NCT05328908

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 770 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Neoplasms

Interventions

Type	Name	Description
DRUG	Nivolumab-relatlimab FDC	Specified dose on specified days
DRUG	Regorafenib	Specified dose on specified days
DRUG	TAS-102	Specified dose on specified days

Timeline

• Start date: 2022-04-28
• Primary completion: 2025-07-14
• Completion: 2025-07-14
• First posted: 2022-04-14
• Last updated: 2025-08-13

Locations

139 sites across 22 countries: United States, Argentina, Australia, Austria, Belgium, Canada, Chile, China, Czechia, France, Germany, Italy, Japan, Netherlands, Poland, Puerto Rico, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan

Regulatory

• FDA-regulated drug study