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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT05526924
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Chemoradiation — RADIATION
    A combination of chemotherapy and radiation given at the same time to treat cancer.
  • Pamiparib — DRUG
    An anti-cancer drug that targets specific cells to help fight cancer given by IV (through a needle inserted into a vein).
  • Hydroxyurea — DRUG
    A chemotherapy drug given in pill form; used to treat leukemia and head and neck cancer.
  • Fluorouracil (5FU) — DRUG
    A chemotherapy drug used to treat different types of cancer.
  • Tislelizumab — DRUG
    An anti-cancer drug.

Study Details

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.

Key Dates

Start date
Mar 7, 2023
Status verified
Mar 2026
Primary completion
Jan 1, 2028
Completion
Jan 1, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose-Finding Group 1: Dose Level 1 (Part 1 of Study)
    The purpose of part 1 is to determine the best tolerated dose of study drugs with the least side effects. Dose escalation means that some participants will receive a different (higher) dose than other participants depending on when they join the study. This is to determine side effects at different doses and find a dose that will be safe to give to all participants. Participants in this group will receive: 1. One dose of tislelizumab (200 mg) 15 days before chemoradiotherapy (CRT) given intravenously (by IV), which means through a vein. 2. Chemoradiotherapy over a period of 5 weeks. During each cycle of CRT, participants will receive: * Pamiparib (20 mg daily on days 0-5 of each cycle) along with 5FU and hydroxyurea for 5 days. * Radiation will also be given two times a day for 5 days 3. After CRT, participants will rest for roughly 8 days without study drugs or radiation then they will receive tislelizumab (200 mg) for 12 months by IV over 30 minutes every 6 weeks.
  • Experimental: Dose-Finding Group 2: Dose Level 2 (Part 1 of Study)
    The purpose of part 1 is to determine the best tolerated dose of study drugs with the least side effects. Dose escalation means that some participants will receive a different (higher) dose than other participants depending on when they join the study. This is to determine side effects at different doses and find a dose that will be safe to give to all participants. Participants in this group will receive: 1. One dose of tislelizumab (200 mg) 15 days before chemoradiotherapy (CRT) given intravenously (by IV), which means through a vein. 2. Chemoradiotherapy over a period of 5 weeks. During each cycle of CRT, participants will receive: * Pamiparib (20 mg twice daily on days 0-5 of each 14 -day cycle) along with 5FU and hydroxyurea for 5 days. * Radiation will also be given two times a day for 5 days 3. After CRT, participants will rest for roughly 8 days without study drugs or radiation then they will receive tislelizumab (200 mg) for 12 months by IV over 30 minutes every 6 weeks.
  • Experimental: Dose-Finding Group 3: Dose Level 3 (Part 1 of Study)
    The purpose of part 1 is to determine the best tolerated dose of study drugs with the least side effects. Dose escalation means that some participants will receive a different (higher) dose than other participants depending on when they join the study. This is to determine side effects at different doses and find a dose that will be safe to give to all participants. Participants in this group will receive: 1. One dose of tislelizumab (200 mg) 15 days before chemoradiotherapy (CRT) given intravenously (by IV), which means through a vein. 2. Chemoradiotherapy over a period of 5 weeks. During each cycle of CRT, participants will receive: * Pamiparib (40 mg twice daily on days 0-5 of each 14 -day cycle) along with 5FU and hydroxyurea for 5 days. * Radiation will also be given two times a day for 5 days 3. After CRT, participants will rest for roughly 8 days without study drugs or radiation then they will receive tislelizumab (200 mg) for 12 months by IV over 30 minutes every 6 weeks.
  • Experimental: Dose Expansion Group ( Part II of Study)
    Part 2 (dose expansion phase): The purpose of this part is to continue to evaluate the dose of study drugs that is the best tolerated and has the least side effects. This part will start once the dose is selected from part 1. Enrollment in this part of the study is dependent on when participants join the study. Approximately 18 subjects will be enrolled in Part 2.

Primary Outcome Measure

Maximum Tolerated Dose/Recommended Phase 2 Dose of Pamiparib in Combination with 5 Fluorouracil-Hydroxea (FHX) and Tislelizumab [ Time Frame: 15 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of ChicagoChicagoIllinois60637
Cancer Clinical Trials Office
[email protected]
855-702-8222

Find similar trials in Chicago, IL

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
The University of Chicago· Chicago, IL

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