Nivolumab with Vidutolimod shows higher pathologic response in Melanoma

Trial results for Nivolumab in combination with Vidutolimod (CMP-001) were posted on 2026-07-02. The PHASE2 study in melanoma patients reported a major pathologic response rate of 75% for the combination arm, compared to 50% for Nivolumab monotherapy.

Background

Nivolumab is an immunotherapy agent. This PHASE2 study investigated its use in patients with melanoma, specifically involving lymph node and/or in-transit/satellite areas. The trial compared Nivolumab alone versus Nivolumab combined with Vidutolimod (CMP-001).

Trial design

The study, identified as NCT04401995, was a PHASE2 trial that was ultimately COMPLETED. It enrolled 9 participants with Melanoma, specifically involving lymph node and/or in-transit/satellite areas. The trial evaluated two main intervention arms: Nivolumab and Vidutolimod (CMP-001) Combination With [18F]F-AraG PET/CT and Nivolumab With [18F]F-AraG PET/CT. The main goal was to determine how these treatments affect the likelihood of destroying melanoma and to evaluate changes in [18F]F-AraG uptake.

Key results

For the outcome of Major Pathologic Response Rate (MPR), the Nivolumab and Vidutolimod (CMP-001) Combination With [18F]F-AraG PET/CT group showed a response rate of 75 percentage of patients. In comparison, the Nivolumab With [18F]F-AraG PET/CT group demonstrated an MPR of 50 percentage of patients.

Regarding survival outcomes, the Distant-metastasis Free Survival (DMFS) for the Nivolumab With [18F]F-AraG PET/CT group was a median of 147 Days, while for the combination group, this value was NA Days. Similarly, the Relapse-Free Survival (RFS) for the Nivolumab With [18F]F-AraG PET/CT group was a median of 147 Days, with the combination group showing NA Days.

What this means

The results from this PHASE2 trial suggest that adding Vidutolimod (CMP-001) to Nivolumab may enhance the major pathologic response in patients with melanoma. The combination arm achieved a 75% MPR, which is numerically higher than the 50% MPR observed with Nivolumab alone. However, median Distant-metastasis Free Survival and Relapse-Free Survival data were not available for the combination arm, making it difficult to fully assess long-term benefits from these specific endpoints. Given the small enrollment of 9 participants, these findings are preliminary and warrant further investigation in larger studies.

Source

These trial results were posted on ClinicalTrials.gov on 2026-07-02. The full details of the study, NCT04401995, are available on clinicaltrials.gov.