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

Head and Neck Cancer Clinical Trial

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)

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05420948
Study type Interventional
Source University of Chicago
Contact Ari Rosenberg, MD
Phone 773-834-3398
Email arirosenberg@medicine.bsd.uchicago.edu
Status Recruiting
Phase Phase 2
Start date October 17, 2022
Completion date December 1, 2026
View Details
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