Actively Recruiting
Phase II Study of Pembrolizumab Combined With Tumor DNA-Guided Chemotherapy for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Led by University of Chicago · Updated on 2026-05-12
30
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying people with recurrent or metastatic head and neck cancer to see if using a blood test that measures tumor DNA in the blood can help guide treatment. They want to find out if adding occasional chemotherapy to immunotherapy works better than immunotherapy alone. This study is a Phase II trial that explores a new combination of approved drugs based on tumor DNA changes. Participants receive either pembrolizumab alone or pembrolizumab combined with chemotherapy drugs carboplatin and paclitaxel. Treatments are given through an intravenous needle every 21 days for two cycles. The study uses tumor DNA levels in the blood to adapt chemotherapy use and aims to gather information about safety and effectiveness of this treatment approach. Participants will be monitored for about two years, with regular assessments to measure tumor response using standard criteria RECIST 1.1. The study tracks side effects, survival, and response duration. Women must have pregnancy tests and use contraception during treatment. The research team will collect tissue samples and blood tests to analyze tumor DNA and monitor health throughout the study.
CONDITIONS
Brief Title
A Study of Pembrolizumab in Combination With Chemotherapy for Head and Neck Cancer
Research Team
A
Ari Rosenberg, MD
A
Ari Rosenberg, MD
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