Dosing Study for Recurrent Head and Neck Cancer
This study is looking at a new combination of treatments for people with head and neck cancer that has come back after previous treatment. It combines radiation with several drugs: tislelizumab (an anti-cancer drug), pamiparib (another anti-cancer drug), and two chemotherapy drugs, fluorouracil (5FU) and hydroxyurea. The main goal is to find the safest and most effective dose of pamiparib when given with these other treatments. Researchers are also looking at specific markers in your body, called PD-1 and PD-L1, which are related to how your immune system fights cancer. To join, you need to have recurrent head and neck cancer and, if your cancer started in the oropharynx, a positive test for HPV (p16). The study is currently recruiting participants.
- Study design
- This study plans to enroll 30 participants. It is an interventional study, meaning participants will receive specific treatments as part of the research.
- What's involved
- Participation in the study should last for about 15 months while you receive tislelizumab and chemoradiotherapy with pamiparib.
- Compensation
- Not stated in the trial record.
- Follow-up
- After treatment, you will return to the clinic for follow-up every 4 months for 2 years, every 6 months for the next 2 years, and then once a year for the rest of your life.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05526924
Dosing Study of Radiation Combined With Tislelizumab and Pamiparib in Patients With Previously Treated Head and Neck Cancer
Recruiting
PHASE1Ages 18+InterventionalTreatmentUniversity of ChicagoInvestigator-initiated
~30 participants
Updated 2026-03-04 on ClinicalTrials.gov
What's tested:ChemoradiationPamiparibHydroxyureaFluorouracil (5FU)Tislelizumab
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum Tolerated Dose/Recommended Phase 2 Dose of Pamiparib in Combination with 5 Fluorouracil-Hydroxea (FHX) and Tislelizumab
Measured over 15 months
Conditions
Where it's being run
1 sites across 1 statesIllinois1
Study leadership
- Ari Rosenberg, MD · PRINCIPAL_INVESTIGATOR · University of Chicago
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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)
Prior radiation therapy completed in 4 months (or longer) , and/or chemotherapy, immunotherapy, or targeted therapy completed 1 month (or earlier) before study entry, and patient should have recovered from any adverse effects.
Prior programmed death-1 (PD-1)/ programmed death ligand-1 (PD-L1) inhibition is permitted.
Prior chemotherapy is permitted.
Patients who undergo surgical salvage therapy with positive margin or extranodal extension or other high-risk patients determined during multidisciplinary tumor board who are eligible for adjuvant re-irradiation therapy are eligible.
18 years of age and older.
Eastern Cooperative Oncology Group performance status of one or less.
Life expectancy of greater than 12 weeks.
Negative serum or urine pregnancy test at screening for patients of childbearing potential.
Patients must have normal organ and marrow functions as defined by lab values that will be confirmed by the study doctor.
Age, Sex, and Reproductive Status:
At a minimum subjects must agree to the use of one method of highly effective contraception as listed in Appendix D. In addition, male subjects are expected to use a condom as noted in Appendix D. The effects of tislelizumab and pamiparib on the developing human fetus are unknown. For this reason and because monoclonal antibodies and PARP inhibitor agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of pamiparib and tislelizumab administration.
Ability to understand and the willingness to sign a written informed consent document.
Exclusion
• 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.
Any condition that required systemic treatment with either corticosteroids (\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study drug(s).
Note: Patients who are currently or have recently been on any of the following corticosteroid regimens are not excluded:
Adrenal replacement corticosteroid (dose ≤ 10 mg daily of prednisone or equivalent)
Topical, ocular, intra-articular, intranasal, or inhalational corticosteroid with minimal systemic absorption
Short course (≤ 7 days) of corticosteroid prescribed prophylactically (e.g., for contrast dye allergy) or for the treatment of a nonautoimmune condition (e.g., delayed-type hypersensitivity reaction caused by contact allergen)
Has hypersensitivity to tislelizumab, pamiparib, or any other drug used in this protocol.
Has a known history of active tuberculosis (Bacillus Tuberculosis infection)
Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer or any tumors that are not likely to influence live expectancy in the subsequent 3 years without active treatment (e.g. low grade prostate cancer in absence of therapy), or prior history of acute myeloid leukemia (AML)/myelodysplastic syndrome (MDS).
Has active autoimmune disease that has required systemic treatment in the past year (i.e. with use of steroids or immunosuppressive drugs). Replacement therapy e.g. levothyroxine, insulin, or physiologic corticosteroid doses for adrenal or pituitary insufficiency, etc. are not considered a form of systemic treatment.
Has known history of, or any evidence of active interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis, or acute lung diseases.
Has a history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected). However, if eradicated subject is eligible.
Has received a live vaccine within 28 days of planned start of study therapy.
Uncontrolled intercurrent illness including but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
Patients receiving any medications or substances that are known to be strong CYP3A inducers (eg. avasimibe, carbamazepine, mitotane, phenobarbital, phenytoin, rifabutin, rifampin/ rifampicin) are ineligible. Patients receiving herbal remedies/medicines such as St. John's Wort (Hypericum perforatum) are also ineligible. See Sections 5.5.2 and 5.5.3 for prohibited medications on study.
Pregnant women are excluded from this study because pamiparib is a PARP inhibitor and tislelizumab is a humanized, immunoglobulin G4 (IgG4)-variant monoclonal antibody agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with pamiparib and tislelizumab, breastfeeding should be discontinued if the mother is treated with pamiparib and tislelizumab.
HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with pamiparib and tislelizumab. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.
Disease/procedure significantly affecting gastrointestinal function, such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction, or gastrointestinal perforation or fistulae. Note: Gastroesophageal reflux disease under treatment with proton pump inhibitors is allowed (assuming no drug interaction potential).
What this trial measures
- Maximum Tolerated Dose/Recommended Phase 2 Dose of Pamiparib in Combination with 5 Fluorouracil-Hydroxea (FHX) and Tislelizumab15 months
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.