Trial results for the Phase 2 study investigating nivolumab in combination with CMP-001 for subjects with advanced melanoma were posted on ClinicalTrials.gov on 2025-04-02. The study, which was terminated, reported a confirmed objective response rate (ORR) of 11.4% by Blinded Independent Central Review (BICR) for the combination therapy.
Background
The study investigated the combination of CMP-001 and nivolumab in participants with refractory unresectable or metastatic melanoma. Melanoma is a serious form of skin cancer that can become life-threatening if it spreads to other parts of the body.
Trial design
The study, identified as NCT04698187, was a Phase 2 trial that enrolled 44 participants. The trial investigated CMP-001 administered intratumorally (IT) in combination with nivolumab administered intravenously (IV) in subjects with refractory unresectable or metastatic melanoma. The primary objective was to determine the confirmed objective response with CMP-001 in combination with nivolumab in this patient population.
Key results
The trial reported a confirmed objective response rate (ORR) by Blinded Independent Central Review (BICR) of 11.4% for participants receiving CMP-001 in combination with nivolumab.
Regarding safety and tolerability, treatment-emergent adverse events (TEAEs) were observed:
- 44 participants experienced any TEAE.
- 12 participants experienced any serious TEAE.
- 1 participant experienced any TEAE leading to discontinuation or death.
The severity of TEAEs, as assessed by NCI CTCAE, included:
- Grade 1: 2 participants
- Grade 2: 18 participants
- Grade 3: 21 participants
- Grade 4: 2 participants
- Grade 5: 1 participant
The median time to response (TTR) by BICR was 2.89 months. The median TTR by Investigator was also 2.89 months.
What this means
The Phase 2 trial of CMP-001 in combination with nivolumab for advanced melanoma was terminated. The reported objective response rate of 11.4% provides initial data on the activity of this combination in a challenging patient population. The safety data indicate that all 44 participants experienced at least one treatment-emergent adverse event, with 12 serious TEAEs and 1 TEAE leading to discontinuation or death, highlighting the importance of monitoring for adverse events in such combination therapies.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04698187, titled "CMP-001 in Combination With Nivolumab in Subjects With Advanced Melanoma," were posted on 2025-04-02 on clinicaltrials.gov.