A Study of Nivolumab-relatlimab Fixed-dose Combination Versus Regorafenib or TAS-102 in Participants With Later-lines of Metastatic Colorectal Cancer

Official Title

A Phase 3, Randomized, Open-label (Sponsor Blinded) Study of Relatlimab-nivolumab Fixed-dose Combination Versus Regorafenib or Trifluridine + Tipiracil (TAS-102) for Participants With Later-lines of Metastatic Colorectal Cancer

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 late-line microsatellite stable (MSS) metastatic colorectal cancer (mCRC) participants who failed at least 1 but no more than 4 prior lines of therapy for metastatic disease.

Trial Description

Primary Outcome:

• Overall survival (OS) in randomized participants with programmed death-ligand 1 (PD-L1) combined positive score (CPS) ≥ 1
• OS in all randomized participants

• Objective response rate (ORR) by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 in randomized participants with PD-L1 CPS ≥ 1
• ORR by BICR per RECIST v1.1 in all randomized participants
• Progression-free survival (PFS) by BICR per RECIST v1.1 in randomized participants with PD-L1 CPS ≥ 1
• PFS by BICR per RECIST v1.1 in all randomized participants
• Duration of response (DoR) by BICR per RECIST v1.1 in responders with PD-L1 CPS ≥ 1
• DoR by BICR per RECIST v1.1 in all responders
• Number of participants with adverse events (AEs)
• Number of participants with serious adverse events (SAEs)
• Number of participants with immune-mediated adverse events (IMAEs)
• Number of participants with AEs leading to discontinuation
• Number of participants with clinical laboratory abnormalities
• DeFS-QoL: The time from randomization to death or at least a 15-points worsening from baseline in the EORTC QLQ-C30 GHS/QoL scale, with no subsequent improvement above the 15-point worsening from baseline score
• DeFS-PF: The time from randomization to death or at least a 10-points worsening from baseline in the EORTC QLQ-C30 physical function scale, with no subsequent improvement above the 10-point worsening from baseline score

View this trial on ClinicalTrials.gov