MedTrace Logo

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

NCT05328908 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 770

Last updated 2025-08-13

No results posted yet for this study

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

DRUG

Nivolumab-relatlimab FDC

Specified dose on specified days

DRUG

Regorafenib

Specified dose on specified days

DRUG

TAS-102

Specified dose on specified days

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-28
Primary Completion
2025-07-14
Completion
2025-07-14
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05328908 on ClinicalTrials.gov