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Trials (Fondazione Policlinico Universitario Agostino Gemelli IRCCS)
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<span style="display:none">forpatients</span> <span style="display:none">forresearchers</span> <span style="display:none">forproviders</span> <span style="display:none">italycountry</span> Go back to [[Fondazione Policlinico Universitario Agostino Gemelli IRCCS]] page === Trials: How to participate === '''Contact information:''' [https://www.policlinicogemelli.it/scienze-innovazione-ricerca/sperimentazioni-cliniche/ Click here to access]. '''NCTID''': NCT05323656 '''Title''': A Study of Setanaxib Co-Administered With Pembrolizumab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN) '''Study Summary''': The primary objective of this study is to compare the change in tumour size per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) in recurrent or metastatic SCCHN patients treated with setanaxib and pembrolizumab versus patients treated with placebo and pembrolizumab. '''Sponsor''': Calliditas Therapeutics Suisse SA '''Intervention''': Setanaxib '''Start Date''': 2022-04-06 '''Last Updated''': 2023-11-29 '''Number of Patients''': 55 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': Squamous Cell Carcinoma of Head and Neck '''NCTID''': NCT05291156 '''Title''': CAVE-2 GOIM Study: a Clinical Study of the Combination of Avelumab Plus Cetuximab as Rechallenge Strategy '''Study Summary''': This is a non-profit phase II, randomized clinical study of the combination of avelumab plus cetuximab as rechallenge strategy, compared to cetuximab alone, in pre-treated RAS/BRAF wild type metastatic colorectal cancer patients (according to liquid biopsy at baseline). Patients have been treated in first line with chemotherapy in combination with cetuximab and have had a clinical benefit (complete or partial response) from treatment. '''Sponsor''': University of Campania âLuigi Vanvitelliâ '''Intervention''': Cetuximab '''Start Date''': 2022-07-21 '''Last Updated''': 2023-10-04 '''Number of Patients''': 173 '''Recruitment Status''': RECRUITING '''Condition''': Metastatic Colorectal Cancer '''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''': NCT04987203 '''Title''': Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma '''Study Summary''': This study will be comparing tivozanib in combination with nivolumab to tivozanib alone in subjects with advanced Renal Cell Carcinoma (RCC) who have had 1 or 2 prior lines of therapy, one of which was an Immune Checkpoint Inhibitor (ICI). '''Sponsor''': AVEO Pharmaceuticals, Inc. '''Intervention''': Tivozanib '''Start Date''': 2021-09-09 '''Last Updated''': 2023-11-28 '''Number of Patients''': 326 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': Renal Cell Carcinoma '''NCTID''': NCT04607668 '''Title''': Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving FOLFOXIRI/Bevacizumab for Metastatic Colorectal Cancer (mCRC): '''Study Summary''': This is a randomized, double-blind, placebo-controlled, global, multicenter, Phase 3 trial evaluating the impact of trilaciclib on myelopreservation and anti-tumor efficacy when administered prior to FOLFOXIRI/bevacizumab in patients with pMMR/MSS mCRC who have not received systemic therapy for metastatic disease. '''Sponsor''': G1 Therapeutics, Inc. '''Intervention''': Trilaciclib '''Start Date''': 2020-10-16 '''Last Updated''': 2023-04-07 '''Number of Patients''': 326 '''Recruitment Status''': TERMINATED '''Condition''': Colorectal Cancer Metastatic '''NCTID''': NCT05317416 '''Title''': Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant '''Study Summary''': The purpose of this study is to evaluate whether elranatamab monotherapy can provide clinical benefit compared to lenalidomide monotherapy (control) in participants with newly diagnosed multiple myeloma after undergoing autologous stem cell transplant. In Part 1 and Part 2 of the study, participants in the study will either receive elranatamab (arm A and C) as an injection under the skin at the study clinic or lenalidomide orally once daily at home (arm B). Participation in the study will be approximately five years '''Sponsor''': Pfizer '''Intervention''': Elranatamab '''Start Date''': 2022-03-25 '''Last Updated''': 2023-11-28 '''Number of Patients''': 760 '''Recruitment Status''': RECRUITING '''Condition''': Multiple Myeloma '''NCTID''': NCT05804682 '''Title''': Fascial Versus Standard Neck Dissection in Patients With N1b Papillary Thyroid Carcinoma '''Study Summary''': Optimal surgical technique for neck dissection (LND) in thyroid carcinoma remains a subject of debate. Fascial ND (FND) implies the removal of the superficial and middle layers of the deep cervical fascia en bloc with lymph-nodes containing fibro-fatty tissue (levels IIa-Vb and VI-VII for cN1b patients). This retrospective cohort study was designed to compare FND with standard, non-fascial, selective ND (SND). '''Sponsor''': Fondazione Policlinico Universitario Agostino Gemelli IRCCS '''Intervention''': Fascial Neck Dissection '''Start Date''': 2018-01-01 '''Last Updated''': 2023-04-07 '''Number of Patients''': 195 '''Recruitment Status''': COMPLETED '''Condition''': Patients With Papillary Thyroid Cancer and N1b Status '''NCTID''': NCT04458259 '''Title''': Study of PF-07265807 in Participants With Metastatic Solid Tumors. '''Study Summary''': A First-in-Human Pharmacokinetic, Safety, and Tolerability Study of PF-07265807 as Monotherapy and in Combination in Participants with Advanced or Metastatic Solid Tumors '''Sponsor''': Pfizer '''Intervention''': PF-07265807 '''Start Date''': 2020-09-24 '''Last Updated''': 2023-11-22 '''Number of Patients''': 67 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': Neoplasm Metastasis '''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 MĂŠdicales '''Intervention''': Ivosidenib Oral Tablet '''Start Date''': 2023-05-03 '''Last Updated''': 2023-09-06 '''Number of Patients''': 220 '''Recruitment Status''': RECRUITING '''Condition''': Cholangiocarcinoma '''NCTID''': NCT03815643 '''Title''': Avelumab Program Rollover Study '''Study Summary''': The main purpose of this study is to monitor the safety and tolerability of avelumab in participants with solid tumors who continue treatment with avelumab under the same treatment regimen as in the parent avelumab study. '''Sponsor''': EMD Serono Research & Development Institute, Inc. '''Intervention''': Avelumab '''Start Date''': 2019-03-22 '''Last Updated''': 2023-11-07 '''Number of Patients''': 161 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': Solid Tumors '''NCTID''': NCT03257267 '''Title''': Study of Cemiplimab in Adults With Cervical Cancer '''Study Summary''': The primary objective is to compare overall survival (OS) for patients with recurrent or metastatic cervical cancer who have histology of squamous cell carcinoma (SCC) and who have any eligible histology treated with either cemiplimab or investigatorâs choice (IC) chemotherapy. The secondary objectives performed among SCC patients and among all eligible histologies (SCC and adenocarcinoma/adenosquamous carcinoma (AC) are: * To compare progression-free survival (PFS) of cemiplimab versus IC chemotherapy * To compare objective response rate (ORR) (partial response <math display="block">PR</math> + complete response <math display="block">CR</math>) of cemiplimab versus IC chemotherapy per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 * To compare the duration of response (DOR) of cemiplimab versus IC chemotherapy * To compare the safety profiles of cemiplimab versus IC chemotherapy by describing adverse events (AE) * To compare quality of life (QOL) for patients treated with cemiplimab versus IC chemotherapy using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) '''Sponsor''': Regeneron Pharmaceuticals '''Intervention''': Cemiplimab '''Start Date''': 2017-09-05 '''Last Updated''': 2023-07-11 '''Number of Patients''': 608 '''Recruitment Status''': COMPLETED '''Condition''': Squamous Cell Carcinoma (SCC) '''NCTID''': NCT03414047 '''Title''': A Study of Prexasertib (LY2606368) in Platinum-Resistant or Refractory Recurrent Ovarian Cancer '''Study Summary''': The purpose of this study is to evaluate the efficacy and safety of prexasertib in women with platinum-resistant or refractory recurrent ovarian cancer. '''Sponsor''': Eli Lilly and Company '''Intervention''': Prexasertib '''Start Date''': 2018-04-10 '''Last Updated''': 2022-08-19 '''Number of Patients''': 172 '''Recruitment Status''': COMPLETED '''Condition''': Ovarian Cancer '''NCTID''': NCT04582487 '''Title''': Advancing Chemical and Genomic Strategies for Relapsed/Refractory T-ALL and ETP-ALL '''Study Summary''': This is a biological study for R/R T-ALL/LBL or ETP-ALL patients. Bone marrow and/or peripheral blood samples will be subjected to genomic, DSRP profiling and phosphoproteomic screening to identify novel potential therapeutic approach and thus, eligibility for treatment based on molecular and DSRP data. As soon as genomic and DSRP profiling are made available, local Investigator can submit to local ethic committee a request for clinical use of identified compound. '''Sponsor''': Gruppo Italiano Malattie EMatologiche dellâAdulto '''Intervention''': bone marrow and/or peripheral blood samples withdrawal '''Start Date''': 2021-05-19 '''Last Updated''': 2022-11-28 '''Number of Patients''': 32 '''Recruitment Status''': RECRUITING '''Condition''': T Acute Lymphoblastic Leukemia '''NCTID''': NCT01074047 '''Title''': Study of Vidaza Versus Conventional Care Regimens for the Treatment of Acute Myeloid Leukemia (AML) '''Study Summary''': The purpose of this study is to compare the effect of azacitidine (Vidaza) to conventional care regimens on overall survival in elderly AML patients. '''Sponsor''': Celgene '''Intervention''': Azacitidine '''Start Date''': 2010-06-01 '''Last Updated''': 2017-08-29 '''Number of Patients''': 488 '''Recruitment Status''': COMPLETED '''Condition''': Acute Myeloid Leukemia '''NCTID''': NCT05750719 '''Title''': BRCA and NACT in TNBC Patients '''Study Summary''': The goal of this observational study is to evaluate data from patients with triple-negative breast cancer (TNBC) treated with neoadjuvant chemotherapy (NACT) in order to better define the impact of germline BRCA1/2 (gBRCA1/2) mutation status on outcomes in this patient population. The aims of the study are: * To evaluate the rate of pathologic complete response (pCR) in patients with locally advanced TNBC who performed NACT, in relation to the mutational status of gBRCA. * To evaluate Evaluate Event Free survival (EFS) and Overall Survival (OS) in this patients population. '''Sponsor''': Fondazione Policlinico Universitario Agostino Gemelli IRCCS '''Intervention''': BRCA1/2 genetic testing '''Start Date''': 2013-01-02 '''Last Updated''': 2023-03-02 '''Number of Patients''': 136 '''Recruitment Status''': COMPLETED '''Condition''': Triple-Negative Breast Cancer '''NCTID''': NCT05896566 '''Title''': A Window-of-Opportunity Trial of Giredestrant +/- Triptorelin vs. Anastrozole + Triptorelin in Premenopausal Patients With ER-positive/HER2-negative Early Breast Cancer '''Study Summary''': PREcoopERA is a randomized (2:2:1), multicenter, open-label, three-arm (A, B, C), Window-of-Opportunity (WOO) trial to evaluate the activity and safety of giredestrant (A) versus giredestrant plus triptorelin (B) versus anastrozole plus triptorelin (C). '''Sponsor''': ETOP IBCSG Partners Foundation '''Intervention''': Giredestrant '''Start Date''': 2023-12-01 '''Last Updated''': 2023-10-18 '''Number of Patients''': 220 '''Recruitment Status''': NOT_YET_RECRUITING '''Condition''': Breast Cancer '''NCTID''': NCT04460807 '''Title''': Exemestane in Hormone Receptor Positive High Grade Ovarian Cancer '''Study Summary''': In this Italian, multicenter, randomized, double-blind, placebo controlled, phase III study the efficacy of exemestane will be evaluated in addition to the standard front line treatment in patients with hormone-receptor-positive high grade serous or endometrioid Epithelian Ovarian Cancer (EOC). The patients enrolled in the EXPERT trial will receive exemestane or placebo in addition to standard treatment. Patients and investigators will be blinded to study treatment. The hypothesis underlying the proposed clinical trial is that exemestane added to standard first line therapy will significantly prolong median progression free survival (PFS). '''Sponsor''': Ente Ospedaliero Ospedali Galliera '''Intervention''': Exemestane '''Start Date''': 2020-02-13 '''Last Updated''': 2020-07-08 '''Number of Patients''': 468 '''Recruitment Status''': UNKNOWN '''Condition''': Ovarian Cancer '''NCTID''': NCT03635567 '''Title''': Efficacy and Safety Study of First-line Treatment With Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Women With Persistent, Recurrent, or Metastatic Cervical Cancer (MK-3475-826/KEYNOTE-826) '''Study Summary''': The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) plus one of four platinum-based chemotherapy regimens compared to the efficacy and safety of placebo plus one of four platinum-based chemotherapy regimens in the treatment of adult women with persistent, recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include: paclitaxel plus cisplatin with or without bevacizumab and paclitaxel plus carboplatin with or without bevacizumab. The primary study hypotheses are that the combination of pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the Investigator, or, 2) Overall Survival (OS). '''Sponsor''': Merck Sharp & Dohme LLC '''Intervention''': Pembrolizumab '''Start Date''': 2018-10-25 '''Last Updated''': 2023-11-14 '''Number of Patients''': 617 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': Cervical Cancer '''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 âblinded,â 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''': 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''': NCT04951622 '''Title''': A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis '''Study Summary''': The purpose of this study is to evaluate the efficacy and safety of nipocalimab compared to placebo in participants with generalized myasthenia gravis (gMG). '''Sponsor''': Janssen Research & Development, LLC '''Intervention''': Nipocalimab '''Start Date''': 2021-07-15 '''Last Updated''': 2023-11-09 '''Number of Patients''': 198 '''Recruitment Status''': RECRUITING '''Condition''': Myasthenia Gravis '''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''': NCT03975647 '''Title''': A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer '''Study Summary''': This study is being done to see if tucatinib with ado-trastuzumab emtansine (T-DM1) works better than T-DM1 alone to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery. Patients in this study will be randomly assigned to get either tucatinib or placebo (a pill with no medicine). This is a blinded study, so neither patients nor their doctors will know whether a patient gets tucatinib or placebo. All patients in the study will get T-DM1, a drug that is often used to treat this cancer. Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills or placebo pills two times every day. Patients will get T-DM1 injections from the study site staff on the first day of every cycle. '''Sponsor''': Seagen Inc. '''Intervention''': tucatinib '''Start Date''': 2019-10-02 '''Last Updated''': 2023-11-21 '''Number of Patients''': 565 '''Recruitment Status''': RECRUITING '''Condition''': HER2-positive Breast Cancer '''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''': NCT05173987 '''Title''': Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma (MK-3475-C93/KEYNOTE-C93/GOG-3064/ENGOT-en15) '''Study Summary''': The purpose of this study is to assess the safety and efficacy of treatment with pembrolizumab (MK-3475) compared to a combination of carboplatin and paclitaxel in women with mismatch repair deficient (dMMR) advanced or recurrent endometrial carcinoma who have not previously been treated with prior systemic chemotherapy. The primary study hypotheses are that pembrolizumab is superior to the combination of carboplatin and paclitaxel with respect to 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) and Overall Survival (OS). '''Sponsor''': Merck Sharp & Dohme LLC '''Intervention''': pembrolizumab '''Start Date''': 2022-02-03 '''Last Updated''': 2023-11-09 '''Number of Patients''': 280 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': Endometrial Neoplasms '''NCTID''': NCT05706883 '''Title''': Clinical and Molecular Findings in Patients With Cervical/Supraclavicular Metastasis From Non-small-cell Lung Cancer (NSCLC) '''Study Summary''': Despite the availability of highly effective endoscopy-based and computed tomography (CT)-based biopsy procedures, up to 50% of patients with advanced lung cancer potentially eligible for targeted therapies or immunotherapy do not have access to a diagnosis or to a thorough molecular profiling for different reasons. Enlarged and/or positron emission tomography (PET) positive cervical/supraclavicular lymph nodes (CSLs) are ideal targets for a minimally invasive diagnosis of lung cancer through a percutaneous ultrasound-guided biopsy (US-NAB). However, the prevalence of metastatic involvement of CSLs in patients with advanced lung cancer was never specifically assessed. Furthermore, the possible association of malignant CSLs involvement with molecular status was never investigated, unlike what was done for several other metastatic sites. '''Sponsor''': Fondazione Policlinico Universitario Agostino Gemelli IRCCS '''Intervention''': Needle or forceps biopsy of cervical and/or supraclavicular lymph nodes '''Start Date''': 2023-01-01 '''Last Updated''': 2023-10-23 '''Number of Patients''': 168 '''Recruitment Status''': RECRUITING '''Condition''': Lung Cancer Metastatic '''NCTID''': NCT05953883 '''Title''': PROTEOGENOMIC SIGNATURES ANALYSIS IN OVARIAN CANCER '''Study Summary''': Proteogenomic analysis to detect individual platinum-induced modifications on tumor tissue of HGSC according to chemotherapy response score (CRS), using a combined approach of High resolution liquid chromatography mass Spectrometry based platform (HR-LC-MS/MS and advanced immunometric methods on illumine platform); multiple supervised machine learning algorithms will be used to discover proteogenomic signatures and biological processes associated with platinum modification during the neoadjuvant chemotherapy treatment. These results contribute to precision medicine by building an accurate proteogenomic profile of ovarian cancer, in order to better understand the underlying mechanisms of different chemotherapy response among affected patients. '''Sponsor''': Fondazione Policlinico Universitario Agostino Gemelli IRCCS '''Intervention''': Tumor and blood sample '''Start Date''': 2022-11-17 '''Last Updated''': 2023-07-20 '''Number of Patients''': 24 '''Recruitment Status''': RECRUITING '''Condition''': Ovarian Cancer '''NCTID''': NCT04674683 '''Title''': Study Comparing Investigational Drug HBI-8000 Combined With Nivolumab vs. Nivolumab in Patients With Advanced Melanoma '''Study Summary''': This is a phase 3 study to compare the efficacy and safety of HBI-8000 or Placebo combined with nivolumab on patients with unresectable or metastatic melanoma and eligible patients who are not adolescents or patients with new, progressive brain metastasis will be stratified by PD-L1 expression and LDH level. '''Sponsor''': HUYABIO International, LLC. '''Intervention''': HBI-8000 in combination with nivolumab '''Start Date''': 2021-08-12 '''Last Updated''': 2023-07-27 '''Number of Patients''': 480 '''Recruitment Status''': RECRUITING '''Condition''': Unresectable or Metastatic Melanoma '''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''': NCT05238922 '''Title''': Study of INCB123667 in Subjects With Advanced Solid Tumors '''Study Summary''': This is an open-label, dose-escalation and dose-expansion study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCB123667 when administered as monotherapy at the RDE(s) in participants with selected advanced or metastatic solid tumors. Part 1A (dose escalation) will determine the recommended dose of INCB123667 for expansion (RDE) and the maximum tolerated dose (MTD). Part 1B (cohort dose expansion phase) will further explore antitumor activity of INCB123667 as a monotherapy in 6 tumor-specific cohorts at the RDE(s) defined in Part 1A. '''Sponsor''': Incyte Corporation '''Intervention''': INCB0123667 '''Start Date''': 2022-07-05 '''Last Updated''': 2023-11-03 '''Number of Patients''': 340 '''Recruitment Status''': RECRUITING '''Condition''': Solid Tumors '''NCTID''': NCT03705403 '''Title''': IMMUNOtherapy and Stereotactic ABlative Radiotherapy (IMMUNOSABR) a Phase II Study '''Study Summary''': This will be a phase II trial testing if the combination of stereotactic ablative body radiotherapy (SABR) and L19-IL2 improve the progression-free survival in patients with limited metastatic non-small cell lung cancer (NSCLC). The trial consists of one cohort with two arms; C-arm and an E-arm. Patients with oligometastatic disease will receive SABR to minimal 1 and max all metastatic sites (max 5 sites irradiated) and patients with diffuse metastatic lesions (6 to max 10) will receive radiotherapy to max 5 sites. In the experimental arm, immunotherapy will be given after irradiation. '''Sponsor''': Maastricht University '''Intervention''': Darleukin '''Start Date''': 2019-04-04 '''Last Updated''': 2020-10-20 '''Number of Patients''': 126 '''Recruitment Status''': RECRUITING '''Condition''': NSCLC Stage IV '''NCTID''': NCT03760003 '''Title''': Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis '''Study Summary''': Phase IIb study to evaluate the efficacy and the safety of 3 dose-levels of ABX464, administered daily in patients with moderate to severe Ulcerative Colitis. '''Sponsor''': Abivax S.A. '''Intervention''': ABX464 25mg '''Start Date''': 2019-09-23 '''Last Updated''': 2021-08-02 '''Number of Patients''': 254 '''Recruitment Status''': COMPLETED '''Condition''': Ulcerative Colitis '''NCTID''': NCT05257083 '''Title''': A Study of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma '''Study Summary''': The purpose of this study is to compare the efficacy of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Ciltacabtagene Autoleucel versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Autologous Stem Cell Transplant (ASCT) in newly diagnosed multiple myeloma patients. '''Sponsor''': European Myeloma Network '''Intervention''': Daratumumab '''Start Date''': 2023-10-10 '''Last Updated''': 2023-11-18 '''Number of Patients''': 750 '''Recruitment Status''': RECRUITING '''Condition''': Multiple Myeloma '''NCTID''': NCT03940703 '''Title''': A Study of Tepotinib Plus Osimertinib in Osimertinib Relapsed MET Amplified NSCLC (INSIGHT 2) '''Study Summary''': This study will assess the antitumor activity, safety, tolerability, and pharmacokinetics (PK) of the Mesenchymal-epithelial Transition Factor (MET) inhibitor tepotinib combined with the 3rd generation EGFR inhibitor osimertinib in participants with advanced or metastatic non-small cell lung cancer (NSCLC). '''Sponsor''': EMD Serono Research & Development Institute, Inc. '''Intervention''': Tepotinib '''Start Date''': 2019-09-19 '''Last Updated''': 2023-08-29 '''Number of Patients''': 120 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': Non-small Cell Lung Cancer '''NCTID''': NCT04733183 '''Title''': Efficacy and Safety of L19TNF in Previously Treated Patients With Advanced Stage or Metastatic Soft-tissue Sarcoma '''Study Summary''': Open label, randomized, controlled phase II study preceded by a safety run-in part in subjects with advanced or metastatic soft-tissue sarcoma. '''Sponsor''': Philogen S.p.A. '''Intervention''': Dacarbazine '''Start Date''': 2020-08-28 '''Last Updated''': 2023-10-10 '''Number of Patients''': 98 '''Recruitment Status''': RECRUITING '''Condition''': Soft Tissue Sarcoma '''NCTID''': NCT03394365 '''Title''': Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) After Failure of Rituximab or Rituximab and Chemotherapy '''Study Summary''': The purpose of this study is to determine the clinical benefit and characterize the safety profile of tabelecleucel for the treatment of Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) in the setting of (1) solid organ transplant (SOT) after failure of rituximab and rituximab plus chemotherapy or (2) allogeneic hematopoietic cell transplant (HCT) after failure of rituximab. '''Sponsor''': Atara Biotherapeutics '''Intervention''': tabelecleucel '''Start Date''': 2017-12-29 '''Last Updated''': 2022-06-24 '''Number of Patients''': 66 '''Recruitment Status''': RECRUITING '''Condition''': Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD) '''NCTID''': NCT02395172 '''Title''': Avelumab in Non-Small Cell Lung Cancer (JAVELIN Lung 200) '''Study Summary''': The main purpose of this study was to demonstrate superiority with regard to overall survival of avelumab versus docetaxel in participants with programmed death ligand 1 (PD-L1) positive, non-small cell lung cancer (NSCLC) after failure of a platinum-based doublet. '''Sponsor''': EMD Serono Research & Development Institute, Inc. '''Intervention''': Avelumab '''Start Date''': 2015-03-24 '''Last Updated''': 2020-08-03 '''Number of Patients''': 792 '''Recruitment Status''': COMPLETED '''Condition''': Carcinoma, Non-Small-Cell Lung '''NCTID''': NCT04666038 '''Title''': Study of LOXO-305 Versus Investigatorâs 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''': NCT04484142 '''Title''': Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations (TROPION-Lung05) '''Study Summary''': This is a study of the efficacy, pharmacokinetics, and safety of DS-1062a in participants with advanced or metastatic non-small cell lung cancer (NSCLC) with known actionable genomic alterations. '''Sponsor''': Daiichi Sankyo, Inc. '''Intervention''': DS-1062a '''Start Date''': 2021-03-30 '''Last Updated''': 2023-11-14 '''Number of Patients''': 137 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': Non-small Cell Lung Cancer '''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''': NCT02291289 '''Title''': A Study of Biomarker-Driven Therapy in Metastatic Colorectal Cancer (mCRC) '''Study Summary''': This randomized, multi-center, active-controlled, open-label, parallel-group study will investigate the efficacy and safety of biomarker-driven maintenance treatment for first-line mCRC. Participants with mCRC are eligible for entry and cannot have received any prior chemotherapy in the metastatic setting. The entire study duration is anticipated to be approximately 7.5 years. '''Sponsor''': Hoffmann-La Roche '''Intervention''': Cetuximab '''Start Date''': 2015-04-17 '''Last Updated''': 2021-05-26 '''Number of Patients''': 609 '''Recruitment Status''': COMPLETED '''Condition''': Colorectal Cancer '''NCTID''': NCT03517449 '''Title''': Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physicianâs 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, KEYTRUDAÂŽ) in combination with lenvatinib (E7080) versus treatment of physicianâs 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 physicianâs 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 physicianâs 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''': NCT03834493 '''Title''': Study of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-641/KEYNOTE-641) '''Study Summary''': The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and enzalutamide in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC, are abiraterone-naĂŻve, or are intolerant to or progressed on abiraterone acetate. There are two primary study hypotheses. Hypothesis 1: The combination of pembrolizumab plus enzalutamide is superior to placebo plus enzalutamide with respect to Overall Survival (OS). Hypothesis 2: The combination of pembrolizumab plus enzalutamide is superior to placebo plus enzalutamide with respect to Radiographic Progression-free Survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review. '''Sponsor''': Merck Sharp & Dohme LLC '''Intervention''': Pembrolizumab '''Start Date''': 2019-07-28 '''Last Updated''': 2023-06-15 '''Number of Patients''': 1244 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': Prostatic Neoplasms '''NCTID''': NCT05808816 '''Title''': âLactobacillus Crispatus M247, LSIL and Microbiotaâ '''Study Summary''': Patients affected by ASC-US/ low-grade HPV cervical lesions will be randomly assigned to treatment arm vs control arm. The treatment arm will include the characterization of the vaginal microbiota at enrollment (T0), 4 months of oral treatment with Lactobacillus Crispatus M 247 (1 buccal stick Die), characterization of the vaginal microbiota at 1 month post treatment (T5 m). The vaginal microbiota will be evaluated by Danagene microbiome vaginal DNA KIT-XMICROGem (XBIOGem) test, with amplification of the variable regions of the 16S ribosomal RNA gene, using the MICROBIOTA kit (CE-IVD - ARROW diagnostics) and second generation sequencing technologies (NGS on Illumina MiSeq platform). The control arm will provide for the characterization of the vaginal microbiota at the same timescales. Patients will be given a medical history questionnaire at T0 and T5m '''Sponsor''': Fondazione Policlinico Universitario Agostino Gemelli IRCCS '''Intervention''': Lactobacillus Crispatus M247 '''Start Date''': 2021-06-16 '''Last Updated''': 2023-04-11 '''Number of Patients''': 90 '''Recruitment Status''': RECRUITING '''Condition''': Vaginal Flora Imbalance '''NCTID''': NCT02725268 '''Title''': A Study of Sapanisertib, Combination of Sapanisertib With MLN1117, Paclitaxel and Combination of Sapanisertib With Paclitaxel in Women With Endometrial Cancer '''Study Summary''': The primary purpose of this study is to determine if sapanisertib in combination with weekly paclitaxel improves progression-free survival (PFS) compared to weekly paclitaxel alone. '''Sponsor''': Millennium Pharmaceuticals, Inc. '''Intervention''': Paclitaxel '''Start Date''': 2016-04-01 '''Last Updated''': 2021-11-24 '''Number of Patients''': 241 '''Recruitment Status''': COMPLETED '''Condition''': Endometrial Neoplasms '''NCTID''': NCT03410693 '''Title''': Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma '''Study Summary''': This is a randomized, open-label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFR-positive locally advanced or metastatic urothelial carcinoma who have received prior platinum-containing chemotherapy. The primary objective is to demonstrate the superiority of rogaratinib over chemotherapy in terms of objective response rate (before: overall survivial) of urothelial carcinoma patients with FGFR positive tumors. At randomization, patients will have locally advanced or metastatic urothelial carcinoma and have received at least one prior platinum-containing chemotherapy regimen. Only patients with FGFR1 or 3 positive tumors can be randomized into the study. Archival tumor tissue is adequate for testing of FGFR1 and 3 mRNA expressions, which will be determined centrally using an RNA in situ hybridization (RNA-ISH) test. Approximately 42 % of UC patients with locally advanced or metastatic UC are identified as FGFR-positive by the RNA-ISH cut-off applied. '''Sponsor''': Bayer '''Intervention''': Rogaratinib (BAY1163877) '''Start Date''': 2018-05-31 '''Last Updated''': 2022-09-28 '''Number of Patients''': 175 '''Recruitment Status''': COMPLETED '''Condition''': Carcinoma, Transitional Cell '''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 âAdverse eventsâ 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 âseriousâ when it leads to death, puts the participantsâ 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 patientsâ eye health using various eye examination techniques * measure patientsâ 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''': NCT05750693 '''Title''': PIK3CA in HER2+ BC and pCR Trial '''Study Summary''': The goal of the study is to evaluate the impact of somatic PI3KCA mutations on pCR in HER2-positive early breast cancer in real life. The main question it aims to answer iS. * Is there a correlation between PIK3CA mutations and response to neoadjuvant chemotherapy in HER2 early breast cancer? Participants who received neoadjuvant chemotherapy in addition to anti-Her2 target therapy will undergo PIK3CA analysis in order to answer to this question. '''Sponsor''': Fondazione Policlinico Universitario Agostino Gemelli IRCCS '''Intervention''': PIK3CA analysis '''Start Date''': 2022-05-02 '''Last Updated''': 2023-03-02 '''Number of Patients''': 58 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': HER2-positive Breast 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''': NCT03914820 '''Title''': Prophylactic Surgery Plus HIPEC With CO2 in Patients Affected by Colorectal Carcinoma. CHECK Study. '''Study Summary''': This is a phase III randomized, multicenter study with two different arm: * experimental: prophylactic surgery plus HIPEC CO2 performed with mitomycin * comparator: standard surgery Adjuvant treatment after surgery is mandatory except for documented cases of non-eligibility. Patient will be randomized in a 1:1 ratio. Randomization will be done during surgery if the total resection of tumour will be reached and will use a stratification procedure based on center '''Sponsor''': Mario Negri Institute for Pharmacological Research '''Intervention''': HIPEC CO2 surgery '''Start Date''': 2020-06-19 '''Last Updated''': 2023-10-27 '''Number of Patients''': 330 '''Recruitment Status''': RECRUITING '''Condition''': Colorectal Neoplasms '''NCTID''': NCT01507168 '''Title''': A Study of GC33 (RO5137382) in Patients With Advanced or Metastatic Hepatocellular Carcinoma '''Study Summary''': This randomized, placebo-controlled, multicenter study will evaluate the efficacy and safety of GC33 (RO5137382) in previously treated patients with unresectable advanced or metastatic hepatocellular carcinoma. Participants will be stratified according to the level of GPC-3 expression in tumors and randomized to receive either GC33 (1600 mg intravenously) or placebo on Days 1 and 8 of Cycle 1 and every 2 weeks thereafter. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. '''Sponsor''': Hoffmann-La Roche '''Intervention''': Placebo '''Start Date''': 2012-02-02 '''Last Updated''': 2020-04-03 '''Number of Patients''': 185 '''Recruitment Status''': COMPLETED '''Condition''': Carcinoma, Hepatocellular '''NCTID''': NCT04459715 '''Title''': A Study of Xevinapant (Debio 1143) in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Participants With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX) '''Study Summary''': The primary objective of the study is to demonstrate superior efficacy of Xevinapant (Debio 1143) vs placebo when added to chemoradiotherapy (CRT) in locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN). '''Sponsor''': EMD Serono Research & Development Institute, Inc. '''Intervention''': Xevinapant (Debio 1143) '''Start Date''': 2020-08-07 '''Last Updated''': 2023-10-24 '''Number of Patients''': 730 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': Squamous Cell Carcinoma of the Head and Neck '''NCTID''': NCT04589845 '''Title''': Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study '''Study Summary''': TAPISTRY is a Phase II, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in rational, specified combinations in participants with unresectable, locally advanced or metastatic solid tumors determined to harbor specific oncogenic genomic alterations or who are tumor mutational burden (TMB)-high as identified by a validated next-generation sequencing (NGS) assay. Participants with solid tumors will be treated with a drug or drug regimen tailored to their NGS assay results at screening. Participants will be assigned to the appropriate cohort based on their genetic alteration(s). Treatment will be assigned on the basis of relevant oncogenotype, will have cohort-specific inclusion/exclusion criteria, and, unless otherwise specified, will continue until disease progression, loss of clinical benefit, unacceptable toxicity, participant or physician decision to discontinue, or death, whichever occurs first. '''Sponsor''': Hoffmann-La Roche '''Intervention''': Entrectinib '''Start Date''': 2021-01-18 '''Last Updated''': 2023-11-13 '''Number of Patients''': 920 '''Recruitment Status''': RECRUITING '''Condition''': Solid Tumors '''NCTID''': NCT03277105 '''Title''': A Study of Subcutaneous Versus (vs.) Intravenous Administration of Daratumumab in Participants With Relapsed or Refractory Multiple Myeloma '''Study Summary''': The purpose of this study is to show that subcutaneous (SC) administration of daratumumab co-formulated with recombinant human hyaluronidase PH20 (Dara SC) is non-inferior to intravenous (IV) administration of daratumumab (Dara IV) in terms of the overall response rate (ORR) and maximum trough concentration (Ctrough). '''Sponsor''': Janssen Research & Development, LLC '''Intervention''': Dara SC '''Start Date''': 2017-10-27 '''Last Updated''': 2023-10-11 '''Number of Patients''': 522 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': Multiple Myeloma '''NCTID''': NCT02993705 '''Title''': Trial On Trabectedin In The Treatment Of Advanced Uterine And Ovarian Carcinosarcoma (CS) '''Study Summary''': Multicenter phase II study on trabectedin in patients advanced uterine and ovarian carcinosarcoma. Patients will receive trabectedin until disease progression or unacceptable toxicity. Disease response evaluation will be assessed every 9 weeks. '''Sponsor''': Fondazione Policlinico Universitario Agostino Gemelli IRCCS '''Intervention''': Trabectedin '''Start Date''': 2017-02-22 '''Last Updated''': 2021-08-25 '''Number of Patients''': 45 '''Recruitment Status''': COMPLETED '''Condition''': Carcinosarcoma, Ovarian '''NCTID''': NCT04646005 '''Title''': Cemiplimab and ISA101b Vaccine in Adult Participants With Recurrent/Metastatic Human Papillomavirus (HPV)16 Cervical Cancer Who Have Experienced Disease Progression After First Line Chemotherapy '''Study Summary''': The primary objective of the study is to estimate the clinical benefit of cemiplimab + ISA101b after progression on first line chemotherapy, as assessed by objective response rate (ORR). The secondary objectives of the study are: * To characterize the safety profile of cemiplimab + ISA101b * To assess preliminary efficacy of cemiplimab + ISA101b as measured by duration of response (DOR), progression-free survival (PFS), and overall survival (OS) '''Sponsor''': Regeneron Pharmaceuticals '''Intervention''': Cemiplimab '''Start Date''': 2021-06-28 '''Last Updated''': 2023-10-03 '''Number of Patients''': 113 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': Cervical Cancer '''NCTID''': NCT06076005 '''Title''': Lung Cancer ID (Identity) Study '''Study Summary''': The distribution of demographic, clinical, radiological, pathological and molecular characteristics of lung cancer at the time of diagnosis, as well as preferential association between elements of those domains, have not been specifically studied in Italy. The aim of the present project is to assess, in a systematic fashion, the demographic, clinical, radiological, pathological and molecular characteristics of advanced lung cancer at the time of diagnosis in a large Italian cohort of consecutive patients referred to two tertiary referral centers. '''Sponsor''': Fondazione Policlinico Universitario Agostino Gemelli IRCCS '''Intervention''': Advanced lung cancer patientsâ group '''Start Date''': 2023-11-01 '''Last Updated''': 2023-10-17 '''Number of Patients''': 1000 '''Recruitment Status''': NOT_YET_RECRUITING '''Condition''': Lung Cancer Stage IV '''NCTID''': NCT03455517 '''Title''': Activity and Safety of Front-line Venetoclax and Rituximab in Young and Fit Patients With Chronic Lymphocytic Leukemia '''Study Summary''': Fludarabine, cyclophosphamide, and rituximab (FCR) is the gold treatment for fit and young patients with Chronic Lymphoid Leukemia (CLL). However, patients with a mutation known as IGVH unmutated and patients with a particular characteristic known as âdisrupted TP53â show an inferior outcome after FCR in terms of survival. Venetoclax as a single agent or combined with rituximab is an effective treatment for relapsed/refractory patients with IGVH unmutated CLL and/or del(17p) and is associated with a high rate of clinical responses. '''Sponsor''': Gruppo Italiano Malattie EMatologiche dellâAdulto '''Intervention''': Venetoclax '''Start Date''': 2018-10-31 '''Last Updated''': 2023-11-24 '''Number of Patients''': 77 '''Recruitment Status''': COMPLETED '''Condition''': Chronic Myeloid Leukemia '''NCTID''': NCT03662126 '''Title''': KRT-232 Versus Best Available Therapy for the Treatment of Subjects With Myelofibrosis Who Are Relapsed or Refractory to JAK Inhibitor Treatment '''Study Summary''': This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with myelofibrosis (MF) who no longer benefit from treatment with a JAK inhibitor. Inhibition of MDM2 is a novel mechanism of action in MF. This study will be conducted in 2 phases. Phase 2 will determine the KRT-232 recommended dose and dosing schedule; Phase 3 will test KRT-232 vs Best Available Therapy (BAT). Patients in the Phase 3 part of the study will be randomized 2:1 to receive either KRT-232 (Arm 1) or BAT (Arm 2). The BAT administered will be determined by the treating physician, with the option to âcross-overâ to KRT-232 treatment after 6 months of BAT or if the disease worsens at any time. '''Sponsor''': Kartos Therapeutics, Inc. '''Intervention''': KRT-232 '''Start Date''': 2019-01-15 '''Last Updated''': 2023-04-28 '''Number of Patients''': 385 '''Recruitment Status''': RECRUITING '''Condition''': Primary Myelofibrosis (PMF) '''NCTID''': NCT04656652 '''Title''': Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01) '''Study Summary''': This study will evaluate the efficacy, safety, and pharmacokinetics of DS-1062a versus docetaxel in participants with previously treated advanced or metastatic non-small cell lung cancer (NSCLC) with or without actionable genomic alterations. '''Sponsor''': Daiichi Sankyo, Inc. '''Intervention''': DS-1062a '''Start Date''': 2020-12-21 '''Last Updated''': 2023-11-18 '''Number of Patients''': 590 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': Non-small Cell Lung Cancer '''NCTID''': NCT03565991 '''Title''': Javelin BRCA/ATM: Avelumab Plus Talazoparib in Patients With BRCA or ATM Mutant Solid Tumors '''Study Summary''': Avelumab in combination with talazoparib will be investigated in patients with locally advanced or metastatic solid tumors with a BRCA or ATM defect. '''Sponsor''': Pfizer '''Intervention''': Avelumab '''Start Date''': 2018-06-18 '''Last Updated''': 2023-09-25 '''Number of Patients''': 202 '''Recruitment Status''': TERMINATED '''Condition''': Locally Advanced or Metastatic Solid Tumors '''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''': NCT04032704 '''Title''': A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors '''Study Summary''': This trial will study ladiratuzumab vedotin (LV) alone and with pembrolizumab to find out if it works to treat different types of solid tumors. It will also find out what side effects may occur. A side effect is anything the drug does besides treating cancer. '''Sponsor''': Seagen Inc. '''Intervention''': ladiratuzumab vedotin '''Start Date''': 2019-10-09 '''Last Updated''': 2023-07-14 '''Number of Patients''': 205 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': Small Cell Lung Cancer '''NCTID''': NCT03751917 '''Title''': Long-term Safety Study of Arsenic Trioxide in Newly Diagnosed, Low-to-intermediate Risk Acute Promyelocytic Leukemia '''Study Summary''': The therapeutic advantage of the association of ATRA + Arsenic Trioxide is more favorable and manageable as compared to ATRA + chemotherapy. Nevertheless, at present, there is not enough information on the incidence of long-term side effects. This study, as well as other similar studies conducted around Europe, will focus on following patients treated with this therapy on a long-term basis. Once all studies in Europe will be concluded, all data will be analyzed together. '''Sponsor''': Gruppo Italiano Malattie EMatologiche dellâAdulto '''Intervention''': Arsenic Trioxide '''Start Date''': 2020-04-14 '''Last Updated''': 2022-01-04 '''Number of Patients''': 100 '''Recruitment Status''': RECRUITING '''Condition''': Acute Promyelocytic Leukemia '''NCTID''': NCT04498117 '''Title''': Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery '''Study Summary''': Study to compare the safety and efficacy of oregovomab versus placebo, administered in combination with specific cycles of a standard six-cycle chemotherapy regimen (paclitaxel and carboplatin), for the treatment of subjects with newly diagnosed advanced ovarian cancer who have undergone optimal debulking. '''Sponsor''': CanariaBio Inc. '''Intervention''': Oregovomab '''Start Date''': 2020-08-25 '''Last Updated''': 2023-10-10 '''Number of Patients''': 615 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': Carcinoma, Ovarian Epithelial '''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''': NCT05769517 '''Title''': PREDICTION OF GERMLINE BRCA 1/2 GENES FROM HEALTHY OVARIES '''Study Summary''': The project aims at enhancing performance metrics and prospectively validating a radiogenomics model based on ovarian US images for predicting germline breast cancer susceptibility gene 1 and/or 2 (BRCA) status in women with healthy ovaries. The project is divided in two operational phases: Retrospective phase AIM 1: To define and implement a proper and fine-tuned image preprocessing pipeline on the existing dataset; AIM 2: To enlarge dataset size with new real images from different centers and apply data augmentation techniques, deep neural network models combined with the aforementioned handcrafted imaging features from radiomics analysis; Prospective phase AIM 3: To further cross-validate the predictive model on US images acquired prospectively in an observational multicenter study. '''Sponsor''': Fondazione Policlinico Universitario Agostino Gemelli IRCCS '''Intervention''': Germinal BRCA '''Start Date''': 2023-03-20 '''Last Updated''': 2023-06-22 '''Number of Patients''': 1300 '''Recruitment Status''': RECRUITING '''Condition''': BRCA Mutation '''NCTID''': NCT04895709 '''Title''': A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors '''Study Summary''': The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab or docetaxel in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors. '''Sponsor''': Bristol-Myers Squibb '''Intervention''': BMS-986340 '''Start Date''': 2021-05-27 '''Last Updated''': 2023-11-13 '''Number of Patients''': 665 '''Recruitment Status''': RECRUITING '''Condition''': Cervical Cancer '''NCTID''': NCT04729608 '''Title''': Batiraxcept (AVB-S6-500)/Placebo in Combination With Paclitaxel in Patients With Platinum-Resistant Recurrent Ovarian Cancer '''Study Summary''': This is a randomized, double-blind Phase 3 study to compare the efficacy and safety of batiraxcept (AVB-S6-500) in combination with paclitaxel (PAC) versus placebo in combination with PAC in patients with platinum resistant recurrent ovarian cancer. '''Sponsor''': Aravive, Inc. '''Intervention''': Batiraxcept '''Start Date''': 2021-04-22 '''Last Updated''': 2023-10-30 '''Number of Patients''': 366 '''Recruitment Status''': TERMINATED '''Condition''': Platinum-resistant Ovarian Cancer '''NCTID''': NCT03045406 '''Title''': Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer '''Study Summary''': Apixaban for the treatment of venous thromboembolism in patients with cancer: a prospective randomized open blinded end-point (PROBE) study '''Sponsor''': Fadoi Foundation, Italy '''Intervention''': Apixaban '''Start Date''': 2017-04-13 '''Last Updated''': 2019-11-14 '''Number of Patients''': 1168 '''Recruitment Status''': UNKNOWN '''Condition''': Venous Thromboembolism '''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''': NCT05176691 '''Title''': HMPL-760 Safety and Tolerability Study in Patients With Previously Treated CLL/SLL or NHL '''Study Summary''': An open label single-arm clinical trial to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of HMPL-760 in patients with previously treated CLL/SLL or NHL '''Sponsor''': Hutchmed '''Intervention''': HMPL-760 '''Start Date''': 2022-02-15 '''Last Updated''': 2023-02-21 '''Number of Patients''': 0 '''Recruitment Status''': WITHDRAWN '''Condition''': CLL/SLL '''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''': NCT02928406 '''Title''': A Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non-Urothelial Carcinoma of the Urinary Tract '''Study Summary''': This Phase IIIb, multicenter study will assess the safety of atezolizumab as second- to fourth-line treatment for participants with locally advanced or metastatic urothelial or non-urothelial cancer of the urinary tract in addition to evaluate the efficacy of atezolizumab and potential tumor biomarkers associated with atezolizumab. '''Sponsor''': Hoffmann-La Roche '''Intervention''': Atezolizumab '''Start Date''': 2016-11-30 '''Last Updated''': 2022-12-22 '''Number of Patients''': 1005 '''Recruitment Status''': COMPLETED '''Condition''': Urinary Tract Cancer '''NCTID''': NCT03726879 '''Title''': A Study To Evaluate the Efficacy and Safety Of Atezolizumab or Placebo in Combination With Neoadjuvant Doxorubicin + Cyclophosphamide Followed By Paclitaxel + Trastuzumab + Pertuzumab In Early Her2-Positive Breast Cancer '''Study Summary''': This study (also known as IMpassion050) will evaluate the efficacy and safety of atezolizumab compared with placebo when given in combination with neoadjuvant dose-dense anthracycline (doxorubicin) + cyclophosphamide followed by paclitaxel + trastuzumab + pertuzumab (ddAC-PacHP) in patients with early HER2-positive breast cancer (T2-4, N1-3, M0). '''Sponsor''': Hoffmann-La Roche '''Intervention''': Atezolizumab '''Start Date''': 2019-01-11 '''Last Updated''': 2023-09-25 '''Number of Patients''': 454 '''Recruitment Status''': COMPLETED '''Condition''': 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''': 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 âtracerâ 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 participantsâ 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 participantsâ 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''': NCT05386550 '''Title''': Phase III Xevinapant (Debio 1143) and Radiotherapy in Resected LA SCCHN, High Risk, Cisplatin-ineligible Participants (XRAY VISION) '''Study Summary''': The purpose of this study is to demonstrate the superior efficacy of Xevinapant (Debio 1143) versus placebo when added to radiotherapy in the treatment of high-risk participants with resected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) who are ineligible to receive cisplatin-based chemoradiation concurrently. Study details include: Study duration: Participants will be followed until the last on-study participant reaches his/her 60-month post-randomization visit, a decision to end the study has been triggered, or until premature discontinuation from study, whichever occurs first. Treatment duration: 18 weeks, consisting of six 3-week cycles. Health measurement/observation: Improved Disease-Free Survival. Visit frequency: Weekly visit during combination therapy period, once every 3 weeks during monotherapy period, and every 3, 4, or 6 months during the Disease-Free Survival Follow-up period in Year 1, 2 and 3, or 4 and 5 (with telephone contact in between), respectively, and every 3 months (telephone visits allowed) during the Overall Survival Follow-up period. '''Sponsor''': EMD Serono Research & Development Institute, Inc. '''Intervention''': Xevinapant (Debio 1143) '''Start Date''': 2022-10-06 '''Last Updated''': 2023-11-02 '''Number of Patients''': 700 '''Recruitment Status''': RECRUITING '''Condition''': Head and Neck Cancer '''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 EluciremÂŽ in DSC-MRI Perfusion of Brain Gliomas '''Study Summary''': This trial aims to study the performance of EluciremÂŽ (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''': NCT02793050 '''Title''': Retrospective Study of Trabectedin in Soft Tissue Sarcomas '''Study Summary''': This is an independent, observational, retrospective post marketing study on the use of trabectedin in a clinical setting. A data collection on the clinical use of the drug will help to improve knowledge and might contribute to optimize the clinical use of the drug. '''Sponsor''': Italian Sarcoma Group '''Intervention''': Trabectedin '''Start Date''': 2016-06-15 '''Last Updated''': 2019-05-10 '''Number of Patients''': 510 '''Recruitment Status''': COMPLETED '''Condition''': Sarcoma, Soft Tissue '''NCTID''': NCT04041050 '''Title''': A Study Evaluating Safety and Tolerability, and Pharmacokinetics of Navitoclax Monotherapy and in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasm '''Study Summary''': There are 5 parts to this study for which the primary objectives are to evaluate safety, tolerability, and pharmacokinetics (PK) of navitoclax when administered alone (Part 1) or when administered in combination with ruxolitinib (Part 2). In Part 2, participants must have been receiving a stable dose of ruxolitinib therapy for at least 12 weeks prior to study enrollment. In Part 3, all eligible participants will receive navitoclax, with the primary objective being to evaluate potential navitoclax effect on QTc prolongation. In Part 4, effect of navitoclax is evaluated on the PK, safety, and tolerability of a single dose of celecoxib. In Part 5, all eligible participants will receive ruxolitinib twice daily and navitoclax once daily for drug-drug interaction (DDI) assessment, followed by continued administration of navitoclax in combination with ruxolitinib. '''Sponsor''': AbbVie '''Intervention''': Navitoclax '''Start Date''': 2019-11-08 '''Last Updated''': 2023-05-16 '''Number of Patients''': 85 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': Myeloproliferative Neoplasm '''NCTID''': NCT03410407 '''Title''': Central Nervous System (CNS) Involvement in Acute Myeloid Leukemia (AML) '''Study Summary''': The present study aims at evaluating the prognostic factors at diagnosis predicting Central Nervous System (CNS) relapse in order to identify a group of patients with higher risk of CNS involvement in which prophylaxis with liposomal Ara-C or other drugs should be indicated. '''Sponsor''': Gruppo Italiano Malattie EMatologiche dellâAdulto '''Intervention''': Observation of CNS involvement '''Start Date''': 2019-03-19 '''Last Updated''': 2022-10-26 '''Number of Patients''': 21 '''Recruitment Status''': TERMINATED '''Condition''': Acute Myeloid Leukemia '''NCTID''': NCT04487067 '''Title''': A Study of Atezolizumab (Tecentriq) in Combination With Bevacizumab to Investigate Safety and Efficacy in Patients With Unresectable Hepatocellular Carcinoma Not Previously Treated With Systemic Therapy-Amethista '''Study Summary''': This is a Phase IIIb, one arm, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab + bevacizumab in patients with unresectable HCC who have received no prior systemic treatment. '''Sponsor''': Hoffmann-La Roche '''Intervention''': Atezolizumab '''Start Date''': 2020-08-25 '''Last Updated''': 2023-11-21 '''Number of Patients''': 152 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': Carcinoma, Hepatocellular '''NCTID''': NCT05587296 '''Title''': A Study to Learn More About How Well Elinzanetant Works and How Safe it is Compared to Placebo for the Treatment of Hot Flashes Caused by Anti-cancer Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer '''Study Summary''': Researchers are looking for a better way to treat women with, or at high risk for developing hormone-receptor positive breast cancer, who have vasomotor symptoms (VMS), a condition of having hot flashes caused by anti-cancer therapy. VMS, also called hot flashes, are very common medical problems in women with hormone-receptor (HR)-positive breast cancer, who are receiving anti-cancer therapy. HR-positive breast cancer is a type of breast cancer, which has hormone-receptors (proteins) for female sex hormones estrogen and/or progesterone. These hormone-receptors may attach to hormones like estrogen and progesterone and thereby help cancer cells to grow and to spread. Treatments that stop these hormones from attaching to these receptors are currently used to slow or stop the growth of HR-positive breast cancer. It is already known that women with HR-positive breast cancer benefit from this treatment. However, hot flashes are common medical problems related to this therapy. They negatively affect quality of life of many women and may lead to discontinuation (stopping) of this therapy. The study treatment, elinzanetant is being developed to treat hot flushes. It works by blocking a substance called neurokinin from sending signals to other parts of the body, which is thought to play a role in starting hot flashes. The main purpose of this study is to learn more about how well elinzanetant helps to treat hot flashes caused by anti-cancer therapy in women with or at high risk for developing HR-positive breast cancer compared to placebo. A placebo is a treatment that looks like a medicine but does not have any medicine in it. To answer this, the doctors will ask the participants to record information about their hot flashes before treatment start and at certain time points during the treatment in an electronic diary. The researchers will then assess possible average changes in number and severity of hot flashes after 4 and 12 weeks of treatment. To see how safe elinzanetant is compared to placebo. The study will collect information about the number of participants who have medical problems after taking treatment. The study participants will be randomly (by chance) assigned to 2 treatment groups, A and B. The participants from treatment group A will take elinzanetant. The participants from treatment group B will start with placebo and then switch to elinzanetant. All participants will continue taking the anti-cancer therapy they have been using when entering the study. Dependent on the treatment group, the participants will either take elinzanetant or placebo as capsules by mouth once a day. After 12 weeks, the participants who have initially received placebo will switch to take elinzanetant for the remaining 40 weeks. Each participant will be in the study for approximately 62 weeks. The treatment duration in the study will be 52 weeks. There will be up to 12 visits to the study site and 6 phone calls in between. Participants who completed the 52 weeks treatment phase, will be offered to continue treatment for another 2 years. Visit frequency: every 24 weeks until week 152. During the study, the participants will: * record information about their hot flashes * answer questions about their quality of life and other symptoms. The doctors and their study team will: * check the participants health and vital signs * take blood and urine samples * examine heart health using electrocardiogram (ECG) * examine pelvic organs like womb or ovaries using a trans vaginal ultrasound scan to see images of these organs * make images of the breast using x-ray (mammogram), a type of radiation that passes through the body to make images of the inside and/or by using ultrasound (if applicable) * check the health of the participantâs cervix (neck of the womb) by taking a small sample of cells (smear test) for an analysis called cervical cytology (if applicable) * take an endometrial biopsy, a small piece of tissue from the lining of the womb (called the endometrium) for analysis. * ask the participants questions about what medicines they are taking and if they are having adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. About 4 weeks after the participants take their last treatment, the study doctors and their team will check the participantsâ health. '''Sponsor''': Bayer '''Intervention''': Elinzanetant (BAY3427080) '''Start Date''': 2022-10-14 '''Last Updated''': 2023-11-13 '''Number of Patients''': 405 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': Vasomotor Symptoms Caused by Adjuvant Endocrine Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer '''NCTID''': NCT02864030 '''Title''': PAINTER: Polymorphism And INcidence of Toxicity in ERibulin Treatment '''Study Summary''': On March 17th, 2011, the European Commission issued a marketing authorization valid throughout the European Union for Eribulin mesylate (Halaven; Eisai Limited), for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapic regimens for advanced disease. As the use of Eribulin will be widespread in this tumor setting, a better knowledge of its safety profile outside clinical trials is warranted. Indeed the possibility to select patients at risk for developing Eribulin-induced neuropathy, will allow the exclusion from these treatment of those patients harbouring the specific single nucleotide polymorphism (SNP). Given that Eribulin toxicity often results in treatment discontinuation, the ability to anticipate which patients will experience severe toxicity could allow for either early intervention or even possibly for prophylactic therapy, or for selection of the patients to be treated. '''Sponsor''': Oncologia Medica dellâOspedale Fatebenefratelli '''Intervention''': ERIBULIN MESYLATE '''Start Date''': 2014-05 '''Last Updated''': 2021-03-04 '''Number of Patients''': 200 '''Recruitment Status''': COMPLETED '''Condition''': Metastatic Breast Cancer '''NCTID''': NCT04272931 '''Title''': DRAGON 1- Training, Accreditation, Implementation and Safety Evaluation of Combined PVE/HVE '''Study Summary''': Brief Summary: Some colorectal liver metastases can only be resected after inducing liver regeneration by portal vein embolization (PVE) to increase size function of the future liver remnant (FLR). While PVE is standard, embolization of portal vein and hepatic veins (PVE/HVE) on one side of the liver may faster and more extensive liver size and function growth. PVE/HVE is a novel procedure and requires a safety and feasibility evaluation in a pretrial (DRAGON1) to then be compared in a randomized controlled trial (RCT) to PVE (DRAGON 2). '''Sponsor''': Maastricht University '''Intervention''': Portal and Hepatic Vein Embolization '''Start Date''': 2020-05-08 '''Last Updated''': 2023-02-03 '''Number of Patients''': 111 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': Colorectal Cancer Liver Metastases '''NCTID''': NCT02576431 '''Title''': A Study to Test the Effect of the Drug Larotrectinib in Adults and Children With NTRK-fusion Positive Solid Tumors '''Study Summary''': This research study is done to test how well different types of cancer respond to the drug called larotrectinib. The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3). Larotrectinib is a drug that blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer. '''Sponsor''': Bayer '''Intervention''': BAY2757556 (Larotrectinib, Vitrakvi) '''Start Date''': 2015-09-30 '''Last Updated''': 2023-11-07 '''Number of Patients''': 204 '''Recruitment Status''': RECRUITING '''Condition''': Solid Tumors Harboring NTRK Fusion '''NCTID''': NCT01728155 '''Title''': European Low and Intermediate Risk Neuroblastoma Protocol '''Study Summary''': The European study, LINES 2009 (Low and Intermediate Risk Neuroblastoma European Study), groups together in a single protocol the treatment of all patients with ânon high riskâ neuroblastoma (NB), with stratification into two groups: low risk and intermediate risk. These two separate cohorts are included in one single protocol to enable patient data from these two groups to be entered into a common database, as the current prognostic classifications determining treatment may evolve further with subsequent more detailed molecular analysis of the tumours. # LOW RISK STUDY The Low Risk Study is proposed in order to: <ul> <li><p>minimise the amount of treatment (chemotherapy and surgery) for all appropriate low risk patients, who in previous studies have been shown to have an excellent long-term outcome (as in the SIOPEN 99.1-2 infant neuroblastoma studies where the overall survival was greater than 97%(H. Rubie, JCO).</p></li> <li><p>improve the EFS and maintain the OS (overall survival) in L2 and Ms patients with a SCA(Segmental Cromosomal Aberration) genomic profile tumour (presence of any segmental chromosomal change (SCA)) by electively treating these patients with chemotherapy despite the absence of symptoms.</p> <ol start="2" style="list-style-type: decimal;"> <li>INTERMEDIATE RISK STUDY</li></ol> </li></ul> The Intermediate Risk Study is proposed in order to: * reduce the amount of chemotherapy for differentiating histology INRG (International Neuroblastoma Risk Group) stage L2 NB and ganglioneuroblastoma nodular patients who in previous SIOPEN study have been shown to have an excellent long-term outcome; * increase the amount of treatment (radiotherapy and 13-cis-RA (13-cis-Retinoic Acid) for poorly differentiated or undifferentiated histology INRG stage L2 NB or ganglioneuroblastoma nodular patients in order to improve the EFS registered in the previous SIOPEN study; * improve the EFS (Event Free Survival) of MYCN (V-Myc myelocytomatosis viral related oncogene, NB derived ,avian )amplified INSS (International NB Staging System) stage 1 NB patients with the introduction of adjuvant treatment; * maintain the very good results obtained in previous SIOPEN study for INRG stage M infants with a moderate treatment. NEONATAL SUPRARENAL MASSES The incidence of suprarenal tumours/masses has increased in the last decade due to the expanded use of prenatal ultrasonography in routine obstetric care and in the neonatal and early infancy care. The differential diagnosis of these masses ranges from benign (adrenal haemorrhage) to malignant processes (neuroblastoma, adrenal carcinoma). Knowledge on perinatal suprarenal masses, although based on a relatively large literature, is scattered amongst studies on very few cases with no methodical approach and often short follow up. Therefore, the optimal management of these masses has not been clearly defined. Neuroblastoma at this age is an intriguing entity with a very good prognosis in most cases. The SIOPEN Group, based on their results in the first multicenter European Trial for infants with neuroblastoma (INES) and the world-wide experience provided in the literature, is launching this European surveillance study (Multi-centre, non-blinded, one armed prospective trial) for these masses. Treatment: Observation '''Sponsor''': Instituto de Investigacion Sanitaria La Fe '''Intervention''': chemotherapy '''Start Date''': 2011-01-01 '''Last Updated''': 2023-09-08 '''Number of Patients''': 685 '''Recruitment Status''': COMPLETED '''Condition''': LOW AND INTERMEDIATE PAEDIATRIC NEUROBLASTOMA AND NEONATAL SUPRARENAL MASSES '''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''': NCT04380766 '''Title''': Covid-19 Pandemic and Pancreatic Surgery in Italy '''Study Summary''': Pancreatic cancer (PC) is recognized as one of the most challenging tumors to deal with and it is still characterized by a poor long-term prognosis. However, treatment of PC in high-volume centers with the support of a multidisciplinary approach has widely demonstrated improvement both in terms of short- and long-term outcomes. The recent worldwide spread of Covid-19 pandemic significantly affected the healthcare systems of most countries in the world, particularly in red areas such as Italy, with more than 100.000 cases in a two-month time lapse. This inevitably reflected in a reorganization of hospital activities, including the diagnostic and therapeutic pathways for PC treatment. With the aim of giving an objective and real representation of the impact of Covid-19 on PC treatment, the investigator here propose a multicenter Italian observational study comparing a 6-month period before and during the Covid-19 pandemic. Only high-volume centers will be involved in the study. A comparison between the general, clinical, endoscopic and surgical outcomes will be performed by means of a global and month-by-month analysis between the two study periods. '''Sponsor''': Fondazione Policlinico Universitario Agostino Gemelli IRCCS '''Intervention''': Evaluation of changes in the diagnostic-therapeutic pathway for patients affected by pancreatic cancer '''Start Date''': 2019-01-01 '''Last Updated''': 2020-08-03 '''Number of Patients''': 730 '''Recruitment Status''': COMPLETED '''Condition''': Pancreatic Cancer '''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''': NCT06071286 '''Title''': SEQUENTIAL PROFILING OF TUMOR-DERIVED CIRCULATING CELL-FREE DNA (ctDNA) IN ADVANCED OVARIAN CANCER PATIENTS '''Study Summary''': Ovarian cancer (OC) is the third most common gynaecologic cancer worldwide and has the highest mortality rate among gynaecologic cancers. Despite the advances in cytoreductive surgery and frontline chemotherapy, recurrence is a common event in the advanced disease setting, with more than 70% of women experiencing relapse within two years from diagnosis. New strategies to anticipate the diagnosis of recurrence have been investigated in the last years. In this context, standard serum biomarkers, such as CA-125, and radiological evaluation are commonly used for disease surveillance, However, the early identification of relapsed disease as well as the identification of patients at higher risk for recurrence are still unmetclinical needs. Novel and reliable molecular biomarkers, which might also better represent the intrinsic molecular complexity of OC, could help clinicians to address this important challenge. Circulating tumor DNA (ctDNA) analysis has recently emerged as a non-invasive tool to profile and monitor tumor evolution over time. CtDNA has been extensively studied in several neoplasms in order to evaluate its ability in anticipating detection of relapse compared to common markers used in clinical practice. Wehave designed a study to assess the ability of ctDNA to detect recurrence and progression of disease and to provide a genomic characterization, during follow-up of patients with advanced OC. If proven effective and reliable, ctDNA could be introduced into routine surveillance programme for OC. '''Sponsor''': Fondazione Policlinico Universitario Agostino Gemelli IRCCS '''Intervention''': Blood samples '''Start Date''': 2023-11-01 '''Last Updated''': 2023-10-06 '''Number of Patients''': 30 '''Recruitment Status''': NOT_YET_RECRUITING '''Condition''': Ovarian Cancer '''NCTID''': NCT04704219 '''Title''': Pembrolizumab Plus Lenvatinib for First-line Advanced/Metastatic Non-clear Cell Renal Cell Carcinoma (1L nccRCC) (MK-3475-B61) '''Study Summary''': This study is being performed as a single-arm open-label study in order to rapidly provide information on the potential benefits of the combination of pembrolizumab and lenvatinib in participants with previously untreated advanced/metastatic non-clear cell renal cell carcinoma. '''Sponsor''': Merck Sharp & Dohme LLC '''Intervention''': Pembrolizumab '''Start Date''': 2021-02-23 '''Last Updated''': 2023-08-29 '''Number of Patients''': 152 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': Renal Cell Carcinoma '''NCTID''': NCT05689619 '''Title''': SILibinin in NSCLC and BC Patients With Single Brain METastasis (SILMET) '''Study Summary''': This study aims to evaluate the efficacy of silibinin in preventing recurrence in the brain after complete resection of a brain metastasis (BM) from non-small-cell lung cancer (NSCLC) or breast cancer (BC). '''Sponsor''': Alessia Pellerino '''Intervention''': Silibinin '''Start Date''': 2023-01-02 '''Last Updated''': 2023-01-19 '''Number of Patients''': 70 '''Recruitment Status''': RECRUITING '''Condition''': Brain Metastases, Adult '''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''': NCT04597125 '''Title''': Investigation of Radium-223 Dichloride (Xofigo), a Treatment That Gives Off Radiation That Helps Kill Cancer Cells, Compared to a Treatment That Inactivates Hormones (New Antihormonal Therapy, NAH) in Patients With Prostate Cancer That Has Spread to the Bone Getting Worse on or After Earlier NAH '''Study Summary''': Researchers in this study want to compare how well drug radium-223 dichloride (Xofigo) and new (novel) anti-hormonal (NAH) therapy work in participants with prostate gland cancer which has spread to the bone and progressed on or after one line of NAH therapy. Meanwhile researchers want to compare the safety of radium-223 dichloride and NAH therapy. Radium-223 dichloride is known as a radioactive drug that is taken up by bones after it is injected into the body. It works by giving off a type of radioactivity that travels a very short distance and kills the tumor cells that have spread to the bone without major effects to the healthy cells. It has been approved in many countries for the treatment of patients with prostate cancer which has spread to the bone. The NAH drugs used in this study will be either abiraterone acetate (Zytiga) (plus prednisone/prednisolone) or enzalutamide (Xtandi). Both of them are standard approved medications which are used in the treatment of advanced prostate cancer. Participants in this study will receive either Radium-223 dichloride or a NAH therapy. Radium-223 dichloride will be given as an infusion into one of the veins on Day 1 of each 4-week cycle for a total of up to 6 cycles. Oral NAH therapy will be given per the standard approved dose once daily until the disease has progressed. Participants will visit the hospital or clinic every 2 weeks for the first 6 cycles, and only on the first day of each cycle from cycle 7 and onwards. Observation for each participant will last for about 2 years in total. Blood and urine samples will be collected from the participants and participants will be asked to complete questionnaires about the well-being and the pain. '''Sponsor''': Bayer '''Intervention''': Radium-223 dichloride (Xofigo, BAY88-8223) '''Start Date''': 2020-11-09 '''Last Updated''': 2023-11-14 '''Number of Patients''': 696 '''Recruitment Status''': RECRUITING '''Condition''': Metastatic Castrate Resistant Prostate Cancer (mCRPC) '''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''': NCT04570631 '''Title''': Study to Determine Recommended Phase 2 Dose of Intravenous (IV) Eftozanermin Alfa in Combination With IV or Subcutaneous (SC) Bortezomib and Oral Dexamethasone Tablet and to Assess Change in Disease Symptoms in Adult Participants With Relapsed or Refractory Multiple Myeloma '''Study Summary''': Multiple myeloma (MM) is a rare cancer caused by abnormal survival of plasma cells (blood cells). Most trial participants with MM relapse (cancer has come back) or become non- responsive to treatment and remission gets shorter after each line of treatment. This is a study to determine recommended Phase 2 dose and change in disease symptoms of eftozanermin alfa in combination with bortezomib and dexamethasone to assess how efficient the treatment is in adult participants with relapsed/refractory (R/R) MM. Eftozanermin alfa (ABBV-621) is an investigational drug being developed for the treatment of R/R Multiple Myeloma (MM). Study doctors put the participants in 1 of the 2 groups, called treatment arms. Each group receives a different treatment. Participants in one arm will receive different doses of eftozanermin alfa in combination with bortezomib and dexamethasone to determine phase 2 dose (RP2D). Participants in the other arm will receive eftozanermin alfa at RP2D in combination with bortezomib and dexamethasone. Around 40 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 20 sites across the world. Participants will receive eftozanermin alfa as an infusion into the vein in combination with bortezomib as an infusion into the vein or an injection under the skin and oral dexamethasone tablets for 12 cycles. Each cycle is 21 days for cycles 1-8 and 35 days for cycles 9-12. 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 a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects. '''Sponsor''': AbbVie '''Intervention''': Eftozanermin alfa '''Start Date''': 2020-11-05 '''Last Updated''': 2023-07-13 '''Number of Patients''': 40 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': Multiple Myeloma '''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''': NCT04008030 '''Title''': A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigatorâs Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC) '''Study Summary''': The main purpose of this study is to compare the clinical benefit, as measured by Progression-Free Survival (PFS), Objective Response Rate (ORR), and Overall Survival (OS), achieved by nivolumab in combination with ipilimumab or by nivolumab monotherapy in participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) metastatic colorectal cancer (mCRC). This study will also compare nivolumab plus ipilimumab combination vs chemotherapy for treatment of MSI-H/dMMR mCRC participants. '''Sponsor''': Bristol-Myers Squibb '''Intervention''': Ipilimumab '''Start Date''': 2019-08-05 '''Last Updated''': 2023-10-27 '''Number of Patients''': 831 '''Recruitment Status''': RECRUITING '''Condition''': Metastatic Colorectal Cancer '''NCTID''': NCT06132321 '''Title''': Quality of Life in Patients Undergone Vulvar Reconstruction After Vulvar Cancer Resection (3233) '''Study Summary''': This study aims to evaluate the patientsâquality of life before and after surgery for vulvar cancer and reconstruction, employing different questionnaires and investigating different items. '''Sponsor''': Fondazione Policlinico Universitario Agostino Gemelli IRCCS '''Intervention''': Quality of life questionnaires '''Start Date''': 2020-06-23 '''Last Updated''': 2023-11-15 '''Number of Patients''': 93 '''Recruitment Status''': RECRUITING '''Condition''': Vulvar Neoplasms '''NCTID''': NCT04209855 '''Title''': A Study of Mirvetuximab Soravtansine vs. Investigatorâs Choice of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression '''Study Summary''': This Phase 3 study is designed to compare the efficacy and safety of mirvetuximab soravtansine vs. investigatorâs choice chemotherapy in patients with platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of FRÎą. Patients will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. Folate receptor alpha (FRÎą) positivity will be defined by the Ventana FOLR1 (FOLR1-2.1) CDx assay. '''Sponsor''': ImmunoGen, Inc. '''Intervention''': Mirvetuximab Soravtansine '''Start Date''': 2019-12-31 '''Last Updated''': 2023-03-06 '''Number of Patients''': 453 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': Epithelial Ovarian Cancer '''NCTID''': NCT05409066 '''Title''': Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma '''Study Summary''': Follicular Lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional treatment and the disease recurs in almost all patients. This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with relapsed or refractory (R/R) FL. Adverse events and change in disease condition will be assessed. Epcoritamab is an investigational drug being developed for the treatment of FL. Study doctors put the participants in 1 of 3 groups, called treatment arms. Each group receives a different treatment. Enrollment to one of the groups is closed. Around 500 adult participants with R/R FL will be enrolled in approximately 300 sites across the world. Participants will receive R2 (375 mg/m^2 intravenous infusion of rituximab up to 5 cycles and oral capsules of 20 mg lenalidomide for up to 12 cycles) alone or in combination with subcutaneous injections of epcoritamab for up to 12 cycles (each cycle is 28 days). 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 a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. '''Sponsor''': AbbVie '''Intervention''': Epcoritamab '''Start Date''': 2022-09-20 '''Last Updated''': 2023-11-27 '''Number of Patients''': 500 '''Recruitment Status''': RECRUITING '''Condition''': Follicular Lymphoma (FL) '''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''': NCT05186753 '''Title''': (Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic Mastocytosis '''Study Summary''': This is a multi-part, randomized, double-blind, placebo-controlled Phase 2 clinical study comparing the safety and efficacy of bezuclastinib (CGT9486) plus best supportive care (BSC) with placebo plus BSC in patients with nonadvanced systemic mastocytosis (NonAdvSM), including indolent systemic mastocytosis and smoldering systemic mastocytosis, whose symptoms are not adequately controlled by BSC. This study will be conducted in three parts. Patients in Parts 1a, 1b and 2 will receive bezuclastinib or placebo, and may roll over onto Part 3 to receive treatment with bezuclastinib. '''Sponsor''': Cogent Biosciences, Inc. '''Intervention''': Bezuclastinib Tablets (Formulation A) '''Start Date''': 2022-06-27 '''Last Updated''': 2023-10-30 '''Number of Patients''': 138 '''Recruitment Status''': RECRUITING '''Condition''': SSM '''NCTID''': NCT01997229 '''Title''': Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis (REGAIN Study) '''Study Summary''': The purpose of this study is to determine if eculizumab is safe and effective for the treatment of refractory generalized Myasthenia Gravis. '''Sponsor''': Alexion Pharmaceuticals, Inc. '''Intervention''': Eculizumab '''Start Date''': 2013-12 '''Last Updated''': 2019-07-16 '''Number of Patients''': 125 '''Recruitment Status''': COMPLETED '''Condition''': Refractory Generalized Myasthenia Gravis '''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''': NCT05796960 '''Title''': European Multicenter Study on Surgical Management of Advanced Thyroid Cancer '''Study Summary''': The main aim of the study is to evaluate peri-operative surgical characteristics, operation extent, postoperative morbidity, and outcomes in patients undergoing surgery for advanced thyroid cancer in different European centers using the EUROCRINEÂŽ database. '''Sponsor''': Fondazione Policlinico Universitario Agostino Gemelli IRCCS '''Intervention''': Thyroidectomy with or without lymphadenectomy or multivisceral resection '''Start Date''': 2022-12-15 '''Last Updated''': 2023-04-04 '''Number of Patients''': 3917 '''Recruitment Status''': RECRUITING '''Condition''': Thyroid Carcinoma '''NCTID''': NCT05930860 '''Title''': Efficacy and Safety of ESD for the Treatment of Superficial Gastric Neoplasms '''Study Summary''': Endoscopic submucosal dissection (ESD) is the technique that has replaced surgery in the treatment of early neoplastic lesions of the stomach (LNPS). ESD of LNPS allows: a) less invasiveness compared to surgery; b) greater chances of âen blocâ resection and R0 resection compared to mucosectomy for lesions larger than 15 mm. Recent 2015 ESGE guidelines provide precise recommendations for the use of ESD in the treatment of LNPS, but Italy lacks prospective data on the efficacy and safety of ESD in a large sample of patients. A multicenter prospective observational study to create a database on the use of ESD in LNPS is essential to provide information regarding the efficacy and safety of ESD in Italy. This database would also provide information regarding the criteria applied in the use of ESD in the treatment of early gastric neoplasia '''Sponsor''': Fondazione Policlinico Universitario Agostino Gemelli IRCCS '''Intervention''': Endoscopic Submucosal Dissection '''Start Date''': 2021-12-12 '''Last Updated''': 2023-07-05 '''Number of Patients''': 200 '''Recruitment Status''': RECRUITING '''Condition''': Gastric Cancer '''NCTID''': NCT04551053 '''Title''': To Evaluate Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib (LIMBER-304) '''Study Summary''': The purpose of the study is to compare the efficacy and safety of parsaclisib when combined with ruxolitinb versus placebo combined with ruxolitinib in participants with myelofibrosis who have suboptimal response while receiving ruxolitinib monotherapy. '''Sponsor''': Incyte Corporation '''Intervention''': parsaclisib '''Start Date''': 2021-05-26 '''Last Updated''': 2023-10-18 '''Number of Patients''': 177 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': Myelofibrosis '''NCTID''': NCT03734029 '''Title''': Trastuzumab Deruxtecan (DS-8201a) Versus Investigatorâs Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04] '''Study Summary''': This study will compare DS-8201a to physician choice standard treatment. Participants must have HER2-low breast cancer that has been treated before. Participantsâ cancer: * Cannot be removed by an operation * Has spread to other parts of the body '''Sponsor''': Daiichi Sankyo, Inc. '''Intervention''': Trastuzumab deruxtecan (DS-8201a) '''Start Date''': 2018-12-27 '''Last Updated''': 2023-06-15 '''Number of Patients''': 557 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': Breast Cancer '''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''': NCT03486873 '''Title''': Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587) '''Study Summary''': The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study. This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will transition to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment. Participants who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up Phase of this study. Participants who were in the Second Course Phase in their parent study will enter Second Course Phase of this study and complete up to 17 doses Q3W or 8 doses Q6W of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment. Any participant originating from a parent trial where crossover to pembrolizumab was permitted upon disease progression may be may be eligible for 35 doses as Q3W or 17 doses Q6W of pembrolizumab (approximately 2 years), if they progress while on the control arm and pembrolizumab is approved for the indication in the country where the potential eligible crossover participant is being evaluated. '''Sponsor''': Merck Sharp & Dohme LLC '''Intervention''': Pembrolizumab '''Start Date''': 2018-08-21 '''Last Updated''': 2023-11-27 '''Number of Patients''': 2300 '''Recruitment Status''': RECRUITING '''Condition''': Solid Tumors '''NCTID''': NCT03833661 '''Title''': M7824 Monotherapy in Locally Advanced or Metastatic Second Line (2L) Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer) '''Study Summary''': The study to evaluate M7824 monotherapy in participants with advanced or metastatic biliary tract cancer (BTC) who failed or were intolerant to first-line (1L) chemotherapy. '''Sponsor''': EMD Serono Research & Development Institute, Inc. '''Intervention''': M7824 '''Start Date''': 2019-03-26 '''Last Updated''': 2023-10-25 '''Number of Patients''': 159 '''Recruitment Status''': COMPLETED '''Condition''': Biliary Tract 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''': NCT05831553 '''Title''': TIP in Patients Affected by Metastatic TNBC '''Study Summary''': Triple-negative breast cancer (TNBC) is defined by the absence of estrogen receptor (ER), progesterone receptor (PgR), and human epidermal growth factor receptor 2 (HER2) expression on cancer cells. TNBCs accounts for 15-20% of all breast cancers (BC).1 It is characterized by a worse prognosis, increased risk of metastasis to vital organs and a relative lack of therapeutic target if compared to other BC subtypes.2 Therefore, the identification of new molecular targets and therapeutic strategies is a critical need in both early and metastatic setting. TNBC appears to be more immunogenic compared to other BC6. Immunotherapy has recently changed the landscape of therapeutic options in TNBC. Recent clinical trials have shown a significant clinical benefit in patients with metastatic TNBC treated with a combination of chemotherapy and anti PD-1 agents.11-12-13-14-15 In particular, results from IMPASSION 130 trial showed a significant benefit in both progression free survival (PFS) and overall survival (OS) in PD-L1 positive (PD-L1+) patients treated with a combination of atezolizumab and nab-paclitaxel.20 However, about 70% of PD-L1+ patients has experienced a disease progression after one year and about 50% was alive at 2 year. Moreover, no difference in survival endpoint has been seen in PD-L1 negative (PD-L1-) population, with an increase of toxicity and costs related to the addition of a checkpoint-inhibitor. Therefore, the identification of novel biomarkers in addition to PD-L1 and the combination of several biomarkers in a profile with higher predictive capacity is considered an area of urgent clinical need. Some immune-related features that can be identified in tumor microenvironment have been demonstrated to be independent prognostic and predictive factors: TILs, PD-L1, CD73. # Tumour-inďŹltrating lymphocytes (TILs) control the clinical progression of various types of cancer7. Breast cancer with higher levels of infiltrating CD8+ cytotoxic T cells have been associated with better patient survival8. Moreover, high levels of stromal CD8+ TILs (sTILs) correlate with higher probability of pCR9. Not only quantitative, but also qualitative analysis of TILs is a promising research area. Some studies suggest that different subtypes of TILs may have an opposite role in tumor microenvironment allowing the induction of both immune activating (es. CD8+) or immune suppressive (es FOXP3+) environment8-9-10. # The interaction between programmed cell death protein 1 (PD-1) and its ligand (PD-L1) represents one of the principal mechanisms of immune escape and a therapeutic target for several malignancies13-14. PD-1/PD-L1 interaction attenuates lymphocyte activation and promotes T-regulatory cell development and function, allowing to terminate the immune response15. In breast cancer the prognostic role of PD-1/PD-L1 axis is still uncertain with limited and contrasting data. PD-L1 positivity (âĽ1%) on immune cells (IC) is the clinical most used threshold, according to the results of IMPASSION 130 trial.18-24 # Recently, CD73 has been identified as a possible further molecular immunosuppressive target in triple negative breast cancer28. CD73 is expressed on the surface of tumoral cells, stromal cells and immunological cells. By increasing extracellular levels of adenosine monophosphate , CD73 suppresses immune responses. CD73 has been found to be overexpressed in several types of human cancers, and it has been associated with a poor prognosis29-30-31. Particularly Loi et al demonstrated that high CD73 expression is associated with poor prognosis in TNBC and to a low rate of pathological complete response32. We defined a tissue immune profile positive (TIP+) as the simultaneous presence of TILsâĽ50%, CD73â¤40% and PD-L1âĽ1%. Any other combination was defined as TIP negative (TIP-) In conclusion, we will evaluate the association between TIP and clinical outcomes (ORR, PFS, OS). '''Sponsor''': Fondazione per la Medicina Personalizzata '''Intervention''': Tissue Immune Profile '''Start Date''': 2022-09-16 '''Last Updated''': 2023-05-06 '''Number of Patients''': 100 '''Recruitment Status''': RECRUITING '''Condition''': Metastatic Triple-negative Breast Cancer '''NCTID''': NCT04294810 '''Title''': A Study of Tiragolumab in Combination With Atezolizumab Compared With Placebo in Combination With Atezolizumab in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1-Selected Non-Small Cell Lung Cancer '''Study Summary''': The purpose of the study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in participants with previously untreated locally advanced, unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. Eligible participants will be randomized in a 1:1 ratio to receive either tiragolumab plus atezolizumab or placebo plus atezolizumab. '''Sponsor''': Hoffmann-La Roche '''Intervention''': Atezolizumab '''Start Date''': 2020-03-04 '''Last Updated''': 2023-11-03 '''Number of Patients''': 620 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': Non-Small Cell Lung Cancer '''NCTID''': NCT03438396 '''Title''': A Trial of Tisotumab Vedotin in Cervical Cancer '''Study Summary''': A Single arm, Multicenter, International Trial of Tisotumab Vedotin (HuMaxÂŽ-TF-ADC) in Previously Treated, Recurrent or Metastatic Cervical Cancer. '''Sponsor''': Seagen Inc. '''Intervention''': tisotumab vedotin '''Start Date''': 2018-06-12 '''Last Updated''': 2023-07-25 '''Number of Patients''': 102 '''Recruitment Status''': COMPLETED '''Condition''': Cervical Cancer '''NCTID''': NCT04764188 '''Title''': An Observational Study to Evaluate the Real-World Clinical Management and Outcomes of ALK-Positive Advanced NSCLC Participants Treated With Alectinib '''Study Summary''': This study aims to characterize the clinical management and outcomes of participants diagnosed with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) who are being treated with alectinib in real-world clinical practice. '''Sponsor''': Hoffmann-La Roche '''Intervention''': Alectinib '''Start Date''': 2021-05-10 '''Last Updated''': 2023-11-08 '''Number of Patients''': 800 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': NSCLC '''NCTID''': NCT05011058 '''Title''': An Open-Label, Phase 2 Trial of Nanatinostat in Combination With Valganciclovir in Patients With Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas '''Study Summary''': A Phase 2 study to evaluate the efficacy of nanatinostat in combination with valganciclovir in patients with relapsed/refractory EBV-positive lymphomas '''Sponsor''': Viracta Therapeutics, Inc. '''Intervention''': Nanatinostat in combination with valganciclovir '''Start Date''': 2021-05-28 '''Last Updated''': 2023-11-27 '''Number of Patients''': 140 '''Recruitment Status''': RECRUITING '''Condition''': Epstein-Barr Virus Associated Lymphoproliferative Disorder '''NCTID''': NCT03545035 '''Title''': Efficacy and Safety in Patients With Chronic Lymphocytic Leukemia (CLL) Treated With Idelalisib and Rituximab in the Clinical Practice: a GIMEMA-ERIC Study '''Study Summary''': The present study aims at obtaining more in-depth information on how patients with chronic lymphocytic leukemia treated with idelalisib and rituximab react to treatment. '''Sponsor''': Gruppo Italiano Malattie EMatologiche dellâAdulto '''Intervention''': idelalisib and rituximab '''Start Date''': 2019-02-06 '''Last Updated''': 2022-05-12 '''Number of Patients''': 104 '''Recruitment Status''': COMPLETED '''Condition''': Chronic Lymphocytic Leukemia '''NCTID''': NCT04515394 '''Title''': Study of Tepotinib Combined With Cetuximab in Participants With Left-Sided RAS/BRAF Wild Type Metastatic Colorectal Cancer (PERSPECTIVE) '''Study Summary''': The purpose of this study was to assess the preliminary antitumor activity, safety and tolerability of tepotinib in combination with cetuximab in participants with RAS/BRAF wild-type left-sided Metastatic Colorectal Cancer (mCRC) having acquired resistance to anti-epidermal growth factor receptor (EGFR) antibody targeted therapy due to mesenchymal epithelial transition (MET) amplification. '''Sponsor''': EMD Serono Research & Development Institute, Inc. '''Intervention''': Tepotinib '''Start Date''': 2021-01-28 '''Last Updated''': 2022-12-22 '''Number of Patients''': 3 '''Recruitment Status''': TERMINATED '''Condition''': Colorectal Neoplasms '''NCTID''': NCT04733118 '''Title''': Chemotherapy-Free pCR-Guided Strategy With Trastuzumab-pertuzumab and T-DM1 in HER2-positive Early Breast Cancer '''Study Summary''': This is a multicenter, open-label, single-arm, one-stage, phase II study to assess the efficacy of a chemotherapy-free pathological complete response (pCR)-guided strategy with trastuzumab and pertuzumab (given as a subcutaneous fixed-dose combination) and T-DM1, for patients with previously untreated HER2-positive early breast cancer. '''Sponsor''': MedSIR '''Intervention''': Trastuzumab and Pertuzumab (FDC SC) and T-DM1 '''Start Date''': 2021-08-05 '''Last Updated''': 2023-04-05 '''Number of Patients''': 393 '''Recruitment Status''': RECRUITING '''Condition''': Early Breast Cancer '''NCTID''': NCT05138094 '''Title''': LIVACOR Trial: Minimally Invasive LIVer And Simultaneous COlorectal Resection '''Study Summary''': The LIVACOR - Trial is a European wide, randomized controlled, open-label, multicenter trial. Patients with synchronous colorectal liver metastases (CRLMs) and primary colorectal tumor are considered eligible and will be randomized between minimally invasive (MI) combined or staged colorectal resection (all colectomies, including high anterior resection) and liver resection of up to three segments. '''Sponsor''': Fondazione Poliambulanza Istituto Ospedaliero '''Intervention''': Minimally invasive simultaneous resection '''Start Date''': 2021-08-06 '''Last Updated''': 2022-07-25 '''Number of Patients''': 82 '''Recruitment Status''': RECRUITING '''Condition''': Colorectal Neoplasms Malignant '''NCTID''': NCT03804372 '''Title''': The Incidence of Hepatitis B in Diffuse Large B-Cell Lymphoma/Chronic Lymphoid Leukemia HBsAg-positive Treated With Rituximab, Chemotherapy and Tenofovir Alafenamide '''Study Summary''': In this study, we will evaluate the incidence of hepatitis B virus reactivation within the first 6 months of treatment with rituximab, standard chemotherapy and TAF in patients with diffuse Large B-Cell Lymphoma/Chronic Lymphoid Leukemia HBsAg-positive. '''Sponsor''': Gruppo Italiano Malattie EMatologiche dellâAdulto '''Intervention''': Rituximab '''Start Date''': 2020-07-07 '''Last Updated''': 2022-01-04 '''Number of Patients''': 180 '''Recruitment Status''': RECRUITING '''Condition''': Large-B-cell Diffuse Lymphoma '''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''': NCT05763472 '''Title''': Breast Cancer After Ovarian Cancer During and/or After Therapy: Genomic Evaluation '''Study Summary''': This study will investigate, in patients with germline BRCA-1/2 mutations and breast cancer, arising during and / or after treatment with platinum-based chemotherapy and / or with PARP-inhibitors for ovarian cancer, the presence of molecular alterations potentially involved in the mechanisms of resistance to antineoplastic treatment on breast and ovarian tumor tissue. '''Sponsor''': Fondazione Policlinico Universitario Agostino Gemelli IRCCS '''Intervention''': Next-generation sequencing (NGS) assay TruSight Oncology 500 (TSO 500). '''Start Date''': 2022-03-01 '''Last Updated''': 2023-03-10 '''Number of Patients''': 10 '''Recruitment Status''': RECRUITING '''Condition''': BRCA-Associated Breast Carcinoma '''NCTID''': NCT05815472 '''Title''': Advanced Patient Monitoring and A.I. Supported Outcomes Assessment in Lung Cancer Using Internet of Things Technologies (A.I. - APALITT) '''Study Summary''': The use of advanced technological tools able to exploit patient-centered âReal World Dataâ, represents an innovative and fascinating challenge for the most modern personalized medicine paradigms. Monitoring oncological patients during multimodal cancer therapies may represent a significant step towards a comprehensive and reliable quality of life assessment, prevention of toxicity before its clinical onset and treatment outcomes prediction. The big data approach, being able to collect, manage and interpret large volumes of health data, eventually supported by artificial intelligence (A.I.) is therefore fundamental in this setting and may be translated in the next future in tangible advantages for the patients. Primary aim of the project is to assess patients experience of using portable monitoring systems during multimodal oncological therapies and follow up period, through the use of a dedicated app and wearable technology (i.e. monitoring bracelet), as Electronic Health Record data harvesting devices. More specifically, the patients report experience measure of man/women affected by locally advanced non-small-cell lung cancer undergoing chemo(radio)therapy followed either by surgery or immunotehrapy (e.g. describing toxicity, instrumental activities of daily living and stress/coping levels) will be analyzed. The machine learning assisted analysis of these data will allow to identify patients profile that may be used as risk categories to optimize assistance and follow up practices. This is an observational study with device, co-financed, monocentric study with a foreseen study duration of 36 months. '''Sponsor''': Fondazione Policlinico Universitario Agostino Gemelli IRCCS '''Intervention''': Fitbit charge '''Start Date''': 2021-09-28 '''Last Updated''': 2023-04-18 '''Number of Patients''': 50 '''Recruitment Status''': RECRUITING '''Condition''': Non-small-cell Lung Cancer '''NCTID''': NCT06020625 '''Title''': Mutational Oncology in Clinical Practice '''Study Summary''': The study of biological profiling is of fundamental importance in the diagnosis and treatment of many diseases, particularly oncological ones, and for this reason, the integration of molecular characterization into clinical practice becomes essential. NGS allows a high number of samples to be sequenced simultaneously, generating a great deal of genomic information in a short time and at reasonable cost. This information is of fundamental importance for the study of oncogenic drivers and gene alterations that may have a prognostic and/or predictive role in response to new molecularly targeted drugs. Policlinico A. Gemelli has begun a process of internal reorganization of the research infrastructure following its recognition in 2018 as an Institute of Hospitalization and Treatment with Scientific Character (IRCCS) for its commitment to the disciplines of âPersonalized Medicineâ and âInnovative Biotechnology.â In particular, with regard to genomics, will be equipped with a state-of-the-art technological asset that includes a fully automated process for sample preparation and the highest gene sequencing power available today. This condition makes it possible to perform extensive genomic profiling for large numbers of patients at low cost and in reasonable time. '''Sponsor''': Fondazione Policlinico Universitario Agostino Gemelli IRCCS '''Intervention''': Diagnostic Test '''Start Date''': 2022-01-01 '''Last Updated''': 2023-08-31 '''Number of Patients''': 20000 '''Recruitment Status''': RECRUITING '''Condition''': Genome Instability '''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''': NCT04404673 '''Title''': Urinary and Sexual Dysfunctions Evaluation After Rectal Resection '''Study Summary''': Advances in the treatment of rectal cancer over the past two decades have improved survival and significantly reduced surgery-related morbidity. As a result, post-treatment quality of life (QoL) issues have become increasingly important. Urinary and sexual functions can be significantly altered after rectal resection, mainly due to the iatrogenic lesions of the pelvic autonomous lexus. Of note, their incidence is reported up to 70% and 30%, respectively. Despite the importance of this topic, most of the studies present in the literature are difficult to interpret for a variety of reasons. Firstly, both sexual and urinary dysfunctions lack a standardized definition. Secondly, the absence of baseline data, missing data, small sample sizes, and heterogeneity in the use of validated and nonvalidated instruments are the main limitation in drawing conclusive results. As additional factor, no clear evidence is present in the literature regarding the best approach to be used in order to preserve as much as possible both the sexual and urinary functionalities and to guarantee, at the same time, an adequate and oncologically correct rectal resection. Moreover, no data are currently present regarding the impact of pre-operative chemo-radiotherapy on the urinary and sexual functionalities. The main objective of the investigatorâs prospective study will be to define in a subjective manner which technique (open, laparoscopic, robot-assisted and Ta-TME) will guarantee the best urinary and sexual outcomes after rectal resection (with or without pre-operative chemo-radiotherapy) for the treatment of rectal carcinomas. Thus, the primary endpoint will the post-operative evaluation at 1, 6 months and 1 year of the urinary and sexual functions by means of specific questionnaires. Secondary endpoints will be: * to investigate which technique (open, robotic, laparoscopic and trans-anal total mesorectal excision (TaTME)) more favorably correlate with urinary and sexual functions after radiochemotherapy (NAD+); * the comparison of both the urinary and sexual dysfunction incidence on the base of the distance of the rectal tumor from the anal verge and the evaluation of the best approach to be used (open, laparoscopic, TaTME or robot-assisted) in relation to the tumor height; * the short- (postoperative morbidity and histopathological data) and long-term (overall and disease-free survival) outcomes comparison among the open, laparoscopic, TaTME and robotic rectal resection. '''Sponsor''': Fondazione Policlinico Universitario Agostino Gemelli IRCCS '''Intervention''': Evaluation of urinary and sexual dysfunction after rectal resection '''Start Date''': 2020-02-21 '''Last Updated''': 2020-05-27 '''Number of Patients''': 1172 '''Recruitment Status''': RECRUITING '''Condition''': Rectal Cancer '''NCTID''': NCT03917173 '''Title''': Prophylactic Surgery Plus HIPEC With CO2 in Patients Affected by Gastric Carcinoma.GOETH Study '''Study Summary''': This is a phase III randomized, multicenter study with two different arm: * experimental: prophylactic surgery plus HIPEC CO2 performed with mitomycin and cisplatin * comparator: standard surgery Adjuvant treatment after surgery is mandatory except for documented cases of non-eligibility in both arms. Patient will be randomized in a 1:1 ratio. Randomization will be performed during surgery if the total resection of tumor will be reached according to center and neoadjuvant chemotherapy as stratification variables. '''Sponsor''': Mario Negri Institute for Pharmacological Research '''Intervention''': Surgery plus HIPEC CO2 '''Start Date''': 2020-06-01 '''Last Updated''': 2023-10-26 '''Number of Patients''': 240 '''Recruitment Status''': RECRUITING '''Condition''': Stomach Neoplasms '''NCTID''': NCT05601700 '''Title''': Letrozole for Estrogen/Progesterone Receptor Positive Low-grade Serous Epithelial Ovarian Cancer (LEPRE Trial) '''Study Summary''': This is an Italian, multicenter, randomized, open-label phase III trial which will evaluate if Letrozole is superior to standard adjuvant chemotherapy in patients with hormone receptor positive low-grade serous epithelial carcinoma of the ovary (LGSCO). The hypothesis is that letrozole will significantly prolong median progression free survival (PFS) compared with the standard chemotherapy treatment, namely carboplatin AUC 5 and paclitaxel 175 mg/m2. '''Sponsor''': Ente Ospedaliero Ospedali Galliera '''Intervention''': Letrozole tablets '''Start Date''': 2022-09-22 '''Last Updated''': 2023-06-29 '''Number of Patients''': 132 '''Recruitment Status''': RECRUITING '''Condition''': Carcinoma, Ovarian Epithelial '''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''': 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 investigatorâs choice of chemotherapy will be assessed compared to placebo plus the investigatorâs 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) âĽ1 and âĽ10. '''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''': NCT05999994 '''Title''': A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer '''Study Summary''': The main purpose of the master is to help the research sites and sponsor carry out several clinical trials more efficiently by providing a common research protocol. Individual clinical trials under this master protocol define drug/disease-specific research goals and activities to test them. New studies will be added as new drugs emerge against different cancers. Participation in the trial will depend on how long the benefit lasts. '''Sponsor''': Eli Lilly and Company '''Intervention''': Ramucirumab '''Start Date''': 2020-01-22 '''Last Updated''': 2023-10-18 '''Number of Patients''': 105 '''Recruitment Status''': RECRUITING '''Condition''': Neoplasms '''NCTID''': NCT04024436 '''Title''': A Study of TAS-120 in Patients With Metastatic Breast Cancer '''Study Summary''': The purpose of the trial is to evaluate a patientâs response to a Fibroblast Growth Factor Receptor (FGFR) inhibitor, futibatinib (TAS-120), used either alone or in combination with the hormonal therapy, fulvestrant. This study will be conducted in patients with metastatic breast cancer who have specific Fibroblast Growth Factor Receptor gene abnormalities and who have previously received conventional therapies to treat their breast cancer, or who are not able to tolerate certain cancer therapies. This study will also evaluate the safety of taking futibatinib, or futibatinib and fulvestrant, by learning about the potential side effects. '''Sponsor''': Taiho Oncology, Inc. '''Intervention''': Futibatinib '''Start Date''': 2019-08-30 '''Last Updated''': 2023-08-21 '''Number of Patients''': 168 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': Metastatic Breast Cancer '''NCTID''': NCT05763524 '''Title''': European Multicenter Study on Role of Lymph Node Dissection in Surgical Management of Adrenal Cortical Carcinoma '''Study Summary''': This project will evaluate of the number of patients who underwent adrenalectomy for ACC in different European centers using the EUROCRINEÂŽ database. The analysis will focus on the extent of lymph nodal dissection (i.e. number of lymph nodes and nodal stations dissected during adrenalectomy). We aim to evaluate the oncologic radicality of surgical treatment and the rate of tumour recurrences after surgery and nodal metastasis related to the stage of the disease and to tumour side (left/right). '''Sponsor''': Fondazione Policlinico Universitario Agostino Gemelli IRCCS '''Intervention''': Adrenalectomy with or without lymphadenectomy '''Start Date''': 2022-12-15 '''Last Updated''': 2023-03-20 '''Number of Patients''': 90 '''Recruitment Status''': RECRUITING '''Condition''': Adrenocortical Carcinoma '''NCTID''': NCT02100696 '''Title''': A Study of the Efficacy and Safety of Etrolizumab in Participants With Ulcerative Colitis Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) Inhibitors '''Study Summary''': This Phase III, double-blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab during induction and maintenance of remission compared with placebo in the treatment of participants with moderately to severely active ulcerative colitis (UC) who have been previously exposed to TNF inhibitors. '''Sponsor''': Hoffmann-La Roche '''Intervention''': Etrozulimab '''Start Date''': 2014-05-21 '''Last Updated''': 2021-08-13 '''Number of Patients''': 609 '''Recruitment Status''': COMPLETED '''Condition''': Ulcerative Colitis '''NCTID''': NCT02394496 '''Title''': Overcoming Endocrine Resistance in Metastatic Breast Cancer '''Study Summary''': Based on these results it can be envisioned that the majority of endocrine-responsive post-menopausal breast cancer patients will be treated with an AI as adjuvant therapy (front-line, switching or extending) and/or as first-line management of metastatic breast cancer. '''Sponsor''': Consorzio Oncotech '''Intervention''': Fulvestrant '''Start Date''': 2007-11 '''Last Updated''': 2016-06-15 '''Number of Patients''': 396 '''Recruitment Status''': UNKNOWN '''Condition''': Metastatic Breast Cancer '''NCTID''': NCT01210495 '''Title''': Axitinib For The Treatment Of Advanced Hepatocellular Carcinoma '''Study Summary''': The study is designed to demonstrate that axitinib plus best supportive care is superior to placebo plus best supportive care in prolonging survival in patients with advanced hepatocellular carcinoma. '''Sponsor''': Pfizer '''Intervention''': Axitinib (AG-013736) '''Start Date''': 2010-12-06 '''Last Updated''': 2019-01-09 '''Number of Patients''': 224 '''Recruitment Status''': COMPLETED '''Condition''': Hepatocellular Carcinoma '''NCTID''': NCT04468984 '''Title''': Study of Oral Navitoclax Tablet in Combination With Oral Ruxolitinib Tablet to Assess Change in Spleen Volume in Adult Participants With Relapsed/Refractory Myelofibrosis '''Study Summary''': Myelofibrosis (MF) is a rare blood cancer, notable for scarring of the bone marrow (the spongy tissue inside bones) and the spleen becoming larger. The purpose of this study is to assess safety and change in spleen volume when navitoclax is given in combination with ruxolitinib, compared to best available therapy, for adult participants with MF. Navitoclax is an investigational drug (not yet approved) being developed for the treatment of MF. Participants in this study will be randomly selected (like picking numbers out of a hat) to be in 1 of 2 treatment arms. Neither participants nor the study doctor will be able to pick which treatment arm a participants enters. In Arm A, participants will receive navitoclax in combination with ruxolitinib. In Arm B, participants will receive the best available therapy (BAT) for MF. Adult participants with a diagnosis of MF that came back or did not get better after earlier treatment will be enrolled. Approximately 330 participants will be enrolled in approximately 210 sites across the world. In Arm A, participants will receive navitoclax tablet by mouth once daily with by mouth ruxolitinib tablet twice daily. In Arm B, participants will receive the BAT available to the investigator. Participants will receive the study drug until they experience no benefit (determined by the investigator), participants cannot tolerate the study drugs, or participants withdraw consent. The approximate treatment duration is about 3 years. 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 a hospital or clinic. The effect of treatment will be checked by medical assessments, blood and bone marrow tests, checking for side effects, and completing questionnaires. '''Sponsor''': AbbVie '''Intervention''': Navitoclax '''Start Date''': 2020-08-31 '''Last Updated''': 2023-11-14 '''Number of Patients''': 330 '''Recruitment Status''': RECRUITING '''Condition''': Myelofibrosis (MF) '''NCTID''': NCT05020236 '''Title''': MagnetisMM-5: Study of Elranatamab (PF-06863135) Monotherapy and Elranatamab + Daratumumab Versus Daratumumab + Pomalidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma '''Study Summary''': The purpose of this study is to evaluate whether the BCMA-CD3 bispecific antibody elranatamab, alone and/or in combination with the anti-CD38 monoclonal antibody, daratumumab, can provide more benefit to people with multiple myeloma compared to a combination therapy including daratumumab, pomalidomide, and dexamethasone. People with multiple myeloma who have received previous treatment including lenalidomide and a proteasome inhibitor will be enrolled in the study. Part 1 of the study will assess the safety and activity of different doses of elranatamab in combination with daratumumab. People participating in Part 2 of the study will be randomly assigned to receive either elranatamab alone, elranatamab plus daratumumab, or daratumumab, pomalidomide, and dexamethasone. Part 2 will compare the safety and activity of (1) elranatamab alone compared to daratumumab, pomalidomide, and dexamethasone, and (2) elranatamab plus daratumumab compared to daratumumab, pomalidomide, and dexamethasone. Part 3 of the study will evaluate an alternative dosing schedule of elranatamab in combination with daratumumab. Participants in all parts of the study will receive study treatment until their disease progresses, they experience unacceptable side effects, or they choose to no longer participate in the study. '''Sponsor''': Pfizer '''Intervention''': Elranatamab '''Start Date''': 2021-10-04 '''Last Updated''': 2023-08-24 '''Number of Patients''': 854 '''Recruitment Status''': RECRUITING '''Condition''': Multiple Myeloma '''NCTID''': NCT03306394 '''Title''': A Study of Trifluridine/Tipiracil (Also Known as S 95005 or TAS-102) in Patients With a Pretreated Colorectal Cancer That Has Spread (Metastatic). '''Study Summary''': The purpose of this study is to collect additional safety and efficacy data during treatment with trifluridine / tipiracil in patients with a pretreated metastatic colorectal cancer (mCRC). Eligible patients may receive an early access to trifluridine / tipiracil through this clinical study until progression of disease, unacceptable toxicity, investigator decision, patient refusal or until market authorization or reimbursement has been granted by the relevant Authority of the country where that patient is treated or until trifluridine / tipiracil is available by a doctorâs prescription or can be accessed from another source or Sponsor decision. '''Sponsor''': Institut de Recherches Internationales Servier '''Intervention''': Trifluridine/Tipiracil hydrochloride (S95005) '''Start Date''': 2016-10-18 '''Last Updated''': 2021-11-17 '''Number of Patients''': 907 '''Recruitment Status''': COMPLETED '''Condition''': Metastatic Colorectal Cancer '''NCTID''': NCT04173494 '''Title''': A Study of Momelotinib Versus Danazol in Symptomatic and Anemic Myelofibrosis Participants (MOMENTUM) '''Study Summary''': MOMENTUM is a randomized, double-blind, active control Phase 3 trial intended to confirm the differentiated clinical benefits of the investigational drug momelotinib (MMB) versus danazol (DAN) in symptomatic and anemic participants who have previously received an approved Janus kinase inhibitor (JAKi) therapy for myelofibrosis (MF). The purpose of this clinical study is to compare the effectiveness and safety of MMB to DAN in treating and reducing: 1) disease related symptoms, 2) the need for blood transfusions and 3) splenomegaly, in adults with primary MF, post-polycythemia vera MF or post-essential thrombocythemia MF. The study is planned in countries including, but not limited to: Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, New Zealand, Poland, Romania, Singapore, South Korea, Spain, Sweden, Taiwan, United Kingdom (UK) and United States (US). Participants must be symptomatic with a Myelofibrosis Symptom Assessment Form (MFSAF) version (v) 4.0 Total Symptom Score of >= 10 at screening, and be anemic with hemoglobin (Hgb) < 10 gram/deciliter (g/dL). For participants with ongoing JAKi therapy at screening, JAKi therapy must be tapered over a period of at least 1 week, followed by a 2-week non-treatment washout interval prior to randomization. Participants will be randomized 2:1 to orally self-administer blinded treatment: MMB plus placebo or DAN plus placebo. Participants randomized to receive MMB who complete the randomized treatment period to the end of Week 24 may continue to receive MMB in the open-label extended treatment period to the end of Week 204 (a total period of treatment of approximately 4 years) if the participants tolerates and continues to benefit from MMB. Participants randomized to receive DAN may cross-over to MMB open-label treatment in the following circumstances: at the end of Week 24 if they complete the randomized treatment period; or at the end of Week 24 if they discontinue treatment with DAN but continue study assessments and do not receive prohibited medications including alternative active anti-MF therapy; or at any time during the randomized treatment period if they meet the protocol-defined criteria for radiographically confirmed symptomatic splenic progression. Participants randomized to receive DAN who are receiving clinical benefit at the end of Week 24 may choose to continue DAN therapy up to Week 48. The comparator treatment, DAN, is an approved medication in the US and in some other countries and is recommended by national guidelines as a treatment for anemia in MF. '''Sponsor''': Sierra Oncology LLC - a GSK company '''Intervention''': Momelotinib '''Start Date''': 2020-02-07 '''Last Updated''': 2023-11-01 '''Number of Patients''': 195 '''Recruitment Status''': COMPLETED '''Condition''': Primary Myelofibrosis '''NCTID''': NCT05099172 '''Title''': First in Human Study of BAY2927088 in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Epidermal Growth Factor Receptor (EGFR) and/or Human Epidermal Growth Factor Receptor 2 (HER2) '''Study Summary''': Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC), a group of lung cancers that have spread to nearby tissues or to other parts of the body. Epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) are proteins that help cells to grow and divide. A damage (also called mutation) to the building plans (genes) for these proteins in cancer cells leads to a production of abnormal EGFR and/or HER2. These abnormal proteins drive the growth and the spread of the cancer. Several EGFR and/or HER2 mutations exist in the cancer cells. Two mutations observed in NSCLC are called EGFR- or HER2exon20ins and EGFR C797X. The study treatment, BAY2927088, works by blocking the mutated EGFR protein and also its ex20ins version which are present in NSCLC. It is also believed to work against HER2 and HER2ex20ins mutations. Researchers think this may help stop the further spread of NSCLC cancer. This is the first time that researchers will study BAY2927088 in humans. In this study, the researchers want to learn more about using BAY2927088 in participants who have NSCLC with EGFR and/or HER2 mutations including EGFRex20ins and/or HER2ex20ins mutations. The main aims of this study are to find for BAY2927088 * how safe BAY2927088 is * how it affects the body (also referred to as tolerability) * how BAY2927088 moves into, through and out of the body * the maximum amount of BAY2927088 that the participants can take without too many side effects. The researchers will also study the action of BAY2927088 against the cancer. The study will have three parts: Dose Escalation, Backfill, and Dose Expansion. Each participant of the first, so called dose escalation part, will be assigned to one of specific sequential dose groups for BAY2927088. The amount of BAY2927088 that is given increases stepwise from one group to the next. The second may be initiated at any dose that has already been tested during the first part and found to be safe and to have either reached a predicted efficacious exposure range or to have induced an objective response. The first part and second part will run concurrently. The participants of the third, so called dose expansion part, will receive the most appropriate dose of BAY2927088 found in the first and second parts. The third part may be initiated in parallel with the first and second part based on emerging data. During the study, the participants will take the study treatment in 3 week periods called âcyclesâ. They will in general take BAY2927088 once daily until their cancer gets worse, until they have medical problems, until they leave the study or until the study is terminated. Participants will have around 5 visits in each cycle. During the study, the study team will: * take blood and urine samples * take regular CT or MRI scans to check if the participantsâ cancer has gotten better or worse * check the participantsâ overall health and heart health * ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. '''Sponsor''': Bayer '''Intervention''': BAY2927088_formulation A '''Start Date''': 2021-10-25 '''Last Updated''': 2023-11-28 '''Number of Patients''': 340 '''Recruitment Status''': RECRUITING '''Condition''': Advanced Non-small Cell Lung Cancer '''NCTID''': NCT05061823 '''Title''': Bintrafusp Alfa Program Rollover Study '''Study Summary''': This study is designed to provide continuous access to treatment with bintrafusp alfa for eligible participants from ongoing bintrafusp alfa parent studies (NCT02517398, NCT03840902, NCT02699515, NCT04246489, NCT04489940, NCT03840915, NCT03631706, NCT04551950, NCT03833661 and NCT04066491) and to collect long-term safety and efficacy data. Study Duration: All participants in this rollover study will be treated with bintrafusp alfa until meeting defined criteria in the protocol for discontinuation, until study intervention is commercially accessible and provisioned via marketed product, or until end of study. The study also includes a 5 years survival follow-up after last dose of the study treatment. Treatment Duration: Treatment under the rollover protocol according to the interval and dosing schedule in the parent protocol until discontinuation. '''Sponsor''': EMD Serono Research & Development Institute, Inc. '''Intervention''': Bintrafusp alfa '''Start Date''': 2021-12-01 '''Last Updated''': 2023-11-07 '''Number of Patients''': 32 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': Lung Cancer '''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''': NCT05654623 '''Title''': A Study to Learn About a New Medicine Called ARV-471 (PF-07850327) in People Who Have Advanced Metastatic Breast Cancer. '''Study Summary''': A study to learn about a new medicine called ARV-471 (PF-07850327) in people who have advanced metastatic breast cancer. '''Sponsor''': Pfizer '''Intervention''': ARV-471 '''Start Date''': 2023-03-03 '''Last Updated''': 2023-09-21 '''Number of Patients''': 560 '''Recruitment Status''': RECRUITING '''Condition''': Advanced Breast 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''': NCT04168502 '''Title''': Gemtuzumab Chemotherapy MRD Levels; Glasdegib Post-transplant, Adult Untreated, de Novo, Fav Interm Risk AML '''Study Summary''': MRD driven study. Addition of gemtuzumab to conventional chemotherapy to reduce MRD of patients with favorable/intermediate-risk AML. Post-consolidation assessment of MRD. Role of a post-SCT maintenance with glasdegib. '''Sponsor''': Gruppo Italiano Malattie EMatologiche dellâAdulto '''Intervention''': Glasdegib '''Start Date''': 2020-09-24 '''Last Updated''': 2022-07-20 '''Number of Patients''': 414 '''Recruitment Status''': RECRUITING '''Condition''': Acute Myeloid Leukemia '''NCTID''': NCT04246177 '''Title''': Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) in Participants With Incurable on-metastatic Hepatocellular Carcinoma (MK-7902-012/E7080-G000-318/LEAP-012) '''Study Summary''': The purpose of this study is to evaluate the efficacy and safety of lenvatinib and pembrolizumab in combination with TACE versus TACE plus oral and intravenous (IV) placebos in participants with incurable, non-metastatic hepatocellular carcinoma (HCC). The primary hypotheses are that pembrolizumab plus lenvatinib in combination with TACE is superior to placebo plus TACE with respect to progression-free survival (PFS) and overall survival (OS). '''Sponsor''': Merck Sharp & Dohme LLC '''Intervention''': Lenvatinib '''Start Date''': 2020-05-22 '''Last Updated''': 2023-09-13 '''Number of Patients''': 450 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': Carcinoma, Hepatocellular '''NCTID''': NCT06065358 '''Title''': Ovarian Tumor Organotypic Slices Cultures for functionAl Drug Testing and Therapy Response Prediction '''Study Summary''': Ex vivo organotypic tumor slice cultures (OTSC) have unique characteristics in terms of tissue processing time and the maintenance of original microenvironment. Moreover, drug screening has been successfully performed on OTSC in a clinically meaningful time window. For these reasons, we designed a study to assess the feasibility of establishing OTSC in OC patients and the concordance between ex vivo sensitivity and in vivo treatment response. If proven effective and reliable, OTSC could be introduced into clinical practice as empirical predictor of patientsâ response to platinum. '''Sponsor''': Fondazione Policlinico Universitario Agostino Gemelli IRCCS '''Intervention''': Tumor biopsy '''Start Date''': 2021-09-13 '''Last Updated''': 2023-10-03 '''Number of Patients''': 48 '''Recruitment Status''': RECRUITING '''Condition''': Ovarian Cancer '''NCTID''': NCT04679064 '''Title''': Trial on NIraparib-TSR-042 (Dostarlimab) vs Physicianâs 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 physicianâs 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''': NCT03059823 '''Title''': A Phase 1 Study of INCMGA00012 in Patients With Advanced Solid Tumors '''Study Summary''': The primary goal of this Phase 1 study is to characterize the safety and tolerability of INCMGA00012 and establish the maximum tolerated dose (MTD) of INCMGA00012 administered on either every two week or every four week schedules of administration among patients with solid tumors. Pharmacokinetics, pharmacodynamics, and the anti-tumor activity of INCMGA00012 will also be assessed. The purpose of Amendment 5 is to obtain additional safety experience at the newly defined recommended Phase 2 dose of 500 mg every 4 weeks in patients with endometrial cancer, specifically either microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). Additionally, every 3 week (Q3W) flat-dosing will be studied in an additional tumor agnostic cohort. '''Sponsor''': Incyte Corporation '''Intervention''': retifanlimab '''Start Date''': 2016-11-15 '''Last Updated''': 2023-07-12 '''Number of Patients''': 325 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': Locally Advanced Solid Tumors '''NCTID''': NCT04650984 '''Title''': A Study Comparing the Efficacy of L19TNF+Doxorubicin vs Doxorubicin Alone as First-line Therapy in Patients With Advanced or Metastatic Soft Tissue Sarcoma '''Study Summary''': The present study is an open-label, randomized, controlled, two-arm multi-center study of the efficacy of L19TNF treatment in combination with doxorubicin versus doxorubicin alone in advanced or metastatic soft-tissue sarcoma patients. In the study, 102 patients will be randomized in a 1:1 ratio to receive doxorubicin treatment (Arm 1) or L19TNF treatment in combination with doxorubicin (Arm 2). The primary objective of the trial is to evaluate if L19TNF in combination with doxorubicin (Arm 2) given for unresectable or metastatic soft tissue sarcoma improves efficacy measured as progression free survival, as compared to doxorubicin alone (Arm 1). '''Sponsor''': Philogen S.p.A. '''Intervention''': Onfekafusp alfa '''Start Date''': 2017-11-29 '''Last Updated''': 2023-10-10 '''Number of Patients''': 102 '''Recruitment Status''': RECRUITING '''Condition''': Soft Tissue Sarcoma '''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''': NCT04472598 '''Title''': Study of Oral Navitoclax Tablet In Combination With Oral Ruxolitinib Tablet When Compared With Oral Ruxolitinib Tablet To Assess Change In Spleen Volume In Adult Participants With Myelofibrosis '''Study Summary''': Myelofibrosis is a type of bone marrow cancer that usually develops slowly and disrupts bodyâs normal production of blood cells. It causes bone marrow scarring, leading to severe anemia that can cause weakness and fatigue. It can also cause a low number of blood-clotting cells called platelets, which increases risk of bleeding. Myelofibrosis often causes an enlarged spleen. The purpose of this study is to see if a combination of navitoclax and ruxolitinib is more effective and safe in assessment of change in spleen volume when compared to ruxolitinib in participants with myelofibrosis. Navitoclax is an investigational drug for the treatment of myelofibrosis. Participants in this study are divided into two groups, called treatment arms. Each group receives a different treatment. Adult participants with a diagnosis of myelofibrosis will be enrolled. Around 230 participants will be enrolled in approximately 190 sites worldwide. Participants will receive oral navitoclax tablet with oral ruxolitinib tablet or oral ruxolitinib tablet with oral placebo (no active drug) tablet and treatment may continue untill the participant cannot tolerate the study drug, or benefit is not achieved, or other reasons which qualify for discontinuation of the study drug. There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, magnetic resonance imaging (MRI) or computed tomography (CT) scan, bone marrow tests, checking for side effects, and completing questionnaires. '''Sponsor''': AbbVie '''Intervention''': Navitoclax '''Start Date''': 2020-09-29 '''Last Updated''': 2023-04-27 '''Number of Patients''': 252 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': Myelofibrosis (MF) '''NCTID''': NCT04770896 '''Title''': A Study of Atezolizumab With Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab '''Study Summary''': This is a Phase III, open-label, multicenter, randomized, two-arm study designed to evaluate the efficacy and safety of atezolizumab plus either lenvatinib or sorafenib versus lenvatinib or sorafenib alone in participants with locally advanced or metastatic Hepatocellular Carcinoma (HCC) who have progressed on prior systemic treatment with atezolizumab plus bevacizumab combination. '''Sponsor''': Hoffmann-La Roche '''Intervention''': Atezolizumab '''Start Date''': 2021-04-26 '''Last Updated''': 2023-11-13 '''Number of Patients''': 554 '''Recruitment Status''': RECRUITING '''Condition''': Unresectable Hepatocellular Carcinoma '''NCTID''': NCT04768296 '''Title''': Berzosertib + Topotecan in Relapsed Platinum-Resistant Small-Cell Lung Cancer (DDRiver SCLC 250) '''Study Summary''': The main purpose of this study is to assess efficacy, safety, tolerability and pharmacokinetics (PK) of Berzosertib in combination with Topotecan in participants with relapsed, platinum-resistant small-cell lung cancer (SCLC). This study will be conducted in two parts: safety run-in part and main part. The safety run-in part will be conducted in Japan. '''Sponsor''': EMD Serono Research & Development Institute, Inc. '''Intervention''': Berzosertib '''Start Date''': 2021-03-29 '''Last Updated''': 2023-08-15 '''Number of Patients''': 76 '''Recruitment Status''': COMPLETED '''Condition''': Small-cell Lung Cancer '''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''': NCT02855944 '''Title''': ARIEL4: A Study of Rucaparib Versus Chemotherapy BRCA Mutant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients '''Study Summary''': The purpose of this study is to determine how patients with ovarian, fallopian tube, and primary peritoneal cancer will best respond to treatment with rucaparib versus chemotherapy. '''Sponsor''': pharmaand GmbH '''Intervention''': Chemotherapy '''Start Date''': 2017-03-01 '''Last Updated''': 2023-06-09 '''Number of Patients''': 349 '''Recruitment Status''': COMPLETED '''Condition''': Ovarian Cancer '''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''': NCT05371223 '''Title''': Combined Nabpaclitaxel Pressurized IntraPeritoneal Aerosol Chemotherapy With Systemic Nabpaclitaxel-Gemcitabine Chemotherapy for Pancreatic Cancer Peritoneal Metastases '''Study Summary''': Combined chemotherapy consisting of endovenous Nabpaclitaxel-Gemcitabine and Nabpaclitaxel-PIPAC may be a promising treatment for patients affected by pancreatic cancer PM who are in need of curative options. The purpose of this study is to evaluate the antitumoral activity of combined Nabpaclitaxel-PIPAC and systemic Nabpaclitaxel-Gemcitabine chemotherapy for pancreatic cancer peritoneal metastases. Secondary objectives include the evaluation of the feasibility, the safety, further assessment of the antitumoral activity, the overall and progression free survival, the QoL, the pharmacokinetics of Nabpaclitaxel PIPAC. Furthermore, the study aims to evaluate the patientsâ nutritional status and the molecular evolution of PM along treatment with a time-course translational research. '''Sponsor''': Fondazione Policlinico Universitario Agostino Gemelli IRCCS '''Intervention''': Combined Nabpaclitaxel Pressurized IntraPeritoneal Aerosol Chemotherapy With Systemic Nabpaclitaxel-Gemcitabine '''Start Date''': 2022-03-01 '''Last Updated''': 2023-01-13 '''Number of Patients''': 38 '''Recruitment Status''': RECRUITING '''Condition''': Peritoneal Carcinomatosis '''NCTID''': NCT04338269 '''Title''': A Study of Atezolizumab in Combination With Cabozantinib Compared to Cabozantinib Alone in Participants With Advanced Renal Cell Carcinoma After Immune Checkpoint Inhibitor Treatment '''Study Summary''': This is a Phase III, multicenter, randomized, open-label study designed to evaluate the efficacy and safety of atezolizumab given in combination with cabozantinib versus cabozantinib alone in participants with inoperable, locally advanced, or metastatic renal cell carcinoma (RCC) who experienced radiographic tumor progression during or after Immune Checkpoint Inhibitor (ICI) treatment in the metastatic setting. '''Sponsor''': Hoffmann-La Roche '''Intervention''': Atezolizumab '''Start Date''': 2020-07-28 '''Last Updated''': 2023-10-27 '''Number of Patients''': 522 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': Carcinoma, Renal Cell '''NCTID''': NCT06117774 '''Title''': Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC) '''Study Summary''': The primary objective of this study is to compare the efficacy of tarlatamab with placebo as assessed by progression free survival (PFS). '''Sponsor''': Amgen '''Intervention''': Tarlatamab '''Start Date''': 2024-01-27 '''Last Updated''': 2023-11-07 '''Number of Patients''': 400 '''Recruitment Status''': NOT_YET_RECRUITING '''Condition''': Limited Stage Small Cell Lung Cancer '''NCTID''': NCT03786081 '''Title''': Safety and Efficacy of Tisotumab Vedotin Monotherapy & in Combination With Other Cancer Agents in Subjects With Cervical Cancer '''Study Summary''': This is an open label, multi-center trial of tisotumab vedotin monotherapy and in combination with bevacizumab, pembrolizumab, or carboplatin in subjects with recurrent or stage IVB cervical cancer. The trial consists of two-parts a dose escalation part and an expansion part. The expansion part of the trial will be initiated once the Recommended Phase 2 Dose (RP2D) of the combinations have been determined in the dose escalation part. '''Sponsor''': Seagen Inc. '''Intervention''': Tisotumab Vedotin '''Start Date''': 2019-02-27 '''Last Updated''': 2023-10-13 '''Number of Patients''': 214 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': Cervical Cancer '''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''': NCT02631876 '''Title''': A Study of Mirvetuximab Soravtansine vs. Investigatorâs 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 (Investigatorâs 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''': NCT05634499 '''Title''': A Study of Giredestrant in Participants With Grade 1 Endometrial Cancer '''Study Summary''': This Phase II, global, single-arm study is designed to evaluate the efficacy, safety, and pharmacokinetics of giredestrant monotherapy in participants with Grade 1 endometrioid endometrial cancer. '''Sponsor''': Hoffmann-La Roche '''Intervention''': Giredestrant '''Start Date''': 2023-06-27 '''Last Updated''': 2023-11-07 '''Number of Patients''': 45 '''Recruitment Status''': RECRUITING '''Condition''': Endometrial Cancer '''NCTID''': NCT04871399 '''Title''': Complete Mesocolic Excision in Comparison With Conventional Surgery for the Right Colon Cancer '''Study Summary''': An Italian randomized controlled trial parallel-group in patients with a malignant tumor of the right or proximal transverse colon requiring right hemicolectomy. '''Sponsor''': University of Turin, Italy '''Intervention''': Conventional Right hemicolectomy (Non-CME) '''Start Date''': 2020-07-13 '''Last Updated''': 2022-11-14 '''Number of Patients''': 416 '''Recruitment Status''': RECRUITING '''Condition''': Colon Cancer '''NCTID''': NCT05789680 '''Title''': European Multicentric Study on Parathyroid Carcinoma '''Study Summary''': The main aim of the study is to evaluate the incidence of post-operative diagnosis of PC and atypical parathyroid neoplasm in patients who underwent surgery for pHPT in different European centers using the EUROCRINEÂŽ database. Moreover, we aim to evaluate the peri-operative surgical characteristics, operation extent, postoperative morbidity, and outcomes in these patients category. '''Sponsor''': Fondazione Policlinico Universitario Agostino Gemelli IRCCS '''Intervention''': Surgical treatment of parathyroid carcinoma '''Start Date''': 2022-12-15 '''Last Updated''': 2023-03-29 '''Number of Patients''': 17 '''Recruitment Status''': RECRUITING '''Condition''': Parathyroid Carcinoma '''NCTID''': NCT04303780 '''Title''': Study to Compare AMG 510 âProposed INN Sotorasibâ 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''': NCT05052801 '''Title''': Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression '''Study Summary''': The main objective of this study is to compare efficacy of bemarituzumab combined with oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS) in participants with FGFR2b âĽ10% 2+/3+ tumor cell staining (FGFR2b âĽ10% 2+/3+TC) '''Sponsor''': Amgen '''Intervention''': Bemarituzumab '''Start Date''': 2022-03-07 '''Last Updated''': 2023-11-27 '''Number of Patients''': 516 '''Recruitment Status''': RECRUITING '''Condition''': Gastric Cancer '''NCTID''': NCT05023980 '''Title''': A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) '''Study Summary''': The purpose of this study is to compare the efficacy and safety of pirtobrutinib (LOXO-305; Arm A) compared to BR (Arm B) in patients with CLL/SLL who have not been treated. Participation could last up to five years. '''Sponsor''': Loxo Oncology, Inc. '''Intervention''': Pirtobrutinib '''Start Date''': 2021-09-23 '''Last Updated''': 2023-07-11 '''Number of Patients''': 250 '''Recruitment Status''': RECRUITING '''Condition''': Chronic Lymphocytic Leukemia '''NCTID''': NCT01849874 '''Title''': A Study of MEK162 vs. Physicianâs 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 physicianâs 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''': NCT03884101 '''Title''': Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001) '''Study Summary''': The purpose of this study is to compare the efficacy of pembrolizumab + lenvatinib to chemotherapy in female participants with Stage III, IV, or recurrent endometrial carcinoma. It is hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for progression-free survival (PFS) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR). It is also hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for overall survival (OS). '''Sponsor''': Merck Sharp & Dohme LLC '''Intervention''': Lenvatinib '''Start Date''': 2019-04-11 '''Last Updated''': 2023-11-02 '''Number of Patients''': 842 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': Endometrial Neoplasms '''NCTID''': NCT05198934 '''Title''': Sotorasib and Panitumumab Versus Investigatorâs Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation '''Study Summary''': The aim of the study is to compare progression-free survival (PFS) in previously treated participants with Kirsten rat sarcoma (KRAS) p.G12C mutated colorectal cancer (CRC) receiving sotorasib 240 mg once daily (QD) and panitumumab vs investigatorâs choice (trifluridine and tipiracil, or regorafenib), and sotorasib 960 mg QD and panitumumab vs investigatorâs choice (trifluridine and tipiracil, or regorafenib). '''Sponsor''': Amgen '''Intervention''': Sotorasib '''Start Date''': 2022-04-19 '''Last Updated''': 2023-09-21 '''Number of Patients''': 160 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': Colorectal Cancer (CRC) '''NCTID''': NCT05312398 '''Title''': CAPRI 2 GOIM Study: Investigate the Efficacy and Safety of a Bio-marker Driven Cetuximab-based Treatment Regimen '''Study Summary''': This clinical program aims to evaluate the activity and efficacy of cetuximab continuation of treatment for three lines of therapy with rotation of chemotherapy (FOLFIRI, FOLFOX, irinotecan) in mCRC patients, whose tumors remain RAS/BRAF WT. The study will also evaluate the activity and efficacy of cetuximab re-introduction in combination with irinotecan as third line therapy in the concept of re-challenge for those patients that will be treated in second line with chemotherapy plus anti-angiogenic drugs (FOLFOX plus bevacizumab), having a RAS or BRAF mutant disease at the time of progression after FOLFIRI plus cetuximab first line treatment. A novel characteristic of this program is that the therapeutic algorithm will be defined at each treatment decision (first line, second line and third line) in a prospective fashion in each patient by liquid biopsy assessment of RAS/BRAF status. '''Sponsor''': University of Campania âLuigi Vanvitelliâ '''Intervention''': Cetuximab '''Start Date''': 2021-07-15 '''Last Updated''': 2023-10-04 '''Number of Patients''': 200 '''Recruitment Status''': RECRUITING '''Condition''': Metastatic Colorectal Adenocarcinoma '''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''': NCT04623541 '''Title''': Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richterâs Syndrome '''Study Summary''': The study is a global, multi-center safety and efficacy trial of epcoritamab, an antibody also known as EPKINLY⢠and GEN3013 (DuoBodyÂŽ-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 Richterâs 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''': NCT04380636 '''Title''': Study of Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC) (MK-7339-012/KEYLYNK-012) '''Study Summary''': The purpose of this study is to assess the efficacy and safety of pembrolizumab in combination with concurrent chemoradiation therapy followed by either pembrolizumab with olaparib placebo (Arm 1) or with olaparib (Arm 2) compared to concurrent chemoradiation therapy followed by durvalumab (Arm 3) in participants with unresectable, locally advanced NSCLC. Arms 1 and 2 will be studied in a double-blind design and Arm 3 will be open-label. The primary hypotheses are: # Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab with olaparib is superior to concurrent chemoradiation therapy followed by durvalumab with respect to progression-free survival (PFS) and overall survival (OS) # Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab is superior to concurrent chemoradiation therapy followed by durvalumab with respect to PFS and OS '''Sponsor''': Merck Sharp & Dohme LLC '''Intervention''': Pembrolizumab '''Start Date''': 2020-07-06 '''Last Updated''': 2023-11-07 '''Number of Patients''': 870 '''Recruitment Status''': RECRUITING '''Condition''': Lung Neoplasms '''NCTID''': NCT05296798 '''Title''': A Study to Evaluate the Efficacy and Safety of Giredestrant in Combination With Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) Versus Phesgo in Participants With Locally Advanced or Metastatic Breast Cancer (heredERA Breast Cancer) '''Study Summary''': This Phase III, randomized, two-arm, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus Phesgo compared with Phesgo after induction therapy with Phesgo plus taxane in participants with human epidermal growth factor receptor 2 (HER2)-positive, estrogen receptor (ER)-positive advanced breast cancer (metastatic or locally advanced disease not amenable to curative treatment) who have not previously received a systemic non-hormonal anti-cancer therapy in the advanced setting. '''Sponsor''': Hoffmann-La Roche '''Intervention''': Phesgo '''Start Date''': 2022-07-04 '''Last Updated''': 2023-11-28 '''Number of Patients''': 812 '''Recruitment Status''': RECRUITING '''Condition''': Locally Advanced or Metastatic Breast Cancer '''NCTID''': NCT04282811 '''Title''': Observational Study Relapsed or Refractory Chronic Lymphocytic Leukemia Venetoclax-based Regimens Outside Clinical Trials in Italy '''Study Summary''': Observational study aimed at describing the characteristics and outcome of CLL patients who started treatment with venetoclax-based regimens according to the local label outside clinical trials in Italy in a period of time ranging from the start of the Venetoclax Named Patient Program (March 2016) until October 31st, 2021. '''Sponsor''': Gruppo Italiano Malattie EMatologiche dellâAdulto '''Intervention''': Venetoclax '''Start Date''': 2020-07-24 '''Last Updated''': 2022-01-04 '''Number of Patients''': 157 '''Recruitment Status''': RECRUITING '''Condition''': Chronic Lymphocytic Leukemia '''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''': NCT01968213 '''Title''': Phase 3 Study of Rucaparib as Switch Maintenance After Platinum in Relapsed High Grade Serous or Endometrioid Ovarian Cancer (ARIEL3) '''Study Summary''': Patients enrolled into this study will be stratified into 3 groups based on gene mutations identified in their tumor tissue. The purpose of this study is to evaluate patient response to maintenance treatment with rucaparib versus placebo. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples. '''Sponsor''': pharmaand GmbH '''Intervention''': Rucaparib '''Start Date''': 2014-04-07 '''Last Updated''': 2023-06-09 '''Number of Patients''': 564 '''Recruitment Status''': COMPLETED '''Condition''': Ovarian Cancer '''NCTID''': NCT04191499 '''Title''': A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer '''Study Summary''': This study will evaluate the efficacy, safety, and pharmacokinetics of inavolisib in combination with palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant in participants with PIK3CA-mutant, hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease. '''Sponsor''': Hoffmann-La Roche '''Intervention''': Inavolisib '''Start Date''': 2020-01-29 '''Last Updated''': 2023-11-18 '''Number of Patients''': 325 '''Recruitment Status''': RECRUITING '''Condition''': Breast Cancer '''NCTID''': NCT05800613 '''Title''': Management of Ovarian Masses in Pediatric Patients: an Italian Survey '''Study Summary''': Objectives: The International Ovarian Tumor Analysis (IOTA) provides a specific terminology for adult ovarian masses, while, currently, there is no systematic classification for preoperative assessment of adnexal lesions in childhood and adolescence. This study aims to survey Italian pediatric surgeons to evaluate ovarian massesâ management (from diagnosis to treatment) in patients aged 1-18. Methods: A 27-question survey was distributed. It consisted of questions regarding the management and use of ultrasound and IOTA terminology in diagnosing ovarian masses in childhood and adolescence, in emergency regimes and in planned surgeries. '''Sponsor''': Fondazione Policlinico Universitario Agostino Gemelli IRCCS '''Intervention''': Survey '''Start Date''': 2022-06-16 '''Last Updated''': 2023-04-05 '''Number of Patients''': 60 '''Recruitment Status''': COMPLETED '''Condition''': Ovarian Cysts '''NCTID''': NCT05446870 '''Title''': Pembrolizumab With Chemotherapy and MK-4830 for Treating Participants With Ovarian Cancer (MK-4830-002) '''Study Summary''': The primary objective is to evaluate in participants with high-grade serous ovarian cancer (HGSOC), whether the reduction from baseline in circulating tumor DNA (ctDNA) at Cycle 3 (ÎctDNA) is larger in participants receiving MK-4830 + pembrolizumab in combination with standard of care (SOC) therapy than in those receiving pembrolizumab + SOC therapy. '''Sponsor''': Merck Sharp & Dohme LLC '''Intervention''': Pembrolizumab '''Start Date''': 2022-07-25 '''Last Updated''': 2023-10-26 '''Number of Patients''': 160 '''Recruitment Status''': ACTIVE_NOT_RECRUITING '''Condition''': High-grade Serous Ovarian Carcinoma <span style="display:none">hasCancerType::C00-D48: All neoplasms</span> <span style="display:none">hasCancerType::C00-C97: All cancer types</span> <span style="display:none">hasCancerType::C00-C14: Mouth/throat cancers</span> <span style="display:none">hasCancerType::C15-C26: Digestive system cancers</span> <span style="display:none">hasCancerType::C30-C39: Lung/chest cancers</span> <span style="display:none">hasCancerType::C40-C41: Bone cancers</span> <span style="display:none">hasCancerType::C43-C44: Skin cancers/melanoma</span> <span style="display:none">hasCancerType::C45-C49: Soft tissue cancer</span> <span style="display:none">hasCancerType::C50: Breast cancer</span> <span style="display:none">hasCancerType::C51-C58: Female genitalia cancers</span> <span style="display:none">hasCancerType::C60-C63: Male genitalia cancer</span> <span style="display:none">hasCancerType::C64-C68: Urinary system cancers</span> <span style="display:none">hasCancerType::C69-C72: Eye and brain cancer</span> <span style="display:none">hasCancerType::C73-C75: Thyroid and other gland cancers</span> <span style="display:none">hasCancerType::C76-C80: Cancers of unknown or unspecified areas</span> <span style="display:none">hasCancerType::C81-C96: Cancers of the blood and immune system</span> <span style="display:none">hasCancerType::C97-C97: Cancers in multiple locations from the start</span> <span style="display:none">hasCancerType::D00-D09: Early-stage cancers not yet spread</span> <span style="display:none">hasCancerType::D10-D36: Benign tumour</span> <span style="display:none">hasCancerType::D37-D48: Growths of uncertain nature</span> <span style="display:none">hasCancerType::unknown</span> <span style="display:none">isTrial</span>
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