Trial results for a Phase 2 study (NCT06046482) investigating pembrolizumab in combination with magrolimab and cetuximab, or docetaxel, for recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) were posted on ClinicalTrials.gov on 2025-10-22. The study, which had an enrollment of only 4 participants, was terminated.
Background
Pembrolizumab (Keytruda) is an established immunotherapy. This study explored its use in combination with other agents for recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).
Trial design
The Phase 2 study (NCT06046482) was designed to investigate the efficacy and safety of magrolimab in combination with cetuximab and pembrolizumab, or docetaxel, for patients with recurrent/metastatic head and neck squamous cell carcinoma. The trial had an enrollment of 4 participants and was terminated. The study aimed to assess if these drug combinations could help control HNSCC and to study the safety of magrolimab.
Key results
The trial reported objective response rates (ORR) and treatment-emergent adverse events (TEAEs) for two cohorts. For Objective Response Rate (ORR):
- In Cohort A, 1 participant showed an objective response. Another entry for Cohort A reported 0 participants with an objective response.
- In Cohort B, 0 participants showed an objective response. Another entry for Cohort B reported 3 participants with an objective response.
Regarding the Number of Treatment-Emergent Adverse Events (TEAEs):
- For Cohort A, the reported number of TEAEs was 0 across multiple entries.
- For Cohort B, the reported number of TEAEs included 1, 2, 0, and 0 across multiple entries.
What this means
Due to the termination of the study and the very limited enrollment of only 4 participants, the results from this Phase 2 trial are highly preliminary and cannot be used to draw definitive conclusions about the efficacy or safety of the investigated drug combinations for recurrent/metastatic head and neck squamous cell carcinoma. The data provides minimal insights into potential objective response rates or adverse event profiles in this patient population.
Source
The information for this article was sourced from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT06046482, titled "Phase II Trial of Magrolimab and Cetuximab With Pembrolizumab or Docetaxel for Recurrent/Metastatic Head Neck Squamous Cell Carcinoma," were posted on 2025-10-22 on clinicaltrials.gov.