Trials (Karolinska Institute and University Hospital): Difference between revisions
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Go back to [[Karolinska Institute and University Hospital]] page | Go back to [[Karolinska Institute and University Hospital]] page | ||
=== Trials: How to participate === | |||
'''Contact information:''' [https://www.karolinska.se/forskning-och-utbildning/kliniska-provningar/bli-forskningsperson/ Click here to access]. | |||
'''NCTID''': NCT01360554 | '''NCTID''': NCT01360554 | ||
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'''Recruitment Status''': TERMINATED | '''Recruitment Status''': TERMINATED | ||
'''Condition''': Small Cell Lung Cancer | '''Condition''': Small Cell Lung Cancer | ||
<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> | |||
Latest revision as of 16:44, 15 December 2025
Go back to Karolinska Institute and University Hospital page
Trials: How to participate[edit | edit source]
Contact information: Click here to access.
NCTID: NCT01360554
Title: ARCHER 1009 : A Study Of Dacomitinib (PF-00299804) Vs. Erlotinib In The Treatment Of Advanced Non-Small Cell Lung Cancer Study Summary: This is a multinational, multicenter, randomized,double-blinded, Phase 3 study comparing the efficacy and safety of treatment with PF-00299804 to treatment with erlotinib in patients with advanced non-small cell lung cancer, previously treated with at least one prior regimen. Analyses of primary objective (Progression Free Survival) will be done in two co-primary populations as defined in the protocol. Sponsor: Pfizer Intervention: Dacomitinib (PF-00299804) Start Date: 2011-06-16 Last Updated: 2017-05-24 Number of Patients: 878 Recruitment Status: COMPLETED Condition: Non-Small Cell Lung Cancer
NCTID: NCT01356290
Title: Antiangiogenic Therapy for Children With Recurrent Medulloblastoma, Ependymoma and ATRT Study Summary: Patients with relapsed medulloblastoma, ependymoma and ATRT have a very poor prognosis whether treated with conventional chemotherapy, high-dose chemotherapy with stem cell rescue, irradiation or combinations of these modalities. Antiangiogenetic therapy has emerged as new treatment option in solid malignancies. The frequent, metronomic schedule targets both proliferating tumor cells and endothelial cells, and minimizes toxicity. In this study the investigators will evaluate the use of biweekly intravenous bevacizumab in combination with five oral drugs (thalidomide, celecoxib, fenofibrate, and alternating cycles of daily low-dose oral etoposide and cyclophosphamide), augmented with alternating courses of intrathecal etoposide and cytarabine. The aim of the study is to extend therapy options for children with recurrent or progressive medulloblastoma, ependymoma and ATRT, for whom no known curative therapy exists, by prolonging survival while maintaining good quality of life. The primary objective of the MEMMAT trial is to evaluate the activity of this multidrug antiangiogenic approach in these heavily pretreated children and young adults. Additionally, progression-free survival (PFS), overall survival (OS), as well as feasibility and toxicity will be examined. Sponsor: Medical University of Vienna Intervention: Bevacizumab Start Date: 2014-04 Last Updated: 2023-04-21 Number of Patients: 100 Recruitment Status: RECRUITING Condition: Medulloblastoma Recurrent
NCTID: NCT05503797
Title: A Study to Assess the Efficacy and Safety of FORE8394 in Participants With Cancer Harboring BRAF Alterations Study Summary: The objective of this study is to evaluate the efficacy of FORE8394 in participants with locally advanced or metastatic solid tumors, or recurrent or progressive primary central nervous system (CNS) tumors harboring BRAF fusions, or in participants with recurrent high-grade glioma (HGG) harboring BRAF V600E mutation. This will be conducted as two single arm open-label subprotocols (F8394-201A; F8394-201B) under one master protocol. Sponsor: Fore Biotherapeutics Intervention: FORE8394 Start Date: 2023-02-21 Last Updated: 2023-08-04 Number of Patients: 135 Recruitment Status: RECRUITING Condition: Cancer Harboring BRAF Alterations
NCTID: NCT03384654
Title: A Study to Evaluate the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Participants Greater Than or Equal to (>=)1 and Less Than or Equal to (<=) 30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma Study Summary: The purpose of this study is to evaluate the efficacy of daratumumab in addition to standard chemotherapy in pediatric participants with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL)/lymphoblastic lymphoma (LL) and T-cell ALL/LL as measured by the complete response (CR) rate. Sponsor: Janssen Research & Development, LLC Intervention: Daratumumab Start Date: 2018-05-14 Last Updated: 2023-10-13 Number of Patients: 47 Recruitment Status: COMPLETED Condition: Precursor Cell Lymphoblastic Leukemia-Lymphoma
NCTID: NCT00419250
Title: A Dose Escalation Study of Lenalidomide in Relapsed or Refractory B-cell Chronic Lymphocytic Leukemia Study Summary: The purpose of this study is to evaluate the safety of lenalidomide and to define the maximum tolerated escalation dose level (MTEDL) when administered by a stepwise dose-escalation schedule in subjects with relapsed or refractory B-cell CLL. Sponsor: Celgene Intervention: lenalidomide Start Date: 2006-12-01 Last Updated: 2019-11-08 Number of Patients: 52 Recruitment Status: COMPLETED Condition: Chronic Lymphocytic Leukemia
NCTID: NCT00774345
Title: A Study to Evaluate the Efficacy and Safety of Lenalidomide as Maintenance Therapy for Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Following Second Line Therapy Study Summary: The purpose of this study is to determine if lenalidomide (Revlimid®) is safe and effective as a maintenance therapy at improving further the quality of the response you achieved with your last therapy and at prolonging the duration of your response. This study will compare the effects (good and bad) of lenalidomide with the dummy drug. Sponsor: Celgene Intervention: Lenalidomide Start Date: 2009-01-27 Last Updated: 2021-12-02 Number of Patients: 317 Recruitment Status: COMPLETED Condition: B-cell Chronic Lymphocytic Leukemia
NCTID: 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: NCT00312845
Title: Study of VELCADE and Rituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin’s Lymphoma Study Summary: The purpose of this study is to determine if the combination of VELCADE and rituximab improves progression free survival relative to rituximab alone in patients with relapsed or refractory B-cell non-Hodgkin’s lymphoma (B-NHL) who never received rituximab or who have previously responded to rituximab. This is an international study being conducted in the United States and in many countries around the world. A complete list of study locations is listed below. Sponsor: Millennium Pharmaceuticals, Inc. Intervention: Bortezomib + Rituximab Start Date: 2006-03 Last Updated: 2012-06-25 Number of Patients: 676 Recruitment Status: COMPLETED Condition: Non-Hodgkin’s Lymphoma
NCTID: NCT02730416
Title: Combination Chemotherapy With Nintedanib / Placebo in Endometrial Cancer Study Summary: This study will evaluate the role of addition of an anti-angiogenic agent (Nintedanib/placebo) to conventional combination chemotherapy as concomitant and maintenance treatment in primary advanced or with first relapse of endometrial cancer. Sponsor: Nordic Society of Gynaecological Oncology - Clinical Trials Unit Intervention: Nintedanib or Placebo; Carboplatin, Paclitaxel Start Date: 2016-12-12 Last Updated: 2023-09-21 Number of Patients: 146 Recruitment Status: COMPLETED Condition: Endometrial Cancer
NCTID: NCT04221945
Title: Study of Chemoradiotherapy With or Without Pembrolizumab (MK-3475) For The Treatment of Locally Advanced Cervical Cancer (MK-3475-A18/KEYNOTE-A18/ENGOT-cx11/GOG-3047) Study Summary: The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus concurrent chemoradiotherapy compared to placebo plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer. The primary hypotheses are that pembrolizumab plus concurrent chemoradiotherapy is superior to placebo plus concurrent chemoradiotherapy with respect to progression-free survival and overall survival. Once the study objectives have been met or the study has ended, participants will be discontinued from this study and will be enrolled in an extension study to continue protocol-defined assessments and treatment. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2020-05-12 Last Updated: 2023-07-20 Number of Patients: 980 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Uterine Cervical Neoplasms
NCTID: NCT04219254
Title: A Study of BI-1206 in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors (KEYNOTE-A04) Study Summary: Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcγRIIB), in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors Previously Treated with Anti-PD-1 or Anti-PD-L1 Antibodies Sponsor: BioInvent International AB Intervention: BI1206 Start Date: 2020-06-29 Last Updated: 2023-11-24 Number of Patients: 90 Recruitment Status: RECRUITING Condition: Solid Tumor, Adult
NCTID: NCT04908956
Title: Osimertinib and Locally Ablative Radiotherapy in Patients With Synchronous Oligo-metastatic EGFR Mutant NSCLC (STEREO) Study Summary: STEREO is single-arm phase II study, which aims to evaluate the safety and efficacy of osimertinib combined with early locally ablative radiotherapy of all cancer sites in patients with synchronous oligo-metastatic (primary tumour and maximum 5 metastases) EGFR-mutant (exon 19 deletion or exon 21 L858R) NSCLC. Eradication of all macroscopic cancer sites at the time of primary diagnosis by combined modality treatment is expected to decrease the risk of resistance development with only microscopic disease potentially remaining. This will result in an improvement of PFS and OS without added high-grade toxicity. Sponsor: ETOP IBCSG Partners Foundation Intervention: Osimertinib Start Date: 2022-08-04 Last Updated: 2023-11-02 Number of Patients: 6 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: NSCLC Stage IV
NCTID: NCT02630654
Title: Study For Evaluating The Value Of A Multi Biomarker Approach In Metastatic GEP NETs Study Summary: This exploratory study aims to evaluate the diagnostic, prognostic and response predictive value of a multi biomarker strategy in patients with Gastroenteropancreatic Neuroendocrine Tumors (GEP NETs) originating from the midgut or pancreas. Using a recently developed methodology enabling the evaluation of 92 concomitant cancer biomarkers will provide an interesting approach to solve this question (Lundberg et al 2011). Sponsor: Ipsen Intervention: This is a non-interventional study. Patients will be treated with any intervention deemed appropriate by the patient’s physician. Start Date: 2014-03-24 Last Updated: 2021-12-07 Number of Patients: 404 Recruitment Status: COMPLETED Condition: Gastroenteropancreatic Neuroendocrine Tumors
NCTID: NCT05876754
Title: An Early Access Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma Study Summary: A Phase 3b research study to consolidate the data that ivosidenib is safe and effective in adult patients with previously treated, locally advanced, or metastatic cholangiocarcinoma (CCA). All patients who meet inclusion criteria will be enrolled to receive ivosidenib tablets orally once daily for 28 day cycles, continuing as long as clinical benefit and consent for participation is maintained. There will be a minimum of 6 study visits from screening until the final follow-up, if one cycle of treatment is completed and consent is maintained through 18 months of follow-up. Each additional cycle completed will add one study visit, on the first day of each cycle. Sponsor: Servier Affaires Médicales Intervention: Ivosidenib Oral Tablet Start Date: 2023-05-03 Last Updated: 2023-09-06 Number of Patients: 220 Recruitment Status: RECRUITING Condition: Cholangiocarcinoma
NCTID: NCT03101475
Title: Synergism of Immunomodulation and Tumor Ablation Study Summary: This is a single-arm, open-label, multi-center early phase II study. This proof of concept study will investigate whether the combined use of local tumor ablation/radiation plus immunomodulating drugs may induce a significant immune response in patient with incurable liver metastases from colorectal cancer (CRC) (+/- limited extrahepatic disease) being stable or in partial remission after completion of 4-6 months first line systemic therapy. The primary objective of the study is to show an overall response rate of lesions not treated by ablation/radiotherapy including the extrahepatic lesions (according to iRECIST criteria) higher than 10%. With the continuation of first line systemic treatment, no further responses are expected. Secondary objectives are: * To establish the feasibility and safety of the combined treatment modalities; * To study the impact of the local technique (RFA/Radiotherapy) on the results; * To investigate biomarkers to predict response to the combined treatment Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Durvalumab (MEDI4736) Start Date: 2018-11-23 Last Updated: 2022-05-31 Number of Patients: 22 Recruitment Status: COMPLETED Condition: Colorectal Cancer
NCTID: NCT03596866
Title: A Study of Brigatinib Compared to Alectinib in Adults With Non-Small-Cell Lung Cancer Study Summary: Brigatinib is a medicine that binds to the surface of tumor cells in some cancers and delivers a dose of chemotherapy directly to the tumor. In this study, participants will be people with non-small-cell lung cancer (NSCLC for short). The main aim of the study is to learn if brigatinib stops the tumors from growing, or if the tumors have shrunk or disappeared, compared to a medicine called alectinib. At the first visit, the study doctor will check who can take part. Participants who can take part will be picked for 1 of 2 treatments by chance: * Brigatinib tablets * Alectinib capsules All participants will take brigatinib or alectinib at about the same time every day. They will continue with treatment throughout the study unless their cancer gets worse, they have side effects from the treatment, they leave the study for certain reasons, or the study is stopped. After stopping treatment, participants will visit the study clinic for a check-up 30 days later. Sponsor: Takeda Intervention: Brigatinib Start Date: 2019-04-19 Last Updated: 2023-05-18 Number of Patients: 248 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: ALK+ Advanced NSCLC
NCTID: NCT04123366
Title: Study of Olaparib (MK-7339) in Combination With Pembrolizumab (MK-3475) in the Treatment of Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-Positive Advanced Cancer (MK-7339-007/KEYLYNK-007) Study Summary: The purpose of this study is to assess the efficacy and safety of treatment with olaparib (MK-7339) in combination with pembrolizumab (MK-3475) in adults with previously treated, advanced (metastatic and/or unresectable) Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-positive solid tumors. Sponsor: Merck Sharp & Dohme LLC Intervention: Olaparib Start Date: 2019-11-18 Last Updated: 2023-06-15 Number of Patients: 300 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Solid Tumors
NCTID: NCT03820986
Title: Safety and Efficacy Study of Pembrolizumab (MK-3475) Combined With Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Advance Melanoma (MK-7902-003/E7080-G000-312/LEAP-003) Study Summary: The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for lenvatinib) as first-line treatment in adults with no prior systemic therapy for their advanced melanoma. The primary study hypotheses are that: 1) The combination of pembrolizumab and lenvatinib is superior to pembrolizumab and placebo as assessed by Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), and 2) The combination of pembrolizumab and lenvatinib is superior to pembrolizumab and placebo as assessed by Overall Survival (OS). For this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2019-03-12 Last Updated: 2023-04-25 Number of Patients: 674 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Malignant Melanoma
NCTID: NCT00030719
Title: Combination Chemotherapy With or Without Filgrastim Before Surgery, High-Dose Chemotherapy, and Radiation Therapy Followed by Isotretinoin With or Without Monoclonal Antibody in Treating Patients With Neuroblastoma Study Summary: RATIONALE: Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person’s immune system recover from the side effects of chemotherapy. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining isotretinoin and monoclonal antibodies may kill any remaining tumor cells following surgery. It is not yet known which treatment regimen is more effective in treating neuroblastoma. PURPOSE: This randomized phase III trial is studying how well combination chemotherapy with or without filgrastim before surgery, high-dose chemotherapy, and radiation therapy followed by isotretinoin with or without monoclonal antibody work in treating patients with neuroblastoma. Sponsor: University of Leicester Intervention: filgrastim Start Date: 2001-12 Last Updated: 2014-06-24 Number of Patients: 175 Recruitment Status: UNKNOWN Condition: Neuroblastoma
NCTID: NCT02098343
Title: p53 Suppressor Activation in Recurrent High Grade Serous Ovarian Cancer, a Phase Ib/II Study of Systemic Carboplatin Combination Chemotherapy With or Without APR-246 Study Summary: The purpose of this study is to make a preliminary assessment of the efficacy of a combined APR-246 and carboplatin/PLD chemotherapy regimen, compared with carboplatin/PLD chemotherapy regimen alone, in patients with platinum sensitive recurrent high grade serous ovarian cancer (HGSOC) with mutated p53. In addition, the study aims to assess the safety profile of the combined APR-246 and carboplatin/PLD chemotherapy regimen compared with carboplatin/PLD chemotherapy regimen alone, to evaluate potential biomarkers, and to assess the biological activity in tumor and surrogate tissues. The trial will enroll up to a maximum of 400 patients. Sponsor: Aprea Therapeutics Intervention: APR-246 Start Date: 2014-03 Last Updated: 2022-10-13 Number of Patients: 247 Recruitment Status: COMPLETED Condition: Platinum Sensitive Recurrent High-grade Serous Ovarian Cancer With Mutated p53
NCTID: NCT01804686
Title: A Long-term Extension Study of PCI-32765 (Ibrutinib) Study Summary: The purpose of this study is to collect long-term safety and efficacy data for participants treated with ibrutinib and to provide ongoing access to ibrutinib for participants who are currently enrolled in ibrutinib studies that have been completed according to the parent protocol, are actively receiving treatment with ibrutinib, and who continue to benefit from ibrutinib treatment. Sponsor: Janssen Research & Development, LLC Intervention: Ibrutinib Start Date: 2013-09-09 Last Updated: 2023-11-09 Number of Patients: 700 Recruitment Status: ENROLLING_BY_INVITATION Condition: Chronic Lymphocytic Leukemia
NCTID: NCT00358566
Title: GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Pancreatic Cancer Study Summary: To investigate the efficacy of GV1001 in sequential combination with gemcitabine in locally advanced and metastatic adenocarcinoma of the pancreas. Sponsor: Pharmexa A/S Intervention: GV1001 Start Date: 2006-06 Last Updated: 2008-05-19 Number of Patients: 360 Recruitment Status: TERMINATED Condition: Advanced Unresectable Pancreatic Cancer
NCTID: NCT01311687
Title: A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide in Combination With Low-Dose Dexamethasone Versus High-Dose Dexamethasone in Subjects With Refractory Multiple Myeloma or Relapsed and Refractory Multiple Myeloma and Companion Study Study Summary: The purpose of this study is to compare efficacy and safety of pomalidomide in combination with low-dose dexamethasone versus high-dose dexamethasone in subjects with refractory or relapsed and refractory multiple myeloma. Sponsor: Celgene Intervention: pomalidomide Start Date: 2011-03-11 Last Updated: 2018-10-24 Number of Patients: 455 Recruitment Status: COMPLETED Condition: Multiple Myeloma
NCTID: NCT02631447
Title: Sequential Combo Immuno and Target Therapy (SECOMBIT) Study Study Summary: To evaluate the best sequencing approach with the combination of target agents (LGX818 plus MEK162) and the combination of immunomodulatory antibodies (ipilimumab plus nivolumab) in patients with metastatic melanoma and BRAF V600 mutation. Sponsor: Fondazione Melanoma Onlus Intervention: LGX818 Start Date: 2016-11-14 Last Updated: 2023-09-13 Number of Patients: 251 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Melanoma
NCTID: NCT01063647
Title: Dose-range Finding Treosulfan-based Conditioning Study Summary: Evaluation of the safety and efficacy of 3 x 10, 3 x 12 or 3 x 14 g/m² Treosulfan resp., combined with 5 x 30 mg/m² fludarabine prior to allogeneic, hematopoietic stem cell transplantation of patients with hematological malignancies, but non-eligible to standard conditioning treatment. Sponsor: medac GmbH Intervention: Treosulfan Start Date: 2001-11 Last Updated: 2023-11-03 Number of Patients: 56 Recruitment Status: COMPLETED Condition: Hematological Malignancies
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: NCT03462719
Title: A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Study Summary: The purpose of this study is to assess progression-free survival (PFS) from treatment with ibrutinib plus venetoclax (I+VEN) compared with obinutuzumab plus chlorambucil (G-Clb) as assessed by an Independent Review Committee (IRC). Sponsor: Janssen Research & Development, LLC Intervention: Ibrutinib Start Date: 2018-04-17 Last Updated: 2023-11-09 Number of Patients: 211 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Leukemia, Lymphocytic, Chronic, B-Cell
NCTID: NCT03625037
Title: First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma Study Summary: The trial is a global, multi-center safety and efficacy trial of epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20). The trial consists of 3 parts: * a dose-escalation part (Phase 1, first-in-human (FIH)) * an expansion part (Phase 2a) * a dose-optimization part (Phase 2a) Sponsor: Genmab Intervention: Epcoritamab Start Date: 2018-06-26 Last Updated: 2023-08-08 Number of Patients: 786 Recruitment Status: RECRUITING Condition: Diffuse Large B-cell Lymphoma (DLBCL)
NCTID: 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: NCT01324947
Title: Study to Evaluate the Safety and Efficacy of Pomalidomide Monotherapy in Subjects With Refractory or Relapsed Refractory Multiple Myeloma Study Summary: The purpose of this study is to evaluate the efficacy and safety of pomalidomide monotherapy in subjects with refractory or relapsed and refractory multiple myeloma who were enrolled in study CC-4047-MM-003 (NCT01311687) and discontinued treatment with high-dose dexamethasone due to disease progression. Sponsor: Celgene Intervention: pomalidomide Start Date: 2011-03-01 Last Updated: 2019-11-19 Number of Patients: 74 Recruitment Status: COMPLETED Condition: Multiple Myeloma
NCTID: NCT05208047
Title: (Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors Study Summary: This is a Phase 3, open-label, international, multicenter study of CGT9486 in combination with sunitinib. This is a multi-part study that will enroll approximately 426 patients. Part 1 consists of two evaluations: 1) confirming the dose of an updated formulation of CGT9486 to be used in subsequent parts in approximately 20 patients who have received at least one prior line of therapy for GIST and 2) evaluating for drug-drug interactions between CGT9486 and sunitinib in approximately 18 patients who have received at least two prior tyrosine kinase inhibitors (TKIs) for GISTs. The second part of the study will enroll approximately 388 patients who are intolerant to, or who failed prior treatment with imatinib only and will compare the efficacy of CGT9486 plus sunitinib to sunitinib alone with patients being randomized in a 1:1 manner. Sponsor: Cogent Biosciences, Inc. Intervention: CGT9486 plus sunitinib Start Date: 2022-04-14 Last Updated: 2023-11-28 Number of Patients: 426 Recruitment Status: RECRUITING Condition: Advanced Gastrointestinal Stromal Tumors
NCTID: NCT04663347
Title: Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL) Study Summary: A phase 1b/2, open-label, multinational, interventional trial to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics/biomarkers, immunogenicity, and preliminary efficacy of epcoritamab (EPKINLY™) in combination with other standard of care (SOC) agents in participants with B-cell Non-Hodgkin Lymphoma (B-NHL). Sponsor: Genmab Intervention: rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone Start Date: 2020-11-03 Last Updated: 2023-08-08 Number of Patients: 662 Recruitment Status: RECRUITING Condition: Diffuse Large B-Cell Lymphoma
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: NCT00004179
Title: Combination Chemotherapy With or Without Rituximab in Treating Patients With Relapsed Non-Hodgkin’s Lymphoma Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether chemotherapy is more effective with or without rituximab for relapsed non-Hodgkin’s lymphoma. PURPOSE: This randomized phase III trial is studying combination chemotherapy and rituximab to see how well they work compared to combination chemotherapy alone in treating patients with relapsed non-Hodgkin’s lymphoma. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: rituximab Start Date: 1999-05 Last Updated: 2021-02-15 Number of Patients: 475 Recruitment Status: COMPLETED Condition: Lymphoma
NCTID: NCT00006479
Title: Surgery With or Without Combination Chemotherapy in Treating Patients With Liver Metastases From Colorectal Cancer Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and combining chemotherapy with surgery may kill more tumor cells. It is not yet known if surgery is more effective with or without chemotherapy for liver metastases. PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients who have liver metastases from colorectal cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: FOLFOX regimen Start Date: 2000-09 Last Updated: 2011-04-18 Number of Patients: NA Recruitment Status: UNKNOWN Condition: Colorectal Cancer
NCTID: NCT04195750
Title: A Study of Belzutifan (MK-6482) Versus Everolimus in Participants With Advanced Renal Cell Carcinoma (MK-6482-005) Study Summary: The primary objective of this study is to compare belzutifan to everolimus 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 to compare everolimus with respect to overall survival (OS). The hypothesis is that belzutifan is superior to everolimus with respect to PFS and OS. Sponsor: Merck Sharp & Dohme LLC Intervention: Belzutifan Start Date: 2020-02-27 Last Updated: 2022-08-01 Number of Patients: 736 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Carcinoma, Renal Cell
NCTID: NCT00646854
Title: Alemtuzumab and CHOP in T-cell Lymphoma Study Summary: The purpose of this study is to determine efficacy and safety of the monoclonal antibody MabCampath® (alemtuzumab) combined with chemotherapy in the treatment of T-cell lymphoma. Sponsor: Aarhus University Hospital Intervention: CHOP14 chemotherapy (cyclophosphamide, hydroxydaunorubicin, vincristin, prednison) plus G-CSF, combined with alemtuzumab Start Date: 2008-06 Last Updated: 2019-03-01 Number of Patients: 136 Recruitment Status: COMPLETED Condition: Lymphoma, T-Cell, Peripheral
NCTID: NCT02807454
Title: A Study to Determine the Safety and Efficacy for the Combination of Durvalumab and Daratumumab in Relapsed and Refractory Multiple Myeloma Study Summary: This is an open-label, multicenter study to confirm the safety and efficacy of durvalumab + daratumumab (D2) in subjects with relapsed and refractory multiple myeloma. This study will also explore the safety and efficacy of the addition of pomalidomide + dexamethasone to durvalumab + daratumumab (PD3). On 05 Sep 2017, a Partial Clinical Hold was placed on this study by the United States (US) Food and Drug Administration (FDA). The decision by the FDA was based on data related to risks of anti-programmed cell death-1 (PD-1) antibody, pembrolizumab, in combination with IMiDs® immunomodulatory drugs in patients with multiple myeloma. As a result, enrollment into this study has been discontinued. Subjects who are receiving clinical benefit, based on the discretion of the investigator, may remain on study treatment after being reconsented. Sponsor: Celgene Intervention: Daratumumab Start Date: 2016-07-07 Last Updated: 2023-02-21 Number of Patients: 37 Recruitment Status: TERMINATED Condition: Multiple Myeloma
NCTID: NCT04099888
Title: PCI Treatment/Gemcitabine & Chemotherapy vs Chemotherapy Alone in Patients With Inoperable Extrahepatic Bile Duct Cancer Study Summary: This study will assess the safety and effectiveness of fimaporfin-induced photochemical internalisation (PCI) of gemcitabine complemented by systemic gemcitabine/cisplatin chemotherapy compared to gemcitabine/cisplatin alone, in patients with inoperable cholangiocarcinoma (CCA). Participants will be randomly assigned to one of the treatment groups and will receive study treatment for 6 months, followed by assessments every 3 months, as applicable. Sponsor: PCI Biotech AS Intervention: Fimaporfin and Gemcitabine Start Date: 2019-05-23 Last Updated: 2023-09-11 Number of Patients: 41 Recruitment Status: TERMINATED Condition: Cholangiocarcinoma
NCTID: NCT00005589
Title: Combination Chemotherapy Plus Peripheral Stem Cell Transplantation With or Without Rituximab in Treating Patients With Relapsed Non-Hodgkin’s Lymphoma Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known if combination chemotherapy plus peripheral stem cell transplantation is more effective with or without rituximab for non-Hodgkin’s lymphoma. PURPOSE: This randomized phase III trial is studying giving combination chemotherapy and peripheral stem cell transplantation together with rituximab to see how well it works compared to combination chemotherapy and peripheral stem cell transplantation alone in treating patients with relapsed non-Hodgkin’s lymphoma. Sponsor: EBMT Solid Tumors Working Party Intervention: filgrastim Start Date: 1999-10 Last Updated: 2013-09-17 Number of Patients: 460 Recruitment Status: COMPLETED Condition: Lymphoma
NCTID: NCT01367665
Title: STEVIE: A Study of Vismodegib in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma Study Summary: This single-arm, open-label, multi-center study will evaluate the safety and efficacy of vismodegib (GDC-0449) in patients with locally advanced or metastatic basal cell carcinoma. Patients will receive oral doses of vismodegib 150 mg once daily until disease progression or unacceptable toxicity. Sponsor: Hoffmann-La Roche Intervention: vismodegib Start Date: 2011-07-01 Last Updated: 2019-06-06 Number of Patients: 1232 Recruitment Status: COMPLETED Condition: Basal Cell Carcinoma
NCTID: NCT03522142
Title: A Study Exploring the Safety and Tolerability of INCB081776 in Participants With Advanced Malignancies Study Summary: The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of single-agent INCB081776 (Part 1) and INCB081776 in combination with INCMGA00012 (Part 2). Sponsor: Incyte Corporation Intervention: INCB081776 Start Date: 2018-08-27 Last Updated: 2023-07-19 Number of Patients: 84 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Advanced Solid Tumors
NCTID: NCT02348489
Title: SGI-110 in Adults With Untreated Acute Myeloid Leukemia (AML), Not Considered Candidates for Intensive Remission Induction Study Summary: To compare efficacy and safety between SGI-110 and Treatment Choice in adults with previously untreated AML who are not considered candidates for intensive remission induction chemotherapy. Sponsor: Astex Pharmaceuticals, Inc. Intervention: SGI-110 (guadecitabine) Start Date: 2015-03-19 Last Updated: 2021-01-14 Number of Patients: 815 Recruitment Status: COMPLETED Condition: Leukemia, Myeloid, Acute
NCTID: NCT02912949
Title: A Study of Zenocutuzumab (MCLA-128) in Patients With Solid Tumors Harboring an NRG1 Fusion (eNRGy) Study Summary: This is a Phase I/II, open-label, multi-center, multi-national, dose escalation, single agent study to assess the safety, tolerability, PK, PD, immunogenicity and anti-tumor activity of zenocutuzumab (MCLA-128) in patients with solid tumors harboring an NRG1 fusion (eNRGy) Sponsor: Merus N.V. Intervention: zenocutuzumab (MCLA-128) Start Date: 2015-01 Last Updated: 2022-12-27 Number of Patients: 250 Recruitment Status: RECRUITING Condition: Solid Tumours Harboring NRG1 Fusion
NCTID: NCT03285763
Title: A Study of Atezolizumab (Tecentriq) to Investigate Long-term Safety and Efficacy in Previously-treated Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Study Summary: This is a Phase III/IV, single-arm, multicenter study of the long-term safety and efficacy of atezolizumab treatment in participants with Stage IIIb or Stage IV NSCLC who have progressed after standard systemic chemotherapy (including if given in combination with anti-programmed cell death protein 1 <math display="block">anti-PD-1</math> therapy, after anti-PD-1 as monotherapy, or after tyrosine kinase inhibitor <math display="block">TKI</math> therapy). The study will consist of a Screening Period, a Treatment Period, a Treatment Discontinuation Visit, and a Follow-Up Period. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2017-10-25 Last Updated: 2022-05-26 Number of Patients: 619 Recruitment Status: COMPLETED Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT05006716
Title: A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies Study Summary: Study consists of two main parts to explore BGB-16673 recommended dosing, a Part 1 monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety expansion of selected doses, and a part 2 (dose expansion cohorts) Sponsor: BeiGene Intervention: BGB-16673 Start Date: 2021-09-13 Last Updated: 2023-11-13 Number of Patients: 291 Recruitment Status: RECRUITING Condition: B-cell Malignancy
NCTID: NCT00932893
Title: An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene Study Summary: This is a Phase 3 trial comparing the safety and anti-tumor activity of PF-02341066 versus pemetrexed or docetaxel in patients with advanced non-small cell lung cancer with specific gene profile involving the ALK gene after failure of one previous chemotherapy regimen that included one platinum drug. Sponsor: Pfizer Intervention: PF-02341066 Start Date: 2009-09 Last Updated: 2017-01-02 Number of Patients: 347 Recruitment Status: COMPLETED Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT03456063
Title: A Study of Neoadjuvant Atezolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Patients With Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer (IMpower030) Study Summary: This is a randomized, double-blinded study designed to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of neoadjuvant treatment with atezolizumab (MPDL3280A) or placebo in combination with platinum-based chemotherapy in participants with resectable Stage II, IIIA, or select IIIB non-small cell lung cancer (NSCLC) followed by open-label adjuvant/postoperative atezolizumab or best supportive care and monitoring. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody Start Date: 2018-04-24 Last Updated: 2023-10-27 Number of Patients: 453 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-Small-Cell Lung
NCTID: NCT03267316
Title: A First-in-Human Study of CAN04 in Patients With Solid Malignant Tumors Study Summary: This study will evaluate the safety, tolerability, and preliminary antitumor activity of CAN04 both as a monotherapy and in combination with standard of care treatment in subjects with solid cancer tumors. Following completion of the first part, the dose escalation cohorts, and determination of maximum tolerated dose or recommended phase 2 dose (MTD/RP2D), safety and tolerability will be further evaluated in an expanded cohort of subjects with pancreatic or lung cancer, as monotherapy or in combination with the standard of care treatment and to identify the RP2D of CAN04 in combination with standard of care. In addition, early signs of efficacy during treatment with CAN04 will be investigated. Sponsor: Cantargia AB Intervention: CAN04 Start Date: 2017-09-19 Last Updated: 2023-10-18 Number of Patients: 167 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non Small Cell Lung Cancer
NCTID: NCT02239120
Title: Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source (RE-SPECT ESUS) Study Summary: This trial will enroll approximately 6,000 patients with recent embolic stroke of unknown source (ESUS). Patients will be randomized to dabigatran or acetylsalicyclic acid (ASA) (1:1 ratio) and have visits every three months. The study doctor may prescribe blinded concomitant ASA for pts with coronary artery disease but this is not mandatory. All Adverse Events (AEs), Serious Adverse Events (SAEs), outcome events will be recorded. The trial will conclude when the required number of stroke events are positively adjudicated which is estimated to take 3 years (including 2.5 years of enrollment). Sponsor: Boehringer Ingelheim Intervention: optional ASA as comedication Start Date: 2014-11-27 Last Updated: 2019-09-06 Number of Patients: 5390 Recruitment Status: COMPLETED Condition: Stroke
NCTID: NCT03301220
Title: A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma Study Summary: The primary objective of this study is to determine whether treatment with daratumumab administered subcutaneously (SC) prolongs progression-free survival (PFS) compared with active monitoring in participants with high-risk smoldering multiple myeloma (SMM). Sponsor: Janssen Research & Development, LLC Intervention: Daratumumab SC: daratumumab + rHuPH20 Start Date: 2017-11-07 Last Updated: 2023-11-09 Number of Patients: 390 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Smoldering Multiple Myeloma
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: NCT03540420
Title: Atezolizumab After Concurrent Chemo-radiotherapy Versus Chemo-radiotherapy Alone in Limited Disease Small-cell Lung Cancer Study Summary: Some patients with limited disease small-cell lung cancer (LD SCLC) are cured after chemo-radiotherapy, but the majority relapse and die from their cancer. Better therapy is needed. Immunotherapy represents the largest advance in cancer therapy in recent years and has demonstrated promising activity in SCLC. In this study we will investigate whether atezolizumab prolongs survival in LD SCLC patients who have undergone chemo-radiotherapy. Sponsor: Norwegian University of Science and Technology Intervention: Atezolizumab Start Date: 2018-07-31 Last Updated: 2023-05-06 Number of Patients: 212 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Small-cell Lung Cancer
NCTID: NCT03000452
Title: A Study to Determine the Efficacy of the Combination of Daratumumab (DARA) Plus Durvalumab (DURVA) (D2) in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM) Study Summary: This is a single-arm, multicenter, Phase 2 study to evaluate the efficacy and safety of the combination regimen of daratumumab plus durvalumab (D2). The study will consist of 2 parts; Part 1 has a 2-stage design while Part 2 consists of an expansion phase. Subjects will receive intravenous (IV) DARA at 16 mg/kg on the same dosing schedule (weekly <math display="block">QW</math>, every 2 weeks <math display="block">Q2W</math> or every 4 weeks <math display="block">Q4W</math> of each 28-day cycle) received on their last prior therapy containing DARA. The dosing schedule for DARA may be adjusted during the course of the study as outlined in the protocol. Subjects will also receive IV DURVA at 1500 mg on Day 2 (Cycle 1) and on Day 1 (Cycles ≥ 2) of each 28-day treatment cycle. Sponsor: Celgene Intervention: DARATUMUMAB Start Date: 2017-03-14 Last Updated: 2018-10-16 Number of Patients: 18 Recruitment Status: COMPLETED Condition: Multiple Myeloma
NCTID: NCT00963105
Title: Study of Lenalidomide to Evaluate Safety and Efficacy in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia Study Summary: The purpose of this study is to determine the safety and effectiveness of different dose regimens of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). Sponsor: Celgene Intervention: lenalidomide Start Date: 2009-10-19 Last Updated: 2018-10-31 Number of Patients: 104 Recruitment Status: COMPLETED Condition: Relapsed or Refractory Chronic Lymphocytic Leukemia
NCTID: 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: NCT04680052
Title: A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma. Study Summary: This is a Phase 3 double-blind, placebo-controlled, randomized study designed to investigate whether tafasitamab and lenalidomide as an add-on to rituximab provides improved clinical benefit compared with lenalidomide as an add-on to rituximab in patients with R/R FL Grade 1 to 3a or R/R MZL. Sponsor: Incyte Corporation Intervention: tafasitamab Start Date: 2021-04-15 Last Updated: 2023-08-18 Number of Patients: 654 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Follicular Lymphoma
NCTID: NCT00043004
Title: Chemotherapy and Bevacizumab With or Without Radiofrequency Ablation in Treating Unresectable Liver Metastases in Patients With Colorectal Cancer Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread by blocking blood flow. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiofrequency ablation uses high-frequency electric current to kill tumor cells. It is not yet known if chemotherapy is more effective with or without radiofrequency ablation in treating liver metastases. PURPOSE: This randomized phase II trial is studying combination chemotherapy, bevacizumab, and radiofrequency ablation to see how well they work compared to combination chemotherapy and bevacizumab alone in treating unresectable liver metastases in patients with colorectal cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: bevacizumab Start Date: 2002-05 Last Updated: 2012-09-24 Number of Patients: 119 Recruitment Status: TERMINATED Condition: Colorectal Cancer
NCTID: NCT04886804
Title: A Study to Test Different Doses of BI 1810631 in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene) Study Summary: The study has 2 parts. The first part is open to adults with different types of advanced cancer (solid tumours with changes in the HER2 gene) for whom previous treatment was not successful. The second part is open to people with non-small cell lung cancer with a specific mutation in the HER2 gene. The purpose of the first study part is to find the highest dose of a medicine called BI 1810631 the participants can tolerate. Once this dose is found, it will be used in the second study part to tests whether BI 1810631 can make tumours shrink. In this study, BI 1810631 is given to people for the first time. Participants take BI 1810631 as tablets once a day or twice a day. The participants are in the study for as long as they benefit from and can tolerate treatment. Study doctors regularly check the participants’ health and monitor the tumours. The doctors also take note of any unwanted effects that could have been caused by BI 1810631. Sponsor: Boehringer Ingelheim Intervention: BI 1810631 Start Date: 2021-06-22 Last Updated: 2023-11-28 Number of Patients: 371 Recruitment Status: RECRUITING Condition: Neoplasm Metastasis
NCTID: NCT04464226
Title: Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer Study Summary: The aim of this study is to provide darolutamide treatment to patients who participated in a previous study with darolutamide supported by Bayer and the treating doctor considers that the continuation of the treatment with darolutamide to be beneficial. Patients will be carried over from the previous studies and continue in this study with darolutamide treatment on the same dosage. They will also return to the study centers for doctor’s visits as often as they did in the previous study. Sponsor: Bayer Intervention: Darolutamide (Nubeqa, BAY1841788) Start Date: 2020-10-20 Last Updated: 2023-11-18 Number of Patients: 678 Recruitment Status: RECRUITING Condition: Cancer
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: NCT02008227
Title: A Study of Atezolizumab Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum-Containing Therapy Study Summary: This global, multicenter, open-label, randomized, controlled study evaluated the efficacy and safety of atezolizumab (an anti-programmed death-ligand 1 <math display="block">anti-PD-L1</math> antibody)compared with docetaxel in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure with platinum-containing chemotherapy. Participants were randomized 1:1 to receive either docetaxel or atezolizumab. Treatment may continue as long as participants experienced clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2014-03-11 Last Updated: 2019-12-20 Number of Patients: 1225 Recruitment Status: COMPLETED Condition: Non-Squamous Non-Small Cell Lung Cancer
NCTID: NCT01732926
Title: Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas Study Summary: The primary objective of this study is to evaluate the addition of idelalisib to bendamustine/rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL). An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line iNHL treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). Sponsor: Gilead Sciences Intervention: Idelalisib Start Date: 2013-01-02 Last Updated: 2018-11-16 Number of Patients: 475 Recruitment Status: TERMINATED Condition: Indolent Non-Hodgkin’s Lymphomas
NCTID: NCT04736706
Title: A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012) Study Summary: The goal of this study is to evaluate the efficacy and safety of pembrolizumab plus belzutifan plus lenvatinib or pembrolizumab/quavonlimab plus lenvatinib versus pembrolizumab plus lenvatinib as first-line treatment in participants with advanced clear cell renal cell carcinoma (ccRCC). The primary hypotheses are (1) pembrolizumab plus belzutifan plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to progression-free survival (PFS) and overall survival (OS), in advanced ccRCC participants; and (2) pembrolizumab/quavonlimab plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to PFS and OS, in advanced ccRCC participants. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2021-04-14 Last Updated: 2023-11-24 Number of Patients: 1653 Recruitment Status: RECRUITING Condition: Carcinoma, Renal Cell
NCTID: NCT01080391
Title: Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma Study Summary: The primary objective was to compare progression-free survival in adults with relapsed multiple myeloma who are receiving CRd vs participants receiving Rd in a randomized multicenter setting. Sponsor: Amgen Intervention: Dexamethasone Start Date: 2010-07-14 Last Updated: 2022-09-21 Number of Patients: 792 Recruitment Status: COMPLETED Condition: Relapsed Multiple Myeloma
NCTID: NCT04526106
Title: REFOCUS: A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With ICC and Other Advanced Solid Tumors Study Summary: This is a Phase 1/2, open-label, FIH study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDy), and antineoplastic activity of RLY-4008, a potent and highly selective FGFR2 inhibitor, in patients with unresectable or metastatic cholangiocarcinoma (CCA) and other solid tumors. The study consists of 3 parts: a dose escalation (Part 1), a dose expansion (Part 2), and an extension (Part 3). Sponsor: Relay Therapeutics, Inc. Intervention: RLY-4008 Start Date: 2020-09-02 Last Updated: 2023-10-25 Number of Patients: 550 Recruitment Status: RECRUITING Condition: FGFR2 Amplification
NCTID: NCT04810208
Title: Intratumoural Injection of a Novel NanoZolid®-Docetaxel Depot Formulation in Patients With Advanced Solid Tumours Study Summary: This is a multicentre, open-label, first in man, study of a novel NanoZolid®-docetaxel depot formulation (NZ-DTX Depot) given as an intra-tumoural injection in patients with advanced solid tumours. The study includes a dose escalation part and a dose expansion part. Sponsor: Lidds AB Intervention: Docetaxel Start Date: 2019-02-28 Last Updated: 2021-12-30 Number of Patients: 6 Recruitment Status: TERMINATED Condition: Solid Tumor
NCTID: NCT01870609
Title: Placebo Controlled Study of VS-6063 in Subjects With Malignant Pleural Mesothelioma Study Summary: This study is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study of defactinib (VS-6063) in subjects with malignant pleural mesothelioma (MPM) who have not progressed (confirmed partial response or stable disease) following ≥ 4 cycles of treatment with pemetrexed/cisplatin or pemetrexed/carboplatin. Prior to entry and randomization to the study, each subject must have tumor Merlin status(high or low) established by immunohistochemistry performed at a central laboratory. Subjects will be randomized in a 1:1 ratio to receive oral VS-6063 400 mg twice per day, or matched placebo. Randomization will be stratified by tumor Merlin status (high versus low). Progression will be assessed both locally and by central review using the Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1. Subjects will continue to receive treatment until disease progression or other discontinuation criteria are met. Following documentation of nonfatal disease progression, all subjects will be followed for overall survival by telephone contact every 2 months until end of life or the close of the study. Sponsor: Verastem, Inc. Intervention: defactinib (VS-6063) Start Date: 2013-09 Last Updated: 2017-01-30 Number of Patients: 344 Recruitment Status: TERMINATED Condition: Malignant Pleural Mesothelioma
NCTID: NCT01506609
Title: Study Evaluating Efficacy And Tolerability Of Veliparib in Combination With Temozolomide (TMZ) or In Combination With Carboplatin and Paclitaxel Versus Placebo in Participants With Breast Cancer Gene (BRCA)1 and BRCA2 Mutation and Metastatic Breast Cancer Study Summary: The primary objective of the study is to assess the progression-free survival (PFS) of oral veliparib in combination with TMZ or in combination with carboplatin and paclitaxel compared to placebo plus carboplatin and paclitaxel in subjects with BRCA1 or BRCA2 mutation and locally recurrent or metastatic breast cancer. Sponsor: AbbVie Intervention: Placebo Start Date: 2012-01-23 Last Updated: 2021-10-25 Number of Patients: 294 Recruitment Status: COMPLETED Condition: Metastatic Breast Cancer
NCTID: NCT00085709
Title: S0106 Cytarabine and Daunorubicin w/ or w/o Gemtuzumab Followed By HD Cytarabine and Either Gemtuzumab or Nothing in de Novo AML Study Summary: RATIONALE: Drugs used in chemotherapy, such as cytarabine and daunorubicin, work in different ways to stop cancer cells from dividing so they stop growing and die. Monoclonal antibodies, such as gemtuzumab ozogamicin, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with gemtuzumab ozogamicin may kill more cancer cells. It is not yet known whether induction therapy using cytarabine and daunorubicin is more effective with or without gemtuzumab ozogamicin or whether postconsolidation therapy using gemtuzumab ozogamicin is more effective than no additional therapy in treating de novo (first occurrence) acute myeloid leukemia. PURPOSE: This randomized phase III trial is comparing two different regimens of chemotherapy and monoclonal antibody therapy to see how well they work in treating patients with previously untreated de novo acute myeloid leukemia. Sponsor: SWOG Cancer Research Network Intervention: gemtuzumab ozogamicin Start Date: 2004-07 Last Updated: 2015-09-30 Number of Patients: 637 Recruitment Status: COMPLETED Condition: Leukemia
NCTID: NCT05983406
Title: Role of Doppler Endoscopic Probe in the Diagnosis of Subepithelial Gastrointestinal Lesions. Study Summary: RESEARCH PLAN I-TITLE Role of Doppler endoscopic probe in the diagnosis of subepithelial gastrointestinal lesions. II-BACKGROUND Subepithelial lesions (SEL) are commonly encountered during routine endoscopies with an estimated prevalence of 3.5%. Most of the SELs are detected during upper gastrointestinal endoscopy. Subsequently, endoscopic ultrasound (EUS) is performed to better characterize the lesion and to rule out the presence of a vascular lesion before tissue sampling due to the high risk of severe bleeding with tissue acquisition in vascular injury. However, EUS can rarely establish a definitive diagnosis per se with limited accuracy. In large lesions, it is possible to use cytology or histology needles via the EUS instrument to collect cells/tissue within the lesion. It can lead to accurate diagnosis and consistent management. However, EUS-guided tissue sampling can be technically challenging, with poor yield for small or mobile SELs. In addition, EUS is an expensive technique, high operator dependency and performed only in tertiary centers. It creates a time gap between endoscopic detection and the EUS examination and increases costs. That delay in diagnosis is a source of anxiety for the patient and for the caregivers. Several methods were proposed to increase the diagnostic yield of tissue acquisition techniques, such as “bite-on-bite” biopsies which showed a limited diagnostic yield. Alternatively, the “unroofing” technique has also been advocated for histological diagnosis. In unroofing, a loop is used to remove the normal epithelium covering the subepithelial lesions and after epithelial removal, a biopsy forceps or loop is used to sample subepithelial lesions. Other techniques include endoscopic resection by snare or submucosal dissection. These enable a surgical specimen but are technically demanding and have been complicated by perforation and bleeding in most series. There is a need for a method that enables rapid diagnosis in the same session as endoscopic detection of SEL regardless of their size. That method should ideally enable histological diagnosis with low risks of complications and should not require high technical expertise and should not be highly dependent on the operator. The ideal solution to address the diagnosis of gastrointestinal (GI) SEL would be one that would provide a tissue sampling after exclusion of a highly vascular lesion, in the same session as endoscopic detection. Doppler endoscopic probe (DEP) is a Doppler endoscopic probe specially developed for the GI system, which enables blood flow detection during endoscopy. DEP is CE and FDA approved and can be used through the working channel of the endoscope. Unlike standard EUS, which requires advanced endoscopic training, DEP is much easier to use. It allows the characterization of lesions as non-vascular, venous or arterial. Recent studies have demonstrated the safety and efficacy of DEP in vascular characterization in the gastrointestinal tract. III PURPOSE Primary objective: * Proof of concept evaluation of the role of DEP in the characterization of GI SEL as non-vascular or vascular (arterial or venous) * Relationship between findings on DEP versus findings on EUS (considered the gold standard) regarding SEL characterization as non-vascular or vascular (arterial or venous). Secondary purposes: * Accuracy in removing the histological characterization of subepithelial GI lesions. * Complications in connection with tissue acquisition * Inter-observer agreement of DEP and EUS results. IV METHODS This is a pilot projective feasibility study that will be run by Karolinska University Hospital in Stockholm Patients with subepithelial GI lesions were referred for EUS evaluation. The study will include 30 patients. A conventional gastroscopy will be performed. After identification of the lesion, DEP is performed. The DEP probe is lubricated and deployed through the working channel of the endoscope. The probe will contact the mucosa slightly, covering the SEL. Then evaluate the lesion in 2 different angels. The results will be characterized and recorded qualitatively: no flow / arterial flow / venous flow and in terms of intensity: soft, medium or high. After DEP, evaluation EUS will be performed by another endoscopist who will be tied to the DEP results. EUS will be considered the gold standard. After both assessments, the lesion is characterized as no vessel / arterial / venous and as soft / medium / high flow intensity. EUS will be followed by removal of SEL in patients where EUS excludes the presence of high vessel disease. “Unroofing” will be performed using a conventional endoscopic loop, through the working channel of the endoscope. After the surface of the lesion is disturbed, a biopsy forceps will be used for tissue acquisition. Tissue will be stored in formalin and processed and evaluated by the pathologist. Sponsor: Francisco Baldaque-Silva Intervention: Doppler investigation Start Date: 2023-08-01 Last Updated: 2023-08-09 Number of Patients: 20 Recruitment Status: RECRUITING Condition: Subepithelial Tumors of the Upper Gastrointestinal Tract
NCTID: NCT04527991
Title: Study of Sacituzumab Govitecan-hziy (IMMU-132) Versus Treatment of Physician’s Choice in Participants With Metastatic or Locally Advanced Unresectable Urothelial Cancer Study Summary: The primary objective of this study is to assess overall survival (OS) with sacituzumab govitecan-hziy in comparison with treatment of physician’s choice (TPC) in participants with metastatic or locally advanced unresectable urothelial cancer (UC). Sponsor: Gilead Sciences Intervention: Sacituzumab Govitecan-hziy Start Date: 2021-01-13 Last Updated: 2023-06-22 Number of Patients: 696 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Locally Advanced or Metastatic Unresectable Urothelial Cancer
NCTID: NCT04763408
Title: A Study to Evaluate the Safety and Tolerability of Lenvatinib in Participants With Advanced or Unresectable Hepatocellular Carcinoma Study Summary: The primary purpose of this study is to further characterise the hepatotoxicity in participants with advanced or unresectable hepatocellular carcinoma (HCC) treated with lenvatinib, and to further characterise the overall safety profile (serious adverse events <math display="block">SAEs</math>, grade 3 to 5 adverse events <math display="block">AEs</math>, dose modifications and discontinuations due to AEs) in participants with advanced or unresectable HCC treated with lenvatinib. Sponsor: Eisai Inc. Intervention: Lenvatinib Start Date: 2021-04-09 Last Updated: 2023-02-28 Number of Patients: 1000 Recruitment Status: RECRUITING Condition: Carcinoma, Hepatocellular
NCTID: NCT01212991
Title: A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer Study Summary: The purpose of this study is to determine the benefit of enzalutamide versus placebo as assessed by overall survival and progression-free survival in patients with progressive metastatic prostate cancer who have failed androgen deprivation therapy but not yet received chemotherapy. Sponsor: Pfizer Intervention: Enzalutamide Start Date: 2010-09-16 Last Updated: 2020-03-17 Number of Patients: 1717 Recruitment Status: COMPLETED Condition: Prostate Cancer
NCTID: NCT03416179
Title: A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia Study Summary: Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population). Glasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population). Sponsor: Pfizer Intervention: glasdegib Start Date: 2018-04-20 Last Updated: 2023-04-21 Number of Patients: 730 Recruitment Status: COMPLETED Condition: Leukemia, Myeloid, Acute
NCTID: NCT03556839
Title: Platinum Chemotherapy Plus Paclitaxel With Bevacizumab and Atezolizumab in Metastatic Carcinoma of the Cervix Study Summary: The study will integrate the efficacy of combining the anti programmed death-ligand 1 (anti-PD-L1) agent atezolizumab with the current standard of care in Stage IVB , persistent or recurrent carcinoma of the cervix, namely cisplatin or carboplatin/paclitaxel/bevacizumab. It will be explored the combination of bevacizumab plus atezolizumab, with no patient selection based on PD-L1 expression, allowing an all-comer assessment of atezolizumab activity. The study is a randomized open label phase III trial to investigate the impact of atezolizumab in combination with bevacizumab and cisplatin or carboplatin /paclitaxel chemotherapy on overall survival and will employ the intent to treat principle, and random assignment to one of the 2 arms will be balanced according to disease histology (squamous cell carcinoma vs adenocarcinoma), prior platinum therapy as a radiation sensitizer (no prior cis-Radiotherapy (RT) versus prior cis-RT) and chemotherapy backbone (cisplatin vs carboplatin). This trial will be run in an open label design due to the following considerations: the control arm is the standard of care for women diagnosed with metastatic, persistant or recurrent cervical cancer because of its impact on overall survival and the primary endpoint of the study is overall survival (OS), so blinding is not needed to ensure a robust assessment. Sponsor: Grupo Español de Investigación en Cáncer de Ovario Intervention: Atezolizumab Start Date: 2018-09-25 Last Updated: 2023-09-13 Number of Patients: 404 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Carcinoma of the Cervix, Stage IVB
NCTID: NCT03649971
Title: A Study of Guselkumab in Participants With Familial Adenomatous Polyposis Study Summary: The purpose of this study is to determine the effect of treatment with guselkumab in participants with familial adenomatous polyposis (FAP) on rectal/pouch polyp burden. Sponsor: Janssen Research & Development, LLC Intervention: Guselkumab Start Date: 2018-11-19 Last Updated: 2023-07-03 Number of Patients: 77 Recruitment Status: COMPLETED Condition: Adenomatous Polyposis Coli
NCTID: NCT04924075
Title: Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015) Study Summary: This is a study to evaluate the efficacy and safety of belzutifan monotherapy in participants with advanced pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumor (pNET), von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Advanced Solid Tumors With hypoxia inducible factor-2 alpha (HIF-2α) related genetic alterations. The primary objective of the study is to evaluate the objective response rate (ORR) of belzutifan per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). Sponsor: Merck Sharp & Dohme LLC Intervention: Belzutifan Start Date: 2021-08-12 Last Updated: 2023-11-27 Number of Patients: 322 Recruitment Status: RECRUITING Condition: Pheochromocytoma/Paraganglioma
NCTID: NCT01650805
Title: Ponatinib in Newly Diagnosed Chronic Myeloid Leukemia (CML) (EPIC) Study Summary: The purpose of this study is to compare the efficacy of ponatinib and imatinib in patients with newly diagnosed chronic myeloid leukemia (CML) in the chronic phase. Sponsor: Ariad Pharmaceuticals Intervention: ponatinib Start Date: 2012-06 Last Updated: 2014-11-17 Number of Patients: 307 Recruitment Status: TERMINATED Condition: Chronic Myeloid Leukemia
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: NCT02562443
Title: Controlled Study of Rigosertib Versus Physician’s Choice of Treatment in MDS Patients After Failure of an HMA Study Summary: The study’s primary objective <math display="block">in a population of patients with MDS after failure of treatment with azacitidine (AZA) or decitabine (DAC)</math>, is to compare the overall survival (OS) of patients in the rigosertib group vs the Physician’s Choice group, in all patients and in a subgroup of patients with IPSS-R very high risk. Sponsor: Onconova Therapeutics, Inc. Intervention: rigosertib Start Date: 2015-12-02 Last Updated: 2022-09-26 Number of Patients: 372 Recruitment Status: TERMINATED Condition: Myelodysplastic Syndrome
NCTID: NCT04603807
Title: A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in Participants With Advanced or Metastatic ROS1 Non-small Cell Lung Cancer (NSCLC) With and Without Central Nervous System (CNS) Metastases Study Summary: The study will compare the efficacy and safety of entrectinib with crizotinib in participants with advanced or metastatic ROS1 non-small cell lung cancer (NSCLC). The participants will self-administer oral entrectinib or crizotinib as described in the protocol and local prescribing information. Treatments will continue until progressive disease, unacceptable toxicity, death, or withdrawal from the study, whichever occurs first. Sponsor: Hoffmann-La Roche Intervention: Entrectinib Start Date: 2021-09-30 Last Updated: 2023-11-29 Number of Patients: 220 Recruitment Status: RECRUITING Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT01307397
Title: A Study of Vemurafenib in Participants With Metastatic Melanoma Study Summary: This multi-center study evaluates the safety and efficacy of vemurafenib in participants with BRAF V600 mutation-positive, surgically incurable, and unresectable Stage IIIC or IV (American Joint Committee on Cancer <math display="block">AJCC</math>) metastatic melanoma. Sponsor: Hoffmann-La Roche Intervention: Vemurafenib Start Date: 2011-03-01 Last Updated: 2017-12-18 Number of Patients: 3219 Recruitment Status: COMPLETED Condition: Malignant Melanoma
NCTID: NCT03445533
Title: A Study of Tilsotolimod in Combo With Ipilimumab vs Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma Study Summary: A Phase 3 comparison of ipilimumab with and without IMO-2125 in advanced melanoma Sponsor: Idera Pharmaceuticals, Inc. Intervention: Ipilimumab Start Date: 2018-05-30 Last Updated: 2022-11-08 Number of Patients: 481 Recruitment Status: TERMINATED Condition: Metastatic Melanoma
NCTID: NCT00049595
Title: Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Stage III or Stage IV Hodgkin’s Lymphoma Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating stage III or stage IV Hodgkin’s lymphoma. PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have stage III or stage IV Hodgkin’s lymphoma. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: bleomycin sulfate Start Date: 2002-08 Last Updated: 2023-11-09 Number of Patients: 552 Recruitment Status: COMPLETED Condition: Lymphoma
NCTID: NCT03515837
Title: Study of Pemetrexed + Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Adults With Tyrosine Kinase Inhibitor- (TKI)-Resistant Epidermal Growth Factor Receptor- (EGFR)-Mutated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-789/KEYNOTE-789) Study Summary: The purpose of this study is to evaluate the efficacy and safety of pemetrexed plus platinum chemotherapy (carboplatin or cisplatin) with or without pembrolizumab (MK-3475; KEYTRUDA®) in the treatment of adults with the following types of tyrosine kinase inhibitor (TKI)-resistant, epidermal growth factor receptor (EGFR)-mutated, metastatic non-squamous non-small cell lung cancer (NSCLC) tumors: 1) TKI-failures (including osimertinib <math display="block">TAGRISSO®</math> failure) with T790M-negative mutation tumors, 2) T790M-positive mutation tumors with prior exposure to osimertinib, and 3) first-line osimertinib failure regardless of T790M mutation status. The primary study hypotheses are that the combination of pembrolizumab plus chemotherapy has superior efficacy compared to saline placebo plus chemotherapy in terms of: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review, and 2) Overall Survival (OS). This study will be considered to have met its success criteria if the combination of pembrolizumab plus chemotherapy is superior to saline placebo plus chemotherapy in terms of PFS or OS. Upon study completion, participants are discontinued and may be enrolled in a pembrolizumab extension study, if available. Sponsor: Merck Sharp & Dohme LLC Intervention: pembrolizumab Start Date: 2018-06-29 Last Updated: 2023-10-11 Number of Patients: 492 Recruitment Status: COMPLETED Condition: Non-small Cell Lung Cancer
NCTID: NCT04509700
Title: Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465) Study Summary: This is a Phase 2, multicenter, open-label study to provide continued supply of parsaclisib as monotherapy or in combination therapy with itacitinib, ruxolitinib, or ibrutinib to participants from Incyte-sponsored studies of parsaclisib. Sponsor: Incyte Corporation Intervention: Parsaclisib Start Date: 2020-08-03 Last Updated: 2023-11-15 Number of Patients: 200 Recruitment Status: RECRUITING Condition: B-Cell Malignancies
NCTID: NCT01928537
Title: Efficacy and Safety of IV Rigosertib in MDS Patients With Excess Blasts Progressing After Azacitidine or Decitabine Study Summary: This study will examine the effect intravenously administered rigosertib has on the relationship between bone marrow blasts response and overall survival in myelodysplastic syndromes (MDS) patients who have 5-30% bone marrow blasts and who progressed on or after treatment with azacitidine or decitabine. Sponsor: Onconova Therapeutics, Inc. Intervention: rigosertib sodium Start Date: 2013-08 Last Updated: 2020-06-30 Number of Patients: 67 Recruitment Status: COMPLETED Condition: Myelodysplastic Syndromes
NCTID: NCT04332822
Title: A Randomized, Multicenter, Phase III Trial Comparing Treatment With R-mini-CHOP With R-mini-CHP + Polatuzumab Vedotin in Patients With Diffuse Large Cell B Cell Lymphoma Study Summary: This is a phase III, randomized, open-label, multicenter trial, conducted in Sweden, Norway, Finland, Denmark, Italy and Switzerland, in elderly patients with untreated diffuse large B-cell lymphoma. Elderly is defined as either ≥80 years of age, or ≥75 years and frail, according to a simplified Comprehensive Geriatric Assessment. Patients will be randomized 1:1 to either the standard treatment for this population, R-miniCHOP, or an experimental regimen, R-pola-miniCHP, where vincristine is substituted by an immunoconjugate, polatuzumab vedotin. The duration of the screening period is up to 4 weeks. The duration of active treatment is 18 weeks in both arms, and patients will be followed up to 36 months after end of treatment. Start of enrollment is planned in Q1 2020, and the last visit of the last patient included (end of trial) is estimated in Q1 2026. Sponsor: Nordic Lymphoma Group Intervention: R-pola-mini-CHP Start Date: 2020-08-19 Last Updated: 2021-07-09 Number of Patients: 200 Recruitment Status: RECRUITING Condition: DLBCL
NCTID: NCT01659021
Title: Efficacy and Safety of Idelalisib in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia Study Summary: The primary objective of this study is to evaluate the effect of the addition of idelalisib to ofatumumab on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL). Sponsor: Gilead Sciences Intervention: Idelalisib Start Date: 2012-12-04 Last Updated: 2019-08-14 Number of Patients: 261 Recruitment Status: TERMINATED Condition: Chronic Lymphocytic Leukemia
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: NCT03869892
Title: Phase III Study in First-line Treatment of Patients With Metastatic Colorectal Cancer Who Are Not Candidate for Intensive Therapy. Study Summary: The main purpose of this study is to demonstrate the superiority of S 95005 in combination with bevacizumab over capecitabine in combination with bevacizumab. Sponsor: Institut de Recherches Internationales Servier Intervention: Trifluridine/tipiracil hydrochloride (S95005) Start Date: 2019-03-21 Last Updated: 2023-11-18 Number of Patients: 856 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Colorectal Cancer
NCTID: NCT04161092
Title: The Swedish Study of Liver Transplantation for Non-resectable Colorectal Cancer Metastases Study Summary: To evaluate if the addition of liver transplantation primarily utilizing liver grafts from extended criteria donors not utilized for approved indications to conventional treatment of non-resectable/ non-abatable colorectal liver metastases (CLM) increases overall survival compared to best alternative care. Sponsor: Vastra Gotaland Region Intervention: Liver transplantation Ltx Start Date: 2020-12-01 Last Updated: 2021-01-05 Number of Patients: 45 Recruitment Status: RECRUITING Condition: Colorectal Cancer
NCTID: NCT03126019
Title: A Study of INCB050465 in Relapsed or Refractory Follicular Lymphoma Study Summary: The purpose of this study is to assess the objective response rate of parsaclisib treatment in participants with relapsed or refractory follicular lymphoma. Sponsor: Incyte Corporation Intervention: Parsaclisib Start Date: 2018-03-14 Last Updated: 2023-07-27 Number of Patients: 126 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Lymphoma
NCTID: NCT02319837
Title: Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK) Study Summary: The purpose of this study is to assess enzalutamide plus leuprolide in patients with high-risk nonmetastatic prostate cancer progressing after radical prostatectomy or radiotherapy or both. The randomized / blinded portion of the study is now completed following primary endpoint analyses. The study remains ongoing in open label format. Sponsor: Pfizer Intervention: Enzalutamide Start Date: 2014-12-17 Last Updated: 2023-08-08 Number of Patients: 1068 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Hormone Sensitive Prostate Cancer
NCTID: NCT05469737
Title: A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Participants With International Prognostic Scoring System Revised (IPSS-R) Low- or Intermediate-risk Myelodysplastic Syndrome (MDS) Study Summary: The purpose of this study is to evaluate the safety and efficacy of oral azacitidine in participants with low to intermediate International Prognostic Scoring System Revised (IPSS-R) myelodysplastic syndrome (MDS). Sponsor: Bristol-Myers Squibb Intervention: Oral Azacitidine Start Date: 2022-12-14 Last Updated: 2023-11-08 Number of Patients: 230 Recruitment Status: RECRUITING Condition: Myelodysplastic Syndromes
NCTID: NCT01059630
Title: A Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+Obinutuzumab (GA101) in Participants With Rituximab-Refractory, Indolent Non-Hodgkin’s Lymphoma (GADOLIN) Study Summary: This open-label, multicenter, randomized Phase III study will investigate the efficacy, safety, pharmacokinetics and pharmacoeconomics of obinutuzumab (RO5072759, GA101) combined with bendamustine followed by continued obinutuzumab treatment (maintenance monotherapy) compared with bendamustine alone treatment in participants with rituximab-refractory indolent Non-Hodgkin’s lymphoma (iNHL). The end of study was defined to when safety follow-up for all patients had been completed (2 years’ safety follow-up from last dose). Sponsor: Genentech, Inc. Intervention: Obinutuzumab Start Date: 2010-04-30 Last Updated: 2020-01-13 Number of Patients: 413 Recruitment Status: COMPLETED Condition: Non-Hodgkin’s Lymphoma
NCTID: NCT00932451
Title: An Investigational Drug, PF-02341066, Is Being Studied In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene Study Summary: This is a Phase 2 trial that will evaluate the safety and efficacy of PF-02341066 in patients with advanced non-small cell lung cancer with a specific gene profile involving the ALK gene. This trial will also allow patients from a Phase 3 trial who received standard of care chemotherapy (Study A8081007) to receive PF-02341066. Sponsor: Pfizer Intervention: PF-02341066 Start Date: 2010-01 Last Updated: 2017-01-13 Number of Patients: 1069 Recruitment Status: COMPLETED Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT00876031
Title: Trial for Localised High-risk Rhabdomyosarcoma and Rhabdomyosarcoma-like Soft Tissue Sarcoma Study Summary: The purpose of this study is to investigate whether the addition of oral maintenance chemotherapy with O-TIE (Etoposide, Idarubicin, Trofosfamide) for 6 months improves the event free survival (EFS) in patients with localised high-risk RMS and RMS-like Soft Tissue Sarcoma. Sponsor: University Hospital Tuebingen Intervention: trofosfamide, idarubicin, etoposide Start Date: 2009-07-01 Last Updated: 2022-11-08 Number of Patients: 195 Recruitment Status: COMPLETED Condition: Soft Tissue Sarcoma
NCTID: NCT04607421
Title: A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer Study Summary: The purpose of this study is to evaluate two study medicines (encorafenib plus cetuximab) taken alone or together with standard chemotherapy for the potential treatment of colorectal cancer that: * has spread to other parts of the body (metastatic); * has a certain type of abnormal gene called “BRAF”; and * has not received prior treatment. Participants in this study will receive one of the following study treatments: * Encorafenib plus cetuximab: These participants will receive encorafenib by mouth at home every day and cetuximab once every two weeks by intravenous (IV) infusion (an injection into the vein) at the study clinic. * Encorafenib plus cetuximab with chemotherapy: These participants will receive encorafenib and cetuximab in the way described in the bullet above. Additionally, they will receive standard chemotherapy by IV infusion and oral treatment at home. * Chemotherapy alone: These participants will receive chemotherapy, the standard treatment for this condition, by IV infusion at the study clinics and oral treatment at home. The study team will monitor how each participant responds to the study treatment for up to about 3 years. Sponsor: Pfizer Intervention: Encorafenib Start Date: 2020-12-21 Last Updated: 2023-09-11 Number of Patients: 815 Recruitment Status: RECRUITING Condition: Neoplasms
NCTID: NCT03036488
Title: Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC) (MK-3475-522/KEYNOTE-522) Study Summary: The purpose of this study is to evaluate the efficacy and safety of pembrolizumab (MK-3475) plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy and pembrolizumab vs placebo as adjuvant therapy in participants who have triple negative breast cancer (TNBC). After a screening phase of approximately 28 days, each participant will receive neoadjuvant study treatment (Pembrolizumab + Chemotherapy OR Placebo + Chemotherapy) based on the randomization schedule for approximately 24 weeks (8 cycles). Each participant will then undergo definitive surgery 3-6 weeks after conclusion of the last cycle of the neoadjuvant study treatment. After definitive surgery, each participant will receive adjuvant study treatment (Pembrolizumab OR Placebo) for approximately 27 weeks (9 cycles). Following adjuvant study treatment, each participant will be monitored for safety, survival and disease recurrence. The primary study hypothesis is that pembrolizumab is superior to placebo, in combination with chemotherapy, as measured by the rate of Pathological Complete Response (pCR) and/or Event-free Survival (EFS), in participants with locally advanced TNBC. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2017-03-07 Last Updated: 2023-07-03 Number of Patients: 1174 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Triple Negative Breast Neoplasms
NCTID: NCT04154189
Title: A Study to Compare the Efficacy and Safety of Ifosfamide and Etoposide With or Without Lenvatinib in Children, Adolescents and Young Adults With Relapsed and Refractory Osteosarcoma Study Summary: This Is a Multicenter, Randomized, Open-Label, Parallel-Group, Phase 2 Study to Compare the Efficacy and Safety of Lenvatinib in Combination with Ifosfamide and Etoposide Versus Ifosfamide and Etoposide in Children, Adolescents, and Young Adults with Relapsed or Refractory Osteosarcoma. Sponsor: Eisai Inc. Intervention: Lenvatinib Start Date: 2020-03-23 Last Updated: 2023-10-17 Number of Patients: 81 Recruitment Status: COMPLETED Condition: Osteosarcoma
NCTID: NCT00900614
Title: Safety Study of APR-246 in Patients With Refractory Hematologic Cancer or Prostate Cancer Study Summary: The purpose of this study is to determine the highest feasible dose (HFD) of intravenous (IV) APR-246 when given to patients with refractory hematologic malignancies or prostate carcinoma. Sponsor: Aprea Therapeutics Intervention: APR-246 Start Date: 2009-05 Last Updated: 2019-07-31 Number of Patients: 36 Recruitment Status: COMPLETED Condition: Hematologic Neoplasms
NCTID: NCT01907100
Title: Nintedanib (BIBF 1120) in Mesothelioma Study Summary: This is a phase II/III confirmatory study designed to evaluate the safety and efficacy of nintedanib (BIBF 1120) in combination + (pemetrexed / cisplatin) followed by nintedanib (BIBF 1120) versus placebo + pemetrexed / cisplatin followed by placebo for the treatment of patients with unresectable malignant pleural mesothelioma. Sponsor: Boehringer Ingelheim Intervention: Nintedanib Start Date: 2013-09-19 Last Updated: 2019-03-18 Number of Patients: 545 Recruitment Status: TERMINATED Condition: Mesothelioma
NCTID: NCT03229200
Title: Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib. Study Summary: Multicenter, open-label, prospective treatment protocol that provides continued access to ibrutinib to subjects who have completed parent ibrutinib studies, are still benefitting from treatment with ibrutinib, and have no access to commercial ibrutinib for their underlying disease within their region. Sponsor: Pharmacyclics Switzerland GmbH Intervention: Ibrutinib Start Date: 2017-05-22 Last Updated: 2023-11-24 Number of Patients: 600 Recruitment Status: ENROLLING_BY_INVITATION Condition: Lymphoma, B-Cell
NCTID: NCT04170283
Title: Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Participants With B-cell Malignancies Study Summary: The purpose of this study is to evaluate the long-term safety of zanubrutinib regimens in participants with B-cell malignancies who participated in a BeiGene parent study for zanubrutinib. Sponsor: BeiGene Intervention: Zanubrutinib Start Date: 2020-01-21 Last Updated: 2023-10-27 Number of Patients: 500 Recruitment Status: ENROLLING_BY_INVITATION Condition: B-cell Malignancies
NCTID: NCT02303821
Title: Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia Study Summary: The purpose of Phase 1b of this study is to: * Asses the safety, tolerability and activity of carfilzomib, alone and in combination with induction chemotherapy, in children with relapsed or refractory acute lymphoblastic leukemia (ALL). * Determine the maximum tolerated dose (MTD) and to recommend a phase 2 dose of carfilzomib in combination with induction chemotherapy. The purpose of Phase 2 of this study is to compare the rate of complete remission (CR) of carfilzomib in combination with vincristine, dexamethasone, PEG asparaginase, daunorubicin (VXLD) at the end of induction therapy to an appropriate external control. Sponsor: Amgen Intervention: Carfilzomib Start Date: 2015-02-16 Last Updated: 2023-10-23 Number of Patients: 130 Recruitment Status: RECRUITING Condition: Acute Lymphoblastic Leukemia (ALL)
NCTID: NCT01558921
Title: Rectal Cancer And Pre-operative Induction Therapy Followed by Dedicated Operation. The RAPIDO Trial Study Summary: Currently the 3-year disease free survival of patients with locally advanced rectal cancer is about 50%. Current standard treatment for patients at high risk of failing locally and/or systemically includes pre-operative long course radiotherapy (5 weeks) in combination with chemotherapy (so called neoadjuvant chemoradiotherapy). The neoadjuvant chemoradiotherapy has been demonstrated to improve local control, but had no effect on the overall survival. Different studies in patients with rectal cancer studying the effect of adjuvant post operative chemotherapy did not result in an improved survival. This may be due the fact that rectal cancer surgery (TME) is associated with a high complication rate so substantial proportion of patients cannot receive chemotherapy postoperatively. An alternative approach is to administer the systemic therapy preoperative. To guarantee control of the rectum tumor short-course radiotherapy (5 days) is given, as different studies showed local control of the tumor for a long time. During this waiting period the patient is in a good condition to receive an optimal dose of chemotherapy. The investigators hypothesize that with this proposed protocol both the local tumour and possible micrometastases are effectively treated and that this will result in an increased survival. The investigators will compare this with the standard treatment of neoadjuvant chemoradiation followed by TME surgery and optional adjuvant chemotherapy. Sponsor: University Medical Center Groningen Intervention: M1 scheme Start Date: 2011-06-21 Last Updated: 2023-01-13 Number of Patients: 920 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Rectal Cancer
NCTID: NCT03334487
Title: Study Evaluating the Safety of Rovalpituzumab Tesirine for Third-Line and Later Treatment of Subjects With Relapsed or Refractory Small Cell Lung Cancer Study Summary: A single-arm, open-label study to assess the overall safety of rovalpituzumab tesirine in participants with relapsed or refractory delta-like protein 3 (DLL3) expressing small cell lung cancer by evaluating the frequency of high grade (>= Grade 3) select treatment-emergent adverse events (TEAEs). Sponsor: AbbVie Intervention: Dexamethasone Start Date: 2018-03-15 Last Updated: 2018-12-26 Number of Patients: 0 Recruitment Status: WITHDRAWN Condition: Small Cell Lung Cancer
NCTID: NCT05229900
Title: A Study of SGN-ALPV in Advanced Solid Tumors Study Summary: This study will test the safety of a drug called SGN-ALPV in participants with solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to your body besides treating your disease. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable). This study will have three parts. Parts A and B of the study will find out how much SGN-ALPV should be given to participants. Part C will use the dose and schedule found in Parts A and B to find out how safe SGN-ALPV is and if it works to treat solid tumor cancers. Sponsor: Seagen Inc. Intervention: SGN-ALPV Start Date: 2022-04-21 Last Updated: 2023-10-16 Number of Patients: 43 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Ovarian Neoplasms
NCTID: NCT02447666
Title: Study With Azacitidine in Pediatric Subjects With Newly Diagnosed Advanced Myelodysplastic Syndrome (MDS) and Juvenile Myelomonocytic Leukemia (JMML) Study Summary: Indication Treatment of pediatric subjects with newly diagnosed advanced myelodysplastic syndrome (MDS) or juvenile myelomonocytic leukemia (JMML) prior to hematopoietic stem cell transplantation (HSCT). Objectives Primary Objective The primary objective is to assess the treatment effect on response rate (MDS: either complete remission <math display="block">CR</math>, partial remission <math display="block">PR</math>, or marrow CR; JMML: either clinical complete remission <math display="block">cCR</math> or clinical partial remission <math display="block">cPR</math>); at Cycle 3 Day 28 (each cycle is 28 days) and to compare against standard therapy using a matched-pairs analysis of historical data. Secondary Objective The secondary objective is to further evaluate safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of azacitidine in this subject population. Study Design This is a prospective, open-label, Phase 2 study consisting of 2 parallel experimental arms, one for each disease group: MDS and JMML. Each arm is designed based on Simon’s Optimal 2 stage study design. The sample size has been calculated to allow evaluation of the response rate at 28 day-Cycle 3 Day 28 in each of the 2 disease groups. Each of the experimental arms will also individually be compared against a historical control arm using data retrospectively collected from the European Working Group of MDS in childhood (EWOG-MDS) registry by means of a matched-pairs analysis; matched for predefined subject baseline characteristics defined before any results from this study are known post Stage 1. If matched pair is not viable then other methodologies will be explored to evaluate and compare response rates reported in literature and also in registry database Twenty subjects with MDS and 35 JMML subjects evaluable for the primary endpoint (ie, subjects that receive at least 1 dose of investigational product <math display="block">IP</math>) will be enrolled at approximately 45 centers in Europe. Each experimental arm has 1 interim analysis planned (at the end of Stage 1). If, during Stage 1 evaluation, less than 2 subjects are observed with a CR, PR, or marrow CR after 3 months of azacitidine in the first 9 subjects with MDS, then enrollment will be stopped. Similarly, if less than 3 subjects are observed with a cPR or cCR after 3 months of azacitidine in the first 18 subjects with JMML, then enrollment will be stopped. Sponsor: Celgene Intervention: Azacitidine Start Date: 2015-09-15 Last Updated: 2019-07-11 Number of Patients: 28 Recruitment Status: COMPLETED Condition: Myelodysplastic Syndrome
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: NCT01909453
Title: Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma Study Summary: This is 2-part, randomized, open label, multi-center, parallel group, phase III study comparing the efficacy and safety of LGX818 plus MEK162 to vemurafenib and LGX818 monotherapy in patients with locally advanced unresectable or metastatic melanoma with BRAF V600 mutation. A total of approximately 900 patients will be randomized. Part 1: Patients will be randomized in a 1:1:1 ratio to one of 3 treatment arms: # LGX818 450 mg QD plus MEK162 45 mg BID (denoted as Combo 450 arm) # LGX818 300 mg QD monotherapy (denoted as LGX818 arm) or # vemurafenib 960 mg BID (denoted as vemurafenib arm) Part 2: Patients will be randomized in a 3:1 ratio to one of the 2 treatment arms: # LGX818 300 mg QD plus MEK162 45 mg BID (denoted as Combo 300 arm) or # LGX818 300 mg QD monotherapy (denoted as LGX818 arm) Sponsor: Pfizer Intervention: LGX818 Start Date: 2013-12-13 Last Updated: 2023-09-07 Number of Patients: 921 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Melanoma
NCTID: NCT05169567
Title: Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer Study Summary: This study will evaluate the effect of adding abemaciclib to fulvestrant for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer that progressed or recurred after previous treatment with a type of drug known as a CDK4/6 inhibitor and endocrine therapy. Participation could last up to 5 years, depending on how you and your tumor respond. Sponsor: Eli Lilly and Company Intervention: Abemaciclib Start Date: 2022-03-11 Last Updated: 2023-10-23 Number of Patients: 350 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Neoplasm
NCTID: NCT03731260
Title: (PIONEER) Study to Evaluate Efficacy and Safety of Avapritinib (BLU-285), A Selective KIT Mutation-targeted Tyrosine Kinase Inhibitor, Versus Placebo in Patients With Indolent Systemic Mastocytosis Study Summary: This is a Phase 2, randomized, double-blind, placebo-controlled study comparing the efficacy and safety of avapritinib + best supportive care (BSC) with placebo + BSC in patients with indolent systemic mastocytosis (ISM) whose symptoms are not adequately controlled by BSC. The study will be conducted in 3 parts. All patients will receive treatment with avapritinib during Part 3 including those rolling over from the placebo group. Sponsor: Blueprint Medicines Corporation Intervention: Avapritinib Start Date: 2019-04-16 Last Updated: 2023-06-15 Number of Patients: 251 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Indolent Systemic Mastocytosis
NCTID: NCT01466660
Title: LUX-Lung 7: A Phase IIb Trial of Afatinib(BIBW2992) Versus Gefitinib for the Treatment of 1st Line EGFR Mutation Positive Adenocarcinoma of the Lung Study Summary: This is a randomised, open-label, phase IIb trial of afatinib to compare to gefitinib in first-line treatment setting with patients who are having epidermal growth factor receptor mutation positive advanced adenocarcinoma of the lung. Sponsor: Boehringer Ingelheim Intervention: Afatinib Start Date: 2011-12-13 Last Updated: 2020-04-07 Number of Patients: 319 Recruitment Status: COMPLETED Condition: Lung Neoplasms
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: NCT02432846
Title: Intratumoral Vaccination With Intuvax Pre-nephrectomy Followed by Sunitinib Post-nephrectomy vs Sunitinib Post-nephrectomy in Newly Diagnosed Metastatic Renal Cell Carcinoma (mRCC) Study Summary: The purpose of this study is to compare tumor response, progression free survival (PFS) and overall survival (OS) in newly diagnosed mRCC patients treated with Intuvax (INN: ilixadencel) pre-nephrectomy followed by Sunitinib post-nephrectomy vs Sunitinib post-nephrectomy patients. Sponsor: Mendus Intervention: Intuvax (INN: ilixadencel) Start Date: 2015-04 Last Updated: 2022-08-22 Number of Patients: 88 Recruitment Status: COMPLETED Condition: Renal Cell Carcinoma, Metastatic
NCTID: NCT04993677
Title: A Study of SEA-CD40 Given With Other Drugs in Cancers Study Summary: This trial is being done to see if an experimental drug (SEA-CD40) works when it’s given with other cancer drugs to treat some types of cancer. It will also study side effects from the drug. There are 2 parts in this trial. In one part, participants have melanoma that has come back after treatment or can’t be removed by surgery. Participants in this part will get SEA-CD40 and pembrolizumab. In the other part, participants have non-small cell lung cancer (NSCLC) that has spread through their body. These participants will get SEA-CD40, pembrolizumab, carboplatin, and pemetrexed. Sponsor: Seagen Inc. Intervention: SEA-CD40 Start Date: 2021-10-06 Last Updated: 2023-03-10 Number of Patients: 77 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Melanoma
NCTID: NCT01358877
Title: A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer Study Summary: This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in participants with operable HER2-positive primary breast cancer. This study will be carried out in collaboration with the Breast International Group (BIG). Sponsor: Hoffmann-La Roche Intervention: 5-Fluorouracil Start Date: 2011-11-08 Last Updated: 2023-10-04 Number of Patients: 4804 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT03924895
Title: Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303) Study Summary: This is a study of perioperative pembrolizumab or enfortumab vedotin in combination with pembrolizumab in participants who are cisplatin-ineligible or decline cisplatin with muscle-invasive bladder cancer (MIBC). The primary hypothesis is that perioperative pembrolizumab plus radical cystectomy (RC) plus pelvic lymph node dissection (PLND) and perioperative enfortumab vedotin in combination with pembrolizumab plus RC+PLND will achieve superior event-free survival (EFS) compared with RC+PLND alone. With Amendment 5, outcome measures for programmed cell death ligand 1 (PD-L1) combined positive score (CPS) were removed. With Amendment 8, the primary outcome measure of pathologic complete response (pCR) rates was changed to a secondary outcome measure. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2019-07-24 Last Updated: 2023-11-27 Number of Patients: 857 Recruitment Status: RECRUITING Condition: Urinary Bladder Cancer, Muscle-invasive
NCTID: NCT05665595
Title: A Study of Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab for Resected High-Risk Melanoma in Participants With High-Risk Stage II-IV Melanoma (MK-7684A-010/KEYVIBE-010) Study Summary: The primary purpose of this study is to compare pembrolizumab/vibostolimab to pembrolizumab with respect to recurrence-free survival (RFS). The primary hypothesis is that pembrolizumab/vibostolimab is superior to pembrolizumab with respect to RFS as assessed by the investigator in participants with high-risk resected Stage IIB, IIC, III and IV melanoma. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab/Vibostolimab Start Date: 2023-01-19 Last Updated: 2023-11-24 Number of Patients: 1560 Recruitment Status: RECRUITING Condition: Melanoma
NCTID: NCT03240523
Title: Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids Study Summary: The primary objective of this study is to describe the efficacy of vilaprisan in subjects with uterine fibroids compared to ulipristal. The secondary objective of this study is to evaluate the efficacy and safety of different treatment regimens of vilaprisan in subjects with uterine fibroids. Sponsor: Bayer Intervention: Vilaprisan (BAY1002670) Start Date: 2017-07-31 Last Updated: 2023-06-07 Number of Patients: 766 Recruitment Status: TERMINATED Condition: Uterine Fibroids
NCTID: NCT02993523
Title: A Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Participants With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy Study Summary: Acute Myeloid Leukaemia (AML) is an aggressive and rare cancer of myeloid cells (a white blood cell responsible for fighting infections). Successful treatment of AML is dependent on what subtype of AML the participant has, and the age of the participant when diagnosed. Venetoclax is an experimental drug that kills cancer cells by blocking a protein (part of a cell) that allows cancer cells to stay alive. This study is designed to see if adding venetoclax to azacitidine works better than azacitidine on its own. This is a Phase 3, randomized, double-blind (treatment is unknown to participants and doctors), placebo controlled study in patients with AML who are >= 18 or more years old and have not been treated before. Participants who take part in this study should not be suitable for standard induction therapy (usual starting treatment). AbbVie is funding this study which will take place at approximately 180 hospitals globally and enroll approximately 400 participants. In this study, 2/3 of participants will receive venetoclax every day with azacitidine and the remaining 1/3 will receive placebo (dummy) tablets with azacitidine. Participants will continue to have study visits and receive treatment for as long as they are having a clinical benefit. The effect of the treatment on AML will be checked by taking blood, bone marrow, scans, measuring side effects and by completing health questionnaires. Blood and bone marrow tests will be completed to see why some people respond better than others. Additional blood tests will be completed for genetic factors and to see how long the drug remains in the body. Sponsor: AbbVie Intervention: Azacitidine Start Date: 2017-02-02 Last Updated: 2023-07-03 Number of Patients: 443 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Acute Myeloid Leukemia (AML)
NCTID: NCT02001623
Title: Tisotumab Vedotin (HuMax®-TF-ADC) Safety Study in Patients With Solid Tumors Study Summary: The purpose of the trial is to establish the tolerability of HuMax-TF-ADC in a mixed population of patients with specified solid tumors. Sponsor: Seagen Inc. Intervention: Tisotumab Vedotin (HuMax-TF-ADC) Start Date: 2013-11-30 Last Updated: 2021-12-29 Number of Patients: 195 Recruitment Status: COMPLETED Condition: Ovary Cancer
NCTID: NCT02106546
Title: Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer Study Summary: The purpose of this study is to evaluate the safety and efficacy of the addition of veliparib plus carboplatin and paclitaxel versus the addition of placebo plus carboplatin and paclitaxel in adults with advanced or metastatic squamous non-small cell lung cancer (NSCLC). Sponsor: AbbVie Intervention: Carboplatin Start Date: 2014-04-10 Last Updated: 2020-11-17 Number of Patients: 970 Recruitment Status: COMPLETED Condition: Squamous Non-Small Cell Lung Cancer
NCTID: NCT03522246
Title: A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy Study Summary: This is a Phase 3, randomized, multinational, double-blind, dual placebo-controlled, 4-arm study evaluating rucaparib and nivolumab as maintenance treatment following response to front-line treatment in newly diagnosed ovarian cancer patients. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples. Sponsor: pharmaand GmbH Intervention: Rucaparib Start Date: 2018-05-14 Last Updated: 2023-09-15 Number of Patients: 1000 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Epithelial Ovarian Cancer
NCTID: NCT04043494
Title: International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma Study Summary: Primary objectives: * Randomization R1, all patients eligible: To examine, whether the cumulative incidence of relapses with involvement of the CNS (CNS relapse, pCICR) can be decreased by a modified induction therapy including dexamethasone (experimental arm) instead of prednisone (standard arm) * Randomization R2, only patients with high risk LBL eligible: to examine, whether the probability of event-free survival (pEFS) in these patients can be improved by receiving an intensified treatment arm versus a standard treatment arm (as used in the EURO-LB 02) Sponsor: University Hospital Muenster Intervention: Cyclophosphamide Start Date: 2019-08-23 Last Updated: 2022-12-16 Number of Patients: 683 Recruitment Status: RECRUITING Condition: Lymphoblastic Lymphoma, Childhood
NCTID: NCT00017095
Title: Biomarker (p53 Gene) Analysis and Combination Chemotherapy Followed by Radiation Therapy and Surgery in Treating Women With Large Operable or Locally Advanced or Inflammatory Breast Cancer Study Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Currently patients with breast cancer are treated with one of several very similar combinations of drugs. Analysis of biomarkers in tumor tissue may help doctors predict how well patients with breast cancer will respond to treatment and help doctors choose the best drug regimen to treat each patient. PURPOSE: This randomized phase III trial is studying giving different regimens of chemotherapy and comparing how well they work in treating women with large operable or locally advanced or inflammatory breast cancer. This study is also looking at whether analyzing a specific biomarker (p53) in tumor tissue may help doctors predict how well patients will respond to treatment and help doctors choose the best drug to treat each patient. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: filgrastim Start Date: 2001-03 Last Updated: 2013-10-24 Number of Patients: 1856 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT02513394
Title: PALbociclib CoLlaborative Adjuvant Study Study Summary: This is a prospective, two arm, international, multicenter, randomized, open-label Phase III study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ / HER2- early breast cancer (EBC). The purpose of the PALLAS study is to determine whether the addition of palbociclib to adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HR+/HER2- early breast cancer. Assessment of a variety of correlative analysis, including evaluation of the effect of palbociclib in genomically defined tumor subgroups, is planned. Sponsor: Alliance Foundation Trials, LLC. Intervention: Palbociclib Start Date: 2015-08 Last Updated: 2023-06-15 Number of Patients: 5796 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT00045032
Title: Herceptin (Trastuzumab) in Treating Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Primary Breast Cancer Study Summary: The purpose of this trial is to evaluate Herceptin treatment for 1 year and 2 years (versus observation
o Herceptin) in women with HER2-overexpressing primary breast cancer who have completed (neo-)adjuvant systemic chemotherapy, definitive surgery, and radiotherapy, if applicable. Efficacy and safety will be assessed for 10 years from randomization for each participant. All participants will continue to be followed for survival until 10 years after enrollment of the last participant.
Sponsor: Hoffmann-La Roche Intervention: Herceptin Start Date: 2001-11 Last Updated: 2017-04-27 Number of Patients: 5099 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT00553410
Title: Letrozole in Preventing Cancer in Postmenopausal Women Who Have Received 4-6 Years of Hormone Therapy for Hormone Receptor-Positive, Lymph Node-Positive, Early-Stage Breast Cancer Study Summary: RATIONALE: Estrogen can cause the growth of breast cancer cells. Letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known which regimen of letrozole is more effective in postmenopausal women who have received hormone therapy for early-stage breast cancer. PURPOSE: This randomized phase III trial is comparing two different regimens of letrozole in preventing cancer in postmenopausal women who have received 4-6 years of hormone therapy for hormone receptor-positive, lymph node-positive, early-stage breast cancer. Sponsor: ETOP IBCSG Partners Foundation Intervention: Letrozole Start Date: 2007-08 Last Updated: 2020-03-11 Number of Patients: 4884 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT03783078
Title: Pembrolizumab (MK-3475) as First-line Therapy for Advanced Merkel Cell Carcinoma (MK-3475-913) Study Summary: This is a single-arm, open-label, multicenter, efficacy, and safety study of pembrolizumab in adult and pediatric participants with previously untreated advanced Merkel Cell Carcinoma (MCC). The primary objective of the trial is to assess the objective response rate, as assessed by blinded independent central review per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, following administration of pembrolizumab. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab (MK-3475) Start Date: 2019-02-25 Last Updated: 2023-02-17 Number of Patients: 55 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Merkel Cell Carcinoma
NCTID: NCT02924272
Title: Ixazomib Rollover Study Study Summary: The purpose of this study is to provide continued access to ixazomib and/or other study drugs from an ixazomib parent study. Sponsor: Takeda Intervention: Ixazomib Start Date: 2016-12-16 Last Updated: 2023-01-31 Number of Patients: 31 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Multiple Myeloma
NCTID: NCT00355355
Title: A Phase 3 Study of Talaporfin Sodium and Interstitial Light Emitting Diodes Treating Hepatocellular Carcinoma (HCC) Study Summary: The purpose of the study is to assess the survival of patients treated with Litx™ versus standard of care therapies in the treatment of unresectable hepatocellular carcinoma (HCC), and to demonstrate the safety of Litx™ therapy. Litx™ consists of a light-activated drug, talaporfin sodium (LS11, Light Sciences Oncology, Bellevue, Washington), and a light generating device, composed of light-emitting diodes (LEDs), that is energized by a power controller and percutaneously placed in the target tissue inside the body. Sponsor: Light Sciences Oncology Intervention: Talaporfin sodium Start Date: 2006-07 Last Updated: 2015-01-30 Number of Patients: 208 Recruitment Status: COMPLETED Condition: Carcinoma, Hepatocellular
NCTID: NCT04928846
Title: A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Study Summary: Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to determine if telisotuzumab vedotin works better than docetaxel and to assess how safe telisotuzumab vedotin is in adult participants with NSCLC who have previously been treated. Change in disease activity and adverse events will be assessed. Telisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC. Participants will be randomly assigned a treatment of Teliso-V or Docetax at an 1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin or IV infusion of docetaxel. Approximately 698 adult participants with c-Met overexpressing NSCLC will be enrolled in the study in approximately 250 sites worldwide. Participants will receive IV telisotuzumab vedotin every 2 weeks or docetaxel every 3 weeks until meeting study drug discontinuation criteria. 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: Telisotuzumab Vedotin Start Date: 2022-03-25 Last Updated: 2023-11-27 Number of Patients: 698 Recruitment Status: RECRUITING Condition: Non Small Cell Lung Cancer
NCTID: NCT02504346
Title: AZD9291, an Irreversible EGFR-TKI, in Relapsed EGFR-mutated Non-small Cell Lung Cancer Patients Previously Treated With an EGFR-TKI, Coupled to Extensive Translational Studies Study Summary: Phase II, single-arm study to assess the safety and efficacy of AZD9291 (80 mg, orally, once daily) in second-line (or later) patients with EGFR mutation-positive, locally advanced or metastatic NSCLC, who have progressed following treatment with an approved epidermal growth factor tyrosine kinase inhibitor agent. Sponsor: Oslo University Hospital Intervention: AZD9291 Start Date: 2015-08 Last Updated: 2023-03-28 Number of Patients: 200 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Lung Cancer
NCTID: NCT00440310
Title: Phase 3 Trial of Litx™ Plus Chemotherapy vs. Chemotherapy Only Treating Colorectal Cancer Patients With Recurrent Liver Metastases Study Summary: The purpose of the study is to assess the overall survival and progression free survival of patients treated with Litx™ + chemotherapy versus chemotherapy alone in the treatment of Colorectal Cancer with recurrent liver metastases, and to demonstrate the safety of Litx™ therapy. Litx™ consists of a light-activated drug, talaporfin sodium (LS11, Light Sciences Oncology, Bellevue, Washington), and a light generating device, composed of light-emitting diodes (LEDs), that is energized by a power controller and percutaneously placed in the target tumor tissue inside the body. Sponsor: Light Sciences Oncology Intervention: Talaporfin sodium Start Date: 2007-02 Last Updated: 2015-08-25 Number of Patients: 483 Recruitment Status: COMPLETED Condition: Liver Metastases
NCTID: NCT04222972
Title: A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) Study Summary: This is an international, randomized, open-label, Phase 3 study designed to evaluate whether the potent and selective RET inhibitor, pralsetinib, improves outcomes when compared to a platinum chemotherapy-based regimen chosen by the Investigator from a list of standard of care treatments, as measured primarily by progression free survival (PFS), for participants with RET fusion-positive metastatic NSCLC who have not previously received systemic anticancer therapy for metastatic disease. Participants who have centrally confirmed progressive disease on the control arm have the option to crossover to pralsetinib. Sponsor: Hoffmann-La Roche Intervention: Pralsetinib Start Date: 2020-07-24 Last Updated: 2023-11-13 Number of Patients: 226 Recruitment Status: RECRUITING Condition: RET-fusion Non Small Cell Lung Cancer
NCTID: NCT02312258
Title: A Study of Oral Ixazomib Maintenance Therapy in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Not Treated With Stem Cell Transplantation (SCT) Study Summary: The purpose of this study is to determine the effect of ixazomib maintenance therapy on progression free survival (PFS) compared with placebo, in participants with NDMM who have had a major response (complete response <math display="block">CR</math>, very good partial response <math display="block">VGPR</math>, or partial response <math display="block">PR</math>) to initial therapy and who have not undergone SCT. Sponsor: Takeda Intervention: Placebo Start Date: 2015-04-09 Last Updated: 2023-09-21 Number of Patients: 706 Recruitment Status: COMPLETED Condition: Multiple Myeloma
NCTID: NCT04895358
Title: Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49) Study Summary: The safety and efficacy of pembrolizumab plus the investigator’s choice of chemotherapy will be assessed compared to placebo plus the investigator’s choice of chemotherapy in the treatment of chemotherapy-candidate hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally recurrent inoperable or metastatic breast cancer. The primary hypotheses are that the combination of pembrolizumab and chemotherapy is superior to placebo and chemotherapy in regards to Progression-Free Survival (PFS) or overall survival (OS) in participants with programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) ≥1 and ≥10. Sponsor: Merck Sharp & Dohme LLC Intervention: pembrolizumab Start Date: 2021-06-18 Last Updated: 2023-11-27 Number of Patients: 800 Recruitment Status: RECRUITING Condition: Breast Neoplasms
NCTID: NCT00689936
Title: Study to Determine Efficacy and Safety of Lenalidomide Plus Low-dose Dexamethasone Versus Melphalan, Prednisone, Thalidomide in Patients With Previously Untreated Multiple Myeloma Study Summary: The purpose of this study is to compare the safety and efficacy of Lenalidomide plus low dose dexamethasone to that of the combination of melphalan, prednisone and thalidomide. Sponsor: Celgene Intervention: Lenalidomide and low-dose dexamethasone Start Date: 2008-08-21 Last Updated: 2019-11-20 Number of Patients: 1623 Recruitment Status: COMPLETED Condition: Multiple Myeloma
NCTID: NCT01734928
Title: Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma Study Summary: The purpose of this study is to compare the efficacy of the combination of pomalidomide, bortezomib and low dose dexamethasone to the combination of bortezomib and low dose dexamethasone in participants with relapsed/refractory multiple myeloma. This study will also assess how safe the combination of pomalidomide, bortezomib and low dose dexamethasone is compared to the combination of bortezomib and low dose dexamethasone. Sponsor: Celgene Intervention: Pomalidomide Start Date: 2013-01-07 Last Updated: 2023-06-06 Number of Patients: 559 Recruitment Status: COMPLETED Condition: Multiple Myeloma
NCTID: NCT02828618
Title: Trial on Radical Upfront Surgery in Advanced Ovarian Cancer Study Summary: This study consists of three parts, whereas Part 1 and Part 2 are performed in Germany only, and Part 3 is a multinational trial. All patients with suspicion of advanced ovarian cancer are detected in the participating study centers in a pre-screening. The study centers will register all patients with suspected ovarian cancer in a screening log. After the patients have given informed consent, they can be enrolled in different parts of the study. TRUST-Trial: This part compares two strategies in the therapy of advanced ovarian cancer. En detail, this part of the trial will evaluate if one of two strategies of timing surgery within the therapeutic procedures may show any significant advances in terms of overall survival over the other. Sponsor: AGO Study Group Intervention: PDS (Primary Debulkdung Surgery) Start Date: 2016-07 Last Updated: 2023-02-03 Number of Patients: 797 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Ovarian 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: NCT04129502
Title: TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations Study Summary: The purpose of this study is to compare the effectiveness of TAK-788 as first-line treatment with that of platinum-based chemotherapy in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors has epidermal growth factor receptor (EGFR) exon 20 insertion mutations. Participants will be randomly assigned to one of the two treatment groups- TAK-788 group or Platinum-based chemotherapy group. Participants will receive TAK-788 orally and pemetrexed/cisplatin or pemetrexed/carboplatin via vein until the participants experience worsening disease (PD) as assessed by blinded independent review committee (IRC), intolerable harmful effects or another discontinuation criteria. Sponsor: Takeda Intervention: TAK-788 Start Date: 2020-01-10 Last Updated: 2023-04-07 Number of Patients: 354 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
NCTID: NCT05144841
Title: A Study to Evaluate Zilovertamab Vedotin (MK-2140) for Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (MK-2140-004) Study Summary: The purpose of this study is to evaluate zilovertamab vedotin with respect to objective response rate and duration of response per Lugano Response Criteria as assessed by blinded independent central review (BICR). Safety and tolerability will also be evaluated in this Phase 2, single arm, interventional study. Sponsor: Merck Sharp & Dohme LLC Intervention: MK-2140 (zilovertamab vedotin) Start Date: 2022-01-08 Last Updated: 2023-11-27 Number of Patients: 140 Recruitment Status: RECRUITING Condition: Relapsed or Refractory Diffuse Large B-Cell Lymphoma
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: NCT04486378
Title: A Phase II Clinical Trial Comparing the Efficacy of RO7198457 Versus Watchful Waiting in Patients With ctDNA-positive, Resected Stage II (High Risk) and Stage III Colorectal Cancer Study Summary: This is a multi-site, open-label, Phase II, randomized, trial to compare the efficacy of RO7198457 versus watchful waiting in patients with circulating tumor DNA (ctDNA) positive, surgically resected Stage II/III rectal cancer, or Stage II (high risk)/Stage III colon cancer. Sponsor: BioNTech SE Intervention: RO7198457 intravenous (i.v.) Start Date: 2021-03-08 Last Updated: 2023-11-08 Number of Patients: 201 Recruitment Status: RECRUITING Condition: Colorectal Cancer Stage II
NCTID: NCT01344018
Title: Surgery With or Without Radiation Therapy in Untreated Nonmetastatic Retroperitoneal Sarcoma Study Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether surgery is more effective with or without radiation therapy in treating nonmetastatic retroperitoneal soft tissue sarcoma. PURPOSE: This randomized phase III trial is studying radiation therapy followed by surgery to see how well it works compared with surgery alone in treating patients with previously untreated nonmetastatic retroperitoneal soft tissue sarcoma. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: therapeutic conventional surgery Start Date: 2012-01 Last Updated: 2023-04-24 Number of Patients: 266 Recruitment Status: COMPLETED Condition: Sarcoma
NCTID: NCT02603432
Title: A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100) Study Summary: The main purpose of this study is to compare maintenance treatment with avelumab plus best supportive care (BSC) with BSC alone, to determine if avelumab has an effect on survival in patients with locally advanced or metastatic urothelial cancer that did not worsen during or following completion of first-line chemotherapy. Sponsor: Pfizer Intervention: Avelumab Start Date: 2016-04-25 Last Updated: 2023-06-06 Number of Patients: 700 Recruitment Status: COMPLETED Condition: Urothelial Cancer
NCTID: NCT04503278
Title: A Trial to Evaluate the Safety and Efficacy of CLDN6 CAR-T +/- CLDN6 RNA-LPX Study Summary: This is a Phase I/IIa, FIH, open-label, multicenter, dose escalation trial with expansion cohorts to evaluate safety and preliminary efficacy of CLDN6 CAR-T/CLDN6 CAR-T(A) with or without CLDN6 RNA-LPX in patients with CLDN6-positive relapsed or refractory advanced solid tumors. The trial started with CLDN6 RNA-LPX, a liposomal formulation comprising an unmodified RNA. In order to optimize CAR-T cell persistence in patients, an alternative RNA-LPX, CLDN6 modRNA-LPX, will be tested once the RP2D dose for CLDN6 CAR-T(A) ± CLDN6 RNA-LPX is identified. Sponsor: BioNTech Cell & Gene Therapies GmbH Intervention: CLDN6 CAR-T/CLDN6 CAR-T(A) Start Date: 2020-09-16 Last Updated: 2023-11-27 Number of Patients: 114 Recruitment Status: RECRUITING Condition: Solid Tumor
NCTID: NCT03511664
Title: Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer Study Summary: The primary objective of this study was to compare the two alternate primary endpoints of radiographic progression-free survival (rPFS) and overall survival (OS) in patients with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who received 177Lu-PSMA-617 in addition to best supportive/best standard of care (BSC/BSoC) versus patients treated with best supportive/best standard of care alone. Sponsor: Endocyte Intervention: 177Lu-PSMA-617 Start Date: 2018-05-29 Last Updated: 2023-10-12 Number of Patients: 831 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Prostate Cancer
NCTID: NCT03867084
Title: Safety and Efficacy of Pembrolizumab (MK-3475) Versus Placebo as Adjuvant Therapy in Participants With Hepatocellular Carcinoma (HCC) and Complete Radiological Response After Surgical Resection or Local Ablation (MK-3475-937 / KEYNOTE-937) Study Summary: This study will evaluate the safety and efficacy of pembrolizumab (MK-3475) versus placebo as adjuvant therapy in participants with hepatocellular carcinoma (HCC) and complete radiological response after surgical resection or local ablation. The primary hypotheses of this study are that adjuvant pembrolizumab is superior to placebo with respect to: 1) recurrence-free survival (RFS) as assessed by blinded independent central review (BICR); and 2) overall survival (OS). Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2019-05-28 Last Updated: 2023-09-08 Number of Patients: 950 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Hepatocellular Carcinoma
NCTID: NCT01607957
Title: Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies Study Summary: The purpose of this study is to compare the efficacy and safety of TAS-102 versus placebo in patients with refractory metastatic colorectal cancer. Sponsor: Taiho Oncology, Inc. Intervention: TAS-102 Start Date: 2012-06-17 Last Updated: 2020-06-04 Number of Patients: 800 Recruitment Status: COMPLETED Condition: Colorectal Cancer
NCTID: NCT03535740
Title: A Study of Brigatinib in Participants With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non-Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib Study Summary: The primary purpose of this study is to determine the efficacy of brigatinib by confirmed objective response rate (ORR) by response evaluation criteria in solid tumors (Response Evaluation Criteria in Solid Tumors <math display="block">RECIST</math>), in participants with ALK+ locally advanced or metastatic NSCLC whose disease has progressed on therapy with alectinib or ceritinib. Sponsor: Ariad Pharmaceuticals Intervention: Brigatinib Start Date: 2019-01-31 Last Updated: 2023-08-25 Number of Patients: 103 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: ALK-positive Advanced NSCLC
NCTID: NCT02003924
Title: Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer Study Summary: The purpose of this study is to assess the safety and efficacy of enzalutamide in patients with non metastatic prostate cancer. Sponsor: Pfizer Intervention: Enzalutamide Start Date: 2013-10-31 Last Updated: 2023-10-10 Number of Patients: 1401 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Nonmetastatic Castration-Resistant Prostate Cancer
NCTID: NCT04497844
Title: A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) Study Summary: The purpose of the study is to determine if the combination of niraparib with Abiraterone Acetate (AA) plus prednisone compared with AA plus prednisone in participants with deleterious germline or somatic Homologous Recombination Repair (HRR) gene-mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) provides superior efficacy in improving radiographic progression-free survival (rPFS). Sponsor: Janssen Research & Development, LLC Intervention: Niraparib Start Date: 2020-09-23 Last Updated: 2023-11-09 Number of Patients: 696 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Castration-sensitive Prostate Cancer
NCTID: NCT00353496
Title: Study of Lanreotide Autogel in Non-functioning Entero-pancreatic Endocrine Tumours Study Summary: The study will compare the difference between lanreotide Autogel and placebo on progression free survival in patients who have an endocrine tumour in the pancreas or intestines. Sponsor: Ipsen Intervention: lanreotide (Autogel formulation) Start Date: 2006-06 Last Updated: 2022-10-12 Number of Patients: 264 Recruitment Status: COMPLETED Condition: Endocrine Tumors
NCTID: NCT05270044
Title: Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation. Study Summary: The purpose of the Columbus-AD study is to evaluate the efficacy and safety of 12 months of encorafenib in combination with binimetinib in adjuvant setting of BRAF V600E/K mutant stage IIB/C melanoma versus the current standard of care (surveillance). Sponsor: Pierre Fabre Medicament Intervention: Encorafenib and Binimetinib Start Date: 2022-05-02 Last Updated: 2023-11-22 Number of Patients: 815 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Melanoma
NCTID: NCT00064974
Title: Efficacy and Safety Study of CC-5013 Monotherapy in Subjects With Myelodysplastic Syndromes Study Summary: This study is a multi-center, single-arm, open-label study of oral CC-5013 monotherapy administered at a dose of 10 mg daily on Days 1-21 every 28 days (28-day cycles) to red blood cell (RBC) transfusion-dependent subjects with low- or intermediate-1-risk MDS who do not have a del (5q31-33) cytogenetic abnormality. Screening procedures will take place within 28 days of first day of study drug treatment. Subjects will receive study drug (CC-5013) in 28-day cycles for up to 6 cycles, or until bone marrow disease progression or progression/relapse following erythroid hematologic improvement (Appendix I) is documented. Study visits will occur every cycle (every 28 days) and laboratory monitoring to assess hematological parameters will occur every 14 days. Safety and efficacy assessments to be performed during the study are outlined in the Schedule of Study Assessments. Sponsor: Celgene Corporation Intervention: CC-5013 Start Date: 2003-06 Last Updated: 2013-04-04 Number of Patients: 215 Recruitment Status: COMPLETED Condition: Myelodysplastic Syndromes
NCTID: NCT04221035
Title: High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN) Study Summary: This is an international multicenter, open-label, randomized phase III trial including three sequential randomizations to assess efficacy of induction and consolidation chemotherapies and radiotherapy for patients with high-risk neuroblastoma. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Vincristine Start Date: 2019-11-05 Last Updated: 2023-02-13 Number of Patients: 800 Recruitment Status: RECRUITING Condition: High-Risk Neuroblastoma
NCTID: NCT04631601
Title: Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer (mCRPC) Study Summary: This is a master protocol designed to evaluate the safety and efficacy of investigational therapies in participants with metastatic castration-resistant prostate cancer (mCRPC). Sponsor: Amgen Intervention: Acapatamab Start Date: 2021-01-15 Last Updated: 2023-11-07 Number of Patients: 65 Recruitment Status: TERMINATED Condition: Metastatic Castration-resistant Prostate Cancer
NCTID: NCT04272034
Title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors Study Summary: The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of INCB099318 in select solid tumors. Sponsor: Incyte Corporation Intervention: INCB099318 Start Date: 2021-03-26 Last Updated: 2023-08-16 Number of Patients: 105 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Advanced Solid Tumors
NCTID: NCT03804580
Title: First-line Treatment With Osimertinib in EGFR-mutated Non-small Cell Lung Cancer Study Summary: Phase II, single-arm study to assess the safety and efficacy of osimertinib (80 mg, orally, once daily) as first-line therapy in patients with EGFR mutation-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously treated with an epidermal growth factor tyrosine kinase inhibitor agent. Sponsor: Vestre Viken Hospital Trust Intervention: osimertinib Start Date: 2018-12-01 Last Updated: 2022-04-07 Number of Patients: 100 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Lung Cancer
NCTID: NCT04303780
Title: Study to Compare AMG 510 “Proposed INN Sotorasib” With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200). Study Summary: A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC) subjects with KRAS p. G12c mutation Sponsor: Amgen Intervention: AMG 510 Start Date: 2020-06-04 Last Updated: 2023-10-23 Number of Patients: 345 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: KRAS p, G12c Mutated /Advanced Metastatic NSCLC
NCTID: 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 ≥10% 2+/3+ tumor cell staining (FGFR2b ≥10% 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: NCT01849874
Title: A Study of MEK162 vs. Physician’s Choice Chemotherapy in Patients With Low-grade Serous Ovarian, Fallopian Tube or Peritoneal Cancer Study Summary: The MILO Study (MEK Inhibitor in Low-grade Serous Ovarian Cancer) is a Phase 3 study during which patients with recurrent or persistent low-grade serous (LGS) carcinomas of the ovary, fallopian tube or primary peritoneum will receive either investigational study drug MEK162 or a chemotherapy chosen by the physician (liposomal doxorubicin, paclitaxel or topotecan). Patients will be followed to compare the effectiveness of the study drug to that of the selected chemotherapies. Patients may be eligible to crossover from physician’s choice chemotherapy to MEK162 if they meet certain inclusion criteria including centrally confirmed disease progression. Approximately 360 patients from North America, Europe and Australia will be enrolled in this study. Sponsor: Pfizer Intervention: MEK162, MEK inhibitor; oral Start Date: 2013-06-27 Last Updated: 2023-10-30 Number of Patients: 341 Recruitment Status: TERMINATED Condition: Low-grade Serous Ovarian Cancer
NCTID: NCT01178281
Title: Study of Pomalidomide in Persons With Myeloproliferative-Neoplasm-Associated Myelofibrosis and RBC-Transfusion-Dependence Study Summary: The objective of this study is to determine whether pomalidomide is safe and effective in reversing red blood cell (RBC)-transfusion-dependence in persons with myeloproliferative neoplasm (MPN)-associated myelofibrosis (global study) and in reversing anemia in Chinese with MPN-associated myelofibrosis and severe anemia not receiving RBC-transfusions (China extension study only) Sponsor: Celgene Intervention: Pomalidomide 0.5 mg Start Date: 2010-09-08 Last Updated: 2019-07-17 Number of Patients: 267 Recruitment Status: COMPLETED Condition: Primary Myelofibrosis
NCTID: NCT03221634
Title: Efficacy and Safety Study of Pembrolizumab (MK-3475) in Combination With Daratumumab in Participants With Relapsed Refractory Multiple Myeloma (MK-3475-668/KEYNOTE-668) Study Summary: The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) in combination with daratumumab in participants with relapsed refractory multiple myeloma (rrMM). The primary outcome measure for this study is the assessment of Objective Response Rate (ORR) in participants with rrMM. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2017-08-01 Last Updated: 2019-03-25 Number of Patients: 0 Recruitment Status: WITHDRAWN Condition: Multiple Myeloma
NCTID: NCT02218801
Title: A Prospective Colorectal Liver Metastasis Database With an Integrated Quality Assurance Program Study Summary: This prospective database has two main objectives; * to evaluate the complication rates, 30-day and 90-day mortality from different surgical strategies for unresectable, borderline resectable or initially unresectable liver metastasis from colorectal cancer. * to establish baseline quality parameters for different surgical strategies for unresectable, borderline and initially unresectable colorectal liver metastasis (CRLM) patients. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Evaluation of treatment for liver metastasis Start Date: 2015-05 Last Updated: 2022-05-31 Number of Patients: 219 Recruitment Status: COMPLETED Condition: Liver Metastasis
NCTID: NCT05735834
Title: Comparison Between Rituximab Plus Zanubrutinib Versus Rituximab Monotherapy in Untreated SMZL Patients Study Summary: The goal of this clinical trial is to compare the efficacy and tolerability of the combination of two medicinal products, rituximab, and zanubrutinib, compared to rituximab monotherapy in patients with Splenic Marginal Zone Lymphoma (SMZL), previously untreated and who need systemic treatment. The main questions it aims to answer are: * Is the combination rituximab and zanubrutinib a more effective therapy than rituximab monotherapy? * Is the combination therapy, rituximab and zanubrutinib, well tolerated? Study participants will be put into one of the two treatment groups (rituximab and zanubrutinib or rituximab alone) for a maximum of two years and will undergo regular visits until three years from treatment start. Sponsor: International Extranodal Lymphoma Study Group (IELSG) Intervention: Rituximab Start Date: 2024-02 Last Updated: 2023-10-23 Number of Patients: 120 Recruitment Status: NOT_YET_RECRUITING Condition: Splenic Marginal Zone Lymphoma
NCTID: NCT00625898
Title: BETH Study: Treatment of HER2 Positive Breast Cancer With Chemotherapy Plus Trastuzumab vs Chemotherapy Plus Trastuzumab Plus Bevacizumab Study Summary: The trial will determine the value of adding bevacizumab to chemotherapy plus trastuzumab in patients with resected node-positive or high risk node-negative, HER2-positive breast cancer. Sponsor: NSABP Foundation Inc Intervention: Docetaxel Start Date: 2008-04 Last Updated: 2020-09-10 Number of Patients: 3509 Recruitment Status: TERMINATED Condition: Breast Cancer
NCTID: NCT02130557
Title: A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia Study Summary: Phase 3, 2-arm, randomized, open label trial. Patients will be randomized to receive bosutinib or imatinib for the duration of the study. Sponsor: Pfizer Intervention: Bosutinib Start Date: 2014-07-15 Last Updated: 2021-05-18 Number of Patients: 536 Recruitment Status: COMPLETED Condition: Leukemia, Myelogenous, Chronic, Breakpoint Cluster Region-Abelson Proto-oncogene (BCR-ABL) Positive
NCTID: NCT00003636
Title: Chemotherapy Plus Surgery in Treating Patients With Stage III or Stage IV Ovarian, Peritoneal, or Fallopian Tube Cancer Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining surgery with chemotherapy may kill more tumor cells. It is not yet known whether chemotherapy before surgery is more effective than chemotherapy after surgery in treating ovarian, peritoneal, or fallopian tube cancer. PURPOSE: This randomized phase III trial is studying chemotherapy given before surgery to see how well it works compared to chemotherapy given after surgery with or without additional surgery in treating patients with stage III or stage IV ovarian cancer, peritoneal cancer, or fallopian tube cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: carboplatin Start Date: 1998-09 Last Updated: 2015-08-05 Number of Patients: 704 Recruitment Status: COMPLETED Condition: Fallopian Tube Cancer
NCTID: NCT03776136
Title: Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) for Advanced Melanoma in Anti-Programmed Death-1/Programmed Death-Ligand 1 (PD-1/L1)-Exposed Participants (MK-7902-004/E7080-G000-225/LEAP-004) Study Summary: This study will evaluate the safety and efficacy of combination therapy of lenvatinib (E7080/MK-7902) and pembrolizumab following approximately 2 years of pembrolizumab therapy and approximately 2 years or more lenvatinib therapy in adult participants with unresectable or advanced melanoma who have been exposed to anti-PD-1/L1 agents approved for unresectable or metastatic melanoma. No statistical hypothesis will be tested in this study. Sponsor: Merck Sharp & Dohme LLC Intervention: lenvatinib Start Date: 2019-01-30 Last Updated: 2023-10-17 Number of Patients: 103 Recruitment Status: COMPLETED Condition: Advanced Melanoma
NCTID: NCT03748641
Title: A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer Study Summary: The purpose of this study is to evaluate the effectiveness of niraparib in combination with abiraterone acetate plus prednisone (AAP) compared to AAP and placebo. Sponsor: Janssen Research & Development, LLC Intervention: Niraparib Start Date: 2019-01-25 Last Updated: 2023-11-13 Number of Patients: 765 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Castration-Resistant Prostatic Cancer
NCTID: NCT05218499
Title: Brightline-1: A Study to Compare BI 907828 With Doxorubicin in People With a Type of Cancer Called Dedifferentiated Liposarcoma Study Summary: This study is open to people with a type of cancer called dedifferentiated liposarcoma. People with advanced liposarcoma aged 18 or older who are not receiving any other cancer treatment can participate. The purpose of this study is to compare a medicine called BI 907828 with doxorubicin in people with liposarcoma. BI 907828 is a so-called MDM2 inhibitor that is being developed to treat cancer. Doxorubicin is a medicine already used to treat cancer including liposarcoma. During the study, participants get either BI 907828 or doxorubicin. Every 3 weeks, participants take BI 907828 as tablets or doxorubicin as an infusion into a vein. Participants can switch to BI 907828 treatment if they did not benefit from doxorubicin treatment. Participants can continue treatment in the study as long as they benefit from it and can tolerate it. Doctors regularly check the size of the tumour and check whether it has spread to other parts of the body. The doctors also regularly check participants’ health and take note of any unwanted effects. Sponsor: Boehringer Ingelheim Intervention: BI 907828 Start Date: 2022-03-25 Last Updated: 2023-11-07 Number of Patients: 400 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Liposarcoma, Dedifferentiated
NCTID: NCT05064670
Title: Exercise as Medicine for People With Cancer Sweden Study Summary: Regular exercise has been shown to have beneficial health effects in cancer survivors, including improving quality of life and other important health outcomes. However, providing people with cancer with easily accessible, high-quality exercise support and programs is a challenge. Therefore, there is a need to develop easily accessible exercise programs that draw upon the current evidence. Supervised, distance-based exercise programs have the benefit of reaching out to many people while providing the support of an exercise professional. The aim of the EX-MED Cancer Sweden trial is to examine the effectiveness of a supervised, distance-based exercise program, in people previously treated for breast, prostate, or colorectal cancer, on health-related quality of life (HRQoL), as well as other physiological and patient-reported health outcomes. Participants will be randomized to a 3-month supervised, distance-based exercise program or to a usual care control group. Testing timepoints are baseline, 3 months (end of intervention) and 6 months (3 month followup). At these timepoints, patients will be asked to fill in online questionaires, and and undergo physical tests. A selection of the particpants and personal trainers involved in the intervention will also be invited to participate in focus group discussion or interviews about the experiences of being involved in the EX-MED Cancer Sweden program. Sponsor: Karolinska Institutet Intervention: Exercise Start Date: 2022-01-11 Last Updated: 2023-01-05 Number of Patients: 200 Recruitment Status: RECRUITING Condition: Prostate Cancer
NCTID: NCT02631070
Title: A Study of Luspatercept (ACE-536) to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes Study Summary: The study will be conducted in compliance with the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements. This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study to determine the efficacy and safety of luspatercept (ACE-536) versus placebo in participants with anemia due to the Revised International Prognostic Scoring System (IPSS-R) very low, low, or intermediate MDS with ring sideroblasts who require red blood cell (RBC) transfusions. Sponsor: Celgene Intervention: Luspatercept Start Date: 2016-02-09 Last Updated: 2021-12-17 Number of Patients: 229 Recruitment Status: COMPLETED Condition: Myelodysplastic Syndromes
NCTID: NCT03033511
Title: A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First- Line Platinum-Based Chemotherapy in Participants With Extensive Stage Small Cell Lung Cancer (MERU) Study Summary: This is a Phase 3, randomized, double-blind, placebo-controlled, multinational, and multicenter study to evaluate the efficacy of rovalpituzumab tesirine as maintenance therapy following first-line platinum-based chemotherapy. Sponsor: AbbVie Intervention: Placebo for dexamethasone Start Date: 2017-02-07 Last Updated: 2021-07-29 Number of Patients: 748 Recruitment Status: TERMINATED Condition: Small Cell Lung Cancer
