Trial results for pembrolizumab (Keytruda) in combination with bavituximab for recurrent/metastatic squamous cell head and neck cancer were posted on ClinicalTrials.gov on 2025-02-28. The Phase 2 study, involving 7 participants, reported 0 complete or partial responses (CR+PR).
Background
This Phase 2 study investigated the combination of pembrolizumab and bavituximab in patients with recurrent/metastatic squamous cell head and neck cancer (HNSCC) who had previously progressed on a PD-1 inhibitor. The trial aimed to explore potential synergy between bavituximab and PD-1 inhibitor therapy to generate an anti-tumor immune response.
Trial design
The single-arm, Phase 2 study (NCT04150900) enrolled 7 participants with Squamous Cell Carcinoma. The trial evaluated the combination of bavituximab and pembrolizumab in patients with recurrent/metastatic squamous cell head and neck cancer who had progressed on prior PD-1 inhibitor therapy.
Key results
The trial results indicated the following outcomes for the 7 enrolled participants:
- For complete response plus partial response (CR+PR), 0 participants were reported.
- For progression, 7 participants were reported.
- Regarding disease progression, individual participant counts reported were 1, 2, 3, and 1.
- For survival, reported participant counts were 6 and 1.
- For participants with laboratory correlates of response, 0 participants showed correlates, out of 7 participants assessed.
What this means
The results from this small Phase 2 trial suggest that the combination of pembrolizumab and bavituximab did not demonstrate clinical efficacy in this cohort of patients with recurrent/metastatic squamous cell head and neck cancer who had progressed on prior PD-1 inhibitor therapy. With 0 complete or partial responses and 7 participants experiencing progression among the 7 enrolled, the data does not support a synergistic anti-tumor immune response in this specific patient population under the study conditions.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04150900, titled "1922GCCC: Pembro and Bavituximab for Squamous Cell Carcinoma of Head and Neck," were posted on 2025-02-28 on clinicaltrials.gov.