Trials (Catalan Institute of Oncology)
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NCTID: NCT02831959
Title: Pivotal, Open-label, Randomized Study of Radiosurgery With or Without Tumor Treating Fields (TTFields) for 1-10 Brain Metastases From Non-small Cell Lung Cancer (NSCLC). Study Summary: The study is a prospective, randomized controlled phase III trial, to test the efficacy, safety and neurocognitive outcomes of advanced NSCLC patients, following stereotactic radiosurgery (SRS) for 1 inoperable brain metastasis or 2-10 brain metastases, treated with NovoTTF-200M and supportive treatment compared to supportive treatment alone. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays. Sponsor: NovoCure GmbH Intervention: NovoTTF-200M device Start Date: 2016-07 Last Updated: 2023-03-10 Number of Patients: 270 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Brain Metastases From Non-small Cell Lung Cancer (NSCLC)
NCTID: NCT02812875
Title: A Study of CA-170 (Oral PD-L1, PD-L2 and VISTA Checkpoint Antagonist) in Patients With Advanced Tumors and Lymphomas Study Summary: CA-170 is a rationally designed and orally available, small molecule that directly targets the Programmed death-ligands 1 and 2 (PD-L1/PD-L2), and V-domain Ig suppressor of T cell activation (VISTA) immune checkpoints and results in activation of T cell proliferation and cytokine production. This is a multi-center, open-label, Phase 1 trial of orally administered CA-170 in adult patients with advanced solid tumors or lymphomas who have progressed or are non-responsive to available therapies and for which no standard therapy exists. Sponsor: Curis, Inc. Intervention: CA-170 Start Date: 2016-05 Last Updated: 2020-06-26 Number of Patients: 71 Recruitment Status: COMPLETED Condition: Advanced Solid Tumors or Lymphomas
NCTID: NCT03725059
Title: Study of Pembrolizumab (MK-3475) Versus Placebo in Combination With Neoadjuvant Chemotherapy & Adjuvant Endocrine Therapy in the Treatment of Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (MK-3475-756/KEYNOTE-756) Study Summary: The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in the treatment of adults who have high-risk early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer. The primary study hypotheses are: 1) pembrolizumab is superior to placebo, both in combination with the protocol-specified neoadjuvant anticancer therapy, as assessed by pathological Complete Response (pCR) rate defined by the local pathologist, and 2) pembrolizumab is superior to placebo (both in combination with the protocol-specified neoadjuvant and adjuvant anticancer therapies) as assessed by Event-Free Survival (EFS) as determined by the investigator. The study is considered to have met its primary objective if pembrolizumab is superior to placebo with respect to either pCR (ypT0/Tis ypN0) or EFS. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab (K) Start Date: 2018-12-27 Last Updated: 2023-09-28 Number of Patients: 1240 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT05514054
Title: A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer Study Summary: The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years. Sponsor: Eli Lilly and Company Intervention: Imlunestrant Start Date: 2022-10-04 Last Updated: 2023-10-24 Number of Patients: 6000 Recruitment Status: RECRUITING Condition: Breast Neoplasms
NCTID: NCT05556616
Title: A Study of Modakafusp Alfa in Adult Participants With Multiple Myeloma Study Summary: The main aims of this study are to test for any side effects from modakafusp alfa in combination therapy and to determine the recommended dose of combination therapy with modakafusp. The dose of modakafusp alfa will be increased a little at a time until the highest dose that does not cause harmful side effects is found. Participants will be given modakafusp alfa through a vein. Sponsor: Takeda Intervention: Modakafusp alfa Start Date: 2022-10-27 Last Updated: 2023-11-15 Number of Patients: 120 Recruitment Status: RECRUITING Condition: Multiple Myeloma
NCTID: NCT03396445
Title: Study of Boserolimab (MK-5890) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Adults With Advanced Solid Tumors (MK-5890-001) Study Summary: The purpose of this study is to assess the safety and pharmacokinetics of boserolimab (MK-5890) when administered alone and in combination with pembrolizumab (MK-3475) in adults with advanced solid tumors. The initial course of boserolimab monotherapy or boserolimab plus pembrolizumab combination therapy will be for up to 35 administrations (approximately 2 years). The safety and pharmacokinetics of boserolimab when administered with pembrolizumab, pemetrexed and carboplatin in adults with non squamous non-small cell lung cancer (NSCLC) and boserolimab when administered with pembrolizumab and nab-paclitaxel in adults with triple-negative breast cancer (TNBC) will also be assessed. Sponsor: Merck Sharp & Dohme LLC Intervention: Boserolimab Start Date: 2018-02-18 Last Updated: 2023-04-11 Number of Patients: 202 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Pharmacokinetics
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: NCT04014075
Title: DS-8201a in HER2-positive Gastric Cancer That Cannot Be Surgically Removed or Has Spread (DESTINY-Gastric02) Study Summary: This study will find out if trastuzumab deruxtecan is safe and works for participants with gastric or gastroesophageal junction cancer. They must have human epidermal growth factor receptor 2 (HER2)-positive gastric or gastro-esophageal junction (GEJ) cancer: * that cannot be removed surgically * that has moved to other parts of the body * that got worse during or after treatment that included trastuzumab The study will enroll about 80 participants. Sites will be in North America and the European Union. Sponsor: Daiichi Sankyo, Inc. Intervention: Trastuzumab deruxtecan Start Date: 2019-11-26 Last Updated: 2023-05-03 Number of Patients: 79 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Adenocarcinoma Gastric Stage IV With Metastases
NCTID: NCT03257267
Title: Study of Cemiplimab in Adults With Cervical Cancer Study Summary: The primary objective is to compare overall survival (OS) for patients with recurrent or metastatic cervical cancer who have histology of squamous cell carcinoma (SCC) and who have any eligible histology treated with either cemiplimab or investigator’s choice (IC) chemotherapy. The secondary objectives performed among SCC patients and among all eligible histologies (SCC and adenocarcinoma/adenosquamous carcinoma (AC) are: * To compare progression-free survival (PFS) of cemiplimab versus IC chemotherapy * To compare objective response rate (ORR) (partial response <math display="block">PR</math> + complete response <math display="block">CR</math>) of cemiplimab versus IC chemotherapy per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 * To compare the duration of response (DOR) of cemiplimab versus IC chemotherapy * To compare the safety profiles of cemiplimab versus IC chemotherapy by describing adverse events (AE) * To compare quality of life (QOL) for patients treated with cemiplimab versus IC chemotherapy using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Sponsor: Regeneron Pharmaceuticals Intervention: Cemiplimab Start Date: 2017-09-05 Last Updated: 2023-07-11 Number of Patients: 608 Recruitment Status: COMPLETED Condition: Squamous Cell Carcinoma (SCC)
NCTID: NCT04844866
Title: Efficacy and Safety of MB-CART2019.1 vs. SoC in Lymphoma Patients Study Summary: This is a pivotal Phase II randomised, multi-centre, open-label study to evaluate the efficacy and safety of MB-CART2019.1 compared to standard of care therapy in participants with relapsed/refractory diffuse large B-cell lymphoma, who are not eligible for high-dose chemotherapy and autologous stem cell transplantation. Sponsor: Miltenyi Biomedicine GmbH Intervention: MB-CART2019.1 Start Date: 2021-08-18 Last Updated: 2023-11-07 Number of Patients: 168 Recruitment Status: RECRUITING Condition: Diffuse Large B-cell Lymphoma
NCTID: NCT05501886
Title: Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1) Study Summary: This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy. Sponsor: Celcuity, Inc. Intervention: Gedatolisib Start Date: 2022-09-30 Last Updated: 2023-08-01 Number of Patients: 701 Recruitment Status: RECRUITING Condition: Breast Cancer
NCTID: NCT02438007
Title: A Study of Galeterone Compared to Enzalutamide In Men Expressing Androgen Receptor Splice Variant-7 mRNA (AR-V7) Metastatic CRPC Study Summary: The purpose of this study is to compare galeterone to enzalutamide in men expressing androgen receptor spice variant-7 mRNA (AR-V7) in metastatic (M1) castrate resistant prostate cancer (CRPC). Sponsor: LTN PHARMACEUTICALS, INC. Intervention: Galeterone Start Date: 2015-06 Last Updated: 2023-03-15 Number of Patients: 953 Recruitment Status: TERMINATED Condition: Prostate Cancer
NCTID: NCT03834519
Title: Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-7339-010/KEYLYNK-010) Study Summary: The purpose of this study is to assess the efficacy and safety of the combination of the polyadenosine 5’-diphosphoribose poly (ADP-ribose) polymerase (PARP) inhibitor olaparib and pembrolizumab in the treatment of participants with mCRPC who have failed to respond to either abiraterone acetate or enzalutamide (but not both) and to chemotherapy. The primary study hypotheses are that the combination of pembrolizumab plus olaparib is superior to abiraterone acetate or enzalutamide with respect to: # Overall Survival (OS) and # Radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 as assessed by blinded independent central review (BICR) As of Amendment 06, the Data Monitoring Committee (DMC) is no longer applicable. Participants still on treatment may have the option to continue receiving study intervention or SOC if they are deriving clinical benefit, until criteria for discontinuation are met. Participants who are still on study treatment and deriving clinical benefit will no longer have tumor response assessments by BICR. However, local tumor imaging assessments should continue per SOC schedule. In addition, ePRO assessments will no longer be performed and biomarker samples will no longer be collected. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2019-05-02 Last Updated: 2023-11-07 Number of Patients: 793 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Prostatic Neoplasms
NCTID: NCT01272037
Title: Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer Study Summary: This randomized phase III clinical trial studies how well tamoxifen citrate, anastrozole, letrozole, or exemestane with or without chemotherapy work in treating patients with breast cancer that has spread from where it began in the breast to surrounding normal tissue (invasive). Estrogen can cause the growth of breast cancer cells. Hormone therapy, using tamoxifen citrate, may fight breast cancer by blocking the use of estrogen by the tumor cells. Aromatase inhibitors, such as anastrozole, letrozole, and exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving tamoxifen citrate, anastrozole, letrozole, or exemestane is more effective with combination chemotherapy in treating patients with breast cancer. Sponsor: National Cancer Institute (NCI) Intervention: Anastrozole Start Date: 2011-01-15 Last Updated: 2023-11-14 Number of Patients: 5018 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Ductal Carcinoma In Situ
NCTID: NCT04211337
Title: A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer Study Summary: The reason for this study is to see if the study drug selpercatinib is safe and more effective compared to a standard treatment in participants with rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC) that cannot be removed by surgery or has spread to other parts of the body. Participants who are assigned to the standard treatment and discontinue due to progressive disease have the option to potentially crossover to selpercatinib. Sponsor: Loxo Oncology, Inc. Intervention: Selpercatinib Start Date: 2020-02-11 Last Updated: 2023-10-30 Number of Patients: 291 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Medullary Thyroid Cancer
NCTID: NCT04674683
Title: Study Comparing Investigational Drug HBI-8000 Combined With Nivolumab vs. Nivolumab in Patients With Advanced Melanoma Study Summary: This is a phase 3 study to compare the efficacy and safety of HBI-8000 or Placebo combined with nivolumab on patients with unresectable or metastatic melanoma and eligible patients who are not adolescents or patients with new, progressive brain metastasis will be stratified by PD-L1 expression and LDH level. Sponsor: HUYABIO International, LLC. Intervention: HBI-8000 in combination with nivolumab Start Date: 2021-08-12 Last Updated: 2023-07-27 Number of Patients: 480 Recruitment Status: RECRUITING Condition: Unresectable or Metastatic Melanoma
NCTID: 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: NCT03694522
Title: A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer Study Summary: The main objective of the Phase 2 part of the study is to evaluate the efficacy of bemarituzumab (FPA144), a targeted antibody, in combination with modified FOLFOX6 compared to placebo in combination with modified FOLFOX6 in participants with advanced gastrointestinal cancer. Sponsor: Five Prime Therapeutics, Inc. Intervention: Bemarituzumab Start Date: 2018-09-14 Last Updated: 2022-12-16 Number of Patients: 155 Recruitment Status: COMPLETED Condition: Gastric Cancer
NCTID: NCT05458297
Title: A Study of Zilovertamab Vedotin (MK-2140) as Monotherapy and in Combination in Participants With Aggressive and Indolent B-cell Malignancies (MK-2140-006) Study Summary: The purpose of this study is to assess the safety and tolerability of zilovertamab vedotin as monotherapy and in combination in participants with select B-cell lymphomas including mantle cell lymphoma (MCL), Richter’s transformation lymphoma (RTL), follicular lymphoma (FL), and chronic lymphocytic leukemia (CLL). This study will also evaluate zilovertamab vedotin as monotherapy and in combination with respect to objective response rate. * Cohort A: Participants with relapsed or refractory MCL relapsed or refractory disease after at least 2 prior systemic therapies including a Bruton’s tyrosine kinase inhibition/inhibitor (BTKi), and post therapy chimeric antigen receptor T (CAR-T) cell therapy or ineligible for CAR-T cell therapy * Cohort B: Participants with relapsed or refractory RT disease after at least 1 prior systemic therapy * Cohort C: Participants with relapsed or refractory MCL relapsed or refractory disease after at least 1 prior systemic therapy and no prior exposure to a non-covalent BTKi * Cohort D: Participants with relapsed or refractory FL and CLL relapsed or refractory disease after at least 2 prior systemic therapies and have no other available therapy * Cohort E: Participants with relapsed or refractory FL after at least 2 prior systemic therapies and have no other available therapy * Cohort F: Participants with relapsed or refractory CLL after at least 2 prior systemic therapies and have no other available therapy The primary study hypothesis is that zilovertamab vedotin monotherapy has an increased Objective Response Rate (ORR) per Lugano Response Criteria as assessed by blinded independent central review (BICR). Sponsor: Merck Sharp & Dohme LLC Intervention: Zilovertamab vedotin Start Date: 2022-07-21 Last Updated: 2023-11-24 Number of Patients: 275 Recruitment Status: RECRUITING Condition: Chronic Lymphocytic Leukemia
NCTID: NCT04931342
Title: A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors Study Summary: This study will evaluate the efficacy and safety of multiple biomarker-selected treatments in patients with persistent or recurrent rare epithelial ovarian, fallopian tube, or primary peritoneal tumors. Enrollment will take place in two phases: a preliminary phase followed by a potential expansion phase. Sponsor: Hoffmann-La Roche Intervention: Ipatasertib Start Date: 2021-10-07 Last Updated: 2023-11-07 Number of Patients: 550 Recruitment Status: RECRUITING Condition: Ovarian Cancer
NCTID: NCT05005442
Title: A Study of Pembrolizumab/Vibostolimab (MK-7684A) in Relapsed/Refractory Hematological Malignancies (MK-7684A-004, KEYVIBE-004) Study Summary: The purpose of the study is to determine the safety and tolerability of pembrolizumab/vibostolimab (MK-7684A) in hematological malignancies. This study will also evaluate the overall response rate (ORR), the duration of response (DOR), and disease control rate (DCR) following administration of pembrolizumab/vibostolimab. In addition, this study will characterize pharmacokinetic (PK) profile of vibostolimab (MK-7684). Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab/vibostolimab coformuation Start Date: 2021-09-28 Last Updated: 2023-09-01 Number of Patients: 180 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Hematological Malignancies
NCTID: NCT03740165
Title: Study of Chemotherapy With Pembrolizumab (MK-3475) Followed by Maintenance With Olaparib (MK-7339) for the First-Line Treatment of Women With BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (MK-7339-001/KEYLYNK-001/ENGOT-ov43/GOG-3036) Study Summary: The purpose of this study is to assess the efficacy and safety of treatment with carboplatin/paclitaxel* PLUS pembrolizumab (MK-3475) and maintenance olaparib (MK-7339) in women with epithelial ovarian cancer (EOC), fallopian tube cancer, or primary peritoneal cancer. The primary study hypotheses are that the combination of pembrolizumab plus carboplatin/paclitaxel* followed by continued pembrolizumab and maintenance olaparib is superior to carboplatin/paclitaxel alone with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in participants with programmed death-ligand 1 (PD-L1)-positive tumors (Combined Positive Score <math display="block">CPS</math>≥10) and in all participants, and that the combination of pembrolizumab plus carboplatin/paclitaxel followed by continued pembrolizumab is superior to carboplatin/paclitaxel alone with respect to PFS per RECIST 1.1 in participants with PD-L1-positive tumors (CPS≥10) and in all participants. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2018-12-18 Last Updated: 2023-09-08 Number of Patients: 1367 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Ovarian Cancer
NCTID: NCT03419572
Title: Non-interventional Study of Cabozantinib in Adults With Advanced Renal Cell Carcinoma Study Summary: The objective of this study is to understand the utilization of cabozantinib in subjects with advanced renal cell carcinoma (RCC) following prior VEGF-targeted therapy in real life settings in terms of dose modifications due to adverse events (AEs) when used as a second line therapy or third and later line therapy. Other patterns of use of cabozantinib will also be described. Sponsor: Ipsen Intervention: Data collection Start Date: 2018-04-24 Last Updated: 2022-08-15 Number of Patients: 689 Recruitment Status: COMPLETED Condition: Renal Cell Carcinoma
NCTID: NCT04728893
Title: Efficacy and Safety of Nemtabrutinib (MK-1026) in Participants With Hematologic Malignancies (MK-1026-003) Study Summary: The purpose of this study is to evaluate the safety and efficacy of nemtabrutinib (formerly ARQ 531) in participants with hematologic malignancies of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), Richter’s transformation, marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), follicular lymphoma (FL), and Waldenström’s macroglobulinemia (WM). Sponsor: Merck Sharp & Dohme LLC Intervention: Nemtabrutinib Start Date: 2021-04-05 Last Updated: 2023-11-24 Number of Patients: 450 Recruitment Status: RECRUITING Condition: Hematologic Malignancies
NCTID: NCT03517449
Title: Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician’s Choice in Participants With Advanced Endometrial Cancer (MK-3475-775/E7080-G000-309 Per Merck Standard Convention [KEYNOTE-775]) Study Summary: This is a study of pembrolizumab (MK-3475, KEYTRUDA®) in combination with lenvatinib (E7080) versus treatment of physician’s choice (doxorubicin or paclitaxel) for the treatment of advanced endometrial cancer. Participants will be randomly assigned to receive either pembrolizumab and lenvatinib or treatment of physician’s choice. The primary study hypothesis is that pembrolizumab in combination with lenvatinib prolongs progression free survival (PFS) and overall survival (OS) when compared to treatment of physician’s choice. Sponsor: Eisai Inc. Intervention: Pembrolizumab Start Date: 2018-06-11 Last Updated: 2023-10-18 Number of Patients: 827 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Endometrial Neoplasms
NCTID: NCT03834493
Title: Study of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-641/KEYNOTE-641) Study Summary: The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and enzalutamide in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC, are abiraterone-naïve, or are intolerant to or progressed on abiraterone acetate. There are two primary study hypotheses. Hypothesis 1: The combination of pembrolizumab plus enzalutamide is superior to placebo plus enzalutamide with respect to Overall Survival (OS). Hypothesis 2: The combination of pembrolizumab plus enzalutamide is superior to placebo plus enzalutamide with respect to Radiographic Progression-free Survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2019-07-28 Last Updated: 2023-06-15 Number of Patients: 1244 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Prostatic Neoplasms
NCTID: NCT04871282
Title: A Study of AL102 in Patients With Progressing Desmoid Tumors Study Summary: The current study is designed to evaluate the efficacy and safety of AL102 in patients with progressive desmoid tumors. Sponsor: Ayala Pharmaceuticals, Inc, Intervention: AL102 Start Date: 2021-03-30 Last Updated: 2023-11-24 Number of Patients: 192 Recruitment Status: RECRUITING Condition: Desmoid
NCTID: NCT05060016
Title: A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC) Study Summary: The main aim of this study is to: * evaluate safety and efficacy (per Response Evaluation Criteria in Solid Tumors version 1.1 <math display="block">RECIST 1.1</math> by investigator) of 2 dose levels of tarlatamab for Part 1 only * evaluate anti-tumor activity of tarlatamab as determined by objective response rate (ORR) per RECIST 1.1 by blinded independent central review (BICR) for Part 1 and 2 * evaluate safety of reduced mandatory monitoring period in Cycle 1 at selected dose of tarlatamab for Part 3 Sponsor: Amgen Intervention: Tarlatamab Start Date: 2021-12-01 Last Updated: 2023-10-18 Number of Patients: 222 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Relapsed/Refractory Small Cell Lung Cancer
NCTID: NCT02259582
Title: A Study of Carboplatin, Pemetrexed Plus Placebo vs Carboplatin, Pemetrexed Plus 1 or 2 Truncated Courses of Demcizumab in Subjects With Non-Squamous Non-Small Cell Lung Cancer Study Summary: A randomized, double-blind, 3-arm (1:1:1) study in subjects with first-line Stage IV non-squamous NSCLC. The purpose is to test the efficacy and safety of demcizumab, when given in combination with carboplatin and pemetrexed compared to placebo. The administration of carboplatin and pemetrexed is a standard treatment for patients with non-squamous non-small cell lung cancer. Sponsor: OncoMed Pharmaceuticals, Inc. Intervention: Pemetrexed Start Date: 2015-02 Last Updated: 2020-09-09 Number of Patients: 82 Recruitment Status: COMPLETED Condition: Nonsquamous Nonsmall Cell Neoplasm of Lung
NCTID: NCT03969004
Title: Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma Study Summary: The primary objective of the study is to compare disease-free survival (DFS) of patients with high-risk cutaneous squamous cell carcinoma (CSCC) treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and radiation therapy (RT). The secondary objectives of the study are: * To compare the overall survival (OS) of high-risk CSCC patients treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and RT * To compare the effect of adjuvant cemiplimab with that of placebo on patients’ freedom from locoregional recurrence (FFLRR) after surgery and RT * To compare the effect of adjuvant cemiplimab with that of placebo on patients’ freedom from distant recurrence (FFDR) after surgery and RT * To compare the effect of adjuvant cemiplimab with that of placebo on the cumulative incidence of second primary CSCC tumors (SPTs) after surgery and RT * To evaluate the safety of adjuvant cemiplimab and that of placebo in high-risk CSCC patients after surgery and RT * To assess cemiplimab pharmacokinetics and immunogenicity in human serum Sponsor: Regeneron Pharmaceuticals Intervention: Cemiplimab Start Date: 2019-06-04 Last Updated: 2023-11-24 Number of Patients: 412 Recruitment Status: RECRUITING Condition: Cutaneous Squamous Cell Carcinoma
NCTID: NCT03564691
Title: Study of MK-4830 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-4830-001) Study Summary: This study consists of several parts: dose escalation, dose expansion, dose expansion in Chinese participants residing in China, and coformulation. Dose escalation is to evaluate the safety, tolerability, and preliminary efficacy of MK-4830 monotherapy administration (Arms A and B) and in combination with pembrolizumab (Arm C). Dose expansion is to evaluate the objective response rate (ORR) of MK-4830 in combination with pembrolizumab (Arms A-F); evaluate the safety and tolerability of MK-4830 administered in combination with pembrolizumab, carboplatin, and pemetrexed (Arm G) and of MK-4830 administered in combination with pembrolizumab and lenvatinib (Arm H); evaluate the safety, tolerability and ORR of MK-4830 in combination with pembrolizumab plus chemotherapy (Arms I-L); and evaluate the safety and tolerability of MK-4830 in combination with pembrolizumab in Chinese participants from China (Arm M). The coformulation part (Arm N) evaluates the safety and tolerability of MK-4830A (coformulation of MK-4830 800 mg + pembrolizumab 200 mg). There is no formal hypothesis testing in this study. Sponsor: Merck Sharp & Dohme LLC Intervention: MK-4830 Start Date: 2018-07-11 Last Updated: 2023-11-07 Number of Patients: 442 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Neoplasms
NCTID: NCT02375204
Title: Standard-Dose Combination Chemotherapy or High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients With Relapsed or Refractory Germ Cell Tumors Study Summary: This randomized phase III trial studies how well standard-dose combination chemotherapy works compared to high-dose combination chemotherapy and stem cell transplant in treating patients with germ cell tumors that have returned after a period of improvement or did not respond to treatment. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, cisplatin, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as filgrastim or pegfilgrastim, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. It is not yet known whether high-dose combination chemotherapy and stem cell transplant are more effective than standard-dose combination chemotherapy in treating patients with refractory or relapsed germ cell tumors. Sponsor: Alliance for Clinical Trials in Oncology Intervention: paclitaxel Start Date: 2015-08-05 Last Updated: 2023-08-31 Number of Patients: 420 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Germ Cell Tumor
NCTID: NCT02685605
Title: Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma Multiforme Study Summary: INTRAGO II resembles a multicentric, prospective, randomized, 2-arm, open-label clinical phase III trial which tests if the median progression-free survival (PFS) of patients with newly diagnosed glioblastoma multiforme (GBM) can be improved by the addition of intraoperative radiotherapy (IORT) to standard radiochemotherapy. Sponsor: Universitätsmedizin Mannheim Intervention: Standard surgery Start Date: 2016-12-09 Last Updated: 2023-05-11 Number of Patients: 314 Recruitment Status: RECRUITING Condition: Glioblastoma
NCTID: NCT04919226
Title: Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE Study Summary: The purpose of the study is to evaluate the efficacy, safety & patient-reported outcomes of peptide receptor radionuclide therapy (PRRT) with 177Lu-Edotreotide as 1st or 2nd line of treatment compared to best standard of care in patients with well-differentiated aggressive grade 2 and grade 3, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin. Sponsor: ITM Solucin GmbH Intervention: 177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT Start Date: 2021-12-21 Last Updated: 2023-09-13 Number of Patients: 202 Recruitment Status: RECRUITING Condition: Neuroendocrine Tumors
NCTID: NCT04938817
Title: Safety and Efficacy Study of Pembrolizumab (MK-3475) in Combination With Investigational Agents for the Treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC) in Need of Second-Line Therapy (MK-3475-B98/KEYNOTE-B98) Study Summary: This study is a rolling arm study of pembrolizumab in combination with investigational agents in participants with anti-programmed cell death 1 (PD-1)/ programmed cell death ligand 1 (PD-L1) refractory ES-SCLC in need of second-line treatment. This study will have 2 parts: an initial safety lead-in to determine safety and tolerability for experimental combinations of investigational agents without an established recommended phase 2 dose (RP2D) followed by an efficacy evaluation. Investigational agents will initiate directly in or be added to the efficacy evaluation after an initial evaluation of safety and tolerability of the investigational agent has been completed in a separate study or in the safety lead-in of this study. If an RP2D for a combination being evaluated in the safety lead-in is established from another study, then the efficacy evaluation may begin at the determined RP2D. There will be no hypothesis testing in this study. Sponsor: Merck Sharp & Dohme LLC Intervention: coformulation pembrolizumab/quavonlimab Start Date: 2021-08-19 Last Updated: 2023-01-04 Number of Patients: 80 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Small Cell Lung Carcinoma
NCTID: NCT03517917
Title: Prospective Tissue Collection Research Protocol Study Summary: This is a multi-solid tumour research study which collects tumour samples from patients alongside a matched whole blood, and/or leukapheresis product for the development of manufacturing processes for potential immunotherapies. Sponsor: Achilles Therapeutics UK Limited Intervention: Tumour tissue collection Start Date: 2018-02-08 Last Updated: 2023-01-18 Number of Patients: 400 Recruitment Status: RECRUITING Condition: Solid Tumor
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: NCT03834506
Title: Study of Pembrolizumab (MK-3475) Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-921/KEYNOTE-921) Study Summary: The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and docetaxel in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC but have progressed on or are intolerant to Next Generation Hormonal Agent (NHA). There are two primary study hypotheses. Hypothesis 1: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone with respect to Overall Survival (OS). Hypothesis 2: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone with respect to Radiographic Progression-free Survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2019-05-02 Last Updated: 2023-08-25 Number of Patients: 1030 Recruitment Status: COMPLETED Condition: Prostatic Neoplasms
NCTID: NCT02343406
Title: Adult Study: ABT-414 Alone or ABT-414 Plus Temozolomide vs. Lomustine or Temozolomide for Recurrent Glioblastoma Pediatric Study: Evaluation of ABT-414 in Children With High Grade Gliomas Study Summary: This study was conducted to evaluate the efficacy and safety of depatuxizumab mafodotin (ABT-414) alone or with temozolomide versus temozolomide or lomustine alone in adult participants with recurrent glioblastoma. The study also included a substudy to evaluate safety, tolerability and pharmacokinetics of ABT-414 in a pediatric population. Sponsor: AbbVie Intervention: Depatuxizumab mafodotin Start Date: 2015-02-17 Last Updated: 2020-05-22 Number of Patients: 266 Recruitment Status: COMPLETED Condition: Glioblastoma
NCTID: NCT01740427
Title: A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2) Study Summary: The study is designed to compare the clinical benefit following treatment with letrozole in combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease. Sponsor: Pfizer Intervention: PD-0332991 Start Date: 2013-02-22 Last Updated: 2022-12-08 Number of Patients: 666 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Neoplasms
NCTID: NCT04619004
Title: HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer Study Summary: This study is designed to evaluate the antitumor activity of patritumab deruxtecan in participants with metastatic or locally advanced NSCLC with an activating EGFR mutation (exon 19 deletion or L858R) who have received and progressed on or after at least 1 EGFR TKI and 1 platinum-based chemotherapy-containing regimen. Sponsor: Daiichi Sankyo, Inc. Intervention: Patritumab Deruxtecan (Fixed dose) Start Date: 2021-02-02 Last Updated: 2023-11-18 Number of Patients: 420 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-Small Cell Lung Cancer Metastatic
NCTID: NCT05063604
Title: Antidepressant Efficacy of Psychotherapy and Citalopram in Patients With Breast Cancer and Major Depression Study Summary: To provide evidence on the antidepressant efficacy of two therapeutic treatments: pharmacological treatment (citalopram) and psychotherapy treatment, in women diagnosed with breast cancer and major depression. Sponsor: Hospital Universitari de Bellvitge Intervention: Citalopram Start Date: 2022-05-10 Last Updated: 2022-07-05 Number of Patients: 40 Recruitment Status: TERMINATED Condition: Breast Cancer
NCTID: NCT00083304
Title: Whole Brain Radiation Therapy With Oxygen, With or Without RSR13, in Women With Brain Metastases From Breast Cancer Study Summary: RSR13 (efaproxiral) is a radiation sensitizer that has shown positive results in a Phase 3, randomized clinical trial of patients with brain metastases. Of 111 eligible breast cancer patients with brain metastases in that trial, 59 patients who received RSR13 prior to radiation therapy had a median survival time that was twice as long as the 52 patients who did not receive RSR13 prior to radiation therapy. RSR13 (efaproxiral) is an experimental drug that increases the amount of oxygen released from blood into the tissues. It is well known that certain types of cancer tumors, including those in brain metastases, lack oxygen. Lack of oxygen in a tumor can reduce the effect of radiation therapy (RT). RSR13 may increase the oxygen level in brain tumors so that radiation therapy works better. This study will enroll up to 360 women with brain metastases from breast cancer, and will evaluate if whole brain radiation therapy given with RSR13 will have a better treatment effect than whole brain radiation therapy alone. RSR13 will be infused intravenously (IV) through a central catheter placed in a central vein. Women randomized (assigned) to receive RSR13, therefore, will need to have a central catheter placed for treatment unless one is already in place. Sponsor: Spectrum Pharmaceuticals, Inc Intervention: Efaproxiral Start Date: 2004-02 Last Updated: 2013-05-10 Number of Patients: 368 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT01702571
Title: A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer Who Have Received Prior Anti-HER2 And Chemotherapy-based Treatment Study Summary: This two-cohort, open-label, multicenter study will assess the safety, efficacy and tolerability of trastuzumab emtansine in participants with HER2-positive locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) who have received prior anti-HER2 and chemotherapy-based treatment. Participants in Cohort 1 will be drawn from the general participant population; Cohort 2 will include only Asian participants. Sponsor: Hoffmann-La Roche Intervention: Trastuzumab Emtansine Start Date: 2012-11-27 Last Updated: 2022-04-04 Number of Patients: 2185 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT03422679
Title: Study of CB-103 in Adult Patients With Advanced or Metastatic Solid Tumours and Haematological Malignancies Study Summary: This is a phase I/II, non randomized, open-label, dose escalation study to investigate the safety, tolerability and preliminary efficacy of CB-103. Sponsor: Cellestia Biotech AG Intervention: CB-103 Start Date: 2017-12-05 Last Updated: 2023-02-09 Number of Patients: 79 Recruitment Status: TERMINATED Condition: Breast Cancer
NCTID: NCT05077709
Title: IO102-IO103 in Combination With Pembrolizumab as First-line Treatment for Patients With Metastatic NSCLC, SCCHN, or mUBC Study Summary: A Phase II Multi-Arm (basket) Trial Investigating the Safety and Efficacy of IO102-IO103 in Combination with pembrolizumab, as First-line Treatment for Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC), Squamous Cell Carcinoma of Head or Neck (SCCHN), or Metastatic Urothelial Bladder Cancer (mUBC) Sponsor: IO Biotech Intervention: IO102-IO103 in combination with pembrolizumab Start Date: 2022-02-14 Last Updated: 2023-06-12 Number of Patients: 90 Recruitment Status: RECRUITING Condition: Lung Cancer Non Small Cell
NCTID: NCT04102020
Title: A Study of Oral Venetoclax Tablets and Oral Azacitidine Versus Oral Azacitidine as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy Study Summary: This study will be conducted in two parts. Part 1 will be the Dose Confirmation portion to determine recommended Phase 3 dose (RPTD) of venetoclax in combination with AZA. Part 3 will be the Dose Finding portion to determine RPTD of venetoclax in combination with CC-486. Part 2 and Part 3 Randomization of the study were removed. Sponsor: AbbVie Intervention: Venetoclax Start Date: 2020-03-26 Last Updated: 2023-10-25 Number of Patients: 112 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Acute Myeloid Leukemia (AML)
NCTID: NCT05007106
Title: MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005) Study Summary: The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of pembrolizumab/vibostolimab co-formulation (MK-7684A) with or without other anticancer therapies in participants with selected advanced solid tumors. The primary hypothesis is that pembrolizumab/vibostolimab co-formulation is superior to pembrolizumab alone in terms of objective response rate or progression-free survival in participants with cervical cancer. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab/Vibostolimab Co-Formulation Start Date: 2021-09-16 Last Updated: 2023-11-24 Number of Patients: 610 Recruitment Status: RECRUITING Condition: Uterine Cervical Neoplasms
NCTID: NCT02269943
Title: Safety and Efficacy of CC-486 in Previously Treated Patients With Locally Advanced or Metastatic Nasopharyngeal Carcinoma
Study Summary: The purpose of this study is to evaluate the safety and efficacy of CC-486 in previously treated patients with locally advanced or metastatic nasopharyngeal carcinoma having failed one to two previous regimens, including platinum-based chemotherapy. Participants will be enrolled according to a Simon two-stage design; if the predefined activity is met (>4 responses <math display="block">complete response; partial response {CR/PR}</math> out of the first 17 evaluable participants based on independent radiological assessment), then the study will continue to enroll an additional 34 participants. If 4 or less responses out of 17 are observed, then the study enrollment will be stopped.
Sponsor: Celgene
Intervention: CC-486
Start Date: 2015-02-13
Last Updated: 2018-12-12
Number of Patients: 36
Recruitment Status: COMPLETED
Condition: Nasopharyngeal Neoplasms
NCTID: NCT03425643
Title: Efficacy and Safety of Pembrolizumab (MK-3475) With Platinum Doublet Chemotherapy as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (MK-3475-671/KEYNOTE-671) Study Summary: This trial will evaluate the safety and efficacy of pembrolizumab (MK-3475) in combination with platinum doublet neoadjuvant chemotherapy (NAC) before surgery <math display="block">neoadjuvant phase</math>, followed by pembrolizumab alone after surgery <math display="block">adjuvant phase</math> in participants with resectable stage II, IIIA, and resectable IIIB (T3-4N2) non-small cell lung cancer (NSCLC). The primary hypotheses of this study are that neoadjuvant pembrolizumab (vs. placebo) in combination with NAC, followed by surgery and adjuvant pembrolizumab (vs. placebo) will improve: 1) event free survival (EFS) by biopsy assessed by local pathologist or by investigator-assessed imaging using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1); and 2) overall survival (OS). Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2018-04-24 Last Updated: 2023-11-13 Number of Patients: 797 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-small Cell Lung Cancer
NCTID: NCT02366143
Title: A Study of Atezolizumab in Combination With Carboplatin Plus (+) Paclitaxel With or Without Bevacizumab Compared With Carboplatin+Paclitaxel+Bevacizumab in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Study Summary: This randomized, open-label study evaluated the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 <math display="block">PD-L1</math> antibody) in combination with carboplatin+paclitaxel with or without bevacizumab compared with treatment with carboplatin+paclitaxel+bevacizumab in chemotherapy-naïve participants with Stage IV non-squamous NSCLC. Participants were randomized in a 1:1:1 ratio to Arm A (Atezolizumab+Carboplatin+Paclitaxel), Arm B (Atezolizumab+Carboplatin+Paclitaxel+Bevacizumab), or Arm C (Carboplatin+Paclitaxel+Bevacizumab). Sponsor: Hoffmann-La Roche Intervention: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody Start Date: 2015-03-31 Last Updated: 2021-09-23 Number of Patients: 1202 Recruitment Status: COMPLETED Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT03869190
Title: Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC) Study Summary: A Phase Ib/II, open-label, multicenter, randomized, umbrella study in participants with MIBC and in participants with locally advanced or metastatic Urothelial Carcinoma (UC) who have progressed during or following a platinum-containing regimen. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the participant population (e.g., with regard to prior anti-cancer treatment or biomarker status). Participants in the mUC Cohort who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment regimen for Stage 2. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2019-06-01 Last Updated: 2023-11-13 Number of Patients: 645 Recruitment Status: RECRUITING Condition: Urothelial Carcinoma
NCTID: NCT00373425
Title: A Study of Erlotinib (Tarceva) After Surgery With or Without Adjuvant Chemotherapy in Non-Small Cell Lung Carcinoma (NSCLC) Patients Who Have Epidermal Growth Factor Receptor (EGFR) Positive Tumors Study Summary: This is a study to evaluate the effectiveness of erlotinib compared with a placebo sugar pill following complete surgical removal of the tumor with or without chemotherapy after surgery in Stage IB-IIIA NSCLC patients. Sponsor: OSI Pharmaceuticals Intervention: Erlotinib Start Date: 2006-09 Last Updated: 2015-09-17 Number of Patients: 1252 Recruitment Status: COMPLETED Condition: Non-small Cell Lung Cancer
NCTID: NCT03820830
Title: Palbociclib for HR Positive / HER2-negative Isolated Locoregional Recurrence of Breast Cancer Study Summary: POLAR is a phase III clinical trial, which will test the safety and efficacy of an investigational combination of drugs to learn whether the combination of drugs works for a specific cancer. Palbociclib (Ibrance®) is the name of the investigational agent, which is assessed together with standard anti-hormone therapy in this study. Palbociclib is used to treat patients with hormone receptor-positive / HER2-negative breast cancer which has spread beyond the original tumor and/or to other organs. During this study, anti-hormone therapy will consist of either a selective estrogen receptor modulator (such as tamoxifen) or an aromatase inhibitor (anastrozole, letrozole, exemestane) or fulvestrant (Faslodex®). Premenopausal women and men may also receive a drug called an LHRH (luteinizing hormone-releasing hormone) agonist by injection. It is standard of care for people with hormone receptor positive breast cancer to take anti-hormone therapy. The study doctor will determine the type of standard anti-hormone therapy that will be given during this trial. The purpose of the POLAR study is to compare the effect of using 3 years of palbociclib in combination with standard anti-hormone therapy with standard anti-hormone therapy alone and to evaluate the time until the breast cancer returns, if it does return. Sponsor: ETOP IBCSG Partners Foundation Intervention: Palbociclib 125mg Start Date: 2019-08-27 Last Updated: 2023-08-29 Number of Patients: 400 Recruitment Status: RECRUITING Condition: Breast Cancer Recurrent
NCTID: NCT04681131
Title: CAB-AXL-ADC Safety and Efficacy Study in Adults With NSCLC Study Summary: The objective of this study is to assess safety and efficacy of CAB-AXL-ADC in NSCLC Sponsor: BioAtla, Inc. Intervention: CAB-AXL-ADC Start Date: 2021-03-17 Last Updated: 2023-09-25 Number of Patients: 240 Recruitment Status: RECRUITING Condition: Non-Small-Cell Lung Cancer
NCTID: NCT04428151
Title: Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed After Platinum Therapy and Immunotherapy (MK-7902-009/E7080-G000-228/LEAP-009) Study Summary: This study is designed to assess the safety and efficacy of lenvatinib in combination with pembrolizumab versus standard of care (SOC) chemotherapy, and to also assess the safety and efficacy of lenvatinib monotherapy in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that have progressed after platinum therapy and a programmed cell death protein 1 (PD-1) or anti-programmed death ligand 1 (PD-L1) inhibitor. The primary hypothesis is that lenvatinib + pembrolizumab is superior to SOC chemotherapy with respect to ORR per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review. Sponsor: Merck Sharp & Dohme LLC Intervention: Lenvatinib Start Date: 2020-08-06 Last Updated: 2023-11-24 Number of Patients: 400 Recruitment Status: RECRUITING Condition: Squamous Cell Carcinoma of Head and Neck
NCTID: NCT05288166
Title: A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer) Study Summary: The purpose of this study is to learn whether adding abemaciclib to abiraterone plus prednisone prolongs the time before prostate cancer gets worse. Participation may last approximately 60 months. Sponsor: Eli Lilly and Company Intervention: Abemaciclib Start Date: 2022-04-14 Last Updated: 2023-10-19 Number of Patients: 900 Recruitment Status: RECRUITING Condition: Prostatic Neoplasms
NCTID: NCT00402519
Title: APBI Versus EBRT Therapy After Breast Conserving Surgery for Low-risk Breast Cancer Study Summary: To assess the role of interstitial brachytherapy alone compared to whole breast irradiation in a defined low-risk group of invasive breast cancer or ductal carcinoma in situ concerning local failure (all ipsilateral local recurrences) to affirm the hypothesis that local control rates in each arm are equivalent. Sponsor: University of Erlangen-Nürnberg Medical School Intervention: Accelerated partial breast irradiation Start Date: 2004-11 Last Updated: 2016-05-13 Number of Patients: 1300 Recruitment Status: UNKNOWN Condition: Breast Cancer
NCTID: NCT01964430
Title: Nab-paclitaxel and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer (the “Apact” Study) Study Summary: The purpose of this study is to compare whether there is a delay or prevention of recurrence or death in participants with surgically removed pancreatic cancer who then take nab-Paclitaxel in combination with gemcitabine compared to those who take gemcitabine alone. Sponsor: Celgene Intervention: nab-Paclitaxel Start Date: 2014-03-28 Last Updated: 2023-06-28 Number of Patients: 866 Recruitment Status: COMPLETED Condition: Pancreatic Neoplasms
NCTID: NCT01837251
Title: Evaluation of Optimal Treatment With Bevacizumab in Patients With Platinum-sensitive Recurrent Ovarian Cancer Study Summary: Evaluation of the best therapeutic index for patients with platinum-sensitive ovarian cancer when treatment with bevacizumab and gemcitabine/carboplatin or with bevacizumab and PLD/carboplatin. Sponsor: AGO Research GmbH Intervention: Carboplatin Start Date: 2013-05 Last Updated: 2021-07-13 Number of Patients: 682 Recruitment Status: COMPLETED Condition: Recurrent Platinum-sensitive Ovarian Cancer
NCTID: NCT04101331
Title: Phase II Study to Assess AFM13 in Patients With R/R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides Study Summary: This is a phase II study to evaluate the antitumor activity and safety of AFM13 given as monotherapy in patients with CD30-positive T-cell lymphoma. The investigational medicinal product AFM13 is a tetravalent bispecific chimeric (anti-human CD30 x anti-human CD16A) recombinant antibody construct which is being developed to treat CD30-positive malignancies. Patients who suffer from peripheral T-cell lymphoma or transformed mycosis fungoides, whose tumor expresses the surface marker CD30, and who have relapsed after an earlier treatment or have refractory disease will be enrolled into this study if all of the study entry criteria are fulfilled. Dependent on their disease type and the magnitude of CD30 expression, study participants will be assigned to one of 3 study cohorts, each cohort receiving the same treatment of weekly AFM13 infusions (a 200mg dose per infusion). The main goal of the study is to assess the efficacy of AFM13 treatment as judged by the rate of overall responses. Further goals are to assess the safety of AFM13 treatment, the immunogenicity of AFM13 (as measured by the potential formation of anti-AFM13 antibodies) and the concentration of AFM13 in the blood. Approx. 1 month after the last dose of AFM13 there will be a final study visit to assess the patients’ health status after therapy, followed by quarterly phone contacts to check on their overall health status and long-term survival. Sponsor: Affimed GmbH Intervention: AFM13 Start Date: 2019-11-13 Last Updated: 2023-08-08 Number of Patients: 108 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Peripheral T Cell Lymphoma
NCTID: NCT04241185
Title: Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Muscle-invasive Bladder Cancer (MIBC) (MK-3475-992/KEYNOTE-992) Study Summary: This study is designed to assess the antitumor efficacy and safety of pembrolizumab in combination with chemoradiotherapy (CRT) versus CRT alone in participants with muscle-invasive bladder cancer (MIBC). The primary hypothesis is that pembrolizumab + chemoradiotherapy is superior to placebo + chemoradiotherapy with respect to bladder intact event-free survival. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2020-05-19 Last Updated: 2023-11-27 Number of Patients: 636 Recruitment Status: RECRUITING Condition: Urinary Bladder Neoplasms
NCTID: NCT03502785
Title: INO-5401 + INO-9012 in Combination With Atezolizumab in Locally Advanced Unresectable or Metastatic/Recurrent Urothelial Carcinoma Study Summary: This is a Phase I/IIA, open-label, multi-center trial to evaluate the safety, immunogenicity and preliminary clinical efficacy of INO-5401 + INO-9012 delivered by intramuscular (IM) injection followed by electroporation (EP), in combination with atezolizumab in participants with locally advanced unresectable or metastatic/recurrent Urothelial Carcinoma (UCa). The trial population is divided into two cohorts: Cohort A: Participants with locally advanced unresectable or metastatic/recurrent UCa, who have confirmed disease progression during or following treatment with anti-Programmed Death receptor-1/Programmed Death receptor Ligand-1 (anti-PD-1/PD-L1) therapy; Cohort B: Participants with locally advanced unresectable or metastatic/recurrent UCa, who are treatment naïve and ineligible for cisplatin-based chemotherapy. A safety run-in will be performed with up to six participants (safety analysis participants) from cohort A. Sponsor: Inovio Pharmaceuticals Intervention: INO-5401 Start Date: 2018-05-24 Last Updated: 2023-05-18 Number of Patients: 35 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Urothelial Carcinoma
NCTID: NCT00989261
Title: Efficacy Study for AC220 to Treat Acute Myeloid Leukemia (AML) Study Summary: AC220 will be administered as a once daily oral solution given continuously as 28-day treatment cycles, without any rest periods, until disease progression, relapse, intolerance to the drug, or elective allogeneic hematopoietic stem cell transplantation (HSCT). Sponsor: Daiichi Sankyo, Inc. Intervention: Compound AC220 Start Date: 2009-11 Last Updated: 2019-12-11 Number of Patients: 333 Recruitment Status: COMPLETED Condition: Acute Myeloid Leukemia
NCTID: NCT02668653
Title: Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML) Study Summary: Quizartinib is an experimental drug. It is not approved for regular use. It can only be used in medical research. Adults might be able to join this study after bone marrow tests show they have a certain kind of blood cancer (FLT3-ITD AML). Participants will have an equal chance of receiving quizartinib or placebo along with their chemotherapy. Sponsor: Daiichi Sankyo, Inc. Intervention: Chemotherapy Start Date: 2016-09-01 Last Updated: 2023-11-18 Number of Patients: 539 Recruitment Status: COMPLETED Condition: Acute Myeloid Leukemia
NCTID: NCT03472560
Title: A Study of Avelumab in Combination With Axitinib In Non-Small Cell Lung Cancer (NSCLC) or Urothelial Cancer (Javelin Medley VEGF) Study Summary: This is a Phase 2 study to evaluate the safety and efficacy of avelumab in combination with axitinib in patients with advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior platinum containing therapy, and in treatment naïve patients with advanced or metastatic urothelial cancer, who are ineligible for cisplatin containing chemotherapy for their advanced disease. Sponsor: Pfizer Intervention: Avelumab (MSB0010718C) Start Date: 2018-05-02 Last Updated: 2023-07-07 Number of Patients: 60 Recruitment Status: TERMINATED Condition: Non-Small Cell Lung Cancer
NCTID: NCT05601973
Title: AMAZE-lung: Amivantamab, Lazertinib and Bevacizumab in Patients With EGFR-mutant Advanced Non-small Cell Lung Cancer With Progression on Previous Third-generation EGFR-TKI Study Summary: AMAZE-lung is a multicenter single-arm phase II trial. The protocol treatment consists of amivantamab, lazertinib and bevacizumab (Zirabev®), given in a three-weekly regimen. The primary objective of the trial is to assess the efficacy of amivantamab and bevacizumab added to continued treatment with the third-generation EGFR-TKI lazertinib, in patients with EGFR-mutant advanced NSCLC, who have been previously treated with a third-generation EGFR-TKI in order to provide data on treatment effect and sample size required for a future phase III trial. In addition, the safety of the treatment combination will be evaluated. Sponsor: ETOP IBCSG Partners Foundation Intervention: Amivantamab Start Date: 2023-03-27 Last Updated: 2023-08-21 Number of Patients: 60 Recruitment Status: RECRUITING Condition: Non Small Cell Lung Cancer
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: NCT02367794
Title: A Study of Atezolizumab in Combination With Carboplatin + Paclitaxel or Carboplatin + Nab-Paclitaxel Compared With Carboplatin + Nab-Paclitaxel in Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower131] Study Summary: This randomized, open-label study will evaluate the safety and efficacy of atezolizumab (MPDL3280A) in combination with carboplatin + paclitaxel or carboplatin + nab-paclitaxel compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naive participants with Stage IV squamous NSCLC. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibody Start Date: 2015-06-11 Last Updated: 2022-03-21 Number of Patients: 1021 Recruitment Status: COMPLETED Condition: Squamous Non-Small Cell Lung Cancer
NCTID: NCT05987332
Title: IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma Study Summary: This is a Phase 2/3, multi-arm, multi-stage, open-label study of human leukocyte antigen (HLA)-A*02:01 negative participants with metastatic uveal melanoma (MUM) who will be randomized to receive either IDE196 + crizotinib or investigator’s choice of treatment (pembrolizumab, ipilimumab + nivolumab, or dacarbazine). Sponsor: IDEAYA Biosciences Intervention: IDE196 Start Date: 2023-10-31 Last Updated: 2023-11-27 Number of Patients: 380 Recruitment Status: RECRUITING Condition: Metastatic Uveal Melanoma
NCTID: NCT05352672
Title: Clinical Study of Fianlimab in Combination With Cemiplimab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma Study Summary: The primary objective of the study is to demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by progression-free survival (PFS) The secondary objectives of the study are: * To demonstrate superiority of fianlimab (REGN3767) + cemiplimab compared to pembrolizumab, as measured by overall survival (OS) * To demonstrate superiority in objective response rate (ORR) with fianlimab + cemiplimab compared to pembrolizumab * To characterize ORR, PFS, and OS with fianlimab + cemiplimab compared to cemiplimab to inform the contribution of each component * To assess immunogenicity of fianlimab and cemiplimab * To assess impact of fianlimab + cemiplimab on physical functioning and role functioning and global health status/quality of life, as compared to pembrolizumab in adults * To characterize safety and tolerability of treatment in patients 12 to <18 years of age * To characterize ORR, PFS, and OS with treatment in patients 12 to <18 years of age * To assess the safety and tolerability of fianlimab + cemiplimab compared to pembrolizumab and to cemiplimab * To characterize pharmacokinetics (PK) of fianlimab and cemiplimab using sparse PK sampling in patients aged ≥12 years Sponsor: Regeneron Pharmaceuticals Intervention: Fianlimab Start Date: 2022-07-14 Last Updated: 2023-11-24 Number of Patients: 1590 Recruitment Status: RECRUITING Condition: Melanoma
NCTID: NCT01572038
Title: A Study of Pertuzumab in Combination With Trastuzumab (Herceptin) and a Taxane in First-Line Treatment in Participants With Human Epidermal Growth Factor 2 (HER2)-Positive Advanced Breast Cancer Study Summary: This multicenter, open-label, single-arm, Phase IIIb study will evaluate the safety and tolerability of pertuzumab in combination with trastuzumab (Herceptin) and a taxane (docetaxel, paclitaxel or nab-paclitaxel) in first-line treatment in participants with metastatic or locally recurrent HER2-positive breast cancer. Participants will receive pertuzumab intravenously (IV) and trastuzumab (Herceptin) IV plus a taxane in cycles of 3 weeks each until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurs first. Sponsor: Hoffmann-La Roche Intervention: Docetaxel Start Date: 2012-06-01 Last Updated: 2020-09-25 Number of Patients: 1436 Recruitment Status: COMPLETED Condition: Breast Neoplasms
NCTID: NCT05084092
Title: IORT After Surgical Resection of Brain Metastases Study Summary: To evaluate the feasibility and efficacy of the Intraoperative Radiation Therapy (IORT) after the resection of a brain metastases to reduce the incidence of local relapse Sponsor: Institut Català d’Oncologia Intervention: Intraoperative Radiotherapy (IORT) Start Date: 2020-06-17 Last Updated: 2022-08-04 Number of Patients: 40 Recruitment Status: RECRUITING Condition: Brain Neoplasms
NCTID: NCT00993655
Title: Intraperitoneal vs Intravenous Chemotherapy Following Neoadjuvant Chemotherapy in Ovarian Cancer Study Summary: RATIONALE: Drugs used in chemotherapy, such as paclitaxel, carboplatin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them in different ways may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating patients with ovarian epithelial cancer, primary peritoneal cancer, and fallopian tube cancer. PURPOSE: This randomized phase II trial is comparing the side effects of three combination chemotherapy regimens and to see how well they work in treating patients with stage IIB, stage IIC, stage III, or stage IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer. Sponsor: Canadian Cancer Trials Group Intervention: carboplatin Start Date: 2010-03-03 Last Updated: 2023-08-28 Number of Patients: 275 Recruitment Status: COMPLETED Condition: Fallopian Tube Cancer
NCTID: NCT02361346
Title: Safety, PD & Efficacy of MT-3724 for the Treatment of Patients With Relapsed or Refractory DLBCL Study Summary: The purpose of this study is to evaluate the safety and tolerability of MT-3724 in subjects with relapsed or refractory B-Cell NHL or relapsed and refractory CLL (Part 1 only) and relapsed and refractory DLBCL (Part 2 and Part 3). Part 3 evaluates the efficacy of MT-3724. Sponsor: Molecular Templates, Inc. Intervention: MT-3724 Phase 1 Start Date: 2015-02 Last Updated: 2022-08-18 Number of Patients: 38 Recruitment Status: TERMINATED Condition: Non-Hodgkin’s B-cell Lymphoma
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: NCT02807636
Title: Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma Study Summary: A Phase III, randomised study of atezolizumab alone and in combination with chemotherapy versus chemotherapy alone in participants with untreated advanced urothelial cancer. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2016-06-30 Last Updated: 2023-06-09 Number of Patients: 1213 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Urothelial Carcinoma
NCTID: NCT03539536
Title: Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer Study Summary: This study is designed to identify the target Non-Small Cell Lung Cancer (NSCLC) population(s) that overexpress c-Met (c-Met+) best suited for telisotuzumab vedotin therapy in the second line or third line setting (Stage 1) and then to expand the group(s) to further evaluate efficacy in the selected population(s) (Stage 2). After the Stage 2 global enrollment is completed, an additional cohort at an alternate dose level will evaluate the safety and efficacy of telisotuzumab vedotin (Stage 3). Sponsor: AbbVie Intervention: Telisotuzumab vedotin Start Date: 2018-10-10 Last Updated: 2023-07-14 Number of Patients: 270 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-small Cell Lung Cancer
NCTID: NCT04398524
Title: A Phase II Study of Cemiplimab and ISA101b in Patients With Recurrent/Metastatic HPV16 Positive OPC Study Summary: This will be an open-label, phase 2 study in which subjects will receive ISA101b and cemiplimab. Sponsor: ISA Pharmaceuticals Intervention: ISA101b Start Date: 2021-07-01 Last Updated: 2023-04-12 Number of Patients: 86 Recruitment Status: RECRUITING Condition: Squamous Cell Carcinoma of the Oropharynx
NCTID: NCT04191096
Title: Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/KEYNOTE-991) Study Summary: This study will assess the efficacy and safety of pembrolizumab plus enzalutamide plus Androgen Deprivation Therapy (ADT) versus placebo plus enzalutamide plus ADT in participants with mHSPC. The primary hypothesis is that in participants with mHSPC, the combination of pembrolizumab plus enzalutamide plus ADT is superior to placebo plus enzalutamide plus ADT with respect to 1) radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR) and 2) overall survival (OS). As of 19-JAN-2023, the study was unblinded and all study participants stopped ongoing treatment with pembrolizumab/placebo and will continue to receive Standard of Care treatment until meeting protocol-specified discontinuation criteria if deriving clinical benefit. Safety analysis will be performed at the end of the study; there will be no further analyses for efficacy and electronic patient-reported outcome (ePRO) endpoints collected from participants beyond the IA1 cutoff date. All study participants will stop ongoing treatment with pembrolizumab/placebo. Exceptions may be requested for study participants who, in the assessment of their study physician, are benefitting from the combination of enzalutamide and pembrolizumab, after consulting with the Sponsor. All other study participants should be discontinued from study and be offered standard of care (SOC) treatment as deemed necessary by the Investigator. If enzalutamide as SOC is not accessible off study to the participant, central sourcing may continue. As of Amendment 04, disease progression will no longer be centrally verified, participants will only be assessed locally. As of Amendment 4, Second Course treatment is not an option for participants. There are currently no participants in the Second Course Phase. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2020-02-12 Last Updated: 2023-11-18 Number of Patients: 1251 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Hormone-Sensitive Prostate Cancer
NCTID: NCT03980041
Title: Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275) Study Summary: The purpose of this study is to measure the effect of IPI-549 in combination with nivolumab when compared to nivolumab monotherapy in advanced urothelial cancer patients. Sponsor: Infinity Pharmaceuticals, Inc. Intervention: IPI-549 (eganelisib) Start Date: 2019-09-25 Last Updated: 2022-11-25 Number of Patients: 49 Recruitment Status: COMPLETED Condition: Bladder Cancer
NCTID: NCT03110562
Title: Bortezomib, Selinexor, and Dexamethasone in Patients With Multiple Myeloma Study Summary: This Phase 3, 2-arm, randomized, active comparator-controlled, open-label, multicenter study will compare the efficacy and health-related quality of life (HR-QoL) and assess the safety of selinexor plus bortezomib (Velcade) plus low-dose dexamethasone (SVd) versus bortezomib plus low-dose dexamethasone (Vd) in adult patients with RRMM who have received 1 to 3 prior anti-multiple myeloma (MM) regimens. Crossover from the Vd Arm to a treatment that includes selinexor (i.e., SVdX or SdX) will be allowed at the point of IRC-confirmed objective disease progression per the IMWG criteria for patients in the Vd Arm. Sponsor: Karyopharm Therapeutics Inc Intervention: Selinexor Start Date: 2017-05-24 Last Updated: 2023-01-26 Number of Patients: 402 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Multiple Myeloma
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: NCT03773302
Title: Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations Study Summary: Infigratinib is an oral drug which selectively binds to fibroblast growth factor receptor (FGFR) 2 and is being developed to treat participants with FGFR2 mutated cholangiocarcinoma. The purpose of the study is to evaluate the efficacy and safety of the investigational agent oral infigratinib vs standard of care chemotherapy (gemcitabine plus cisplatin) in first-line treatment of participants with unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion/rearrangement. Subjects will be randomized 2:1 to receive infigratinib or gemcitabine plus cisplatin. Sponsor: QED Therapeutics, Inc. Intervention: BGJ398 Start Date: 2019-12-27 Last Updated: 2023-04-03 Number of Patients: 48 Recruitment Status: TERMINATED Condition: Advanced Cholangiocarcinoma
NCTID: NCT02610777
Title: An Efficacy and Safety Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine in Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML) and Low-Blast Acute Myelogenous Leukemia (AML) Study Summary: The purpose of this study is to evaluate the efficacy and safety of pevonedistat plus azacitidine versus single-agent azacitidine in participants with HR-MDS or CMML, or low-blast AML. Sponsor: Millennium Pharmaceuticals, Inc. Intervention: Azacitidine Start Date: 2016-04-14 Last Updated: 2022-09-19 Number of Patients: 120 Recruitment Status: COMPLETED Condition: Myelodysplastic Syndromes
NCTID: NCT03230318
Title: Derazantinib in Subjects With FGFR2 Gene Fusion-, Mutation- or Amplification- Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma Study Summary: This pivotal, open-label, single-arm study will evaluate the anti-cancer activity of derazantinib by Objective Response Rate (ORR) by central radiology review as per RECIST v1.1 in subjects with inoperable or advanced intrahepatic cholangiocarcinoma (iCCA) whose tumors harbor FGFR2 gene fusions (by FISH performed by the central laboratory) or FGFR2 gene mutations or amplifications (based on NGS testing performed or commissioned by the respective study center) and who received at least one prior regimen of systemic therapy. Subjects will be dosed orally once per day at 300 mg of derazantinib capsules. Sponsor: Basilea Pharmaceutica Intervention: derazantinib Start Date: 2017-11-10 Last Updated: 2022-11-23 Number of Patients: 148 Recruitment Status: COMPLETED Condition: Intrahepatic Cholangiocarcinoma
NCTID: NCT05936502
Title: Ascertaining the Radiologic Prognostic Importance of Extranodal Extension on Imaging (iENE) in Head and Neck Cancer Study Summary: Extranodal extension (ENE) refers to the spread of head and neck squamous cell carcinoma (HNSCC) outside the lymph nodes. It is a well-known factor that indicates a poorer prognosis and outcome for patients who have undergone surgical removal of the cancer. In such cases, it is recommended to combine chemotherapy with radiation therapy after surgery. As the number of cases of HNSCC related to the human papillomavirus (HPV) is increasing, treatment approaches have shifted towards using radiation therapy as the primary treatment method instead of surgery. This raises an important question about the significance of ENE observed through imaging tests (referred to as iENE) and its impact on the prognosis. Unfortunately, this question remains unanswered. The objective of this project is to conduct a comprehensive study across multiple medical institutions. The investigators will gather data including scan results, histopathology reports, and data from patient charts from individuals who have been treated for head and neck cancer. The aim is to analyze and correlate the findings between the pathological evidence of ENE and the imaging results, while also assessing the prognostic value of iENE. Additionally, the investigators will explore the influence of HPV status on these factors. By collecting and analyzing this data, the investigators hope to establish standardized criteria that can assist radiologists in accurately identifying ENE through imaging tests. This research is essential for enhancing our understanding of HNSCC and improving the effectiveness of diagnostic procedures and treatment planning. Sponsor: Head and Neck Cancer International Group Intervention: Extranodal extension Start Date: 2023-07-11 Last Updated: 2023-07-12 Number of Patients: 2000 Recruitment Status: RECRUITING Condition: Head and Neck Squamous Cell Carcinoma
NCTID: NCT04924101
Title: Efficacy and Safety of Pembrolizumab Plus Investigational Agents in Combination With Chemotherapy as First-Line Treatment in Extensive-Stage Small Cell Lung Cancer (ES-SCLC) (MK-3475-B99/ KEYNOTE-B99) Study Summary: The purpose of this study is to evaluate the use of investigational agents (MK-4830, boserolimab (MK-5890) and lenvatinib (MK-7902)) in combination with pembrolizumab (MK-3475) and etoposide/platinum chemotherapy for the first-line treatment of participants with extensive-stage small cell Lung Cancer (ES-SCLC). No formal hypothesis testing will be performed for this study. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2021-07-15 Last Updated: 2023-04-10 Number of Patients: 120 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Small Cell Lung Cancer
NCTID: NCT02289898
Title: Study of Gemcitabine, Abraxane® Plus Placebo Versus Gemcitabine, Abraxane® Plus 1 or 2 Truncated Courses of Demcizumab in Subjects With 1st-Line Metastatic Pancreatic Ductal Adenocarcinoma Study Summary: This is a randomized, double blind, 3 arm (1:1:1) study in subjects with 1st-line metastatic pancreatic ductal adenocarcinoma. The purpose is to test the efficacy and safety of demcizumab, when given in combination with gemcitabine and Abraxane® compared to placebo. The administration of gemcitabine and Abraxane® is a standard treatment for patients with metastatic pancreatic ductal adenocarcinoma. Sponsor: OncoMed Pharmaceuticals, Inc. Intervention: Demcizumab Start Date: 2015-04-20 Last Updated: 2020-09-28 Number of Patients: 207 Recruitment Status: COMPLETED Condition: Pancreatic Cancer
NCTID: NCT02599324
Title: Study to Evaluate Ibrutinib Combination Therapy in Patients With Selected Gastrointestinal and Genitourinary Tumors Study Summary: The purpose of this study is to evaluate the safety, tolerability, and efficacy of single agent ibrutinib or the combination treatments of ibrutinib with everolimus, paclitaxel, docetaxel, pembrolizumab or cetuximab in selected advance gastrointestinal and genitourinary tumors. Sponsor: Pharmacyclics LLC. Intervention: ibrutinib Start Date: 2015-12-01 Last Updated: 2023-11-18 Number of Patients: 263 Recruitment Status: COMPLETED Condition: Metastatic Renal Cell Carcinoma
NCTID: NCT05008224
Title: Study of Safety and Efficacy of Pembrolizumab and Chemotherapy in Participants With Newly Diagnosed Classical Hodgkin Lymphoma (cHL) (MK-3475-C11/KEYNOTE-C11) Study Summary: The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) monotherapy, followed by chemotherapy, followed by pembrolizumab consolidation. The primary hypothesis of the study is that the complete response (CR) rate at the end of study intervention according to Lugano 2014 response criteria is higher than conventional chemotherapy. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2021-10-07 Last Updated: 2023-10-25 Number of Patients: 146 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Classical Hodgkin Lymphoma
NCTID: NCT04436744
Title: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Giredestrant Plus Palbociclib Compared With Anastrozole Plus Palbociclib for Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Untreated Early Breast Cancer (coopERA Breast Cancer) Study Summary: This is a randomized, multicenter, open-label, two-arm, Phase II study to evaluate the efficacy, safety, and pharmacokinetics of giredestrant versus anastrozole (in the window-of-opportunity phase) and giredestrant plus palbociclib compared with anastrozole plus palbociclib (in the neoadjuvant phase) in postmenopausal women with untreated, estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative, early breast cancer. The study consists of a screening period of up to 28 days, a window-of-opportunity phase for 14 days, followed by a neoadjuvant treatment phase for 16 weeks (four 28-day cycles), surgery, and an end of study visit (28 days after the final dose of study treatment). Sponsor: Hoffmann-La Roche Intervention: Giredestrant Start Date: 2020-09-04 Last Updated: 2023-02-02 Number of Patients: 221 Recruitment Status: COMPLETED Condition: Early Breast Cancer
NCTID: NCT03539744
Title: A Study Designed to Evaluate the Safety and Efficacy of Venetoclax Plus Dexamethasone (VenDex) Compared With Pomalidomide Plus Dexamethasone (PomDex) in Participants With t(11;14)-Positive Relapsed or Refractory Multiple Myeloma. Study Summary: A study designed tocompare progression-free survival (PFS) in participants with t(11;14)-positive MM treated with venetoclax in combination with dexamethasone versus pomalidomide in combination with dexamethasone. Sponsor: AbbVie Intervention: Pomalidomide Start Date: 2018-10-22 Last Updated: 2023-11-28 Number of Patients: 244 Recruitment Status: RECRUITING Condition: Multiple Myeloma
NCTID: NCT02434081
Title: NIvolumab COmbination With Standard First-line Chemotherapy and Radiotherapy in Locally Advanced Stage IIIA/B Non-Small Cell Lung Carcinoma Study Summary: The aim of the study is to investigate the tolerability (how severe the side effects are) and the efficacy (how well the treatment works) when nivolumab is added to the current standard treatment (chemotherapy and radiotherapy) given to patients with advanced NSCLC. Sponsor: ETOP IBCSG Partners Foundation Intervention: Nivolumab Start Date: 2015-11-25 Last Updated: 2022-08-24 Number of Patients: 94 Recruitment Status: COMPLETED Condition: Non-small Cell Lung Cancer Stage III
NCTID: NCT06119581
Title: A Study of LY3537982 Plus Immunotherapy With or Without Chemotherapy in Participants With Non-Small Cell Lung Cancer (NSCLC) With a Change in a Gene Called KRAS G12C Study Summary: The purpose of this study is to assess if adding LY3537982 in combination with standard of care anti-cancer drugs is more effective than standard of care in participants with untreated advanced NSCLC. NSCLC must have a change in a gene called KRAS G12C. Study participation, including follow-up, could last up to 3 years, depending on how you and your lung cancer are doing. Sponsor: Eli Lilly and Company Intervention: LY3537982 Start Date: 2024-01-03 Last Updated: 2023-11-07 Number of Patients: 1016 Recruitment Status: NOT_YET_RECRUITING Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT03179436
Title: Study of Quavonlimab (MK-1308) in Combination With Pembrolizumab (MK-3475) in Advanced Solid Tumors (MK-1308-001) Study Summary: This study will assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of escalating doses of quavonlimab when used in combination with pembrolizumab in participants with advanced solid tumors. Sponsor: Merck Sharp & Dohme LLC Intervention: Quavonlimab Start Date: 2017-07-02 Last Updated: 2023-02-08 Number of Patients: 348 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Advanced Solid Tumors
NCTID: NCT02952534
Title: A Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency Study Summary: The purpose of this study is to determine how patients with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib. Sponsor: pharmaand GmbH Intervention: Rucaparib Start Date: 2017-02-15 Last Updated: 2023-06-09 Number of Patients: 277 Recruitment Status: COMPLETED Condition: Metastatic Castration Resistant Prostate 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: 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: NCT03132636
Title: PD-1 in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy Study Summary: The primary objective is to estimate the objective response rate (ORR) for metastatic Basal Cell Carcinoma (BCC) (group 1) and for unresectable locally advanced BCC (group 2) when treated with cemiplimab as a monotherapy Sponsor: Regeneron Pharmaceuticals Intervention: cemiplimab Start Date: 2017-06-29 Last Updated: 2023-06-18 Number of Patients: 138 Recruitment Status: COMPLETED Condition: Carcinoma, Basal Cell
NCTID: NCT05296798
Title: A Study to Evaluate the Efficacy and Safety of Giredestrant in Combination With Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) Versus Phesgo in Participants With Locally Advanced or Metastatic Breast Cancer (heredERA Breast Cancer) Study Summary: This Phase III, randomized, two-arm, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus Phesgo compared with Phesgo after induction therapy with Phesgo plus taxane in participants with human epidermal growth factor receptor 2 (HER2)-positive, estrogen receptor (ER)-positive advanced breast cancer (metastatic or locally advanced disease not amenable to curative treatment) who have not previously received a systemic non-hormonal anti-cancer therapy in the advanced setting. Sponsor: Hoffmann-La Roche Intervention: Phesgo Start Date: 2022-07-04 Last Updated: 2023-11-28 Number of Patients: 812 Recruitment Status: RECRUITING Condition: Locally Advanced or Metastatic Breast Cancer
NCTID: NCT05446870
Title: Pembrolizumab With Chemotherapy and MK-4830 for Treating Participants With Ovarian Cancer (MK-4830-002) Study Summary: The primary objective is to evaluate in participants with high-grade serous ovarian cancer (HGSOC), whether the reduction from baseline in circulating tumor DNA (ctDNA) at Cycle 3 (ΔctDNA) is larger in participants receiving MK-4830 + pembrolizumab in combination with standard of care (SOC) therapy than in those receiving pembrolizumab + SOC therapy. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2022-07-25 Last Updated: 2023-10-26 Number of Patients: 160 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: High-grade Serous Ovarian Carcinoma
