RecruitingPhase 2NCT05420948

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)


Sponsor

University of Chicago

Enrollment

30 participants

Start Date

Oct 17, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing pembrolizumab (an immunotherapy drug) in combination with chemotherapy for people with head and neck cancer that has returned after prior treatment or spread to other parts of the body. Pembrolizumab works by helping the immune system recognize and attack cancer cells. **You may be eligible if...** - You have head and neck cancer that is recurrent (came back) or metastatic (spread to other areas) - You have not previously received systemic treatment (chemotherapy or immunotherapy) for recurrent or metastatic disease - Your cancer has been confirmed by biopsy - You are in adequate health to tolerate chemotherapy and immunotherapy **You may NOT be eligible if...** - You have already received systemic treatment for recurrent or metastatic head and neck cancer - You have active autoimmune disease - You have had serious side effects from prior immunotherapy - You are pregnant or breastfeeding - You have uncontrolled infections or significant organ problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab

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.

DRUGCarboplatin

A chemotherapy drug used to treat cancer.

DRUGPaclitaxel

A chemotherapy drug used to treat cancer.


Locations(1)

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

View Full Details on ClinicalTrials.gov

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NCT05420948


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