tumors harboring MET amplification, solid tumors harboring MET fusion, primary CNS tumors harboring MET alterations, solid tumors harboring wild-type MET with overexpression of HGF and MET * efficacy of APL-101 as an add-on therapy to EGFR inhibitor for the treatment of NSCLC harboring EGFR activating mutations and developed acquired resistance with MET amplification and disease progression after documented CR or PR with 1st line EGFR inhibitors (EGFR-I) Sponsor: Apollomics Inc. Intervention: APL-101 Oral Capsules Start Date: 2017-09-27 Last Updated: 2023-10-23 Number of Patients: 497 Recruitment Status: RECRUITING Condition: Solid Tumors
NCTID: NCT00598624
Title: Clinical Trial to Evaluate the Safety and Efficacy of Treosulfan Based Conditioning Prior to Allogeneic Haematopoietic Stem Cell Transplantation (HSCT) Study Summary: This is a multicentric, non-randomized, non-controlled open-label phase II trial to evaluate the safety and efficacy of treosulfan in a combination regimen with fludarabine as conditioning therapy prior to allogeneic stem cell transplantation (SCT) in patients with haematological malignancies. The aim is to demonstrate a clinical benefit compared with historical data on intravenous busulfan (BusulfexTM, BusilvexTM), the only drug so far registered in the indication conditioning before allogeneic stem cell transplantation. Sponsor: IRCCS San Raffaele Intervention: Treosulfan IV Start Date: 2005-09 Last Updated: 2009-08-11 Number of Patients: 175 Recruitment Status: UNKNOWN Condition: Leukemia
NCTID: NCT05091424
Title: A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia Study Summary: This study will assess the safety, tolerability, pharmaokinetics, and preliminary efficacy of mosunetuzumab in participants with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL). Sponsor: Hoffmann-La Roche Intervention: Mosunetuzumab Start Date: 2022-03-07 Last Updated: 2023-11-02 Number of Patients: 56 Recruitment Status: RECRUITING Condition: Chronic Lymphocytic Leukemia
NCTID: NCT03940196
Title: Effect of Tumor Treating Fields (TTFields, 200 kHz) Concomitant With Weekly Paclitaxel for the Treatment of Recurrent Ovarian Cancer (ENGOT-ov50 / GOG-3029 / INNOVATE-3) Study Summary: The study is a prospective, randomized controlled phase III trial aimed to test the efficacy and safety of Tumor Treating Fields (TTFields) concomitant with weekly paclitaxel for the treatment of recurrent ovarian cancer . The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays. Sponsor: NovoCure Ltd. Intervention: NovoTTF-100L(O) Start Date: 2019-03-22 Last Updated: 2022-04-20 Number of Patients: 540 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Ovarian Cancer
NCTID: NCT03262935
Title: SYD985 vs. Physician’s Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer Study Summary: The purpose of this study is to demonstrate that SYD985 <math display="block">(vic-)trastuzumab duocarmazine</math> is superior to physician’s choice in prolonging progression free survival. Sponsor: Byondis B.V. Intervention: (vic-)trastuzumab duocarmazine Start Date: 2017-12-15 Last Updated: 2023-10-19 Number of Patients: 437 Recruitment Status: COMPLETED Condition: Metastatic Breast Cancer
NCTID: NCT04384484
Title: Study to Evaluate Loncastuximab Tesirine With Rituximab Versus Immunochemotherapy in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma Study Summary: The purpose of this study is to evaluate the efficacy of loncastuximab tesirine (ADCT-402) combined with rituximab compared to standard immunochemotherapy. Sponsor: ADC Therapeutics S.A. Intervention: Loncastuximab Tesirine Start Date: 2020-09-16 Last Updated: 2023-09-21 Number of Patients: 350 Recruitment Status: RECRUITING Condition: Relapsed Diffuse Large B-Cell Lymphoma
NCTID: NCT05498428
Title: A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer Study Summary: The purpose of this study is to assess the anti-tumor activity and safety of amivantamab which will be administered as a co-formulation with recombinant human hyaluronidase PH20 (rHuPH20) (subcutaneous co-formulation <math display="block">SC-CF</math>) in combination treatment (all cohorts except Cohort 4) and to characterize the safety of amivantamab SC-CF (Cohort 4). Sponsor: Janssen Research & Development, LLC Intervention: Amivantamab Start Date: 2022-11-11 Last Updated: 2023-11-18 Number of Patients: 390 Recruitment Status: RECRUITING Condition: Carcinoma, Non-small-Cell Lung
NCTID: NCT04793932
Title: Short-course Versus Long-course Pre-operative Chemotherapy With mFOLFIRINOX or PAXG (CASSANDRA TRIAL) Study Summary: The main aim of this study is to compare the efficacy of short-course versus long-course pre-operative chemotherapy with PAXG or mFOLFIRINOX in patients who receive a diagnosis of pancreatic ductal adenocarcinoma (PDAC) resectable or borderline resectable. Sponsor: Associazione Italiana per lo Studio del Pancreas Intervention: PAXG Start Date: 2020-11-03 Last Updated: 2021-03-11 Number of Patients: 261 Recruitment Status: UNKNOWN Condition: Pancreas Ductal Adenocarcinoma
NCTID: NCT04740918
Title: A Study of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo as a Treatment for Participants With Human Epidermal Growth Factor 2 (HER2)-Positive and Programmed Death-ligand 1 (PD-L1)-Positive Locally Advanced (LABC) or Metastatic Breast Cancer (MBC) Study Summary: This study will evaluate the efficacy, safety and patient-reported outcomes of trastuzumab emtansine plus atezolizumab compared with trastuzumab emtansine plus placebo in participants with HER2-positive and PD-L1-positive LABC or MBC.Participants must have progressed either during or after prior trastuzumab- (+/- pertuzumab) and taxane-based therapy for LABC/MBC; or during (or within 6 months after completing) trastuzumab- (+/-pertuzumab) and taxane-based therapy in the neoadjuvant and/or adjuvant setting. Sponsor: Hoffmann-La Roche Intervention: Trastuzumab Emtansine Start Date: 2021-06-07 Last Updated: 2023-11-18 Number of Patients: 96 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Breast Cancer
NCTID: NCT04359732
Title: Assessment of Response to nCRT for GEJ Cancer Using a Fully Integrated PET/MRI Study Summary: Evaluate the potential role of PET/MRI as a predictor of esophageal and junctional cancers in response to neoadjuvant chemoradiotherapy (nCRT). Sponsor: IRCCS San Raffaele Intervention: hybrid PET/MRI Start Date: 2020-05-08 Last Updated: 2023-01-26 Number of Patients: 155 Recruitment Status: RECRUITING Condition: Esophageal Cancer
NCTID: NCT02439489
Title: Study of the Combination of BKM120 and Cisplatin or Carboplatin in Patients With Advanced Solid Tumors Study Summary: PI3K signaling is a hallmark of many cancers. Subsets of cancers become dependent on PI3K pathway signaling as a result of mutations of the PIK3CA gene itself or of regulators of PI3K (e.g. PTEN, HER2). As a consequence, pathway mutated tumors are particularly sensitive towards PI3K-pathway inhibition. BKM120 is a potent and highly specific oral pan-class I PI3K-inhibitor. The study FM-11-F01b is a phase Ib single institution study using the combination of BKM120 and cisplatin or carboplatin in patient with pathologically confirmed recurrent or metastatic advanced solid tumor, for which treatment with a platinum agent is indicated (preferentially head and neck, NSCLC, ovary, endometrial). The primary objective of the study is to define the phase II recommended dose of daily oral BKM120 and cisplatin (Group 1) or carboplatin (Group 2), given intravenously (IV) on day 1 every 3 weeks. Sponsor: Fondazione Michelangelo Intervention: BKM120-CIS Start Date: 2012-12 Last Updated: 2018-06-20 Number of Patients: 34 Recruitment Status: COMPLETED Condition: Solid Tumors
NCTID: NCT03529110
Title: DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03] Study Summary: This study is designed to compare the anti-tumor activity as well as the safety and efficacy of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane. Sponsor: Daiichi Sankyo, Inc. Intervention: Trastuzumab deruxtecan (T-DXd) Start Date: 2018-08-09 Last Updated: 2023-02-09 Number of Patients: 524 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT03569241
Title: PEACE V: Salvage Treatment of OligoRecurrent Nodal Prostate Cancer Metastases Study Summary: A proportion of prostate cancer (PCa) patients develop relapse following curative local treatment. Regional nodal recurrence is an emerging clinical situation since the introduction of new molecular imaging methods in the restaging of recurrent prostate cancer. More specifically, a subgroup of these patients is being diagnosed with a recurrence confined to the regional lymph nodes and limited in number (oligorecurrence) using choline or PSMA PET-CT. As there are no specific treatment recommendations for these type of patients, different treatment approaches are currently used, mostly focusing on local ablative treatments using radiotherapy or surgery. These treatments are coined metastasisdirected therapy (MDT). MDT in combination with or without temporary ADT could delay the subsequent risk of progression, and even cure limited regional nodal recurrences. Consequently, lifelong palliative ADT, with its toxicity and excess in non-cancer mortality might be postponed. The proposed trial randomizes patients with oligorecurrent nodal prostate cancer following primary PCa treatment to either metastasis-directed therapy (MDT) (salvage lymph node dissection, sLND or stereotactic body radiotherapy, SBRT) or MDT plus whole pelvis radiotherapy (WPRT: 45 Gy in 25 fractions). Sponsor: University Ghent Intervention: whole pelvic radiotherapy Start Date: 2018-04-27 Last Updated: 2023-06-28 Number of Patients: 196 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Prostate Cancer
NCTID: NCT01358084
Title: Phase II Study of NGR-hTNF Versus Placebo as Maintenance Treatment in Patients With Advanced MPM Study Summary: The main objective of the trial is to document the efficacy of NGR-hTNF administered as maintenance treatment at 0.8 µg/m2 weekly in advanced malignant pleural mesothelioma Sponsor: AGC Biologics S.p.A. Intervention: NGR-hTNF Start Date: 2011-03 Last Updated: 2019-01-15 Number of Patients: 137 Recruitment Status: COMPLETED Condition: Advanced Malignant Pleural Mesothelioma
NCTID: NCT03379441
Title: Pembrolizumab (MK-3475) as Maintainance in Treated Patients With Unresectable Stage III NSCLC Study Summary: Maintainance therapy in patients with unresectable stage III, NSCLC Stage IIIA-B, unresectable, NSCLC, treated with definitive Chemo-Radiotherapy Sponsor: University of Turin, Italy Intervention: Pembrolizumab Injectable Product Start Date: 2018-01-01 Last Updated: 2017-12-22 Number of Patients: 126 Recruitment Status: UNKNOWN Condition: Non Small Cell Lung Cancer Patients
NCTID: NCT06039384
Title: A Study of INCB099280 in Combination With Adagrasib in Adults With Advanced Solid Tumors Harboring a KRASG12C Mutation Study Summary: The purpose of this study is to evaluate the safety and tolerability of INCB099280 in combination with adagrasib and to establish the MTD or identify RDE(s) for the combination of INCB099280 and adagrasib. Sponsor: Incyte Corporation Intervention: INCB099280 Start Date: 2024-01-10 Last Updated: 2023-11-24 Number of Patients: 125 Recruitment Status: RECRUITING Condition: Advanced Solid Tumors
NCTID: NCT04697628
Title: Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer Study Summary: This trial is being done to find out whether tisotumab vedotin works better than chemotherapy to treat cervical cancer. People in this study have cervical cancer that has spread to other parts of the body (metastatic) or has come back after being treated (recurrent). Participants in this trial will be randomly assigned to one of two groups. One group will be treated with tisotumab vedotin. Participants in the other group will get one of five different chemotherapy drugs (topotecan, vinorelbine, gemcitabine, pemetrexed, or irinotecan). Participants and their doctors will know which group they are in. Participants in the chemotherapy group will decide with their study doctor which drug they will take. Sponsor: Seagen Inc. Intervention: tisotumab vedotin Start Date: 2021-02-22 Last Updated: 2023-11-14 Number of Patients: 556 Recruitment Status: RECRUITING Condition: Cervical Cancer
NCTID: NCT05239728
Title: A Study of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Clear Cell Renal Cell Carcinoma Post Nephrectomy (MK-6482-022) Study Summary: The purpose of this study is to assess the efficacy and safety of oral belzutifan (MK-6482) plus intravenous (IV) pembrolizumab (MK-3475) compared to placebo plus pembrolizumab, in the adjuvant treatment of Clear Cell Renal Cell Carcinoma (ccRCC) post nephrectomy. The primary study hypothesis is that belzutifan plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS). Sponsor: Merck Sharp & Dohme LLC Intervention: Belzutifan Start Date: 2022-03-15 Last Updated: 2023-11-28 Number of Patients: 1800 Recruitment Status: RECRUITING Condition: Carcinoma, Renal Cell
NCTID: NCT00914628
Title: Efficacy Study on the Strategy of HSV-Tk Engineering Donor Lymphocytes to Treat Patients With High Risk Acute Leukemia Study Summary: The main objective of this randomized trial is to compare disease-free survival (DFS) in high risk leukemia patients who underwent haploidentical HCT followed by an add back strategy of HSV-Tk donor lymphocytes or standard haploidentical HCT Sponsor: AGC Biologics S.p.A. Intervention: HSV-Tk Start Date: 2010-04-12 Last Updated: 2021-06-22 Number of Patients: 92 Recruitment Status: TERMINATED Condition: Acute Leukemia (Category)
NCTID: NCT00003028
Title: MEN-10755 in Treating Adults With Recurrent or Refractory Solid Tumors Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of MEN-10755 in treating adults who have recurrent or refractory solid tumors. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: sabarubicin Start Date: 1997-04 Last Updated: 2012-07-02 Number of Patients: 5 Recruitment Status: COMPLETED Condition: Unspecified Adult Solid Tumor, Protocol Specific
NCTID: NCT03125902
Title: A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC) Study Summary: This Phase 3, multicenter, randomized, double-blind, placebo controlled study is designed to evaluate the efficacy and safety of atezolizumab (MPDL3280A, an anti-programmed death-ligand 1 <math display="block">PD-L1</math> antibody) administered in combination with paclitaxel compared with placebo in combination with paclitaxel in participants with previously untreated, inoperable locally advanced or metastatic, centrally confirmed TNBC. Participants will be randomized in a 2:1 ratio to receive atezolizumab or placebo plus paclitaxel until disease progression or unacceptable toxicity or end of study, whichever occurs first (maximum up to approximately 40 months). In addition, the Sponsor may decide to terminate the study at any time. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody Start Date: 2017-08-25 Last Updated: 2023-02-15 Number of Patients: 653 Recruitment Status: COMPLETED Condition: Triple-Negative Breast Cancer
NCTID: NCT04608318
Title: Ibrutinib Monotherapy Versus Fixed-duration Venetoclax Plus Obinutuzumab Versus Fixed-duration Ibrutinib Plus Venetoclax in Patients With Previously Untreated Chronic Lymphocytic Leukaemia (CLL) Study Summary: The aim of this study is to compare the efficacy of continuous ibrutinib monotherapy with fixed-duration venetoclax plus obinutuzumab and fixed-duration ibrutinib plus venetoclax by measuring progression-free survival (PFS) in patients with previously untreated CLL. Sponsor: German CLL Study Group Intervention: Ibrutinib Start Date: 2021-03-01 Last Updated: 2023-02-23 Number of Patients: 897 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Chronic Lymphoid Leukemia
NCTID: NCT03745378
Title: Secondary Cancers in Myeloproliferative Neoplasms (MPN-K Study) Study Summary: The incidence of secondary cancer (SC) in patients with myeloproliferative neoplasms (MPN) is high and comparable to that of thrombosis. However, the identification of patient subgroups that might be at increased susceptibility of developing SC has not been systematically addressed. This international case-control study (MPN-K) is aimed to elucidate the prognostic role of JAK2V617F mutation in predicting the occurrence of SC in patients with classical MPN, polycythemia vera (PV), essential thrombocythemia (ET) and myelofibrosis (MF) Sponsor: Fondazione per la Ricerca Ospedale Maggiore Intervention: JAK2V617F mutation Start Date: 2018-05-15 Last Updated: 2019-12-06 Number of Patients: 1881 Recruitment Status: COMPLETED Condition: Polycythemia Vera
NCTID: NCT05714202
Title: A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer Study Summary: The purpose of this study is to compare event-free survival (EFS) in participants with Bacillus Calmette-Guerin (BCG)-naive high-risk non-muscle invasive bladder cancer (HR-NMIBC), including high-grade papillary Ta, any T1, or carcinoma in situ (CIS), between TAR-200 plus cetrelimab (Group A) and TAR-200 alone (Group C) versus intravesical BCG (Group B). Sponsor: Janssen Research & Development, LLC Intervention: TAR-200 Start Date: 2023-03-23 Last Updated: 2023-11-08 Number of Patients: 1050 Recruitment Status: RECRUITING Condition: Bladder Cancer
NCTID: NCT00281918
Title: Fludarabine and Cyclophosphamide With or Without Rituximab in Patients With Previously Untreated Chronic B-Cell Lymphocytic Leukemia Study Summary: This randomized phase III trial is studying fludarabine, cyclophosphamide, and rituximab to see how well they work compared to fludarabine and cyclophosphamide in treating patients with B-cell chronic lymphocytic leukemia. Sponsor: Hoffmann-La Roche Intervention: Rituximab Start Date: 2003-07 Last Updated: 2013-09-19 Number of Patients: 817 Recruitment Status: COMPLETED Condition: Leukemia
NCTID: NCT03400332
Title: A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers Study Summary: The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers. Sponsor: Bristol-Myers Squibb Intervention: BMS-986253 Start Date: 2018-02-12 Last Updated: 2023-10-17 Number of Patients: 372 Recruitment Status: RECRUITING Condition: Cancer
NCTID: NCT02486718
Title: Study to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [IMpower010] Study Summary: This is a Phase III, global, multicenter, open-label, randomized study to compare the efficacy and safety of 16 cycles (1 cycle duration=21 days) of atezolizumab (MPDL3280A) treatment compared with best supportive care (BSC) in participants with Stage IB-Stage IIIA non-small cell lung cancer (NSCLC) following resection and adjuvant chemotherapy, as measured by disease-free survival (DFS) as assessed by the investigator and overall survival (OS). Participants, after completing up to 4 cycles of adjuvant cisplatin-based chemotherapy, will be randomized in a 1:1 ratio to receive atezolizumab for 16 cycles or BSC. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2015-10-31 Last Updated: 2023-11-02 Number of Patients: 1280 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-Small Cell Lung Cancer
NCTID: NCT01068132
Title: Prognostic Factors for Patients With Advanced Colorectal Cancer Treated With Cetuximab. Study Summary: Italian, multicentre, non comparative trial in patients with advanced Colorectal Cancer(CRC)and KRAS wild-type, defined by molecular evaluation. Patients will receive Cetuximab + FOLFIRI until disease progression, unacceptable toxicity developed or patient refusal. The aim of this study is to assess the prognostic role of PTEN in terms of Progression free survival. Although the role of Cetuximab as first line treatment in metastatic CRC will be soon established, it is still unclear which is the best schedule for Cetuximab and the role of biological factors in order to select the most appropriate subset of pts for recommending Cetuximab. The data supporting a benefit of Cetuximab in KRAS wild-type pts open the perspective to study the role of other molecular markers in this subset of pts. On the basis of these considerations this study is aimed at testing a different schedule of Cetuximab and better characterize the prognosis of pts for which Cetuximab is appropriate. Sponsor: Regione Lombardia Intervention: Cetuximab Start Date: 2009-04 Last Updated: 2014-05-12 Number of Patients: 54 Recruitment Status: COMPLETED Condition: Colorectal Cancer
NCTID: NCT00027794
Title: Radical Prostatectomy in Treating Patients With Locally Advanced Prostate Cancer Study Summary: RATIONALE: Radical prostatectomy may be an effective treatment for locally advanced prostate cancer. PURPOSE: Phase II trial to study the effectiveness of radical prostatectomy in treating patients who have locally advanced prostate cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: conventional surgery Start Date: 2001-09 Last Updated: 2012-09-24 Number of Patients: 40 Recruitment Status: COMPLETED Condition: Prostate Cancer
NCTID: NCT04502394
Title: Safety and Efficacy of KRT-232 in Combination With Acalabrutinib in Subjects With R/R DLBCL or R/R CLL Study Summary: This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, combined with acalabrutinib for the treatment of adults with Diffuse Large B-Cell Lymphoma and Chronic Lymphocytic Leukemia. Participants must be relapsed/refractory (having failed prior therapy) Sponsor: Kartos Therapeutics, Inc. Intervention: KRT-232 Start Date: 2021-02-23 Last Updated: 2022-08-04 Number of Patients: 84 Recruitment Status: RECRUITING Condition: Diffuse Large B Cell Lymphoma
NCTID: NCT01763164
Title: Study Comparing the Efficacy of MEK162 Versus Dacarbazine in Unresectable or Metastatic NRAS Mutation-positive Melanoma Study Summary: Two-arm, randomized, prospective, open-label, multi-center, phase III study to compare the efficacy and safety of MEK162 (45 mg BID) versus dacarbazine (1000 mg/m2 IV every 3 weeks) in patients with advanced (Stage IIIC) unresectable or metastatic (Stage IV) NRAS Q61 mutation-positive cutaneous or unknown primary melanoma. The mutation analysis will be performed at a central laboratory. Only those patients with Q61 mutation per central laboratory and meet all eligibility criteria will be randomized. A total of 393 patients will be randomized 2:1 to receive either MEK162 or dacarbazine. Patients will be stratified according to AJCC stage (IIIC, IVM1a, and IVM1b versus IVM1c), ECOG Performance status (0 versus 1) and any prior number of lines of immunotherapy (immunotherapies versus none). This study will use an Interactive Response Technology (IRT). The primary end point of the study is progression-free survival. Key secondary end point is overall survival Sponsor: Pfizer Intervention: MEK162 Start Date: 2013-07-12 Last Updated: 2021-03-22 Number of Patients: 402 Recruitment Status: COMPLETED Condition: Metastatic or Unresectable Cutaneous Melanoma
NCTID: NCT04679064
Title: Trial on NIraparib-TSR-042 (Dostarlimab) vs Physician’s Choice CHEmotherapy in Recurrent, Ovarian, Fallopian Tube or Primary Peritoneal Cancer Patients Not Candidate for Platinum Retreatment Study Summary: Randomized phase 3 trial evaluating niraparib plus dostarlimab vs chemotherapy at physician’s choice in the treatment of recurrent ovarian, fallopian tube or primary peritoneal cancer patients for which platinum is not an option Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Intervention: Niraparib Start Date: 2020-12-01 Last Updated: 2021-08-27 Number of Patients: 427 Recruitment Status: RECRUITING Condition: Ovarian Cancer
NCTID: NCT05024773
Title: Study of ONCOFID-P-B (PACLITAXEL-HYALURONIC ACID) Study Summary: This is a phase III, single-arm, multicenter, international study to assess the efficacy and safety of ONCOFID-P-B following intravesical instillation in adult patients with histologically and cytologically confirmed CIS, with or without concomitant Ta-T1, who are unresponsive to BCG therapy and unwilling or unfit to undergo radical cystectomy. After providing written informed consent (in presence of an Independent Witness, if applicable), patients will receive an induction therapy consisting of 12 weekly intravesical instillations of ONCOFID-P-B (induction phase). Patients who achieve a CR by Investigator assessment at the end of the induction phase will enter the maintenance phase and receive monthly treatment for an additional 12 months or until recurrence of CIS/Ta-T1 or progression to MIBC or extravesical disease. Sponsor: Fidia Farmaceutici s.p.a. Intervention: ONCOFID P-B (PACLITAXEL-HYALURONIC ACID) Start Date: 2022-12-29 Last Updated: 2023-11-27 Number of Patients: 112 Recruitment Status: RECRUITING Condition: Bladder Carcinoma in Situ (CIS)
NCTID: NCT04640623
Title: A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy Study Summary: The purpose of this study is to evaluate the overall complete response (CR) rate in participants treated with TAR-200 in combination with cetrelimab (Cohort 1), or TAR-200 alone (Cohort 2), or cetrelimab alone (Cohort 3) with Carcinoma in Situ (CIS), with or without concomitant high-grade Ta or T1 papillary disease; and disease-free survival (DFS) in participants treated with TAR-200 alone with papillary disease only (Cohort 4). Sponsor: Janssen Research & Development, LLC Intervention: TAR-200 Start Date: 2020-12-18 Last Updated: 2023-11-08 Number of Patients: 200 Recruitment Status: RECRUITING Condition: Urinary Bladder Neoplasms
NCTID: NCT02858258
Title: ASCT After a Rituximab/Ibrutinib/Ara-c Containing iNduction in Generalized Mantle Cell Lymphoma Study Summary: The primary objective of the the trial is to establish one of three study arms, as future standard based on the comparison of the investigator-assessed failure-free survival. Sponsor: Prof. Dr. M. Dreyling (co-chairman) Intervention: R-CHOP/R-DHAP Start Date: 2016-07 Last Updated: 2017-12-19 Number of Patients: 870 Recruitment Status: RECRUITING Condition: Mantle Cell Lymphoma
NCTID: NCT04924101
Title: Efficacy and Safety of Pembrolizumab Plus Investigational Agents in Combination With Chemotherapy as First-Line Treatment in Extensive-Stage Small Cell Lung Cancer (ES-SCLC) (MK-3475-B99/ KEYNOTE-B99) Study Summary: The purpose of this study is to evaluate the use of investigational agents (MK-4830, boserolimab (MK-5890) and lenvatinib (MK-7902)) in combination with pembrolizumab (MK-3475) and etoposide/platinum chemotherapy for the first-line treatment of participants with extensive-stage small cell Lung Cancer (ES-SCLC). No formal hypothesis testing will be performed for this study. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2021-07-15 Last Updated: 2023-04-10 Number of Patients: 120 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Small Cell Lung Cancer
NCTID: NCT02000934
Title: A Study of TAK-659 in Adult Participants With Advanced Solid Tumor and Lymphoma Malignancies Study Summary: This study is an open-label, multicenter, phase 1, dose escalation study of TAK-659 in adult participants with advanced solid tumor and lymphoma malignancies. This study will be the first to administer TAK-659 to humans. The participants population during dose escalation (Part A) will consist of adults previously diagnosed with any form of a solid tumor or lymphoma for which standard, curative, or life-prolonging treatment does not exist or is no longer effective. This first-in-human (FIH) study will include 5 dose expansion cohorts in refractory and/or relapsed Chronic Lymphocytic Leukemia (CLL), Diffuse Large B Cell Lymphoma (DLBCL), indolent Non Hodgkin Lymphoma (iNHL), Mantle Cell Lymphoma (MCL), Post Transplant Lymphoproliferative Disorder (PTLD) (Part B) following completion of dose escalation (Part A). Sponsor: Calithera Biosciences, Inc Intervention: TAK-659 Start Date: 2013-12-31 Last Updated: 2023-02-08 Number of Patients: 143 Recruitment Status: COMPLETED Condition: Advanced Solid Tumor and Lymphoma Malignancies
NCTID: NCT02834780
Title: Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B-6527 in Participants With Advanced Hepatocellular Carcinoma Study Summary: The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of H3B-6527, and to assess the safety, tolerability and pharmacokinetics of H3B-6527. Sponsor: H3 Biomedicine Inc. Intervention: H3B-6527 Start Date: 2016-12-28 Last Updated: 2023-11-13 Number of Patients: 128 Recruitment Status: COMPLETED Condition: Advanced Hepatocellular Carcinoma
NCTID: NCT04704934
Title: Trastuzumab Deruxtecan for Subjects With HER2-Positive Gastric Cancer or Gastro-Esophageal Junction Adenocarcinoma After Progression on or After a Trastuzumab-Containing Regimen (DESTINY-Gastric04) Study Summary: This study will evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) compared with ramucirumab and paclitaxel (Ram + PTX) in participants with HER2-positive gastric or gastro-esophageal junction (GEJ) adenocarcinoma who have progressed on or after a trastuzumab-containing regimen and have not received any additional systemic therapy. Sponsor: Daiichi Sankyo, Inc. Intervention: Trastuzumab deruxtecan Start Date: 2021-05-21 Last Updated: 2023-09-07 Number of Patients: 490 Recruitment Status: RECRUITING Condition: Gastric Cancer, Adenocarcinoma
NCTID: NCT01980498
Title: PEctin Rapid Fentanyl Efficacy Clinical Trial For pAin at Swallowing Undergoing radioTherapy Study Summary: The primary objective of the present phase IIIb study is to assess the efficacy of FPNS compared with Physician Choice-Usual Care (PC-UC) in the reduction of swallowing predictable BTP in head and neck cancer patients undergoing radiotherapy with or without chemotherapy. Sponsor: L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A. Intervention: Fentanyl pectin nasal spray (FPNS) Start Date: 2014-09 Last Updated: 2015-10-07 Number of Patients: 0 Recruitment Status: WITHDRAWN Condition: Predictable BTP at Swallowing in in Head
eck Cancer Patients Undergoing Radiotherapy Already Receiving Opioid Therapy for Background Pain NCTID: NCT02724540
Title: Randomized Embolization Trial for NeuroEndocrine Tumor Metastases To The Liver Study Summary: The primary aim of this trial is to estimate the duration of hepatic progression-free survival (HPFS) in participants treated with bland embolization (BE), transcatheter arterial Lipiodol chemoembolization (TACE), and embolization by drug-eluting beads (DEB). The primary hypothesis is that chemoembolization will be nearly twice as durable as bland embolization; thatis, the hazard ratio for HPFS will be 1.76 or better. Sponsor: Abramson Cancer Center at Penn Medicine Intervention: Bland Embolization Start Date: 2016-03 Last Updated: 2023-09-26 Number of Patients: 162 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Neuroendocrine Tumor, Malignant
NCTID: NCT04370457
Title: MyPal ePRO-based Early Palliative Care System in Adult Patients With Hematologic Malignancies Study Summary: Randomized unblinded interventional clinical trial: Arm Intervention Experimental arm (n=150): Intervention group Administration of the MyPal ePRO system the intervention group will use the ePRO tools provided in the project. Standard care arm (n=150): no intervention besides general palliative care if required general palliative care if required. Patients will be randomly assigned in a 1:1 fashion to use the MyPal system and receive related-intervention versus general palliative care, stratified by cancer type (i.e. CLL vs MDS), using a computer-generated number sequence, which will be concealed until after group assignment. Sponsor: Centre for Research and Technology Hellas Intervention: Administration of the MyPal ePRO system Start Date: 2021-01-01 Last Updated: 2021-08-04 Number of Patients: 300 Recruitment Status: UNKNOWN Condition: Chronic Lymphocytic Leukemia
NCTID: NCT02517398
Title: MSB0011359C (M7824) in Metastatic or Locally Advanced Solid Tumors Study Summary: The main purpose of this Phase I study is to test MSB0011359C (M7824) at different dose levels to see if it is safe and well tolerated when given once every 2 weeks. Phase I means the study drug has not previously been given to humans or has only been given to a limited number of people, although it has been extensively studied in animals. Based on this information, it is hoped to find out which dose could be best for the treatment of patients. There are two parts of this research study: a dose-escalation part and an expansion part. Dose escalation means that the first people taking part in the study will receive low doses of the study drug, and as more people take part, the additional participants will receive a higher dose. This is done to find the safest dose for the study drug. Expansion means that after the dose-escalation part of the study has looked at the safety and effectiveness of different doses, many more people will be invited to take part in the study and will receive the study drug at the safest dose. Additional purposes of the study are to find out whether the study drug has anti-cancer effects and how the study drug is processed by the body. Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: MSB0011359C Start Date: 2015-08-31 Last Updated: 2022-06-15 Number of Patients: 600 Recruitment Status: COMPLETED Condition: Solid Tumors
NCTID: NCT02491398
Title: Efficacy and Safety of Bendamustine Plus Rituximab in Chronic Lympocytic Leukemia Study Summary: This study is intended for Chronic Lymphocytic Leukemia patients who have already undergone a first or second treatment with drugs named bendamustine and rituximab. It will observe the results of this treatment and evaluate its efficacy and side effects. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: Bendamustine + Rituximab Start Date: 2016-02 Last Updated: 2020-10-06 Number of Patients: 494 Recruitment Status: COMPLETED Condition: Chronic Lymphocytic Leukemia
NCTID: NCT00423124
Title: Infusion of Donor Lymphocytes Transduced With the Suicide Gene HSV TK in Patients With Haematological Malignancies Study Summary: The aim of the study is to obtain immune reconsitutuion as well as reduction of infective episodes and disease relapse in patient with haematological malignancies who underwent SCT(and subsequent T lymphocytes infusions) and selectively controlling GvHD. Sponsor: AGC Biologics S.p.A. Intervention: HSV-TK Start Date: 2002-07 Last Updated: 2014-05-30 Number of Patients: 57 Recruitment Status: COMPLETED Condition: Hematological Malignancies
NCTID: NCT02003924
Title: Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer Study Summary: The purpose of this study is to assess the safety and efficacy of enzalutamide in patients with non metastatic prostate cancer. Sponsor: Pfizer Intervention: Enzalutamide Start Date: 2013-10-31 Last Updated: 2023-10-10 Number of Patients: 1401 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Nonmetastatic Castration-Resistant Prostate Cancer
NCTID: NCT04497844
Title: A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) Study Summary: The purpose of the study is to determine if the combination of niraparib with Abiraterone Acetate (AA) plus prednisone compared with AA plus prednisone in participants with deleterious germline or somatic Homologous Recombination Repair (HRR) gene-mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) provides superior efficacy in improving radiographic progression-free survival (rPFS). Sponsor: Janssen Research & Development, LLC Intervention: Niraparib Start Date: 2020-09-23 Last Updated: 2023-11-09 Number of Patients: 696 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Castration-sensitive Prostate Cancer
NCTID: NCT03767244
Title: A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy Study Summary: The purpose of this study is to determine if treatment with apalutamide plus androgen deprivation therapy (ADT) before and after radical prostatectomy (RP) with pelvic lymph node dissection (pLND) in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response (pCR) rate and metastasis-free survival (MFS) as compared to placebo plus ADT. Sponsor: Janssen Research & Development, LLC Intervention: Apalutamide Start Date: 2019-06-11 Last Updated: 2023-11-09 Number of Patients: 2517 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Prostatic Neoplasms
NCTID: NCT05270044
Title: Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation. Study Summary: The purpose of the Columbus-AD study is to evaluate the efficacy and safety of 12 months of encorafenib in combination with binimetinib in adjuvant setting of BRAF V600E/K mutant stage IIB/C melanoma versus the current standard of care (surveillance). Sponsor: Pierre Fabre Medicament Intervention: Encorafenib and Binimetinib Start Date: 2022-05-02 Last Updated: 2023-11-22 Number of Patients: 815 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Melanoma
NCTID: NCT04660344
Title: A Study of Atezolizumab Versus Placebo as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Bladder Cancer Who Are ctDNA Positive Following Cystectomy Study Summary: This is a global Phase III, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with placebo in participants with MIBC who are ctDNA positive and are at high risk for recurrence following cystectomy. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2021-05-03 Last Updated: 2023-10-10 Number of Patients: 520 Recruitment Status: RECRUITING Condition: Muscle-invasive Bladder Cancer
NCTID: NCT04586244
Title: An Umbrella Study to Determine the Safety and Efficacy of Various Monotherapy or Combination Therapies in Neoadjuvant Urothelial Carcinoma Study Summary: This is a multicenter, open-label, randomized, Phase 2 umbrella study of various neoadjuvant treatment combinations in participants who have muscle-invasive urothelial carcinoma of the bladder and are cisplatin-ineligible or refusing cisplatin therapy and awaiting radical cystectomy. Sponsor: Incyte Corporation Intervention: retifanlimab Start Date: 2022-01-14 Last Updated: 2023-11-13 Number of Patients: 30 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Urothelial Carcinoma
NCTID: NCT03656536
Title: A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma Study Summary: The purpose of this study is to evaluate the efficacy and safety of pemigatinib versus gemcitabine plus cisplatin chemotherapy in first-line treatment of participants with unresectable or metastatic cholangiocarcinoma with FGFR2 rearrangement. Sponsor: Incyte Corporation Intervention: Pemigatinib Start Date: 2019-06-03 Last Updated: 2023-11-15 Number of Patients: 434 Recruitment Status: RECRUITING Condition: Unresectable Cholangiocarcinoma
NCTID: NCT04165798
Title: KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Advanced Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01) Study Summary: This study is referred to as the “umbrella master protocol” for pembrolizumab (MK-3475) in the treatment of non-small cell lung cancer (NSCLC). This pembrolizumab NSCLC umbrella master protocol uses a platform design and consists of this master screening study and three substudies. Each substudy will enroll a different population of NSCLC participants. The goal of this umbrella master protocol is to screen potential participants with NSCLC for enrollment into 1 of 3 substudies. Participants must first enroll in this pembrolizumab master protocol study and undergo screening for NSCLC that will be used to assign them to participation in 1 of 3 pembrolizumab substudies. Sponsor: Merck Sharp & Dohme LLC Intervention: Tumor Imaging Start Date: 2019-12-19 Last Updated: 2023-11-18 Number of Patients: 260 Recruitment Status: RECRUITING Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT03326674
Title: Tesetaxel Plus Reduced Dose of Capecitabine vs. Capecitabine in HER2 Negative, HR Positive, LA/MBC Study Summary: CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel in patients with HER2 negative, HR positive LA/MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. The primary objective of the study is to compare the efficacy of tesetaxel plus a reduced dose of capecitabine versus the approved dose of capecitabine alone based on progression-free survival (PFS) as assessed by the Independent Radiologic Review Committee (IRC). 685 patients were enrolled. Sponsor: Odonate Therapeutics, Inc. Intervention: Tesetaxel and Capecitabine Start Date: 2017-12-21 Last Updated: 2021-07-30 Number of Patients: 685 Recruitment Status: TERMINATED Condition: Breast Cancer
NCTID: NCT05196269
Title: Comparing Decision on Aesthetics After Breast Cancer Locoregional Treatment. Study Summary: Breast cancer is the most commonly diagnosed cancer, with an estimated 2.3 million new cases per year globally. Approximately 90% of these patients will undergo breast surgery with/without radiation (locoregional treatment). Different surgical techniques can be offered to the patient, each leading to completely different aesthetic outcomes. Moreover, the aesthetic outcome could be completely different for patients undergoing the same surgery based on individual patient factors (e.g., age, body habitus). In the CINDERELLA trial, the investigators will be using the (Breast Locoregional (BreLO) AI system (an artificial intelligence-based tool for the classification of aesthetic outcomes and matching data and photographs) integrated into CANKADO (a cloud-based healthcare platform) to create an easy-to-use application that can be used on any electronic device, to simulate visually to the patient the aesthetic outcome of a certain surgery or radiation treatment. In the CINDERELLA trial, the investigators plan to compare whether the application helped fulfil the expectations and lead to a better quality of life compared with the classical approach. In the classical approach (control arm), doctors usually propose a locoregional treatment and explain theoretically how the result will be. Nurses help by explaining further details about the surgery and possible outcomes. In most centres, no photographic evaluation is done, and expectations are not measured. The CINDERELLA trial will help overcome miscommunication and potential boundaries in the patient’s or physician’s understanding of the potential outcomes of locoregional breast cancer treatment. Sponsor: Fundacao Champalimaud Intervention: Artificial Intelligence and Digital Health Arm Start Date: 2023-08-08 Last Updated: 2023-11-21 Number of Patients: 1030 Recruitment Status: RECRUITING Condition: Breast Cancer
NCTID: NCT01942135
Title: Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3) Study Summary: The study is a randomized, double blind, placebo controlled, Phase 3 clinical trial with the primary objective of demonstrating the superiority of palbociclib in combination with fulvestrant (Faslodex®) over fulvestrant alone in prolonging PFS in women with HR+, HER2 negative metastatic breast cancer whose disease has progressed after prior endocrine therapy. The safety between the two treatment arms will also be compared. During study treatment, pre- and perimenopausal women must be receiving therapy with the LHRH agonist goserelin (Zoladex® or generic). Sponsor: Pfizer Intervention: Palbociclib Start Date: 2013-09-26 Last Updated: 2023-04-27 Number of Patients: 521 Recruitment Status: COMPLETED Condition: Metastatic Breast Cancer
NCTID: NCT04762069
Title: A Study of Berubicin in Adult Subjects With Recurrent Glioblastoma Multiforme Study Summary: This is an open-label, multicenter, randomized, parallel, 2-arm, efficacy and safety study. Patients with GBM after failure of standard first line therapy will be randomized in a 2:1 ratio to receive berubicin or lomustine for the evaluation of OS. Additional endpoints will include response and progression outcomes evaluated by a blinded central reviewer for each patient according to RANO criteria. A pre-planned, non-binding futility analysis will be performed after approximately 30 to 50% of all planned patients have completed the primary endpoint at 6 months. This review will include additional evaluation of safety as well as secondary efficacy endpoints. Enrollment will not be paused during this interim analysis. Sponsor: CNS Pharmaceuticals, Inc. Intervention: Berubicin Start Date: 2021-05-18 Last Updated: 2023-09-13 Number of Patients: 210 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Glioblastoma Multiforme, Adult
NCTID: NCT03197935
Title: A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer Study Summary: This is a global Phase III, double-blind, randomized, placebo-controlled study designed to evaluate the efficacy and safety of neoadjuvant treatment with atezolizumab (anti-programmed death-ligand 1 <math display="block">anti-PD-L1</math> antibody) and nab-paclitaxel followed by doxorubicin and cyclophosphamide (nab-pac-AC), or placebo and nab-pac-AC in participants eligible for surgery with initial clinically assessed triple-negative breast cancer (TNBC). Sponsor: Hoffmann-La Roche Intervention: Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody Start Date: 2017-07-24 Last Updated: 2023-10-26 Number of Patients: 333 Recruitment Status: COMPLETED Condition: Triple-negative Breast Cancer
NCTID: NCT01889069
Title: A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Rituximab (MabThera/Rituxan) in Participants With Diffuse Large B Cell Lymphoma (DLBCL) or Follicular Lymphoma (FL) Study Summary: This single arm, multicenter study will evaluate the safety, efficacy and pharmacokinetic (PK) of subcutaneous (SC) rituximab in previously untreated participants with cluster of differentiation 20 positive (CD20+) DLBCL or FL. In addition to standard chemotherapy, participants will receive at least 4 doses of rituximab 1400 mg SC once a month during the Induction period, and at least 6 doses of rituximab 1400 mg SC once every two months during the Maintenance period. Sponsor: Hoffmann-La Roche Intervention: Rituximab Start Date: 2013-07-31 Last Updated: 2020-08-13 Number of Patients: 159 Recruitment Status: COMPLETED Condition: Lymphoma
NCTID: NCT03767335
Title: MEN1611 With Trastuzumab (+/- Fulvestrant) in Metastatic Breast Cancer Study Summary: The main purpose of this open-label, dose-escalation, phase Ib study is to identify the appropriate dose of MEN1611 to be used in combination with Trastuzumab with/without Fulvestrant for the treatment of advanced or metastatic HER2-positive breast cancer Sponsor: Menarini Group Intervention: MEN1611 Start Date: 2018-07-19 Last Updated: 2023-05-24 Number of Patients: 62 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Advanced or Metastatic Breast Cancer
NCTID: NCT02961881
Title: A Phase 1b Open-Label Study Investigating the Safety and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of Relapsed/Refractory Indolent Non-Hodgkin’s Lymphoma Study Summary: Primary Objective: • To evaluate the safety and tolerability of subcutaneous (SC) blinatumomab dose administrations Secondary Objectives: * To determine pharmacokinetics (PK) with continuous intravenous (cIV) and SC administrations * To estimate the maximum tolerated dose (MTD) tested for blinatumomab administered subcutaneously * To determine the incidence of anti-blinatumomab antibody formation following SC administration * To evaluate efficacy response following treatment with SC blinatumomab administration Exploratory Objective: * To determine the pharmacodynamics (PD) time profiles for B-and T-lymphocytes as well as cytokine profiles during SC administration * To evaluate efficacy response following treatment with SC blinatumomab administration using Lugano criteria if positron emission tomography-computed tomography (PET/CT) is used for evaluation Sponsor: Amgen Intervention: blinatumomab Start Date: 2017-09-18 Last Updated: 2022-01-11 Number of Patients: 36 Recruitment Status: COMPLETED Condition: Non-Hodgkin’s Lymphoma
NCTID: NCT05483374
Title: The Head and Neck Registry of the European Reference Network on Rare Adult Solid Cancers Study Summary: Cancer care for head and neck cancers is multidisciplinary and complex and knowledge on the rare ones is limited. There is a wide consensus that to support clinical research on rare cancers, clinical registries should be developed within networks specializing in rare cancers. Our hypothesis is that our head and neck cancer registry established in the framework of the European reference network on rare adults solid cancers will help to: describe the natural history of rare head and neck cancers; evaluate factors that influence prognosis; assess treatment effectiveness; measure indicators of quality of care. The registry is a prospective observational real-world registry. It collects data from already available registries/database and/or directly from expert health care providers (HCP). Information are prospectively collected on patient characteristics; exposure, outcomes and potential confounders (https://euracan.eu/research/starter/rare-head-and-neck-cancer-registry/#codebook). The registry if federated (i.e. data are stored by the data provider). Analyses will be performed using the federated learning approach which split computations into a local part and a central part. The data providers will share sub-computations only. Data quality checks are envisioned to assess whether data value are present, valid and believable. Validity and plausibility checks are embedded in the electronic case report form (CRF) in the form of alerts and errors during the data input. Additional checks are implemented in R and run using the federated learning to ensure a central data quality monitoring. The data analyses will include descriptive statistics showing frequency and patterns of patients’ and cancers’ variables; analytical analyses investigating the association of patients/disease and/or treatment characteristics and health outcomes. Fondazione IRCCS Istituto Nazionale dei Tumori (INT) is the coordinator of the EURACAN registry as well as a data provider. At the INT, and at each HCP involved, responsible investigators ensure that the EURACAN registry will be implemented in compliance with the protocol, following the instructions and procedures described herein. Each HCP is a controller and will identify a data processor. The processing of patients’ personal data taking part in the registry is compliant with local privacy legislation and the General Data Protection Regulation 2016/679 of the EU. Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Intervention: observation Start Date: 2022-05-31 Last Updated: 2022-08-02 Number of Patients: 13600 Recruitment Status: RECRUITING Condition: Head and Neck Cancer
NCTID: NCT03456076
Title: A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer Study Summary: This randomized, active-controlled, multicenter, open-label, Phase III study is designed to investigate the efficacy and safety of alectinib compared with platinum-based in the adjuvant setting. Participants in the experimental arm will receive alectinib at 600 mg orally twice daily (BID) taken with food for 24 months. Participants in the control arm will receive one of the protocol specified platinum based chemotherapy regimens for 4 cycles. Following treatment completion, participants will be followed up for their disease until disease recurrence. At the time of disease recurrence, participants will enter a survival follow-up until death, withdrawal of consent or study closure, whichever occurs earlier. Sponsor: Hoffmann-La Roche Intervention: Alectnib Start Date: 2018-08-16 Last Updated: 2023-09-21 Number of Patients: 257 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT03144674
Title: A Study of INCB050465 in Subjects With Relapsed or Refractory Marginal Zone Lymphoma (CITADEL-204) Study Summary: The purpose of this study is to evaluate the safety and efficacy of two parsaclisib treatment regimens in participants diagnosed with relapsed or refractory marginal zone lymphoma (MZL) who are naive to or were previously treated with a Bruton’s tyrosine kinase (BTK) inhibitor. Sponsor: Incyte Corporation Intervention: Parsaclisib Start Date: 2017-12-18 Last Updated: 2023-10-26 Number of Patients: 110 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Lymphoma
NCTID: NCT04449874
Title: A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation Study Summary: This is a Phase I dose-escalation and dose-expansion study that will evaluate the safety, pharmacokinetics (PK), and preliminary activity of GDC-6036 in patients with advanced or metastatic solid tumors with a KRAS G12C mutation. Sponsor: Genentech, Inc. Intervention: GDC-6036 Start Date: 2020-07-29 Last Updated: 2023-11-13 Number of Patients: 498 Recruitment Status: RECRUITING Condition: Non-Small Cell Lung Cancer
NCTID: NCT00389181
Title: A Randomized Trial of Unruptured Brain AVMs Study Summary: The purpose of this study is to determine if medical management is better than invasive therapy for improving the long-term outcome of patients with unruptured brain arteriovenous malformations. Sponsor: Columbia University Intervention: Interventional therapy Start Date: 2006-10 Last Updated: 2015-06-04 Number of Patients: 226 Recruitment Status: COMPLETED Condition: Arteriovenous Malformations, Cerebral
NCTID: NCT03567876
Title: Rituximab, Bendamustine and Cytarabine Followed by Venetoclax in High Risk Elderly Patients With MCL Study Summary: Prospective, multicenter, phase II trial designed to evaluate whether the addition of Venetoclax after rituximab, bendamustine and cytarabine (R-BAC) to high risk patients with mantle cell lymphoma improves the results of the standard R-BAC, in terms of Progression Free Survival. Sponsor: Fondazione Italiana Linfomi - ETS Intervention: Venetoclax Start Date: 2018-09-03 Last Updated: 2023-09-13 Number of Patients: 141 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Lymphoma, Mantle-Cell
NCTID: NCT05714111
Title: Radiology Registry on Pancreatic Malignancies Study Summary: The purpose of this study is to collect all radiological data which evaluated with clinical data may help assess malignancy and prognosis of pancreatic disease.This registry aims to collect retrospective data from 2014 and prospective data until 2027 with a maximum follow-up of 3 years per patient. Sponsor: IRCCS San Raffaele Intervention: Radiology evaluations and interventions Start Date: 2022-03-04 Last Updated: 2023-02-06 Number of Patients: 1300 Recruitment Status: RECRUITING Condition: Pancreatic Cancer
NCTID: NCT03779113
Title: An Open-label, Dose Escalation Trial to Evaluate the Safety and Pharmacokinetics of HMPL-523 in Patients With Lymphoma Study Summary: This is a Phase I, open-label, multicenter study of HMPL-523 administered orally to patients with relapsed or refractory lymphoma who have exhausted approved therapy options. This study consists of a dose escalation stage (Stage1) and a dose expansion stage (Stage 2). Sponsor: Hutchmed Intervention: HMPL-523 Start Date: 2019-09-26 Last Updated: 2023-02-23 Number of Patients: 140 Recruitment Status: RECRUITING Condition: Non Hodgkin Lymphoma
NCTID: NCT04148911
Title: A Study of Atezolizumab Plus Nab-Paclitaxel in the Treatment of Unresectable Locally Advanced or Metastatic PD-L1-Positive Triple-Negative Breast Cancer Study Summary: Study MO39874 is an open-label, Phase IIIb, single arm, global study conducted in participants with unresectable locally advanced or metastatic PD-L1-positive Triple-Negative Breast Cancer (TNBC) who have not received chemotherapy for their unresectable locally advanced or metastatic disease. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2019-12-17 Last Updated: 2023-09-21 Number of Patients: 184 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Triple-Negative Breast Cancer
NCTID: NCT02756611
Title: A Study to Evaluate the Efficacy of Venetoclax Monotherapy in Relapsed/Refractory Participants With Chronic Lymphocytic Leukemia (CLL) Study Summary: The purpose of this study is to evaluate the efficacy of venetoclax monotherapy in participants with relapsed/refractory CLL with or without the 17p deletion or TP53 mutation, including those who have received prior treatment with a B-cell receptor inhibitor. Sponsor: AbbVie Intervention: Venetoclax Start Date: 2016-06-22 Last Updated: 2023-04-10 Number of Patients: 258 Recruitment Status: COMPLETED Condition: Chronic Lymphocytic Leukemia
NCTID: NCT02631876
Title: A Study of Mirvetuximab Soravtansine vs. Investigator’s Choice of Chemotherapy in Women With Folate Receptor (FR) Alpha Positive Advanced Epithelial Ovarian Cancer (EOC), Primary Peritoneal or Fallopian Tube Cancer Study Summary: This is a Phase 3, open label, randomized study designed to compare the safety and efficacy of mirvetuximab soravtansine to that of selected single-agent chemotherapy (Investigator’s choice) in women with platinum-resistant FR-alpha positive advanced EOC, primary peritoneal cancer and/or fallopian tube cancer. Sponsor: ImmunoGen, Inc. Intervention: Mirvetuximab soravtansine Start Date: 2016-03-02 Last Updated: 2020-10-14 Number of Patients: 366 Recruitment Status: COMPLETED Condition: Epithelial Ovarian Cancer
NCTID: NCT02374099
Title: Study to Assess the Efficacy and Safety of the Epigenetic Modifying Effects of CC-486 (Oral Azacitidine) in Combination With Fulvestrant Study Summary: The purpose of this study to Assess the Efficacy and Safety of the Epigenetic Modifying Effects of CC-486 (Oral Azacitidine) in Combination With Fulvestrant in Postmenopausal Women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 (HER2-) Metastatic Breast Cancer Who Have Progressed on an Aromatase Inhibitor (AI). Sponsor: Celgene Intervention: CC-486 Start Date: 2015-03-13 Last Updated: 2018-12-14 Number of Patients: 97 Recruitment Status: TERMINATED Condition: Breast Neoplasms
NCTID: NCT02737501
Title: ALTA-1L Study: A Study of Brigatinib Versus Crizotinib in Anaplastic Lymphoma Kinase Positive (ALK+) Advanced Non-small Cell Lung Cancer (NSCLC) Participants Study Summary: The purpose of the study is to compare the efficacy of brigatinib to that of crizotinib in ALK+ locally advanced or metastatic non-small cell lung cancer (NSCLC) participants naive to ALK inhibitors, as evidenced by progression-free survival (PFS). Sponsor: Ariad Pharmaceuticals Intervention: Brigatinib Start Date: 2016-05-26 Last Updated: 2021-08-20 Number of Patients: 275 Recruitment Status: COMPLETED Condition: Non-small Cell Lung Cancer
NCTID: NCT05342636
Title: A Study of Combination Therapies With Pembrolizumab (MK-3475) in Participants With Advanced Esophageal Cancer (MK-3475-06A) Study Summary: This is a phase I/II multicenter, open-label umbrella platform study that will evaluate the safety and efficacy of investigational agents with pembrolizumab, plus chemotherapy or lenvatinib, for the treatment of participants with advanced esophageal cancer who have failed 1 prior line of therapy and have not been previously exposed to programmed cell death 1 protein (PD-1)/ programmed cell death ligand 1 (PD-L1) based treatment. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2022-07-27 Last Updated: 2023-10-27 Number of Patients: 120 Recruitment Status: RECRUITING Condition: Esophageal Squamous Cell Carcinoma (ESCC)
NCTID: NCT00133224
Title: Docetaxel in Combination With GVAX ® Immunotherapy Versus Docetaxel and Prednisone in Prostate Cancer Patients Study Summary: The primary objective of this study is to compare the duration of survival between patients receiving docetaxel in combination with the GVAX® vaccine for prostate cancer versus patients receiving docetaxel and prednisone treatment in patients with prostate cancer who no longer respond to hormone therapy, who have documented metastases with pain. Patients may have had up to one prior non-taxane chemotherapy treatment. Sponsor: Cell Genesys Intervention: Immunotherapy allogeneic GM-CSF secreting cellular vaccine Start Date: 2005-07 Last Updated: 2008-09-23 Number of Patients: 408 Recruitment Status: TERMINATED Condition: Prostate Cancer
NCTID: NCT02530424
Title: “Neo-Adjuvant Treatment With Palbociclib: Effect on Ki67 and Apoptosis Before, During and After Treatment” Study Summary: This is a multicenter neoadjuvant trial conducted under the sponsorship and overall trial management of the Fondazione Michelangelo in Italy. Women with a diagnosis of invasive unilateral non metastatic ER-positive breast cancer expressing HER2 and suitable for neoadjuvant therapy Patients in this study will receive: Trastuzumab+Pertuzumab+Palbociclib with or without Fulvestrant (HPPF) Trastuzumab 8 mg/kg loading dose IV, then 6 mg/kg IV q.3 wks (repeat for a total of 6 administrations) Pertuzumab 840 mg loading dose IV, then 420 mg IV q. 3 wks (repeat for a total of 6 administrations) Palbociclib 125 mg po q.d. x 21 q. 4 wks (= 1 cycle; repeat for a total of 5 cycles) Fulvestrant will be given intra-muscle at the dose of 500 mg every 4 weeks (repeat for 5 times) with an additional 500 mg dose given two weeks after the initial dose (total administrations including the additional one = 6) The total duration of neoadjuvant palbociclib (5 cycles every 4 weeks) and fulvestrant (5 administrations every 4 weeks plus the additional dose given two weeks after the initial dose) was selected to match as closely as possible the total duration of the six planned 3-weekly administrations of trastuzumab and pertuzumab Definitive surgery will be performed not earlier than 14 days and not later than 28 days after the last dose of any of the drugs in the combination reported above After completion of the neoadjuvant and surgical treatment patients will receive irradiation as locally acceptable. Patients will also continue to receive systemic drug therapy including chemotherapy (plus standard anti-HER2 treatment until completion of full 1 year if HER2 3+ or neu amplified, i.e. cohorts A and B) and endocrine therapy according to local guidelines at the Investigator’s discretion. Sponsor: Fondazione Michelangelo Intervention: Trastuzumab Start Date: 2015-05 Last Updated: 2020-07-15 Number of Patients: 102 Recruitment Status: COMPLETED Condition: Breast Neoplasms
NCTID: NCT04746924
Title: A Study of Ociperlimab With Tislelizumab Compared to Pembrolizumab in Participants With Untreated Lung Cancer Study Summary: The purpose of the study is to compare progression-free survival (PFS) between Arm A (ociperlimab in combination with tislelizumab) and Arm B (pembrolizumab in combination with placebo) as assessed by investigators according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) and to compare overall survival (OS) between Arm A and Arm B. Sponsor: BeiGene Intervention: Tislelizumab Start Date: 2021-06-08 Last Updated: 2023-11-13 Number of Patients: 660 Recruitment Status: RECRUITING Condition: Non-small Cell Lung Cancer
NCTID: NCT03898180
Title: Study of First-line Pembrolizumab (MK-3475) With Lenvatinib (MK-7902/E7080) in Urothelial Carcinoma Cisplatin-ineligible Participants Whose Tumors Express Programmed Cell Death-Ligand 1 and in Participants Ineligible for Platinum-containing Chemotherapy (MK-7902-011/E7080-G000-317/ LEAP-011) Study Summary: The purpose of this study is to evaluate the efficacy and safety of lenvatinib (MK-7902/E7080) in combination with pembrolizumab (MK-3475) in the treatment of cisplatin-ineligible participants with a Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10, or in participants ineligible for any platinum-containing chemotherapy regardless of CPS, with advanced/unresectable or metastatic urothelial carcinoma (UC). The primary hypotheses for this study are that: # Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR), and # Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Overall Survival (OS). With Amendment 3 (effective: September <math display="block">Sep</math>-24-2021) participants discontinued lenvatinib and placebo; participants who remained on treatment in the study arms received open-label pembrolizumab. With Amendment 3 the external Data Monitoring Committee was discontinued. With Amendment 4 (effective: December-5-2022) Second Course will no longer be offered. Any participant receiving Second Course treatment prior to initiation of Amendment 4 will be able to complete treatment as planned. With Amendment 4 study participation will end after the final administration of pembrolizumab. Participants who either complete 35 administrations of pembrolizumab or discontinue pembrolizumab will discontinue from the study following the safety follow-up visit. AEs and spontaneously reported pregnancies will be reported and followed per protocol. All participants in efficacy follow-up prior to initiation of Amendment 4 will stop efficacy assessments and be discontinued from the study. All participants in survival follow-up prior to initiation of Amendment 4 are considered to have completed the study and should have a final survival contact. The overall study ends when the last participant completes the last study-related contact or visit, withdraws from the study, or is lost to follow-up. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2019-05-06 Last Updated: 2023-10-31 Number of Patients: 487 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Urothelial Carcinoma
NCTID: NCT04303780
Title: Study to Compare AMG 510 “Proposed INN Sotorasib” With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200). Study Summary: A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC) subjects with KRAS p. G12c mutation Sponsor: Amgen Intervention: AMG 510 Start Date: 2020-06-04 Last Updated: 2023-10-23 Number of Patients: 345 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: KRAS p, G12c Mutated /Advanced Metastatic NSCLC
NCTID: NCT02329080
Title: New Combination of Chemoimmunotherapy for Systemic B-cell Lymphoma With Central Nervous System Involvement Study Summary: This is an open, non comparative, multicentre phase II trial, to evaluate the efficacy and feasibility of a new sequential combination of HD-MTX-AraC-based chemoimmunotherapy, followed by R-ICE regimen, and by high-dose chemotherapy supported by ASCT. Sponsor: International Extranodal Lymphoma Study Group (IELSG) Intervention: Methotrexate Start Date: 2014-12 Last Updated: 2023-05-18 Number of Patients: 76 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Diffuse Large B-cell Lymphoma
NCTID: NCT05406401
Title: A Study of Zilovertamab Vedotin (MK-2140) in Combination With Cyclophosphamide, Doxorubicin, and Prednisone Plus Rituximab or Rituximab Biosimilar (Truxima) (R-CHP) in Participants With Diffuse Large B-Cell Lymphoma (DLBCL) (MK-2140-007) Study Summary: This study consists of a dose escalation/confirmation phase and an efficacy expansion phase. The dose escalation/confirmation phase is to determine the safety and tolerability and establish a preliminary recommended Phase 2 dose (RP2D) of zilovertamab vedotin when administered in combination with R-CHP in participants with DLBCL who have received no prior treatment for their disease. The efficacy expansion phase is to determine the efficacy of the RP2D of zilovertamab vedotin when administered in combination with R-CHP in participants with DLBCL who have received no prior treatment for their disease. Sponsor: Merck Sharp & Dohme LLC Intervention: Zilovertamab Vedotin Start Date: 2022-07-14 Last Updated: 2023-11-24 Number of Patients: 60 Recruitment Status: RECRUITING Condition: Lymphoma, Large B-Cell, Diffuse (DLBCL)
NCTID: NCT00041301
Title: Assessing Quality of Life of Patients With Prostate Cancer Study Summary: RATIONALE: Quality of life assessment in patients undergoing prostate cancer treatment may help determine the intermediate and long-term effects of the treatment on these patients. PURPOSE: Clinical trial to study the effectiveness of two questionnaires in assessing quality of life of patients who have prostate cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: QoL assessment Start Date: 2002-03 Last Updated: 2012-08-27 Number of Patients: 625 Recruitment Status: COMPLETED Condition: Prostate Cancer
NCTID: NCT04487080
Title: A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer Study Summary: The purpose of this study is to assess the efficacy of the amivantamab and lazertinib combination, compared with osimertinib, in participants with epidermal growth factor receptor (EGFR) mutation (Exon 19 deletions <math display="block">Exon 19del</math> or Exon 21 L858R substitution) positive, locally advanced or metastatic non-small cell lung cancer (NSCLC). Sponsor: Janssen Research & Development, LLC Intervention: Amivantamab Start Date: 2020-09-30 Last Updated: 2023-11-08 Number of Patients: 1074 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT01117441
Title: International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia Study Summary: Rationale/Purpose: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating young patients with acute lymphoblastic leukemia (ALL). This trial is studying several different combination chemotherapy regimens to compare how well they work in treating young patients with ALL. Study objectives Primary study questions: * Non high-risk (non-HR) precursor-B ALL (pB-ALL) patients with TEL/AML1-negative ALL or unknown TEL/AML1 status and flow cytometry minimal residual disease (MRD) in bone marrow on day 15 <0.1% or with TEL/AML1-positive ALL (randomized study question R1): Can the daunorubicin dose in Protocol IA be safely reduced by 50 % with a non-inferior EFS and a reduction of toxicity (treatment-related mortality and AE/SAE in Protocol I)? * Patients with pB-ALL and risk group medium risk (MR) (randomized study question R2): Can the clinical outcome be improved by protracted asparagine depletion achieved through application of intensified PEG-L-asparaginase during reintensification and early maintenance? * High-risk (HR) patients (as identified by day 33 - randomized study question RHR): Can the clinical outcome be improved by protracted exposure to PEG-L-asparaginase during Protocol IB? Secondary study questions: * Standard risk (SR) patients identified by at least one sensitive marker: Is the clinical outcome comparable to that obtained in SR patients (identified with two sensitive markers) in AIEOP-BFM ALL 2000, or can the outcome even be improved with the use of PEG-L-asparaginase instead of native E. coli L-ASP? * T-ALL non-HR patients: Can the high level of outcome which was obtained for these patients in study AIEOP-BFM ALL 2000 be preserved or even improved with the use of PEG-L-ASP instead of native E. coli L-ASP? * HR patients with persisting high MRD levels despite the use of the HR blocks in the intensified consolidation phase “MRD Non-Responders”: Is it possible to improve the outcome and to achieve a further reduction of leukemic cell burden by administration of an innovative treatment schedule (DNX-FLA)? * Patients participating in the randomized asparaginase studies (pB-ALL/MR, HR): Are asparaginase activity and asparaginase antibodies associated with development of allergic reactions, and do they have an effect on the outcome of the patients? * What is the relative value of different methods of MRD monitoring in the definition of alternative stratification systems within a BFM-oriented protocol? Sponsor: University Hospital Schleswig-Holstein Intervention: PEG-L-asparaginase Start Date: 2010-06 Last Updated: 2022-05-24 Number of Patients: 6136 Recruitment Status: COMPLETED Condition: Leukemia
NCTID: NCT04231981
Title: Efficacy of INCMGA00012 in Penile Squamous Cell Carcinoma (ORPHEUS) Study Summary: This is a multicenter, open-label, single-arm, phase II clinical trial to evaluate the efficacy and safety of INCMGA00012 in Advanced Penile Squamous Cell Carcinoma Sponsor: MedSIR Intervention: INCMGA0012 Start Date: 2020-04-28 Last Updated: 2023-01-19 Number of Patients: 18 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Penile Cancer
NCTID: NCT01849874
Title: A Study of MEK162 vs. Physician’s Choice Chemotherapy in Patients With Low-grade Serous Ovarian, Fallopian Tube or Peritoneal Cancer Study Summary: The MILO Study (MEK Inhibitor in Low-grade Serous Ovarian Cancer) is a Phase 3 study during which patients with recurrent or persistent low-grade serous (LGS) carcinomas of the ovary, fallopian tube or primary peritoneum will receive either investigational study drug MEK162 or a chemotherapy chosen by the physician (liposomal doxorubicin, paclitaxel or topotecan). Patients will be followed to compare the effectiveness of the study drug to that of the selected chemotherapies. Patients may be eligible to crossover from physician’s choice chemotherapy to MEK162 if they meet certain inclusion criteria including centrally confirmed disease progression. Approximately 360 patients from North America, Europe and Australia will be enrolled in this study. Sponsor: Pfizer Intervention: MEK162, MEK inhibitor; oral Start Date: 2013-06-27 Last Updated: 2023-10-30 Number of Patients: 341 Recruitment Status: TERMINATED Condition: Low-grade Serous Ovarian Cancer
NCTID: NCT04097301
Title: Study of CAR T-cell Therapy in Acute Myeloid Leukemia and Multiple Myeloma Study Summary: The purpose of this first-in-man Phase I-IIa study is to evaluate the safety and antitumor activity of autologous CD44v6 CAR T-cells in patients with acute myeloid leukemia (AML) and multiple myeloma (MM). Sponsor: AGC Biologics S.p.A. Intervention: MLM-CAR44.1 T-cells at day 0 Single intravenous infusion Start Date: 2019-08-27 Last Updated: 2022-01-19 Number of Patients: 8 Recruitment Status: TERMINATED Condition: Acute Myeloid Leukemia
NCTID: NCT05363657
Title: International REgistry of COnservative or Radical Treatment of Localized Kidney Tumors Study Summary: Partial nephrectomy (PN) is the standard treatment for localized renal masses and should be preferred in clinical T1 (<7 cm tumor diameter) renal tumors over radical nephrectomy (RN) whenever technically feasible. Nonetheless, indications, approaches, techniques for PN, and correct reporting of outcomes, are still a matter of great debate within the urology community. Concurrently, case-report series suggested that alternative strategies for the treatment of localized renal tumors (ablation techniques (AT), watchful waiting (WW), active surveillance (AS)) could be feasible with acceptable oncologic outcomes in particular settings of patients with localized renal tumors. In this complex clinical scenario, the role surgeon-related and environmental factors (such as surgical experience, hospital resources, countries’ social background and performance of health system) are important to address the best personalized approach in patients with renal tumors. In the light of current evidence, many unsolved questions still remain and many unmet needs must be addressed. In particular, 1) the risk-benefit trade-offs between PN and RN for anatomically complex renal localized tumors; 2) the definition of evidence-based strategies to tailor the management strategy (AT vs WW vs AS vs surgery) in different subset of patients with particular clinical conditions (i.e. old, frail, comorbid patients); and 3) the definition of evidence-based recommendations to adapt surgical approach (open vs laparoscopic vs robotic) and resection techniques to different patient-, tumor-, and surgeon-specific characteristics. To meet the challenges, to overcome the limitations of current kidney cancer literature (such as the retrospective study design, potential risk of biases, and heterogeneous follow-up of most series), and to provide high-quality evidence for future development of effective clinical practice Guidelines, we designed the international REgistry of COnservative or Radical treatment of localized kiDney tumors (i-RECORD) Project. The expected impact of the i-RECORD project is to provide robust evidence on the leading clinical and environmental factors driving selection of the management strategy in patients with kidney cancer, and the differential impact of different management strategies (including AS, WW, AT, PN and RN) on functional, perioperative and oncological outcomes, as well as quality of life assessment, at a mid-long term follow-up (5-10 years). Sponsor: Azienda Ospedaliero-Universitaria Careggi Intervention: Partial Nephrectomy (PN) Start Date: 2022-01-10 Last Updated: 2022-05-06 Number of Patients: 10000 Recruitment Status: RECRUITING Condition: Kidney Cancer
NCTID: NCT05714124
Title: Liver Embolization Approaches for Tumor Management Study Summary: The goal of this evaluate short, medium and long term outcome of the different embolization techniques in patients with primary and secondary hepatic tumors. The main aim is to evaluate progression free survival following embolization in this study population or evaluate residual hepatic volume in cases in which these techniques are used to induce liver regeneration. This study is an observational registry - all patients will follow their normal therapeutic and treatment scheme as per clinical practice, without any additional intervention. Sponsor: IRCCS San Raffaele Intervention: Embolization Start Date: 2021-05-21 Last Updated: 2023-02-06 Number of Patients: 580 Recruitment Status: RECRUITING Condition: Hepatocellular Carcinoma
NCTID: NCT04700124
Title: Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304) Study Summary: The purpose of this study is to assess the antitumor efficacy and safety of perioperative enfortumab vedotin (EV) plus pembrolizumab and radical cystectomy (RC) + pelvic lymph node dissection (PLND) compared with the current standard of care (neoadjuvant chemotherapy <math display="block">gemcitabine plus cisplatin</math> and RC + PLND) for participants with MIBC who are cisplatin-eligible. The primary hypothesis is perioperative EV and pembrolizumab and RC + PLND (Arm A) will achieve superior event free survival (EFS) compared with neoadjuvant gemcitabine + cisplatin and RC + PLND (Arm B). Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2021-04-21 Last Updated: 2023-11-18 Number of Patients: 784 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Muscle Invasive Bladder Cancer
NCTID: NCT02130557
Title: A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia Study Summary: Phase 3, 2-arm, randomized, open label trial. Patients will be randomized to receive bosutinib or imatinib for the duration of the study. Sponsor: Pfizer Intervention: Bosutinib Start Date: 2014-07-15 Last Updated: 2021-05-18 Number of Patients: 536 Recruitment Status: COMPLETED Condition: Leukemia, Myelogenous, Chronic, Breakpoint Cluster Region-Abelson Proto-oncogene (BCR-ABL) Positive
NCTID: NCT02928224
Title: Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer Study Summary: This is a multicenter, randomized, open-label, 3-arm Phase 3 study to evaluate encorafenib + cetuximab plus or minus binimetinib versus Investigator’s choice of either irinotecan/cetuximab or FOLFIRI/cetuximab, as controls, in patients with BRAFV600E mCRC whose disease has progressed after 1 or 2 prior regimens in the metastatic setting. The study contains a Safety Lead-in Phase in which the safety and tolerability of encorafenib + binimetinib + cetuximab will be assessed prior to the Phase 3 portion of the study. Sponsor: Pfizer Intervention: Encorafenib Start Date: 2016-10-13 Last Updated: 2023-05-06 Number of Patients: 702 Recruitment Status: COMPLETED Condition: BRAF V600E-mutant Metastatic Colorectal Cancer
NCTID: NCT04489940
Title: Bintrafusp Alfa in High Mobility Group AT-Hook 2 (HMGA2) Expressing Triple Negative Breast Cancer Study Summary: The main purpose of this study was to evaluate bintrafusp alfa monotherapy in participants with triple negative breast cancer (TNBC) who express high levels of HMGA2 as determined by a centralized reverse transcriptase-polymerase chain reaction (RT-PCR) test. Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: Bintrafusp alfa Start Date: 2020-10-12 Last Updated: 2023-04-10 Number of Patients: 11 Recruitment Status: TERMINATED Condition: Triple Negative Breast Neoplasms
NCTID: NCT00945724
Title: Safety and Feasibility Study of Combination of State of Art Chemoimmunotherapy, Intensive Central Nervous System Prophylaxis and Scrotal Irradiation to Treat Primary Diffuse Large B-cell Lymphoma of Testis Study Summary: This trial is a phase II non-comparative study aimed to determine the feasibility and toxicity of the R-CHOP regimen in combination with intrathecal liposomal cytarabine and systemic intermediate-dose methotrexate followed by loco-regional radiotherapy. Sponsor: International Extranodal Lymphoma Study Group (IELSG) Intervention: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate Start Date: 2009-04 Last Updated: 2023-03-10 Number of Patients: 54 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Large B-cell Diffuse Lymphoma of Testis
NCTID: NCT05305040
Title: Study of Posoleucel (ALVR105,Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant Study Summary: This is a Phase 3 study to evaluate posoleucel (ALVR105, Viralym-M); an allogeneic, off-the-shelf multi-virus specific T cell therapy that targets six viral pathogens: BK virus, cytomegalovirus, adenovirus, Epstein-Barr virus, human herpesvirus 6 and JC virus. Sponsor: AlloVir Intervention: Posoleucel (ALVR105) Start Date: 2022-03-21 Last Updated: 2023-07-17 Number of Patients: 302 Recruitment Status: RECRUITING Condition: Adenovirus Infection
NCTID: NCT05215340
Title: Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations Study Summary: This study is designed to assess the efficacy and safety of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab versus pembrolizumab alone in participants with advanced or metastatic non-small cell lung cancer (NSCLC). Sponsor: Daiichi Sankyo, Inc. Intervention: Datopotamab Deruxtecan Start Date: 2022-03-04 Last Updated: 2023-11-18 Number of Patients: 740 Recruitment Status: RECRUITING Condition: Metastatic Non Small Cell Lung Cancer
NCTID: NCT04623541
Title: Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter’s Syndrome Study Summary: The study is a global, multi-center safety and efficacy trial of epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20). Epcoritamab will either be studied as: * Monotherapy, or * Combination therapy: ** epcoritamab + venetoclax ** epcoritamab + lenalidomide ** epcoritamab + R-CHOP (i.e., rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine and prednisone). The study includes patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL)/small lymphocytic lymphoma (SLL) and patients with Richter’s Syndrome (RS). Study participants with R/R CLL/SLL are treated either with epcoritamab as monotherapy or epcoritamab + venetoclax. Study participants with RS are treated either with epcoritamab as monotherapy or epcoritamab + lenalidomide or epcoritamab + R-CHOP. The trial consists of two parts, a dose-escalation phase (phase Ib) and an expansion phase (phase II). Patients with RS are only included in the expansion phase. Sponsor: Genmab Intervention: Epcoritamab Start Date: 2020-11-25 Last Updated: 2023-11-15 Number of Patients: 184 Recruitment Status: RECRUITING Condition: Relapsed/Refractory Chronic Lymphocytic Leukemia
NCTID: NCT03624036
Title: Study to Evaluate the Safety and Tolerability of Brexucabtagene Autoleucel (KTE-X19) in People With Relapsed/Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma Study Summary: The primary objective of this study is to evaluate the safety and tolerability of brexucabtagene autoleucel (KTE-X19) in adults with relapsed/refractory chronic lymphocytic leukemia (r/r CLL) and small lymphocytic lymphoma (r/r SLL) who have received at least 2 prior lines of treatment, one of which must include a Bruton’s tyrosine kinase (BTK) inhibitor. After the end of KTE-C19-108, participants who received an infusion of brexucabtagene autoleucel will complete the remainder of the 15-year follow-up assessments in a separate Long-term Follow-up study, KT-US-982-5968 (NCT05041309). Sponsor: Kite, A Gilead Company Intervention: brexucabtagene autoleucel Start Date: 2018-11-15 Last Updated: 2023-11-18 Number of Patients: 16 Recruitment Status: TERMINATED Condition: Relapsed/Refractory Chronic Lymphocytic Leukemia and Relapsed/Refractory Small Lymphocytic Lymphoma
NCTID: NCT01287741
Title: A Study of Obinutuzumab in Combination With CHOP Chemotherapy Versus Rituximab With CHOP in Participants With CD20-Positive Diffuse Large B-Cell Lymphoma (GOYA) Study Summary: This open-label, randomized, parallel group study will evaluate the efficacy and safety of obinutuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisolone or prednisone (CHOP) chemotherapy versus rituximab (MabThera/Rituxan) with CHOP in previously untreated participants with cluster of differentiation 20 (CD20)-positive diffuse large B-cell lymphoma (DLBCL). Participants will be randomized to receive either obinutuzumab 1000 milligrams (mg) intravenously (IV) every 21 days or rituximab 375 milligrams per square meter (mg/m^2) IV every 21 days for 8 cycles, in addition to 6-8 cycles of CHOP chemotherapy IV every 21 days. Participants randomized to the obinutuzumab arm will receive an additional two doses on Days 8 and 15 of Cycle 1. Anticipated time on study treatment is 24 weeks. Sponsor: Hoffmann-La Roche Intervention: Rituximab Start Date: 2011-07-26 Last Updated: 2019-04-12 Number of Patients: 1418 Recruitment Status: TERMINATED Condition: Diffuse Large B-Cell Lymphoma
NCTID: NCT03528941
Title: The Incidence of Hepatitis B Reactivations in Patients Affected by Chronic Lymphocytic Leukemia With Ibrutinib Study Summary: This observational retrospective study will enroll at least 158 patients affected by Chronic Lymphoid Leukemia (CLL) with previous HBV exposure (HBsAg negative, anti-HBc positive with or without anti-HBs) treated with Ibrutinib single agent according to the IWCLL criteria 2008. Patients will be divided into two cohorts, one encompassing patients who received lamivudine and the second one including patients who received no prophylaxis. Each patient will be observed for one year from the first administration of Ibrutinib. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: Lamivudine Start Date: 2018-11-28 Last Updated: 2022-05-12 Number of Patients: 109 Recruitment Status: COMPLETED Condition: Chronic Lymphocytic Leukemia
NCTID: NCT03748641
Title: A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer Study Summary: The purpose of this study is to evaluate the effectiveness of niraparib in combination with abiraterone acetate plus prednisone (AAP) compared to AAP and placebo. Sponsor: Janssen Research & Development, LLC Intervention: Niraparib Start Date: 2019-01-25 Last Updated: 2023-11-13 Number of Patients: 765 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Castration-Resistant Prostatic Cancer
NCTID: NCT06071598
Title: The Role of Lipid Transporter MFSD2A in the Resolution of Colorectal Cancer-associated Inflammation Study Summary: The intrinsic connection between inflammation and tumor promotion is well characterized and is a key pathogenic event in patients with colorectal cancer (CRC), the second most common cause of tumor-related death in western countries. Environmental factors and chronic inflammation represent the major causes of intestinal carcinogenesis. In fact, patients suffering from inflammatory bowel diseases, including Crohn’s disease and Ulcerative Colitis (UC), have high risk of developing colitis-associated CRC with poor prognoses. Therefore, targeting the cancer-associated inflammation may offer new avenues for cancer treatment. In fact, several anti-inflammatory drugs, have been used for prophylaxis and have shown efficacy in contrasting cancer, despite various adverse side effects. Thus, there is an urgent need to discover novel cancer-associated mechanisms to develop alternative therapies that may reduce aberrant inflammatory responses without interfering with physiological defenses against infection and functional anti-tumor immunity. A novel approach promoting anti-tumor immunity has been recently proposed after the discovery of potent, endogenous, specialized pro-resolving mediators (SPMs), including lipoxins, resolvins, protectins, and maresins, mainly derived from omega-3 polyunsaturated fatty acid (PUFA) docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) via COX, LOX and CYP450 pathways, mediated by MFSD2A. Due to the potent bioactivity of SPMs in resolving inflammation and because of the correlation between inflammation and cancer, the roles of these lipid mediators have attracted great attention for their potential therapeutic role in cancer treatment, including CRC. Nevertheless, the understanding of the endogenous mechanisms that limit the inflammatory response during CRC development is incomplete and requires further investigation. Based on the preliminary results indicating that dysfunctional MFSD2A-dependent pro-resolving pathways may foster CRC development, the investigators aim to define the functional role of MFSD2A in orchestrating pro-resolving pathways in the intestinal endothelium of metastatic and not metastatic CRC patients. This is a cross-sectional single-center observational study involving patients with CRC. The investigators will enroll 15 patients with colorectal cancer (CRC) stratified by tumor stage (T0 / T1-T4, M0 / M1, N0 / N1 / N2) undergoing surgery in the Gastroenterology and Digestive Endoscopy unit within Gastro Center (IRCCS Ospedale San Raffaele). Human Intestinal Microvascular Endothelial Cells (HIMEC) will be generated from each sample of cancer surgical specimens, while the healthy cells will be derived from the healthy margins of the colorectal resection of the same CRC patients. MFSD2A will be overexpressed or silenced and the investigators will evaluate its biological effects in both tumor-derived HIMECs and healthy tissue-derived HIMECs through transcriptomics and lipidomics analysis. The investigators will also exploit a possible novel therapy based on the delivery of MFSD2A encoding plasmid-conjugated liposomes. Sponsor: IRCCS San Raffaele Intervention: Surgical specimens of CRC-affected patients Start Date: 2023-03-15 Last Updated: 2023-10-06 Number of Patients: 15 Recruitment Status: RECRUITING Condition: Colorectal Cancer
NCTID: NCT01064557
Title: “AIDA” Protocol (LAP 0493) Study Summary: The main purposes of the AIDA protocol are to test the role of intermittent maintenance therapy with ATRA, standard maintenance chemotherapy with methotrexate and 6-mercaptopurine of both in PCR negative patients at the end of the consolidation phase and to evaluate the role of allogeneic or autologous bone marrow transplantation in PCR positive patients at the end of the consolidation phase. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: all-trans retinoic acid (ATRA) Start Date: 1993-10 Last Updated: 2020-10-14 Number of Patients: 1068 Recruitment Status: UNKNOWN Condition: Leukemia
NCTID: NCT04476199
Title: Venetoclax and Decitabine Assessment in Patients (≥60 - <75 Years) With Newly Diagnosed AML Eligible for Allo-SCT Study Summary: This trial is a no profit, prospective, phase II, multicentre, non-randomised, uncontrolled, single group assignment, open label study to evaluate the safety and efficacy of the “chemo-free” combination Venetoclax plus Decitabine (VEN-DEC) as “bridge” to allo-SCT in elderly (≥ 60 - < 75 years) AML patients. The primary objective is to evaluate the proportion of elderly (≥60 - <75 years) patients with newly diagnosed AML, eligible for allo-SCT, treated with the “chemo-free” combination Venetoclax plus Decitabine (VEN-DEC) who get allo-SCT in CR/Cri/MLFS. Sponsor: Gruppo Italiano Trapianto di Midollo Osseo Intervention: Venetoclax and Decitabine Start Date: 2019-12-09 Last Updated: 2023-03-10 Number of Patients: 100 Recruitment Status: COMPLETED Condition: Acute Myeloid Leukemia
NCTID: NCT03367299
Title: Sequential Chemotherapy and Blinatumomab to Improve MRD Response and Survival in Acute Lymphoblastic Leukemia Study Summary: The present study aims at analyzing the response to treatment of adult patients homogeneously treated with supportive care, chemotherapy and blinatumomab. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: Chemotherapy + Blinatumomab Start Date: 2018-06-08 Last Updated: 2022-01-04 Number of Patients: 149 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Acute Lymphoid Leukemia
NCTID: NCT05605899
Title: Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma Study Summary: The goal of this clinical study is to compare the study drug, axicabtagene ciloleucel, versus standard of care (SOC) in first-line therapy in participants with high-risk large B-cell lymphoma. Sponsor: Kite, A Gilead Company Intervention: Axicabtagene Ciloleucel Start Date: 2023-02-10 Last Updated: 2023-11-18 Number of Patients: 300 Recruitment Status: RECRUITING Condition: High-risk Large B-cell Lymphoma (LBCL)
NCTID: NCT01009970
Title: Study With Rituximab, Cyclophosphamide, Doxorubicin Liposomal (Myocet®), Vincristine, Prednisone, (R-COMP) to Treat Non-Hodgkin’s Lymphoma Study Summary: This is a multicenter study phase II, open-label for cardiopathic patients affected by Non-Hodgkin’s lymphoma diffuse large B cell CD20 + grade IIIb follicular. The purpose is to study the feasibility of R-COMP in this cohort of patients. Sponsor: Fondazione Italiana Linfomi - ETS Intervention: Rituximab Start Date: 2010-05 Last Updated: 2011-10-13 Number of Patients: 50 Recruitment Status: UNKNOWN Condition: Diffuse Large B-Cell Lymphoma
NCTID: NCT04165070
Title: KEYMAKER-U01 Substudy 1: Efficacy and Safety Study of Pembrolizumab (MK-3475) Plus Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Advanced Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A) Study Summary: The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) PLUS chemotherapy in combination with vibostolimab (MK-7684), boserolimab (MK-5890), MK-4830, or MK-0482 in treatment-naïve participants with advanced squamous or non-squamous NSCLC. This study is one of three pembrolizumab substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01/KEYMAKER-U01). Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2019-12-19 Last Updated: 2023-11-13 Number of Patients: 360 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT01801111
Title: A Study of Alectinib (RO5424802) in Participants With Non-Small Cell Lung Cancer Who Have Anaplastic Lymphoma Kinase (ALK) Mutation and Failed Crizotinib Treatment Study Summary: This open-label, non-randomized, multicenter, Phase 1/2 study will evaluate the safety and efficacy of alectinib in participants with non-small cell lung cancer who have ALK mutation and failed crizotinib treatment. In Part 1, cohorts of participants will receive escalating doses of alectinib orally twice daily. In Part 2, participants will receive the recommended phase 2 dose (RP2D) of alectinib as determined in Part 1. Treatment will continue in Part 1 and Part 2 on the same dose until disease progression. In Part 3, following disease progression, participants without epidermal growth factor receptor (EGFR) mutation will be offered continued treatment with alectinib, participants with EGFR mutations will be offered a combination of alectinib and erlotinib. Sponsor: Hoffmann-La Roche Intervention: Erlotinib Start Date: 2013-06-20 Last Updated: 2018-11-02 Number of Patients: 138 Recruitment Status: COMPLETED Condition: Non-Small-Cell Lung Carcinoma
NCTID: NCT04045613
Title: Derazantinib and Atezolizumab in Patients With Urothelial Cancer Study Summary: The purpose of this study was to evaluate efficacy of derazantinib monotherapy or derazantinib-atezolizumab in combination in patients with advanced urothelial cancer harboring fibroblast growth factor receptor (FGFR) genetic aberrations (GA) of various clinical stages of disease progression and prior treatments. Sponsor: Basilea Pharmaceutica Intervention: Derazantinib 300 mg once daily monotherapy Start Date: 2019-08-02 Last Updated: 2023-10-13 Number of Patients: 95 Recruitment Status: COMPLETED Condition: Urothelial Carcinoma
NCTID: NCT04919811
Title: Taletrectinib Phase 2 Global Study in ROS1 Positive NSCLC Study Summary: The main purpose of the study is to evaluate safety and efficacy of taletrectinib (also known as AB-106 or DS-6051b) monotherapy in the treatment of advanced NSCLC. Sponsor: AnHeart Therapeutics Inc. Intervention: Taletrectinib Start Date: 2021-09-01 Last Updated: 2023-04-11 Number of Patients: 154 Recruitment Status: RECRUITING Condition: Non Small Cell Lung Cancer
NCTID: NCT02354313
Title: Phase III, Randomized Trial: Lenalidomide vs Observation After Induction With Rituximab Followed by Cht and ASCT in MCL Adult Patients Study Summary: A phase III multicenter, randomized study with Lenalidomide (Revlimid®) maintenance versus observation after intensified induction regimen containing rituximab followed by high dose chemotherapy and Autologous Stem Cell Transplantation as first line treatment in adult patients with advanced Mantle Cell Lymphoma: IIL study (MCL0208). Sponsor: Fondazione Italiana Linfomi - ETS Intervention: Lenalidomide Start Date: 2010-05 Last Updated: 2018-02-09 Number of Patients: 300 Recruitment Status: UNKNOWN Condition: MANTLE CELL LYMPHOMA
NCTID: NCT02136511
Title: Expanded Access for Idelalisib in Combination With Rituximab in Chronic Lymphocytic Leukemia Study Summary: This study is to provide idelalisib (IDELA) to individuals with relapsed, previously treated chronic lymphocytic leukemia (CLL) who have limited treatment options and are not eligible for other Gilead-sponsored studies. Sponsor: Gilead Sciences Intervention: Idelalisib Start Date: NA Last Updated: 2014-10-28 Number of Patients: NA Recruitment Status: APPROVED_FOR_MARKETING Condition: Chronic Lymphocytic Leukemia (CLL)
NCTID: NCT04826211
Title: Axillary Staging in Node Positive Breast Cancer Patients Receiving PST. SNB vs PET/MRI Study Summary: The management of axillary nodes in breast cancer patients is a highly debated and evolving field. To date, an increasing number of patients with positive lymph nodes receives primary systemic therapy (PST) prior to surgery leading to down-staging axillary nodes in about 40% of women. However, the available diagnostic methods have several limitations in properly evaluating the response after treatment both in the breast and in the nodes and might lead to either under or over-treatment in these patients. Fully integrated scanners capable of simultaneous acquisition of PET and MRI have now been developed, with the potential to combine the specificity obtained by the functional imaging of PET, with the superior sensitivity of MRI, to provide higher diagnostic accuracy. It is expected that PET/MRI could better determine the response after PST to distinguish patients with negative versus patients with positive axillary nodes after medical treatment. As the excision of axillary nodes has mainly a staging purpose, the reliable identification of node negative patients might eventually spare women from unnecessary surgery. An accurate over-time and final imaging work-up might help choose the appropriate type of surgery according to the extent of nodal involvement: either SNB or complete axillary clearance. Sponsor: Oreste Davide Gentilini Intervention: PET/MRI Start Date: 2019-11-04 Last Updated: 2023-09-28 Number of Patients: 110 Recruitment Status: RECRUITING Condition: Breast Cancer Female
