ClinicalTrials.gov posted results on 26 August 2026 from a terminated Phase 3 trial of nivolumab-relatlimab fixed-dose combination treatment in later-line metastatic colorectal cancer. Among the reported measures, objective response rates were low, while median progression-free survival was 1.87 months in Arm A and 2.10 months in Arm B.

Background

The study evaluated a fixed-dose combination of nivolumab and relatlimab in participants with non-MSI-H/dMMR metastatic colorectal cancer who had failed at least one and no more than four prior lines of therapy for metastatic disease. The registered interventions were nivolumab-relatlimab fixed-dose combination, regorafenib, and TAS-102. The condition listed in the registry was colorectal neoplasms.

Trial design

This was a Phase 3 study that enrolled 769 participants with metastatic colorectal cancer. The trial compared nivolumab-relatlimab fixed-dose combination with regorafenib or TAS-102. The registry listed the study status as terminated. No primary outcome entries were supplied in the record, but reported measures included objective response rate, progression-free survival, and duration of response, each assessed by blinded independent central review.

Key results

For objective response rate, the registry reported 3.1% in Arm A versus 1.7% in Arm B in one reported comparison. A second set of response-rate values was 3.8% versus 2.2%. The listed differences in objective response rates were 1.4 percentage points, with a 95% confidence interval of −0.8 to 3.6, and 1.6 percentage points, with a 95% confidence interval of −1.9 to 5.0, for the specified overall and PD-L1 CPS ≥1 analyses.

Median progression-free survival was 1.87 months in Arm A and 2.10 months in Arm B. The registry listed hazard ratios of 1.63 with a 95% confidence interval of 1.39 to 1.9 for two specified analyses, and additional hazard ratios of 1.26 with a 95% confidence interval of 1.0 to 1.58 and 1.24 with a 95% confidence interval of 0.91 to 1.7.

Median duration of response was reported as 11.10 months versus 5.55 months in one set of Arm A and Arm B results, and 8.34 months versus 5.55 months in another. The supplied record did not identify which population or analysis corresponded to each duplicated result set. No p-values or adverse-event summary were provided.

What this means

The posted results showed a small numerical difference in objective response rates favoring Arm A, but median progression-free survival was numerically shorter in Arm A than in Arm B. The hazard-ratio results also did not establish a favorable progression-free-survival comparison for Arm A in the listed analyses. Because the registry did not provide primary outcome entries, p-values, complete measurement assignments, or safety results, these data alone do not establish a new approval or comparative safety conclusion.

Source

Source: ClinicalTrials.gov, trial-results record for NCT05328908, posted 26 August 2026. The registry record is available at clinicaltrials.gov/study/NCT05328908.