Terminated
PHASE3
INTERVENTIONAL
NCT05328908
A Study of Nivolumab-relatlimab Fixed-dose Combination Versus Regorafenib or TAS-102 in Participants With Later-lines of Metastatic Colorectal Cancer
View on ClinicalTrials.gov
Updated Dec 15, 2025
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.
Interventions
Name:
Nivolumab-relatlimab FDC
Type:
DRUG
Description:
Specified dose on specified days
Name:
Regorafenib
Type:
DRUG
Description:
Specified dose on specified days
Name:
TAS-102
Type:
DRUG
Description:
Specified dose on specified days
Primary Outcomes
Measure:
Overall survival (OS) in randomized participants with programmed death-ligand 1 (PD-L1) combined positive score (CPS) ≥ 1
TimeFrame:
Up to 5 years after last participant randomized
Description:
Measure:
OS in all randomized participants
TimeFrame:
Up to 5 years after last participant randomized
Description:
Trial Information
NCT ID
NCT05328908
Status
Terminated
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
Bristol-Myers Squibb
Last Updated
December 15, 2025