Dosing Study of Radiation Combined With Tislelizumab and Pamiparib in Patients With Previously Treated Head and Neck Cancer
NCT05526924 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-03-04
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.
Conditions
- Head and Neck Cancer
- Head and Neck Squamous Cell Carcinoma
- Head and Neck Carcinoma
- Head and Neck Cancer Stage IV
- Head and Neck Cancers - Throat
Interventions
- RADIATION
-
Chemoradiation
A combination of chemotherapy and radiation given at the same time to treat cancer.
- DRUG
-
Pamiparib
An anti-cancer drug that targets specific cells to help fight cancer given by IV (through a needle inserted into a vein).
- DRUG
-
Hydroxyurea
A chemotherapy drug given in pill form; used to treat leukemia and head and neck cancer.
- DRUG
-
Fluorouracil (5FU)
A chemotherapy drug used to treat different types of cancer.
- DRUG
-
Tislelizumab
An anti-cancer drug.
Sponsors & Collaborators
-
University of Chicago
lead OTHER
Principal Investigators
-
Ari Rosenberg, MD · University of Chicago
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-03-07
- Primary Completion
- 2028-01-01
- Completion
- 2028-01-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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