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
University of Chicago
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.
Description
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. During the study, participants will first receive one dose of tislelziumab. Tislelzumab is an experimental drug, meaning, it is not approved by the U.S. Food and Drug Administration (FDA) to treat cancer. Next, participants will receive pamiparib in combination with CRT (chemotherapy and…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Clinically documented recurrent head and neck cancer requiring regional therapy. * Human papillomavirus (HPV) testing for oropharynx primary tumors by p16 immunohistochemistry (IHC) positivity * Availability of more than (or equal to) 10 unstained 5 micron slides (to be provided to Human Tissue Resource Center at the University of Chicago). Subjects who cannot fulfill this requirement will need to undergo a new biopsy prior to enrollment on study. * Recurrent or second primary, previously irradiated head and neck squamous cell carcinoma without clinically measurably dist…
Interventions
- RadiationChemoradiation
A combination of chemotherapy and radiation given at the same time to treat cancer.
- DrugPamiparib
An anti-cancer drug that targets specific cells to help fight cancer given by IV (through a needle inserted into a vein).
- DrugHydroxyurea
A chemotherapy drug given in pill form; used to treat leukemia and head and neck cancer.
- DrugFluorouracil (5FU)
A chemotherapy drug used to treat different types of cancer.
- DrugTislelizumab
An anti-cancer drug.
Location
- The University of ChicagoChicago, Illinois