A Phase 3 clinical trial (NCT05328908) investigating nivolumab-relatlimab fixed-dose combination for later-line metastatic colorectal cancer was terminated. The trial, which had an enrollment of 770 participants, reached its primary completion date on 2025-07-14, with its overall status subsequently recorded as terminated.
Background
The study aimed to evaluate the nivolumab-relatlimab fixed-dose combination (also referred to as BMS-986213) for the treatment of non-microsatellite instability high (MSI-H)/deficient mismatch repair (dMMR) metastatic colorectal cancer (mCRC) in participants who had previously failed at least 1 but no more than 4 prior lines of therapy for metastatic disease.
Trial design
The study, identified as NCT05328908, was a Phase 3 trial. It was designed to enroll 770 participants with Colorectal Neoplasms. The interventions included the nivolumab-relatlimab fixed-dose combination, compared against regorafenib or TAS-102.
What this means
The termination of this Phase 3 trial for nivolumab-relatlimab fixed-dose combination in metastatic colorectal cancer indicates that further development of this specific regimen for this patient population, as evaluated in this study, has ceased. This outcome will influence future research and treatment strategies for non-MSI-H/dMMR mCRC, particularly in later-line settings.
Source
The information regarding the primary completion and termination of this clinical trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The record for study NCT05328908, titled "A Study of Nivolumab-relatlimab Fixed-dose Combination Versus Regorafenib or TAS-102 in Participants With Later-lines of Metastatic Colorectal," was updated with a primary completion date of 2025-07-14 and an overall status of "TERMINATED" on clinicaltrials.gov.