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

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 r

Trial Details

NCT ID
NCT05526924
Phase
PHASE1
Sponsor
University of Chicago
Status
RECRUITING
Cancer Type
Head and Neck Cancer
Interventions
  • Chemoradiation
  • Pamiparib
  • Hydroxyurea
  • Fluorouracil (5FU)
  • Tislelizumab
Locations (sample)
  • Chicago, Illinois, United States|41.85003,-87.65005

Key Eligibility 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).…
  • Recurrent or second primary, previously irradiated head and neck squamous cell carcinoma without clinically measurably distant metastatic disease, …

For full eligibility, visit ClinicalTrials.gov.

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