RecruitingPhase 1NCT05526924

Dosing Study of Radiation Combined With Tislelizumab and Pamiparib in Patients With Previously Treated Head and Neck Cancer

A Phase I Trial of Re-Irradiation With Concurrent Chemotherapy in Combination With Tislelizumab and Pamiparib in Patients With Previously Treated Head and Neck Squamous Cell Carcinoma

Sponsor

University of Chicago

Enrollment

30 participants

Start Date

Mar 7, 2023

Study Type

INTERVENTIONAL

Conditions

Head and Neck Carcinoma Head and Neck Cancer Head and Neck Squamous Cell Carcinoma Head and Neck Cancer Stage IV Head and Neck Cancers - Throat

Summary

The purpose of this study is to evaluate the safety, tolerability and maximum tolerated dose of tislelizumab in combination with pamiparib plus chemoradiotherapy (chemotherapy and radiation) in individuals with recurrent head and neck cancer, which means that the person's cancer has come back after treatment. Participation in the study should last for about 15 months while participants receive tislelizumab and chemoradiotherapy with pamiparib. Afterwards, they will return to the clinic for follow up every 4 months for 2 years, every 6 month for the next 2 years, and then once a year for the rest of their life.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is finding the right dose of a combination treatment — radiation therapy plus two drugs (tislelizumab, an immunotherapy, and pamiparib, a PARP inhibitor) — in people with head and neck squamous cell cancer that has come back after prior radiation treatment. **You may be eligible if...** - You are 18 or older with recurrent or second-primary head and neck squamous cell cancer that was previously treated with radiation - Your cancer has returned in the same region, with little to no distant spread (or limited spread treatable with focused radiation) - You completed prior radiation at least 4 months ago; prior chemotherapy or immunotherapy must be finished at least 1 month ago - You are in good functional health (ECOG 0–1) - For oropharynx cancers: HPV/p16 testing has been performed **You may NOT be eligible if...** - You have widely spread (measurable distant) metastases that cannot be treated with focused therapies - You have not recovered from side effects of prior treatment 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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