NCT05420948

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

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)

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Cancer
• Head and Neck Squamous Cell Carcinoma
• Head and Neck Neoplasms
• Head Cancer
• Throat Carcinoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab	A drug that binds to a protein called programmed cell death 1 (PD-1) to help immune cells kill cancer cells better. Pembrolizumab is used to treat many different types of cancer.
DRUG	Carboplatin	A chemotherapy drug used to treat cancer.
DRUG	Paclitaxel	A chemotherapy drug used to treat cancer.

Timeline

• Start date: 2022-10-17
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2022-06-15
• Last updated: 2026-04-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study