drugset / Trial / NCT05328908

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

NCT05328908 ↗

Phase 3 Terminated 770 enrolled Bristol-Myers Squibb
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2022-04-28
Primary completion
2025-07-14
Completion
2025-07-14

Outcome

Outcome not reported

Stopped: “Inability to meet protocol objectives”

Drugs

EvaluationDrugModalityDoseRoute
Subject Nivolumab-relatlimab FDC Unknown — —
Comparator Regorafenib Small molecule — —
Comparator TAS-102 Small molecule — —

Indications