Actively Recruiting
Dosing Study of Radiation Combined With Tislelizumab and Pamiparib in Patients With Previously Treated Head and Neck Cancer
Led by University of Chicago · Updated on 2026-03-04
30
Participants Needed
1
Research Sites
251 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Dosing Study of Radiation Combined With Tislelizumab and Pamiparib in Patients With Previously Treated Head and Neck Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinically documented recurrent head and neck cancer requiring regional therapy
- HPV testing by p16 immunohistochemistry positivity for oropharynx primary tumors
- Availability of at least 10 unstained 5 micron slides or willingness to undergo new biopsy
- Recurrent or second primary previously irradiated head and neck squamous cell carcinoma without clinically measurable distant metastases or low volume oligometastatic disease treatable with curative intent
- Completion of prior radiation therapy at least 4 months ago and chemotherapy, immunotherapy, or targeted therapy at least 1 month before study entry with recovery from adverse effects
- Prior PD-1/PD-L1 inhibition or chemotherapy allowed
- Eligibility for adjuvant re-irradiation therapy after surgical salvage with high-risk features
- Age 18 years or older
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Life expectancy greater than 12 weeks
- Negative pregnancy test for patients of childbearing potential
- Normal organ and marrow functions as confirmed by lab tests
- Women of childbearing potential must agree to use effective contraception during treatment and for 6 months after last dose
- Men sexually active with women of childbearing potential must agree to use contraception during treatment and for 6 months after last dose
- Ability to understand and sign informed consent
You will not qualify if you...
- Previously untreated patients with locoregional-only disease
- Chemotherapy within 4 weeks before study entry or not recovered from related adverse events
- Receiving other investigational agents
- History of allergic reactions to study drug components
- Systemic corticosteroid or immunosuppressive treatment over 10 mg prednisone daily within 14 days before first study drug dose (with specified exceptions)
- Hypersensitivity to tislelizumab, pamiparib, or other drugs in the protocol
- Active tuberculosis infection
- Active progressing malignancy requiring treatment except certain skin cancers or in situ cervical cancer
- Active autoimmune disease requiring systemic treatment in past year
- Active interstitial lung disease, pneumonitis, or uncontrolled lung disease
- HIV infection
- Active Hepatitis B or C infection (eradicated infection allowed)
- Live vaccine within 28 days before treatment start
- Uncontrolled illness including infection, heart failure, unstable angina, arrhythmia, or psychiatric/social conditions limiting compliance
- Known brain metastases
- Use of strong CYP3A inducers or certain herbal remedies
- Pregnancy or breastfeeding
- HIV-positive patients on antiretroviral therapy
- Significant gastrointestinal conditions affecting function such as malabsorption, bowel obstruction, or fistulae (except treated GERD)
AI-Screening
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Trial Site Locations
Total: 1 location
1
The University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
Research Team
C
Cancer Trial Intake
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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