A Study of Nivolumab-relatlimab Fixed-dose Combination Versus Regorafenib or TAS-102 in Participants With Later-lines of Metastatic Colorectal Cancer
- Conditions
- Colorectal Neoplasms
- Interventions
- Registration Number
- NCT05328908
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to evaluate relatlimab in combination with nivolumab, administered as a fixed-dose combination (nivolumab-relatlimab FDC, also referred to as BMS-986213) for the treatment of non-microsatellite instability high (MSI-H)/deficient mismatch repair (dMMR) metastatic colorectal cancer (mCRC) participants who failed at least 1 but no more than 4 prior lines of therapy for metastatic disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 700
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A: Nivolumab + Relatlimab Fixed-dose Combination (FDC) Nivolumab-relatlimab FDC - Arm B: Investigator's Choice Regorafenib Treatment with Regorafenib or TAS-102 Arm B: Investigator's Choice TAS-102 Treatment with Regorafenib or TAS-102
- Primary Outcome Measures
Name Time Method Overall survival (OS) in randomized participants with programmed death-ligand 1 (PD-L1) combined positive score (CPS) ≥ 1 Up to 5 years after last participant randomized OS in all randomized participants Up to 5 years after last participant randomized
- Secondary Outcome Measures
Name Time Method Objective response rate (ORR) by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in randomized participants with PD-L1 CPS ≥ 1 Up to 5 years after last participant randomized ORR by BICR per RECIST v1.1 in all randomized participants Up to 5 years after last participant randomized Progression-free survival (PFS) by BICR per RECIST v1.1 in randomized participants with PD-L1 CPS ≥ 1 Up to 5 years after last participant randomized PFS by BICR per RECIST v1.1 in all randomized participants Up to 5 years after last participant randomized Duration of response (DoR) by BICR per RECIST v1.1 in responders with PD-L1 CPS ≥ 1 Up to 5 years after last participant randomized DoR by BICR per RECIST v1.1 in all responders Up to 5 years after last participant randomized Number of participants with adverse events (AEs) Up to 135 days after participant's last dose Number of participants with serious adverse events (SAEs) Up to 135 days after participant's last dose Number of participants with immune-mediated adverse events (IMAEs) Up to 135 days after participant's last dose Number of participants with AEs leading to discontinuation Up to 135 day's after participant's last dose Number of participants with clinical laboratory abnormalities Up to 135 days after participant's last dose Time Until Definitive Deterioration-Physical Function (TUDD-PF): The time from randomization until definitive deterioration in the EORTC QLQ-C30 physical function scale score in randomized participants with PD-L1 CPS ≥ 1 Up to follow up visit 2 (approximately 135 days after last dose) The EORTC (European Organisation for Research and Treatment of Cancer) Quality of Life Questionnaire-Core 30 (QLQ-C30) consists of 30 questions incorporated into 5 functional scales (physical, role, cognitive, emotional, and social functioning), 3 multi-item symptom scales (fatigue, pain, nausea and vomiting), a global health status / Quality of Life scale, and six single symptom items. All of the scale and single-item measures range in score from 0 to 100, where a higher score represents a higher response level. High functional scores indicates more favorable outcomes and a higher score on the symptom domains indicates higher symptom burden/less favorable patient outcome.
TUDD-PF: The time from randomization until definitive deterioration in the EORTC QLQ-C30 physical function scale score in all randomized participants Up to follow up visit 2 (approximately 135 days after last dose) TUDD-QoL: The time from randomization until definitive deterioration in the EORTC QLQ-C30 global health status/QoL scale score in randomized participants with PD-L1 CPS ≥ 1 Up to follow up visit 2 (approximately 135 days after last dose) QoL = Quality of Life. The EORTC (European Organisation for Research and Treatment of Cancer) Quality of Life Questionnaire-Core 30 (QLQ-C30) consists of 30 questions incorporated into 5 functional scales (physical, role, cognitive, emotional, and social functioning), 3 multi-item symptom scales (fatigue, pain, nausea and vomiting), a global health status / Quality of Life scale, and six single symptom items. All of the scale and single-item measures range in score from 0 to 100, where a higher score represents a higher response level. High functional scores indicates more favorable outcomes and a higher score on the symptom domains indicates higher symptom burden/less favorable patient outcome.
TUDD-QoL: The time from randomization until definitive deterioration in the EORTC QLQ-C30 global health status/QoL scale score in all randomized participants Up to follow up visit 2 (approximately 135 days after last dose) PFS by investigator per RECIST v1.1 in randomized participants with PD-L1 CPS ≥ 1 Up to 5 years after last participant randomized PFS by investigator per RECIST v1.1 in all randomized participants Up to 5 years after last participant randomized ORR by investigator per RECIST v1.1 in randomized participants with PD-L1 CPS ≥ 1 Up to 5 years after last participant randomized ORR by investigator per RECIST v1.1 in all randomized participants Up to 5 years after last participant randomized DoR by investigator per RECIST v1.1 in responders with PD-L1 CPS ≥ 1 Up to 5 years after last participant randomized DoR by investigator per RECIST v1.1 in all randomized participants Up to 5 years after last participant randomized
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Trial Locations
- Locations (139)
Local Institution - 0044
🇺🇸Springdale, Arkansas, United States
Local Institution - 0012
🇺🇸Los Angeles, California, United States
Local Institution - 0117
🇺🇸Norwich, Connecticut, United States
Local Institution - 0025
🇺🇸Miami, Florida, United States
Local Institution - 0031
🇺🇸Atlanta, Georgia, United States
Local Institution - 0071
🇺🇸Boise, Idaho, United States
Local Institution - 0081
🇺🇸Fort Wayne, Indiana, United States
Massachusetts General Hospital,
🇺🇸Boston, Massachusetts, United States
Local Institution - 0042
🇺🇸Ann Arbor, Michigan, United States
Local Institution - 0043
🇺🇸East Brunswick, New Jersey, United States
Scroll for more (129 remaining)Local Institution - 0044🇺🇸Springdale, Arkansas, United States