Study Evaluating the Efficacy of Niraparib and Dostarlimab (TSR-042) in Recurrent/Metastatic HNSCC
NCT ID: NCT04313504
Last Updated: 2024-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
23 participants
INTERVENTIONAL
2020-11-04
2025-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Niraparib & Dostarlimab
Niraparib starting on Day 0. Niraparib will be administered as continuous daily dose, orally 200 or 300 mg.
Dostarlimab IV administered via a 30-minute infusion on Day 1 of every 21 day cycle. 500mg for first 4 doses followed by 1000 mg every 6 weeks.
Niraparib
Niraparib \& Dostarlimab combination
Dostarlimab
Niraparib \& Dostarlimab combination
Interventions
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Niraparib
Niraparib \& Dostarlimab combination
Dostarlimab
Niraparib \& Dostarlimab combination
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ECOG performance status ≤2
* Patients must be able to swallow pills
Exclusion Criteria
* Patients who have not recovered from adverse events due to prior anti-cancer therapy with the exception of alopecia
* Prior exposure to both immunotherapy drugs (PD-1, PDL-1, CTLA-4 inhibitors) and PARP inhibitors. Single exposure to either immunotherapy or PARP inhibitors is allowable.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to niraparib or dostarlimab.
* Patients with uncontrolled intercurrent illness.
* Requirement of any use of steroids greater than the equivalent of 10mg prednisone daily is not allowed.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Trisha Wise-Draper
OTHER
Responsible Party
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Trisha Wise-Draper
Principal Investigator
Principal Investigators
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Trisha Wise-Draper, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
Locations
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University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Countries
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Other Identifiers
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UCCI-HN-19-03
Identifier Type: -
Identifier Source: org_study_id
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