Trial results for the Phase 2 study NCT04633278, investigating pembrolizumab in combination with CMP-001 for recurrent or metastatic head and neck squamous cell carcinoma, were posted on ClinicalTrials.gov on 2025-04-08. The study reported an investigator-assessed confirmed objective response rate of 17.6% for participants in the Schedule A treatment arm.
Background
The study investigated CMP-001 in combination with pembrolizumab (Keytruda), a programmed cell death protein 1 (PD-1) blocking antibody, for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). Participants in this study had not been previously treated with a PD-1 blocking antibody.
Trial design
The study NCT04633278 was a Phase 2 trial that was terminated and enrolled 24 participants. The trial investigated CMP-001 intratumoral (IT) and pembrolizumab intravenous (IV) in participants with squamous cell carcinoma of head and neck who had not been previously treated with a PD-1 blocking antibody. The primary objective was to determine the investigator-assessed confirmed objective response with CMP-001 in combination with pembrolizumab.
Key results
The trial evaluated the confirmed objective response rate (ORR) and safety profile across two treatment schedules. For the outcome of "Confirmed Objective Response Rate (ORR)":
- In the CMP-001 IT + Pembrolizumab - Schedule A group, the ORR was 17.6% (Percentage of participants).
- In the CMP-001 IT + Pembrolizumab - Schedule B group, the ORR was 0% (Percentage of participants).
Regarding safety, for the outcome "Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death":
- In the CMP-001 IT + Pembrolizumab - Schedule A group, 17 participants experienced any TEAE, 7 participants experienced any serious TEAE, and 1 participant experienced a TEAE leading to discontinuation or death.
- In the CMP-001 IT + Pembrolizumab - Schedule B group, 7 participants experienced any TEAE, 5 participants experienced any serious TEAE, and 0 participants experienced a TEAE leading to discontinuation or death.
What this means
The results from this Phase 2 trial indicate a varied objective response to the combination of CMP-001 and pembrolizumab in recurrent or metastatic head and neck squamous cell carcinoma, depending on the treatment schedule. While Schedule A showed an ORR of 17.6%, Schedule B did not demonstrate any objective responses. The safety data indicates that treatment-emergent adverse events occurred in both schedules, with some serious events and one discontinuation/death in Schedule A. The trial was terminated, which may influence the interpretation of these results.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04633278, titled "CMP-001 in Combination With Pembrolizumab in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma," were posted on 2025-04-08 on clinicaltrials.gov.