Trial results for the Phase 2/3 study (NCT04695977) investigating nivolumab monotherapy versus CMP-001 in combination with nivolumab for advanced melanoma were posted on ClinicalTrials.gov on 2025-09-05. The study showed that nivolumab monotherapy achieved a confirmed objective response rate (ORR) of 73%, while the combination therapy resulted in an ORR of 44%.
Background
The study investigated nivolumab for the treatment of unresectable or metastatic melanoma.
Trial design
The Phase 2/3 study (NCT04695977), titled "CMP-001 in Combination With Nivolumab Compared to Nivolumab Monotherapy in Subjects With Advanced Melanoma," was a randomized trial that enrolled 20 participants. The study evaluated first-line CMP-001 in combination with nivolumab compared to nivolumab monotherapy in subjects with unresectable or metastatic melanoma. The primary objective for Phase 2 was to determine the confirmed objective response rate (ORR) for the combination versus monotherapy. The overall status of the trial is TERMINATED.
Key results
The trial reported the following key measurements:
- Confirmed Objective Response Rate (ORR) by Blinded Independent Central Review (BICR):
- Nivolumab Monotherapy: 73% of participants.
- CMP-001 and Nivolumab: 44% of participants.
- Treatment-Emergent Adverse Events (TEAEs):
- Any TEAE: 11 participants in the Nivolumab Monotherapy group; 9 participants in the CMP-001 and Nivolumab group.
- Any Serious TEAE: 5 participants in the Nivolumab Monotherapy group; 2 participants in the CMP-001 and Nivolumab group.
- TEAEs Leading to Discontinuation or Death: 0 participants in both groups.
- Severity of TEAEs (NCI CTCAE):
- Grade 3 TEAEs: 2 participants in the Nivolumab Monotherapy group; 0 participants in the CMP-001 and Nivolumab group.
- Grade 4 TEAEs: 1 participant in the Nivolumab Monotherapy group; 6 participants in the CMP-001 and Nivolumab group.
What this means
The trial results indicate that nivolumab monotherapy demonstrated a higher objective response rate compared to the combination of CMP-001 and nivolumab in participants with advanced melanoma. While the number of participants with any TEAE was similar, the combination group showed a higher number of participants experiencing Grade 4 TEAEs (6 vs 1), suggesting a potentially different safety profile. The termination of this Phase 2/3 study, coupled with these results, suggests that the combination of CMP-001 with nivolumab did not show a favorable efficacy or safety advantage over nivolumab monotherapy in this small cohort.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04695977, titled "CMP-001 in Combination With Nivolumab Compared to Nivolumab Monotherapy in Subjects With Advanced Melanoma," were posted on 2025-09-05 on clinicaltrials.gov.