Clinical Trial

Preoperative Pembrolizumab and Chemotherapy in Resectable, Recurrent HNSCC

Recruiting Phase 2
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Summary
This research study is evaluating effectiveness and safety of a combination of immunotherapy drug, pembrolizumab, with chemotherapy, as a possible treatment before and after surgery for squamous cell carcinoma of the head and neck (HNSCC). The combination of pembrolizumab and chemotherapy will be given prior to your surgery, while immunotherapy pembrolizumab will be continued for approximately 1 year after surgery. The names of the study drugs involved in this research study are: * pembrolizumab (a type of immunotherapy) * docetaxel (a type of chemotherapy) * cisplatin (a type of chemotherapy) * carboplatin (a type of chemotherapy)
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2023-02-11; most recent amendment 2026-06-21.
Status change: Not Yet Recruiting → Recruiting 2023-10-03
Trial Details
NCT Number NCT05726370
Lead Sponsor Dana-Farber Cancer Institute
Collaborators: Merck Sharp & Dohme LLC
Conditions Head and Neck Squamous Cell Carcinoma, Head and Neck Cancer, Resectable Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma, Second Primary Squamous Cell Carcinoma of the Head and Neck
Enrollment 28 participants
Start Date 2023-05-20
Primary Completion 2027-12-31 (estimated)
Study Completion 2030-05-20 (estimated)
Updated on ClinicalTrials.gov 2026-06-23