RecruitingPhase 1NCT04754321

Combining Immunotherapy Salvage Surgery & IORT Tx Persistent/Recurrent Head & Neck Cancer

HNSALV Trial: Combining Immunotherapy With Salvage Surgery and IORT for Treatment of Persistent/Recurrent Head and Neck Cancers

Sponsor

Ohio State University Comprehensive Cancer Center

Enrollment

45 participants

Start Date

May 12, 2022

Study Type

INTERVENTIONAL

Conditions

Locally Recurrent Head and Neck Squamous Cell Carcinoma Recurrent Laryngeal Squamous Cell Carcinoma Recurrent Oral Cavity Squamous Cell Carcinoma Head and Neck Carcinoma of Unknown Primary Resectable Head and Neck Squamous Cell Carcinoma Recurrent Pharyngeal Squamous Cell Carcinoma

Summary

This phase I trial is to find out the possible side effects of pembrolizumab and radiation therapy before and during surgery in treating patients with head and neck squamous cell cancer that remains despite treatment (persistent) or has come back (recurrent). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays or protons to kill tumor cells and shrink tumors. Giving pembrolizumab and radiation therapy before and during surgery may kill more tumor cells.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination approach for head and neck cancer that has come back or not responded to prior treatment: surgery to remove the tumor followed by immunotherapy and targeted radiation delivered directly to the surgical area (IORT — intraoperative radiation therapy). **You may be eligible if...** - You have confirmed recurrent or persistent squamous cell carcinoma of the head and neck (mouth, throat, larynx, or unknown primary) - Your tumor is considered removable by the surgical team - You are 18 years or older and in reasonably good health (ECOG performance status less than 2) - Your blood, kidney, and liver function are adequate **You may NOT be eligible if...** - Your cancer cannot be surgically removed - You are in poor general health - You have had prior treatment that disqualifies you from this combination approach 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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