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.
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 distant metastatic disease, or low volume oligometastatic disease amenable to Stereotactic Body Radiation Therapy (SBRT) or other curative-intent therapy (e.g. surgery, radiation frequency ablation therapy)
• Previously untreated patients with locoregional-only disease are not eligible.
Patients who have had chemotherapy within 4 weeks prior to entering the study, or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
Patients may not be receiving any other investigational agents.
History of allergic reactions attributed to compounds of similar chemical composition or excipients used in the study.
Sequential
Chemoradiation
RadiationA combination of chemotherapy and radiation given at the same time to treat cancer.
Pamiparib
DrugAn anti-cancer drug that targets specific cells to help fight cancer given by IV (through a needle inserted into a vein).
Hydroxyurea
DrugA chemotherapy drug given in pill form; used to treat leukemia and head and neck cancer.
Fluorouracil (5FU)
DrugA chemotherapy drug used to treat different types of cancer.
Tislelizumab
DrugAn anti-cancer drug.
Maximum Tolerated Dose/Recommended Phase 2 Dose of Pamiparib in Combination with 5 Fluorouracil-Hydroxea (FHX) and Tislelizumab
Determine the maximally tolerated dose (MTD)/ recommended phase 2 dose (RP2D) for pamiparib in combination with FHX and tislelizumab in subjects with recurrent head and neck squamous cell carcinoma (HNSCC) as assessed by the incidence of dose-limiting toxicities (side effects) reported among study participants. Dose-limiting toxicities will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Progression Free Survival of Participants Receiving Pamiparib in Combination with 5 Fluorouracil-Hydroxea (FHX) and Tislelizumab
The progression free survival (PFS) of participants receiving pamiparib in combination with FHX and tislelizumab in subjects with recurrent head and neck squamous cell carcinoma, defined as the time from initiation of treatment with tislelizumab to the earliest of disease progression per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or death from any cause.
Overall Free Survival of Participants Receiving Pamiparib in Combination with 5 Fluorouracil-Hydroxea (FHX) and Tislelizumab
Overall survival (OS) of participants receiving pamiparib in combination with FHX and tislelizumab in subjects with recurrent head and neck squamous cell carcinoma, defined as the time from initiation of treatment with tislelizumab to death due to any cause.
Click on the lead sponsor to view all of their trials.
