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Dosing Study of Radiation Combined With Tislelizumab and Pamiparib in Patients With Previously Treated Head and Neck Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

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

NCT05526924•University of Chicago

View on ClinicalTrials.gov

Summary

Detailed 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 radiation). Pamiparib is also an experimental drug and not approved by the FDA. Chemoradiotherapy will consist of chemotherapy drugs, 5-FU and hydroxyurea, plus radiation therapy. 5-FU is approved by the FDA to treat many types of cancer such as colon cancer but has not been approved for the treatment of head and neck cancer. Its use is experimental in this study. Hydroxyurea is approved by the FDA to treat many types of cancer, including in combination with radiation therapy for the local control of squamous carcinoma of the head and neck. The combination of tislelizumab, hydroxyurea with 5-FU, radiation, and pamiparib, is considered experimental in this study. 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 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.
+12 more criteria

Exclusion Criteria

•* 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)
+14 more criteria

Locations (1)

The University of Chicago

Chicago, Illinois, United States

Key Dates

Start Date

March 7, 2023

Primary Completion Date

January 1, 2028

Completion Date

January 1, 2028

Last Updated

March 4, 2026

Enrollment

ESTIMATED participants

Conditions

Head and Neck CancerHead and Neck Squamous Cell CarcinomaHead and Neck CarcinomaHead and Neck Cancer Stage IVHead and Neck Cancers - Throat

Interventions

Chemoradiation

RADIATION

Pamiparib

DRUG

Hydroxyurea

DRUG

Fluorouracil (5FU)

DRUG

Tislelizumab

DRUG

Contacts

Cancer Trial Intake

CONTACT

1-855-702-8222 cancerclinicaltrials@bsd.uchicago.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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