Trial results for a Phase 3 study (NCT05002569) assessing nivolumab plus relatlimab fixed-dose combination versus nivolumab alone in participants with completely resected Stage III-IV melanoma were posted on ClinicalTrials.gov on 2026-01-08. The study, which was terminated, reported a median Recurrence Free Survival (RFS) of 33.84 months for the nivolumab plus relatlimab arm.
Background
The study investigated nivolumab plus relatlimab fixed-dose combination (FDC) versus nivolumab alone as adjuvant immunotherapy for completely resected Stage III-IV melanoma. Nivolumab is an established immunotherapy, and this trial explored the combination's potential benefit.
Trial design
The study (NCT05002569) was a Phase 3 trial that enrolled 1093 participants with completely resected Stage III-IV melanoma. The trial was designed to compare adjuvant immunotherapy with nivolumab plus relatlimab fixed-dose combination against nivolumab alone. The study's overall status is listed as TERMINATED.
Key results
The trial results provided data for Recurrence Free Survival (RFS) and safety events. For RFS:
- The nivolumab plus relatlimab fixed-dose combination arm (Treatment 2) reported a median RFS of 33.84 Months.
- The nivolumab alone arm (Treatment 1) reported median RFS as NA.
Regarding safety related events:
- In the nivolumab alone arm (Treatment 1), 522 and 483 participants experienced safety events, across two measurements.
- In the nivolumab plus relatlimab fixed-dose combination arm (Treatment 2), 520 and 438 participants experienced safety events, across two measurements.
Other outcomes, including Overall Survival (OS), Distant Metastasis Free Survival (DMFS), and Progression Free Survival on Next-Line Systemic Therapy (PFS2), were reported as NA for both arms.
What this means
The termination of this Phase 3 trial for nivolumab plus relatlimab fixed-dose combination in resected Stage III-IV melanoma means the study did not conclude as planned. While a median Recurrence Free Survival of 33.84 months was reported for the combination arm, the absence of comparative data for the nivolumab alone arm limits definitive conclusions. Safety event counts were broadly similar between the two arms.
Source
The information for this article was sourced from ClinicalTrials.gov, a public database of clinical studies. The trial results for study NCT05002569, titled "A Study to Assess Adjuvant Immunotherapy With Nivolumab Plus Relatlimab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma," were posted on 2026-01-08 on clinicaltrials.gov.