Study Evaluating the Efficacy of Niraparib and Dostarlimab (TSR-042) in Recurrent/Metastatic HNSCC
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|ClinicalTrials.gov Identifier: NCT04313504|
Recruitment Status : Active, not recruiting
First Posted : March 18, 2020
Last Update Posted : February 2, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: Niraparib Drug: Dostarlimab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Phase II Study Evaluating the Efficacy of Niraparib and Dostarlimab (TSR-042) in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma Patients|
|Actual Study Start Date :||November 4, 2020|
|Estimated Primary Completion Date :||June 1, 2024|
|Estimated Study Completion Date :||June 1, 2027|
Experimental: 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 & Dostarlimab combination
Other Name: ZEJULA
Niraparib & Dostarlimab combination
Other Name: TSR-042
- Overall Response [ Time Frame: 8 weeks ]Measured by assessing best overall response using RECIST 1.1 in subjects in recurrent and/or metastatic HNSCC patients receiving combination of niraparib and dostarlimab.
- Rate of all Adverse Events [ Time Frame: 30 days after completion of treatment ]As determined by CTCAE v5.0 in subjects with recurrent and/or metastatic HNSCC receiving combination of niraparib and dostarlimab.
- Progression Free Survival [ Time Frame: 1 and 3 years ]Measured using Kaplan Meier Curves from time of treatment start until time of progression
- Overall Survival [ Time Frame: 5 years ]Measured using Kaplan Meier Curves from diagnosis until time of death
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Histologically, cytologically, or radiographically confirmed recurrent or metastatic non cutaneous HNSCC for which there are no surgical or radiation curative options.
- ECOG performance status ≤2
- Patients must be able to swallow pills
- Nasopharyngeal and salivary gland tumors
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04313504
|United States, Ohio|
|University of Cincinnati Medical Center|
|Cincinnati, Ohio, United States, 45219|
|Principal Investigator:||Trisha Wise-Draper, MD, PhD||University of Cincinnati|
|Responsible Party:||Trisha Wise-Draper, Principal Investigator, University of Cincinnati|
|Other Study ID Numbers:||
|First Posted:||March 18, 2020 Key Record Dates|
|Last Update Posted:||February 2, 2023|
|Last Verified:||January 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Head and Neck Neoplasms
Neoplasms by Site
Poly(ADP-ribose) Polymerase Inhibitors
Molecular Mechanisms of Pharmacological Action