Trials (University Cancer Institute Toulouse-Oncopole)

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NCTID: NCT06112314

Title: IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301) 
Study Summary: This is a phase 3, randomized, controlled study of IMC-F106C plus nivolumab compared to standard nivolumab regimens in HLA-A*02:01-positive participants with previously untreated advanced melanoma. 
Sponsor: Immunocore Ltd 
Intervention: IMC-F106C 
Start Date: 2023-12-01 
Last Updated: 2023-11-01 
Number of Patients: 680 
Recruitment Status: NOT_YET_RECRUITING 
Condition: Advanced Melanoma 

NCTID: NCT04717414

Title: An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK2 Inhibitor Therapy and Who Require Red Blood Cell Transfusions 
Study Summary: The purpose of this Phase 3 study is to evaluate the efficacy and safety of Luspatercept compared with placebo in subjects with myeloproliferative neoplasm (MPN)-associated Myelofibrosis (MF) and anemia on concomitant Janus kinase 2 (JAK2) inhibitor therapy and who require red blood cell count (RBC) transfusions.  The study is divided into Screening Period, a Treatment Phase (consisting of a Blinded Core Treatment Period, a Day 169 Response Assessment, a Blinded Extension Treatment Period, and an Open-label Extension Treatment Period), and a Posttreatment Follow-up Period.  Following the Day 169 Response Assessment, subjects who did not show clinical benefit will have the option to unblind. Subjects who were on placebo during the Blinded Core Treatment Period will have the opportunity to crossover into the Open-Label Extension Treatment Period and receive Luspatercept. 
Sponsor: Celgene 
Intervention: ACE-536 
Start Date: 2021-02-25 
Last Updated: 2023-11-14 
Number of Patients: 309 
Recruitment Status: RECRUITING 
Condition: Myeloproliferative Disorders 

NCTID: NCT05572515

Title: A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma 
Study Summary: The purpose of this study is to compare the efficacy of teclistamab with PVd/Kd. 
Sponsor: Janssen Research & Development, LLC 
Intervention: Teclistamab 
Start Date: 2023-03-29 
Last Updated: 2023-09-13 
Number of Patients: 590 
Recruitment Status: RECRUITING 
Condition: Relapsed or Refractory Multiple Myeloma 

NCTID: NCT05508867

Title: A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Physician’s Choice Chemotherapy in PD-(L)1-refractory, Relapsed or Refractory Classical Hodgkin Lymphoma (MK-4280A-008) 
Study Summary: The purpose of this study is to compare efficacy of coformulated favezelimab/pembrolizumab (MK-4280A) with physician’s choice chemotherapy of bendamustine or gemcitabine in participants with PD-(L)1-refractory, relapsed or refractory classical Hodgkin Lymphoma. The study will also assess the safety and tolerability of coformulated favezelimab/pembrolizumab. The primary study hypotheses are that coformulated favezelimab/pembrolizumab is superior to physician’s choice chemotherapy with respect to progression-free survival (PFS) and overall survival (OS). 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: favezelimab/pembrolizumab 
Start Date: 2022-10-18 
Last Updated: 2023-11-27 
Number of Patients: 360 
Recruitment Status: RECRUITING 
Condition: Hodgkin Lymphoma 

NCTID: NCT02824159

Title: Association Between Side Effects Occurrence and Concentrations of Ibrutinib and Idelalisib 
Study Summary: Recently, European Medicines Agency approved ibrutinib and idelalisib to treat Chronic Lymphocytic Leukemia (CLL) and two lymphomas: Follicular Lymphoma (FL) for ibrutinib and Mantle cell lymphoma (MCL) for idelalisib.  Clinical trials for ibrutinib and idelalisib were performed with a small number of patients (300-350) and showed several side effects profiles. Since, pharmacokinetic properties of these 2 drugs highlight a interindividual variability of pharmacokinetic. The aim of this study is to determine the association between clinically significant side effects occurrence during the first year of treatment and plasma mean concentration of the steady state of ibrutinib or idelalisib at 1 month. 
Sponsor: University Hospital, Toulouse 
Intervention: Blood samples for pharmacokinetics exploration 
Start Date: 2016-04 
Last Updated: 2020-12-28 
Number of Patients: 121 
Recruitment Status: COMPLETED 
Condition: Hematological Malignancies 

NCTID: NCT04172675

Title: A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) 
Study Summary: The purpose of this study is to evaluate recurrence-free survival (RFS) in participants treated with erdafitinib vs Investigator’s Choice, for participants with high-risk non-muscle-invasive bladder cancer (NMIBC) who harbor fibroblast growth factor receptor (FGFR) mutations or fusions, and who recurred after bacillus calmette-guerin (BCG) therapy. 
Sponsor: Janssen Research & Development, LLC 
Intervention: Erdafitinib 
Start Date: 2020-02-28 
Last Updated: 2023-11-13 
Number of Patients: 107 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Urinary Bladder Neoplasms 

NCTID: NCT05050097

Title: A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma 
Study Summary: The purpose of this study is to characterize the safety and tolerability of talquetamab when administered in different combination regimens and to identify the safe dose(s) of talquetamab combination regimens. 
Sponsor: Janssen Research & Development, LLC 
Intervention: Talquetamab 
Start Date: 2021-09-22 
Last Updated: 2023-11-08 
Number of Patients: 182 
Recruitment Status: RECRUITING 
Condition: Multiple Myeloma 

NCTID: NCT03762447

Title: A Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB086550 in Participants With Advanced Solid Tumors 
Study Summary: The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of INCB086550 in participants with advanced solid tumors who have failed prior treatments. 
Sponsor: Incyte Corporation 
Intervention: INCB086550 
Start Date: 2018-12-10 
Last Updated: 2023-11-02 
Number of Patients: 138 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Solid Tumors 

NCTID: NCT03333655

Title: Study to Explore the Mechanism of Acquired Immune Escape In Participants With Metastatic Cancer Progressing on CPI Therapy 
Study Summary: The purpose of this study is to identify mechanisms associated with acquired immune escape by comparing baseline and at-progression tissue samples from participants who derive clinical benefit from CPI treatment of metastatic cancer or hematologic malignancies. 
Sponsor: Hoffmann-La Roche 
Intervention: Biopsy 
Start Date: 2018-02-16 
Last Updated: 2022-08-12 
Number of Patients: 15 
Recruitment Status: COMPLETED 
Condition: Neoplasms 

NCTID: NCT03662126

Title: KRT-232 Versus Best Available Therapy for the Treatment of Subjects With Myelofibrosis Who Are Relapsed or Refractory to JAK Inhibitor Treatment 
Study Summary: This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with myelofibrosis (MF) who no longer benefit from treatment with a JAK inhibitor. Inhibition of MDM2 is a novel mechanism of action in MF.  This study will be conducted in 2 phases. Phase 2 will determine the KRT-232 recommended dose and dosing schedule; Phase 3 will test KRT-232 vs Best Available Therapy (BAT). Patients in the Phase 3 part of the study will be randomized 2:1 to receive either KRT-232 (Arm 1) or BAT (Arm 2). The BAT administered will be determined by the treating physician, with the option to “cross-over” to KRT-232 treatment after 6 months of BAT or if the disease worsens at any time. 
Sponsor: Kartos Therapeutics, Inc. 
Intervention: KRT-232 
Start Date: 2019-01-15 
Last Updated: 2023-04-28 
Number of Patients: 385 
Recruitment Status: RECRUITING 
Condition: Primary Myelofibrosis (PMF) 

NCTID: NCT05317416

Title: Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant 
Study Summary: The purpose of this study is to evaluate whether elranatamab monotherapy can provide clinical benefit compared to lenalidomide monotherapy (control) in participants with newly diagnosed multiple myeloma after undergoing autologous stem cell transplant. In Part 1 and Part 2 of the study, participants in the study will either receive elranatamab (arm A and C) as an injection under the skin at the study clinic or lenalidomide orally once daily at home (arm B). Participation in the study will be approximately five years 
Sponsor: Pfizer 
Intervention: Elranatamab 
Start Date: 2022-03-25 
Last Updated: 2023-11-28 
Number of Patients: 760 
Recruitment Status: RECRUITING 
Condition: Multiple Myeloma 

NCTID: NCT04589845

Title: Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study 
Study Summary: TAPISTRY is a Phase II, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in rational, specified combinations in participants with unresectable, locally advanced or metastatic solid tumors determined to harbor specific oncogenic genomic alterations or who are tumor mutational burden (TMB)-high as identified by a validated next-generation sequencing (NGS) assay. Participants with solid tumors will be treated with a drug or drug regimen tailored to their NGS assay results at screening. Participants will be assigned to the appropriate cohort based on their genetic alteration(s). Treatment will be assigned on the basis of relevant oncogenotype, will have cohort-specific inclusion/exclusion criteria, and, unless otherwise specified, will continue until disease progression, loss of clinical benefit, unacceptable toxicity, participant or physician decision to discontinue, or death, whichever occurs first. 
Sponsor: Hoffmann-La Roche 
Intervention: Entrectinib 
Start Date: 2021-01-18 
Last Updated: 2023-11-13 
Number of Patients: 920 
Recruitment Status: RECRUITING 
Condition: Solid Tumors 

NCTID: NCT03859427

Title: A Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma 
Study Summary: Compare efficacy of 56 mg/m2 carfilzomib administered once-weekly in combination with lenalidomide and dexamethasone (KRd 56 mg/m2) to 27 mg/m2 carfilzomib administered twice-weekly in combination with lenalidomide and dexamethasone (KRd 27 mg/m2) in subjects with relapsed or refractory multiple myeloma (RRMM) with 1 to 3 prior lines of therapy. 
Sponsor: Amgen 
Intervention: Carfilzomib 
Start Date: 2019-05-08 
Last Updated: 2023-10-27 
Number of Patients: 454 
Recruitment Status: COMPLETED 
Condition: Relapsed or Refractory Multiple Myeloma 

NCTID: NCT06045806

Title: A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation 
Study Summary: The purpose of this study is to compare the efficacy, safety, and tolerability of ide-cel with lenalidomide (LEN) maintenance to that of LEN maintenance alone in adult participants with Newly Diagnosed Multiple Myeloma (NDMM) who have achieved a suboptimal response post autologous stem cell transplantation (ASCT). 
Sponsor: Bristol-Myers Squibb 
Intervention: idecabtagene vicleucel 
Start Date: 2023-10-16 
Last Updated: 2023-11-07 
Number of Patients: 618 
Recruitment Status: RECRUITING 
Condition: Multiple Myeloma 

NCTID: NCT04181827

Title: A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma 
Study Summary: The purpose of this study is to compare the efficacy of JNJ-68284528 (ciltacabtagene autoleucel <math display="block">cilta-cel</math>) with standard therapy, either Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd). 
Sponsor: Janssen Research & Development, LLC 
Intervention: JNJ-68284528 
Start Date: 2020-06-12 
Last Updated: 2023-11-09 
Number of Patients: 419 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Multiple Myeloma 

NCTID: NCT04691804

Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study of Fuzuloparib Combined With Abiraterone Acetate and Prednisone (AA-P) Versus Placebo Combined With AA-P as First-Line Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer 
Study Summary: To evaluate whether Fuzuloparib plus AA-P is superior to placebo plus AA-P as first-line treatment by assessment of radiographic progression-free survival (rPFS) in mCRPC subjects unselected for deoxyribonucleic acid (DNA) damage repair deficiencies (DRD) status (Cohort 1) to evaluate whether Fuzuloparib plus AA-P is superior to placebo plus AA-P as first-line treatment by assessment of rPFS in mCRPC subjects harboring DRD (Cohort 2). 
Sponsor: Jiangsu HengRui Medicine Co., Ltd. 
Intervention: Fuzuloparib , Abiraterone acetate and Prednisone 
Start Date: 2021-03-18 
Last Updated: 2022-08-01 
Number of Patients: 804 
Recruitment Status: RECRUITING 
Condition: Metastatic Castration-Resistant Prostate Cancer (mCRPC) 

NCTID: NCT03424005

Title: A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer 
Study Summary: This is an umbrella study evaluating the efficacy and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer.  The study will be performed in two stages. During Stage 1, four cohorts will be enrolled in parallel in this study:  Cohort 1 will consist of Programmed death-ligand 1 (PD-L1)-positive participants who have received no prior systemic therapy for metastatic or inoperable locally advanced triple-negative breast cancer (TNBC) (first-line <math display="block">1L</math> PD-L1+ cohort).  Cohort 2 will consist of participants who had disease progression during or following 1L treatment with chemotherapy for metastatic or inoperable locally-advanced TNBC and have not received cancer immunotherapy (CIT) (second-line <math display="block">2L</math> CIT-naive cohort).  Cohort 3 will consist of participants with locally-advanced or metastatic HR+, HER2-negative disease with PIK3CA mutation who may or may not have had disease progression during or following previous lines of treatment for metastatic disease (HR+cohort).  Cohort 4 will consist of participants with locally-advanced or metastatic HER2+ /HER2-low disease with PIK3CA mutation who had disease progression on standard-of-care therapies (HER2+ /HER2-low cohort).  In each cohort, eligible participants will initially be assigned to one of several treatment arms (Stage 1). In addition, participants in the 2L CIT-naïve cohort who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment combination (Stage 2), provided Stage 2 is open for enrollment. 
Sponsor: Hoffmann-La Roche 
Intervention: Capecitabine 
Start Date: 2018-04-02 
Last Updated: 2023-11-07 
Number of Patients: 242 
Recruitment Status: RECRUITING 
Condition: Breast Cancer 

NCTID: NCT02034916

Title: A Phase 2, 2-Stage, 2-Cohort Study of Talazoparib (BMN 673), in Locally Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (ABRAZO Study) 
Study Summary: The purpose of this 2-stage, 2-cohort Phase 2 trial is to evaluate the safety and efficacy of talazoparib (also known as BMN 673) in subjects with locally advanced or metastatic breast cancer with a deleterious germline BRCA 1 or BRCA 2 mutation. Subjects will be assigned to either Cohort 1 or 2 based on prior chemotherapy for metastatic disease:  * Cohort 1) Subjects with a documented PR or CR to a prior platinum-containing regimen for metastatic disease with disease progression > 8 weeks following the last dose of platinum; or * Cohort 2) Subjects who have received > 2 prior chemotherapy regimens for metastatic disease and who have had no prior platinum therapy for metastatic disease 
Sponsor: Pfizer 
Intervention: talazoparib 
Start Date: 2013-12-13 
Last Updated: 2019-10-14 
Number of Patients: 84 
Recruitment Status: TERMINATED 
Condition: Breast Neoplasms 

NCTID: NCT03589326

Title: A Study of Ponatinib Versus Imatinib in Adults With Acute Lymphoblastic Leukemia 
Study Summary: In this study, adults with newly-diagnosed Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) will receive first-line therapy of ponatinib or imatinib.  The main aim of this study is to compare the number of participants on each treatment that show no signs of disease.  Participants will take tablets of either ponatinib or imatinib at the same time each day combined with reduced-intensity chemotherapy for up to 20 months. Then, they will continue with single-agent therapy (ponatinib or imatinib) until they meet the discontinuation criteria from the study. 
Sponsor: Takeda 
Intervention: Ponatinib 
Start Date: 2018-10-04 
Last Updated: 2023-10-27 
Number of Patients: 245 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL) 

NCTID: 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: NCT04023526

Title: A Study of Cusatuzumab Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy 
Study Summary: The purpose of this study is to determine the efficacy of cusatuzumab in combination with azacitidine in participants with previously untreated acute myeloid leukemia (AML) who are not eligible for intensive chemotherapy. 
Sponsor: OncoVerity, Inc. 
Intervention: Azacitidine 
Start Date: 2019-07-29 
Last Updated: 2023-08-09 
Number of Patients: 103 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Leukemia, Myeloid, Acute 

NCTID: NCT03822117

Title: Efficacy and Safety of Pemigatinib in Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207) 
Study Summary: The purpose of this study is to evaluate the efficacy and safety of pemigatinib in participants with previously treated locally advanced/metastatic or surgically unresectable solid tumor malignancies harboring activating FGFR mutations or translocations. 
Sponsor: Incyte Corporation 
Intervention: Pemigatinib 
Start Date: 2019-10-17 
Last Updated: 2023-03-20 
Number of Patients: 111 
Recruitment Status: TERMINATED 
Condition: Solid Tumor Malignancy 

NCTID: NCT04923893

Title: A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy 
Study Summary: The purpose of this study is to compare the efficacy of Bortezomib, Lenalidomide and Dexamethasone (VRd) induction followed by a single administration of ciltacabtagene autoleucel (cilta-cel) versus VRd induction followed by Lenalidomide and Dexamethasone (Rd) maintenance in newly diagnosed multiple myeloma participants for whom ASCT is not planned as initial therapy in terms of Progression Free Survival (PFS). 
Sponsor: Janssen Research & Development, LLC 
Intervention: Bortezomib 
Start Date: 2021-08-19 
Last Updated: 2023-11-09 
Number of Patients: 650 
Recruitment Status: RECRUITING 
Condition: Multiple Myeloma 

NCTID: NCT05455320

Title: A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment 
Study Summary: The purpose of the study is to compare the efficacy of talquetamab subcutaneous(ly) (SC) in combination with daratumumab SC and pomalidomide (Tal-DP) and talquetamab SC in combination with daratumumab SC (Tal-D), respectively, with daratumumab SC in combination with pomalidomide and dexamethasone (DPd). 
Sponsor: Janssen Research & Development, LLC 
Intervention: Talquetamab 
Start Date: 2022-10-13 
Last Updated: 2023-11-08 
Number of Patients: 810 
Recruitment Status: RECRUITING 
Condition: Relapsed or Refractory Multiple Myeloma 

NCTID: NCT01080391

Title: Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma 
Study Summary: The primary objective was to compare progression-free survival in adults with relapsed multiple myeloma who are receiving CRd vs participants receiving Rd in a randomized multicenter setting. 
Sponsor: Amgen 
Intervention: Dexamethasone 
Start Date: 2010-07-14 
Last Updated: 2022-09-21 
Number of Patients: 792 
Recruitment Status: COMPLETED 
Condition: Relapsed Multiple Myeloma 

NCTID: NCT02920008

Title: Phase 3 Randomized, Open-Label Study of Guadecitabine vs Treatment Choice in Previously Treated Acute Myeloid Leukemia 
Study Summary: Multicenter, randomized, open-label, parallel-group study of guadecitabine vs treatment choice (TC). Participants will be randomly assigned in a 1:1 ratio to either guadecitabine or TC. TC options include the 8 high or low intensity, locally available regimens below; or Best supportive Care (BSC) alone:  * High intensity (intermediate or high dose cytarabine <math display="block">HiDAC</math>; mitoxantrone, etoposide, and cytarabine <math display="block">MEC</math>; or fludarabine, cytarabine, granulocyte colony stimulating factor <math display="block">G-CSF</math>, +/- idarubicin <math display="block">FLAG/FLAG-Ida</math>). * Low intensity (low dose cytarabine <math display="block">LDAC</math>, decitabine, or azacitidine). * BSC. 
Sponsor: Astex Pharmaceuticals, Inc. 
Intervention: guadecitabine 
Start Date: 2017-03-16 
Last Updated: 2023-05-25 
Number of Patients: 302 
Recruitment Status: COMPLETED 
Condition: Acute Myeloid Leukemia 

NCTID: NCT02005471

Title: A Study to Evaluate the Benefit of Venetoclax Plus Rituximab Compared With Bendamustine Plus Rituximab in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) 
Study Summary: The purpose of this open-label, multicenter, randomized, Phase III study is to evaluate the benefit of venetoclax in combination with rituximab compared with bendamustine in combination with rituximab in participants with relapsed or refractory CLL. Participants will be randomly assigned in 1:1 ratio to receive either venetoclax + rituximab (Arm A) or bendamustine + rituximab (Arm B). 
Sponsor: Hoffmann-La Roche 
Intervention: Bendamustine 
Start Date: 2014-03-17 
Last Updated: 2023-10-17 
Number of Patients: 389 
Recruitment Status: COMPLETED 
Condition: Chronic Lymphocytic Leukemia 

NCTID: NCT01945775

Title: A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study) 
Study Summary: The purpose of this open-label, 2:1 randomized phase III trial is to compare the safety and efficacy of talazoparib (also known as BMN 673) versus protocol-specific physician’s choice in patients who have locally advanced and/or metastatic breast cancer with germline BRCA mutations. 
Sponsor: Pfizer 
Intervention: talazoparib 
Start Date: 2013-10-14 
Last Updated: 2022-01-20 
Number of Patients: 431 
Recruitment Status: COMPLETED 
Condition: Breast Neoplasms 

NCTID: NCT05267106

Title: Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Glioblastoma or Other Primary Central Nervous System Tumors Harboring Activating FGFR1-3 Alterations 
Study Summary: This is an open-label, monotherapy study of pemigatinib in participants with recurrent glioblastoma (GBM) or other recurrent gliomas, circumscribed astrocytic gliomas, and glioneuronal and neuronal tumors with an activating FGFR1-3 mutation or fusion/rearrangement. This study consists of 2 cohorts, Cohorts A, and B, and will enroll approximately 82 participants into each cohort. Participants will receive pemigatinib 13.5 mg QD on a 2-week on-therapy and 1-week off-therapy schedule as long as they are receiving benefit and have not met any criteria for study withdrawal. 
Sponsor: Incyte Corporation 
Intervention: Pemigatinib 
Start Date: 2022-05-20 
Last Updated: 2023-11-15 
Number of Patients: 164 
Recruitment Status: RECRUITING 
Condition: Glioblastoma 

NCTID: NCT04722146

Title: A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma 
Study Summary: The purpose of this study is to characterize the safety and tolerability of teclistamab when administered in different combination regimen and to identify the optimal dose(s) of teclistamab combination regimens. 
Sponsor: Janssen Research & Development, LLC 
Intervention: Teclistamab 
Start Date: 2021-03-12 
Last Updated: 2023-11-09 
Number of Patients: 140 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Multiple Myeloma 

NCTID: NCT05238922

Title: Study of INCB123667 in Subjects With Advanced Solid Tumors 
Study Summary: This is an open-label, dose-escalation and dose-expansion study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCB123667 when administered as monotherapy at the RDE(s) in participants with selected advanced or metastatic solid tumors. Part 1A (dose escalation) will determine the recommended dose of INCB123667 for expansion (RDE) and the maximum tolerated dose (MTD). Part 1B (cohort dose expansion phase) will further explore antitumor activity of INCB123667 as a monotherapy in 6 tumor-specific cohorts at the RDE(s) defined in Part 1A. 
Sponsor: Incyte Corporation 
Intervention: INCB0123667 
Start Date: 2022-07-05 
Last Updated: 2023-11-03 
Number of Patients: 340 
Recruitment Status: RECRUITING 
Condition: Solid Tumors 

NCTID: NCT05800964

Title: Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors. 
Study Summary: The primary objective of this study is to: * Evaluate the safety and tolerability of AMG 305 in adult participants * Determine the optimal biologically active dose (OBD), at or below the maximum tolerated dose (MTD) with MTD 1 as the maximum tolerated starting dose and MTD 2 as the maximum tolerated target dose * Determine the recommended phase 2 dose (RP2D) 
Sponsor: Amgen 
Intervention: AMG 305 
Start Date: 2023-06-13 
Last Updated: 2023-11-27 
Number of Patients: 260 
Recruitment Status: RECRUITING 
Condition: Advanced Solid Tumors 

NCTID: NCT04551053

Title: To Evaluate Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib (LIMBER-304) 
Study Summary: The purpose of the study is to compare the efficacy and safety of parsaclisib when combined with ruxolitinb versus placebo combined with ruxolitinib in participants with myelofibrosis who have suboptimal response while receiving ruxolitinib monotherapy. 
Sponsor: Incyte Corporation 
Intervention: parsaclisib 
Start Date: 2021-05-26 
Last Updated: 2023-10-18 
Number of Patients: 177 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Myelofibrosis 

NCTID: NCT04634877

Title: Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053) 
Study Summary: The purpose of this study is to compare pembrolizumab + adjuvant chemotherapy with placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to disease-free survival (DFS) as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to overall survival (OS). The primary hypotheses are that pembrolizumab + adjuvant chemotherapy is superior to placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to DFS as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to OS. 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Pembrolizumab 
Start Date: 2021-01-10 
Last Updated: 2023-11-21 
Number of Patients: 990 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Endometrial Neoplasms 

NCTID: NCT04221035

Title: High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN) 
Study Summary: This is an international multicenter, open-label, randomized phase III trial including three sequential randomizations to assess efficacy of induction and consolidation chemotherapies and radiotherapy for patients with high-risk neuroblastoma. 
Sponsor: Gustave Roussy, Cancer Campus, Grand Paris 
Intervention: Vincristine 
Start Date: 2019-11-05 
Last Updated: 2023-02-13 
Number of Patients: 800 
Recruitment Status: RECRUITING 
Condition: High-Risk Neuroblastoma 

NCTID: NCT03850535

Title: A Study Evaluating the Safety and Efficacy of Idasanutlin in Combination With Cytarabine and Daunorubicin in Patients Newly Diagnosed With Acute Myeloid Leukemia (AML) and the Safety and Efficacy of Idasanutlin in the Maintenance of First AML Complete Remission 
Study Summary: This Phase Ib/II, open-label, multicenter, non-randomized study will evaluate the safety, efficacy, and pharmacokinetics of idasanutlin when it is given in combination with cytarabine and daunorubicin in induction, in combination with cytarabine in consolidation, and as a single agent in maintenance for treating participants with acute myeloid leukemia (AML). 
Sponsor: Hoffmann-La Roche 
Intervention: Idasanutlin 
Start Date: 2019-03-25 
Last Updated: 2022-06-21 
Number of Patients: 24 
Recruitment Status: TERMINATED 
Condition: Acute Myeloid Leukemia 

NCTID: NCT05079230

Title: Study of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Participants With Acute Myeloid Leukemia 
Study Summary: The goal of this clinical study is to compare the study drugs, magrolimab + venetoclax + azacitidine, versus placebo + venetoclax + azacitidine in participants with untreated acute myeloid leukemia (AML) who are not able to have chemotherapy. 
Sponsor: Gilead Sciences 
Intervention: Magrolimab 
Start Date: 2022-07-07 
Last Updated: 2023-10-30 
Number of Patients: 432 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Acute Myeloid Leukemia 

NCTID: NCT04003610

Title: Pemigatinib + Pembrolizumab vs Pemigatinib Alone vs Standard of Care for Urothelial Carcinoma (FIGHT-205) 
Study Summary: The purpose of this study is to evaluate the safety and efficacy of pemigatinib plus pembrolizumab or pemigatinib alone versus the standard of care for participants with metastatic or unresectable urothelial carcinoma who are not eligible to receive cisplatin, are harboring FGFR3 mutation or rearrangement, and who have not received prior treatment. 
Sponsor: Incyte Corporation 
Intervention: Pemigatinib 
Start Date: 2020-05-14 
Last Updated: 2022-05-26 
Number of Patients: 7 
Recruitment Status: TERMINATED 
Condition: Metastatic Urothelial Carcinoma 

NCTID: NCT03652064

Title: A Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Participants With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy 
Study Summary: The purpose of this study to determine if the addition of daratumumab to bortezomib + lenalidomide + dexamethasone (VRd) will improve overall minimal residual disease (MRD) negativity rate compared with VRd alone. 
Sponsor: Janssen Research & Development, LLC 
Intervention: Daratumumab 
Start Date: 2018-11-06 
Last Updated: 2023-11-09 
Number of Patients: 395 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Multiple Myeloma 

NCTID: NCT03011372

Title: A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203) 
Study Summary: The purpose of this study is to evaluate the efficacy and safety of pemigatinib (INCB054828) in subjects with myeloid/lymphoid neoplasms with fibroblast growth factor receptor (FGFR) 1 rearrangement. 
Sponsor: Incyte Corporation 
Intervention: Pemigatinib 
Start Date: 2017-04-25 
Last Updated: 2023-07-03 
Number of Patients: 47 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: MPN (Myeloproliferative Neoplasms) 

NCTID: NCT03462719

Title: A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) 
Study Summary: The purpose of this study is to assess progression-free survival (PFS) from treatment with ibrutinib plus venetoclax (I+VEN) compared with obinutuzumab plus chlorambucil (G-Clb) as assessed by an Independent Review Committee (IRC). 
Sponsor: Janssen Research & Development, LLC 
Intervention: Ibrutinib 
Start Date: 2018-04-17 
Last Updated: 2023-11-09 
Number of Patients: 211 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Leukemia, Lymphocytic, Chronic, B-Cell 

NCTID: NCT04580485

Title: INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors 
Study Summary: This is a multicenter, open-label, dose-escalation/dose-expansion Phase 1 clinical study to investigate the safety, tolerability, PK profile, pharmacodynamics, and preliminary clinical efficacy of INCB106385 when given as monotherapy or in combination with INCMGA00012 in participants with selected CD8 T-cell-positive advanced solid tumors including SCCHN, NSCLC, ovarian cancer, CRPC, TNBC, bladder cancer, and specified GI malignancies (defined as CRC, gastric/GEJ cancer, HCC, PDAC, or SCAC) 
Sponsor: Incyte Corporation 
Intervention: INCB106385 
Start Date: 2021-02-03 
Last Updated: 2023-11-09 
Number of Patients: 54 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Ovarian Cancer 

NCTID: NCT04122625

Title: Study to Assess Safety and Efficacy of the Second Mitochondrial-derived Activator of Caspases (SMAC) Mimetic Debio 1143 
Study Summary: Part A (dose-optimization)- to determine the recommended phase 2 dose (RP2D) taking into account dose-limiting toxicity (DLT/s) in Cycle 1, overall safety/tolerability and pharmacokinetic (PK), by optimizing doses of Debio 1143 when combined with the standard dose of nivolumab, as well as treatment compliance in participants with advanced solid malignancies who failed prior systemic standard treatments.  Part B (basket trial)- to evaluate the preliminary anti-tumor activity of Debio 1143 at the RP2D in combination with nivolumab at the standard dose, overall and in each participant cohort (Cohort 1: small cell lung cancer <math display="block">SCLC</math>; Cohort 2: squamous cell carcinoma of the head and neck <math display="block">SCCHN</math>; Cohort 3: gastrointestinal (GI) cancers with known microsatellite instability-high/mismatch repair deficiency (MSI-H/MMRd) or other deoxyribonucleic acid (DNA) damage repair (DDR) abnormalities, including homologous recombination deficiency (HRD); Cohort 4: platinum-resistant epithelial ovarian cancer <math display="block">EOC</math>, endometrial cancer, primary peritoneal cancer (PPC) or cervical cancer, with known MSIH/MMRd, hereditary/somatic mutations of the breast cancer 1 (BRCA1) and BRCA2 genes or other DNA DDR abnormalities (incl. HRD). 
Sponsor: Debiopharm International SA 
Intervention: Debio 1143 
Start Date: 2019-04-26 
Last Updated: 2023-06-12 
Number of Patients: 46 
Recruitment Status: COMPLETED 
Condition: Solid Tumor 

NCTID: NCT04703192

Title: Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01) 
Study Summary: This study will characterize the safety and clinical benefit of valemetostat tosylate in participants with relapsed/refractory peripheral T-cell lymphoma, including relapsed/refractory adult T-cell leukemia/lymphoma. 
Sponsor: Daiichi Sankyo, Inc. 
Intervention: Valemetostat Tosylate 
Start Date: 2021-06-03 
Last Updated: 2023-05-26 
Number of Patients: 148 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Relapsed/Refractory Peripheral T-Cell Lymphoma 

NCTID: NCT03274492

Title: A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Diffuse Large B-Cell Lymphoma 
Study Summary: This Phase III, randomized, double-blind, placebo-controlled study will compare the efficacy, safety, and pharmacokinetics of polatuzumab vedotin plus R-CHP versus R-CHOP in participants with previously untreated diffuse large B-cell lymphoma (DLBCL). 
Sponsor: Hoffmann-La Roche 
Intervention: Polatuzumab Vedotin 
Start Date: 2017-11-16 
Last Updated: 2023-11-24 
Number of Patients: 1000 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Diffuse Large B-Cell Lymphoma 

NCTID: NCT03273153

Title: A Study of Cobimetinib Plus Atezolizumab Versus Pembrolizumab in Participants With Previously Untreated Advanced BRAFv600 Wild-Type Melanoma 
Study Summary: This is a Phase III, multicenter, open-label, randomized study designed to evaluate the efficacy, safety, and pharmacokinetics of cobimetinib plus atezolizumab compared with pembrolizumab in treatment-naive participants with advanced BRAFV600 wild-type melanoma. 
Sponsor: Hoffmann-La Roche 
Intervention: Cobimetinib 
Start Date: 2017-12-11 
Last Updated: 2022-09-21 
Number of Patients: 446 
Recruitment Status: TERMINATED 
Condition: Advanced BRAFV600 Wild-type Melanoma 

NCTID: NCT03397394

Title: Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma 
Study Summary: The purpose of the ATLAS study is to determine how patients with locally advanced unresectable or metastatic urothelial carcinoma respond to treatment with rucaparib. 
Sponsor: pharmaand GmbH 
Intervention: Rucaparib 
Start Date: 2018-06-01 
Last Updated: 2023-06-09 
Number of Patients: 97 
Recruitment Status: TERMINATED 
Condition: Bladder Cancer 

NCTID: NCT01969578

Title: Androgen Deprivation Therapy in Advanced Salivary Gland Cancer 
Study Summary: Salivary Gland (SG) Cancers are a rare and heterogeneous group of tumors, usually approached by multidisciplinary teams in high specialized centers. Until today no standard of care exists to treat these cancers. The identification of a target, the androgen receptor, in SG tumors has allowed for new treatment strategies options for this rare group of diseases. As a matter of fact, strong positivity for androgen expression has been found in salivary duct carcinoma and adenocarcinomas. The purpose of this study is therefore to evaluate the efficacy and safety of chemotherapy versus androgen deprivation therapy (ADT) in patients with recurrent and/or metastatic AR expressing SGCs.  The study will include two cohorts of patients: Cohort A, which comprises chemo-naïve patients, and Cohort B, which comprises pretreated patients. 
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC 
Intervention: bicalutamide + triptorelin 
Start Date: 2015-09-24 
Last Updated: 2023-09-11 
Number of Patients: 149 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Salivary Gland Cancer 

NCTID: NCT03059823

Title: A Phase 1 Study of INCMGA00012 in Patients With Advanced Solid Tumors 
Study Summary: The primary goal of this Phase 1 study is to characterize the safety and tolerability of INCMGA00012 and establish the maximum tolerated dose (MTD) of INCMGA00012 administered on either every two week or every four week schedules of administration among patients with solid tumors. Pharmacokinetics, pharmacodynamics, and the anti-tumor activity of INCMGA00012 will also be assessed.  The purpose of Amendment 5 is to obtain additional safety experience at the newly defined recommended Phase 2 dose of 500 mg every 4 weeks in patients with endometrial cancer, specifically either microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). Additionally, every 3 week (Q3W) flat-dosing will be studied in an additional tumor agnostic cohort. 
Sponsor: Incyte Corporation 
Intervention: retifanlimab 
Start Date: 2016-11-15 
Last Updated: 2023-07-12 
Number of Patients: 325 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Locally Advanced Solid Tumors 

NCTID: NCT06039384

Title: A Study of INCB099280 in Combination With Adagrasib in Adults With Advanced Solid Tumors Harboring a KRASG12C Mutation 
Study Summary: The purpose of this study is to evaluate the safety and tolerability of INCB099280 in combination with adagrasib and to establish the MTD or identify RDE(s) for the combination of INCB099280 and adagrasib. 
Sponsor: Incyte Corporation 
Intervention: INCB099280 
Start Date: 2024-01-10 
Last Updated: 2023-11-24 
Number of Patients: 125 
Recruitment Status: RECRUITING 
Condition: Advanced Solid Tumors 

NCTID: NCT04740918

Title: A Study of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo as a Treatment for Participants With Human Epidermal Growth Factor 2 (HER2)-Positive and Programmed Death-ligand 1 (PD-L1)-Positive Locally Advanced (LABC) or Metastatic Breast Cancer (MBC) 
Study Summary: This study will evaluate the efficacy, safety and patient-reported outcomes of trastuzumab emtansine plus atezolizumab compared with trastuzumab emtansine plus placebo in participants with HER2-positive and PD-L1-positive LABC or MBC.Participants must have progressed either during or after prior trastuzumab- (+/- pertuzumab) and taxane-based therapy for LABC/MBC; or during (or within 6 months after completing) trastuzumab- (+/-pertuzumab) and taxane-based therapy in the neoadjuvant and/or adjuvant setting. 
Sponsor: Hoffmann-La Roche 
Intervention: Trastuzumab Emtansine 
Start Date: 2021-06-07 
Last Updated: 2023-11-18 
Number of Patients: 96 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Metastatic Breast Cancer 

NCTID: NCT05949684

Title: ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions 
Study Summary: The purpose of the study is to compare the efficacy and safety of Luspatercept vs epoetin alfa in the treatment of anemia in adults due to IPSS-R very low, low, intermediate-risk MDS in ESA-naïve participants who are non-transfusion dependent (NTD). 
Sponsor: Bristol-Myers Squibb 
Intervention: Luspatercept 
Start Date: 2023-10-24 
Last Updated: 2023-11-18 
Number of Patients: 360 
Recruitment Status: RECRUITING 
Condition: Myelodysplastic Syndromes 

NCTID: NCT05651932

Title: A Study of an MMSET Inhibitor in Patients With Relapsed and Refractory Multiple Myeloma 
Study Summary: A Phase I study to evaluate the safety of a novel, orally available, selective, and potent small molecule inhibitor of the histone lysine methyl transferase MMSET (also known as NSD2/WHSC1) to prevent the dimethylation of H3K36 in adult patients with relapsed or refractory multiple myeloma (RRMM). 
Sponsor: K36 Therapeutics, Inc. 
Intervention: KTX-1001 
Start Date: 2023-02-22 
Last Updated: 2023-10-24 
Number of Patients: 60 
Recruitment Status: RECRUITING 
Condition: Multiple Myeloma 

NCTID: NCT02924402

Title: Study to Evaluate Safety and Tolerability of XmAb13676 (Plamotamab) in Patients With CD20-expressing Hematologic Malignancies 
Study Summary: The purpose of this study is to determine the safety and tolerability of intravenous (IV) and subcutaneous (SC) administration of XmAb13676 and to determine the maximally tolerated dose (MTD) and/or recommended dose (RD). 
Sponsor: Xencor, Inc. 
Intervention: XmAb13676 
Start Date: 2016-10 
Last Updated: 2023-03-01 
Number of Patients: 270 
Recruitment Status: RECRUITING 
Condition: B-cell Non-Hodgkins Lymphoma 

NCTID: NCT03772028

Title: Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC) 
Study Summary: stage III epithelial ovarian cancer randomizing between primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy 
Sponsor: The Netherlands Cancer Institute 
Intervention: cisplatin 
Start Date: 2020-01-01 
Last Updated: 2023-09-08 
Number of Patients: 538 
Recruitment Status: RECRUITING 
Condition: Ovarian Cancer 

NCTID: NCT04811560

Title: A Study of JNJ-75276617 in Participants With Acute Leukemia 
Study Summary: The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D<math display="block">s</math>) of JNJ-75276617 in Part 1 (Dose Escalation) and to determine safety and tolerability at the RP2D(s) in Part 2 (Dose Expansion). 
Sponsor: Janssen Research & Development, LLC 
Intervention: JNJ-75276617 
Start Date: 2021-05-19 
Last Updated: 2023-11-09 
Number of Patients: 110 
Recruitment Status: RECRUITING 
Condition: Acute Leukemias 

NCTID: NCT04700124

Title: Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304) 
Study Summary: The purpose of this study is to assess the antitumor efficacy and safety of perioperative enfortumab vedotin (EV) plus pembrolizumab and radical cystectomy (RC) + pelvic lymph node dissection (PLND) compared with the current standard of care (neoadjuvant chemotherapy <math display="block">gemcitabine plus cisplatin</math> and RC + PLND) for participants with MIBC who are cisplatin-eligible. The primary hypothesis is perioperative EV and pembrolizumab and RC + PLND (Arm A) will achieve superior event free survival (EFS) compared with neoadjuvant gemcitabine + cisplatin and RC + PLND (Arm B). 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Pembrolizumab 
Start Date: 2021-04-21 
Last Updated: 2023-11-18 
Number of Patients: 784 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Muscle Invasive Bladder Cancer 

NCTID: NCT02130557

Title: A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia 
Study Summary: Phase 3, 2-arm, randomized, open label trial. Patients will be randomized to receive bosutinib or imatinib for the duration of the study. 
Sponsor: Pfizer 
Intervention: Bosutinib 
Start Date: 2014-07-15 
Last Updated: 2021-05-18 
Number of Patients: 536 
Recruitment Status: COMPLETED 
Condition: Leukemia, Myelogenous, Chronic, Breakpoint Cluster Region-Abelson Proto-oncogene (BCR-ABL) Positive 

NCTID: NCT04471844

Title: Pivotal, Randomized, Open-label Study of Optune® (Tumor Treating Fields) Concomitant With RT & TMZ for the Treatment of Newly Diagnosed GBM 
Study Summary: To test the effectiveness and safety of Optune® given concomitantly with radiation therapy (RT) and temozolomide (TMZ) in newly diagnosed GBM patients, compared to radiation therapy and temozolomide alone. In both arms, Optune® and maintenance temozolomide are continued following radiation therapy. 
Sponsor: NovoCure GmbH 
Intervention: Optune® 
Start Date: 2020-12-08 
Last Updated: 2023-11-01 
Number of Patients: 950 
Recruitment Status: RECRUITING 
Condition: Glioblastoma Multiforme 

NCTID: NCT02719574

Title: Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation 
Study Summary: This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 (olutasidenib) as a single agent or in combination with azacitidine or cytarabine. The Phase 1 stage of the study is split into 2 distinct parts: a dose escalation part, which will utilize an open-label design of FT-2102 (olutasidenib) (single agent) and FT-2102 (olutasidenib) + azacitidine (combination agent) administered via one or more intermittent dosing schedules followed by a dose expansion part. The dose expansion part will enroll patients in up to 5 expansion cohorts, exploring single-agent FT-2102 (olutasidenib) activity as well as combination activity with azacitidine or cytarabine. Following the completion of the relevant Phase 1 cohorts, Phase 2 will begin enrollment. Patients will be enrolled across 8 different cohorts, examining the effect of FT-2102 (olutasidenib) (as a single agent) and FT-2102 (olutasidenib) + azacitidine (combination) on various AML/MDS disease states. 
Sponsor: Forma Therapeutics, Inc. 
Intervention: FT-2102 (olutasidenib) 
Start Date: 2016-04 
Last Updated: 2023-11-18 
Number of Patients: 336 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Acute Myeloid Leukemia 

NCTID: NCT02467270

Title: Ponatinib in Participants With Resistant Chronic Phase Chronic Myeloid Leukemia (CP-CML) to Characterize the Efficacy and Safety of a Range of Doses 
Study Summary: The purpose of this study is to characterize the efficacy of ponatinib administered in 3 starting doses (45 mg, 30 mg, and 15 mg daily) in participants with CP-CML who are resistant to prior tyrosine-kinase inhibitor (TKI) therapy or have T315I mutation, as measured by <=1 % Breakpoint Cluster Region-Abelson Transcript Level using International Scale (BCR-ABL1IS) at 12 months. 
Sponsor: Takeda 
Intervention: Ponatinib 
Start Date: 2015-06-30 
Last Updated: 2023-01-25 
Number of Patients: 283 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Myeloid Leukemia, Chronic, Chronic Phase 

NCTID: NCT02631070

Title: A Study of Luspatercept (ACE-536) to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes 
Study Summary: The study will be conducted in compliance with the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.  This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study to determine the efficacy and safety of luspatercept (ACE-536) versus placebo in participants with anemia due to the Revised International Prognostic Scoring System (IPSS-R) very low, low, or intermediate MDS with ring sideroblasts who require red blood cell (RBC) transfusions. 
Sponsor: Celgene 
Intervention: Luspatercept 
Start Date: 2016-02-09 
Last Updated: 2021-12-17 
Number of Patients: 229 
Recruitment Status: COMPLETED 
Condition: Myelodysplastic Syndromes 

NCTID: NCT03309111

Title: Study of ISB 1342, a CD38/CD3 Bispecific Antibody, in Subjects With Previously Treated Multiple Myeloma 
Study Summary: The purpose of this study is to assess safety, efficacy, pharmacokinetic (PK)/pharmacodynamic (PD), and immunogenicity with ISB 1342 in subjects with relapsed/refractory multiple myeloma. 
Sponsor: Ichnos Sciences SA 
Intervention: ISB 1342 
Start Date: 2017-10-25 
Last Updated: 2022-05-16 
Number of Patients: 245 
Recruitment Status: RECRUITING 
Condition: Relapsed/Refractory Multiple Myeloma

hasTrialTitle::IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301) hasTrialTitle::An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK2 Inhibitor Therapy and Who Require Red Blood Cell Transfusions hasTrialTitle::A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma hasTrialTitle::A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Physician’s Choice Chemotherapy in PD-(L)1-refractory, Relapsed or Refractory Classical Hodgkin Lymphoma (MK-4280A-008) hasTrialTitle::Association Between Side Effects Occurrence and Concentrations of Ibrutinib and Idelalisib hasTrialTitle::A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) hasTrialTitle::A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma hasTrialTitle::A Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB086550 in Participants With Advanced Solid Tumors hasTrialTitle::Study to Explore the Mechanism of Acquired Immune Escape In Participants With Metastatic Cancer Progressing on CPI Therapy hasTrialTitle::KRT-232 Versus Best Available Therapy for the Treatment of Subjects With Myelofibrosis Who Are Relapsed or Refractory to JAK Inhibitor Treatment hasTrialTitle::Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant hasTrialTitle::Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study hasTrialTitle::A Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma hasTrialTitle::A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation hasTrialTitle::A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma hasTrialTitle::A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study of Fuzuloparib Combined With Abiraterone Acetate and Prednisone (AA-P) Versus Placebo Combined With AA-P as First-Line Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer hasTrialTitle::A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer hasTrialTitle::A Phase 2, 2-Stage, 2-Cohort Study of Talazoparib (BMN 673), in Locally Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (ABRAZO Study) hasTrialTitle::A Study of Ponatinib Versus Imatinib in Adults With Acute Lymphoblastic Leukemia hasTrialTitle::Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE hasTrialTitle::A Study of Cusatuzumab Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy hasTrialTitle::Efficacy and Safety of Pemigatinib in Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207) hasTrialTitle::A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy hasTrialTitle::A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment hasTrialTitle::Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma hasTrialTitle::Phase 3 Randomized, Open-Label Study of Guadecitabine vs Treatment Choice in Previously Treated Acute Myeloid Leukemia hasTrialTitle::A Study to Evaluate the Benefit of Venetoclax Plus Rituximab Compared With Bendamustine Plus Rituximab in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) hasTrialTitle::A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study) hasTrialTitle::Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Glioblastoma or Other Primary Central Nervous System Tumors Harboring Activating FGFR1-3 Alterations hasTrialTitle::A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma hasTrialTitle::Study of INCB123667 in Subjects With Advanced Solid Tumors hasTrialTitle::Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors hasTrialTitle::To Evaluate Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib (LIMBER-304) hasTrialTitle::Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053) hasTrialTitle::High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN) hasTrialTitle::A Study Evaluating the Safety and Efficacy of Idasanutlin in Combination With Cytarabine and Daunorubicin in Patients Newly Diagnosed With Acute Myeloid Leukemia (AML) and the Safety and Efficacy of Idasanutlin in the Maintenance of First AML Complete Remission hasTrialTitle::Study of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Participants With Acute Myeloid Leukemia hasTrialTitle::Pemigatinib + Pembrolizumab vs Pemigatinib Alone vs Standard of Care for Urothelial Carcinoma (FIGHT-205) hasTrialTitle::A Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Participants With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy hasTrialTitle::A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203) hasTrialTitle::A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) hasTrialTitle::INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors hasTrialTitle::Study to Assess Safety and Efficacy of the Second Mitochondrial-derived Activator of Caspases (SMAC) Mimetic Debio 1143 hasTrialTitle::Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01) hasTrialTitle::A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Diffuse Large B-Cell Lymphoma hasTrialTitle::A Study of Cobimetinib Plus Atezolizumab Versus Pembrolizumab in Participants With Previously Untreated Advanced BRAFv600 Wild-Type Melanoma hasTrialTitle::Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma hasTrialTitle::Androgen Deprivation Therapy in Advanced Salivary Gland Cancer hasTrialTitle::A Phase 1 Study of INCMGA00012 in Patients With Advanced Solid Tumors hasTrialTitle::A Study of INCB099280 in Combination With Adagrasib in Adults With Advanced Solid Tumors Harboring a KRASG12C Mutation hasTrialTitle::A Study of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo as a Treatment for Participants With Human Epidermal Growth Factor 2 (HER2)-Positive and Programmed Death-ligand 1 (PD-L1)-Positive Locally Advanced (LABC) or Metastatic Breast Cancer (MBC) hasTrialTitle::ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions hasTrialTitle::A Study of an MMSET Inhibitor in Patients With Relapsed and Refractory Multiple Myeloma hasTrialTitle::Study to Evaluate Safety and Tolerability of XmAb13676 (Plamotamab) in Patients With CD20-expressing Hematologic Malignancies hasTrialTitle::Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC) hasTrialTitle::A Study of JNJ-75276617 in Participants With Acute Leukemia hasTrialTitle::Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304) hasTrialTitle::A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia hasTrialTitle::Pivotal, Randomized, Open-label Study of Optune® (Tumor Treating Fields) Concomitant With RT & TMZ for the Treatment of Newly Diagnosed GBM hasTrialTitle::Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation hasTrialTitle::Ponatinib in Participants With Resistant Chronic Phase Chronic Myeloid Leukemia (CP-CML) to Characterize the Efficacy and Safety of a Range of Doses hasTrialTitle::A Study of Luspatercept (ACE-536) to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes hasTrialTitle::Study of ISB 1342, a CD38/CD3 Bispecific Antibody, in Subjects With Previously Treated Multiple Myeloma