ClinicalTrials.gov posted results on 31 August 2026 from a completed trial of nivolumab plus relatlimab in patients with unresectable or metastatic melanoma who had not received prior immunotherapy in the metastatic setting. The Phase 2 study enrolled 43 participants and reported single-cell RNA sequencing measurements for LAG3 gene expression and PD1 expression across relatlimab, nivolumab, and combination groups.
Background
The trial evaluated relatlimab and nivolumab in combination for metastatic melanoma without prior immunotherapy treatment in the metastatic setting. The registered interventions were relatlimab, nivolumab, and relatlimab plus nivolumab. The supplied record identifies melanoma as the study condition and lists the overall study status as completed.
Trial design
This was a Phase 2 study of patients with unresectable or metastatic melanoma who were naïve to prior immunotherapy in the metastatic setting. The study’s main goal was to evaluate the antitumor activity of relatlimab and nivolumab in combination. The registry record lists an enrollment of 43 participants and includes separate relatlimab, nivolumab, and combination intervention groups.
The posted results included biomarker measurements from single-cell RNA sequencing. No primary outcome entries were supplied in the data block. The record also did not provide an adverse-event summary.
Key results
For LAG3 gene expression from single-cell RNA sequencing, the reported means were 0.78% with a standard deviation of 1.27% for relatlimab, 2.94% with a standard deviation of 4.28% for nivolumab, and 9.37% with a standard deviation of 10.93% for the combination. A second set of LAG3 measurements reported means of 0.96%, 13.12%, and 13.50%, respectively; the corresponding standard deviations were 2.01%, 22.02%, and 9.31%.
For PD1 expression, one reported set showed means of 9.29% for relatlimab, 5.43% for nivolumab, and 12.28% for the combination. The corresponding standard deviations were 14.77%, 5.09%, and 9.47%. A second set showed means of 2.91%, 5.78%, and 6.19%, with standard deviations of 3.11%, 4.78%, and 5.09%.
The supplied statistical analyses used a Wilcoxon signed-rank test to compare cell densities between week 0 and week 4 during the lead-in phase, both across all patients and within each lead-in arm. Bonferroni adjustment was used. The listed p-values were 1 and 0.16; the data block did not link individual p-values to specific biomarker entries or provide confidence intervals.
What this means
The posted record provides biomarker measurements from a completed Phase 2 melanoma study evaluating relatlimab, nivolumab, and their combination in patients without prior metastatic-setting immunotherapy. The combination arm had higher reported means than both single-agent groups for several listed LAG3 and PD1 measurements, although the data include multiple measurement sets and substantial standard deviations.
These results do not, by themselves, establish clinical antitumor efficacy, a statistically significant treatment difference, a safety result, or a change in nivolumab’s approved use. The supplied record contains no primary outcome results, response data, confidence intervals, or adverse-event summary.
Source
Source: ClinicalTrials.gov, trial registry record for “Nivolumab, BMS-936558 in Combination With Relatlimab, BMS-986016 in Patients With Metastatic Melanoma Naïve to Prior Immunotherapy in the Metastatic Setting,” NCT03743766, with results posted on 31 August 2026. The record is available at clinicaltrials.gov/study/NCT03743766.