Spots Global Cancer Trial Database for A Study of Pembrolizumab in Combination With Chemotherapy for Head and Neck Cancer

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Trial Identification

Brief Title: A Study of Pembrolizumab in Combination With Chemotherapy for Head and Neck Cancer

Official Title: A Phase II Study of Pembrolizumab in Combination With Circulating Tumor DNA Response-Adaptive Pulsed Chemotherapy in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma: The SINERGY Trial (Squamous Cell Carcinoma of Head and Neck Response-Guided Therapy)

Study ID: NCT05420948

Conditions

Head and Neck Cancer

Head and Neck Squamous Cell Carcinoma

Head and Neck Neoplasms

Head Cancer

Throat Carcinoma

Interventions

Pembrolizumab

Carboplatin

Paclitaxel

Study Description

Brief Summary: By doing this study, the research team would like to learn if using a blood test that measures the amount of tumor DNA in blood can help guide how to use chemotherapy combined with immunotherapy for individuals with head and neck cancer. Using this blood test, the research team hopes to learn if intermittent (occasional) chemotherapy added to immunotherapy will work better than immunotherapy alone. Participation in this research will last about two years.

Detailed Description: By doing this study, the research team hopes to learn if using a blood test that measures the amount of tumor DNA in blood can help guide how to use chemotherapy combined with immunotherapy for individuals with head and neck cancer. Using this blood test, the research team hopes to learn if intermittent (occasional) chemotherapy added to immunotherapy will work better than immunotherapy alone. Participation in this research will last about two years. The purpose of this research is to gather information on how well immunotherapy with intermittent chemotherapy guided by measurements of tumor DNA in blood will work and to learn about the safety and effectiveness of this new treatment strategy. All of the drugs used in this trial are approved by the US Food and Drug Administration (FDA); however, they are being combined in a new way based on changes in tumor DNA in the participant's blood which can only be done in a research study.