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Terminated Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT05328908

Public ClinicalTrials.gov record NCT05328908. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 27, 2026, 12:04 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05328908
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 3
Lead sponsor
Bristol-Myers Squibb
Industry
Enrollment
769 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 28, 2022 (Actual)
Primary completion
Jul 14, 2025 (Actual)
Completion
Jul 14, 2025 (Actual)
Last update posted
Aug 26, 2026

2022 – 2025

United States locations

U.S. sites
20
U.S. states
19
U.S. cities
20
Facility City State ZIP Site status
Local Institution - 0044 Springdale Arkansas 72762-5328 —
Local Institution - 0012 Los Angeles California 90089-0112 —
Local Institution - 0117 Norwich Connecticut 06360-2753 —
Local Institution - 0025 Miami Florida 33176 —
Local Institution - 0031 Atlanta Georgia 30342 —
Local Institution - 0071 Boise Idaho 83712-6267 —
Local Institution - 0081 Fort Wayne Indiana 46805 —
Massachusetts General Hospital, Boston Massachusetts 02214 —
Local Institution - 0042 Ann Arbor Michigan 48109-1382 —
Local Institution - 0043 East Brunswick New Jersey 08816-3340 —
Local Institution - 0009 Durham North Carolina 27710 —
Local Institution - 0082 Cincinnati Ohio 45220 —
Local Institution - 0095 Columbus Ohio 43210-1240 —
Local Institution - 0147 Philadelphia Pennsylvania 19111-2434 —
Local Institution - 0008 Charleston South Carolina 29414 —
Local Institution - 0096 Sioux Falls South Dakota 57104 —
Local Institution - 0127 Nashville Tennessee 37203-2173 —
Local Institution - 0097 Fort Worth Texas 76104-4611 —
Local Institution - 0132 Richmond Virginia 23284 —
Local Institution - 0005 Madison Wisconsin 53705-2275 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 119 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05328908, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 26, 2026 · Synced Oct 27, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05328908 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →