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Study Evaluating the Efficacy of Niraparib and Dostarlimab (TSR-042) in Recurrent/Metastatic HNSCC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04313504
Recruitment Status : Active, not recruiting
First Posted : March 18, 2020
Last Update Posted : February 2, 2023
Information provided by (Responsible Party):
Trisha Wise-Draper, University of Cincinnati

Brief Summary:
The purpose of this study is to determine the best overall response of the combination of dostarlimab and niraparib in patients with recurrent and/or metastatic HNSCC patients.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: Niraparib Drug: Dostarlimab Phase 2

Detailed Description:
Recurrent and/or metastatic HNSCC patients will be treated with combination of the PD-1 inhibitor (dostarlimab) and PARPi (niraparib) concurrently and ORR, PFS and OS will be determined.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Drug: Niraparib
Niraparib & Dostarlimab combination
Other Name: ZEJULA

Drug: Dostarlimab
Niraparib & Dostarlimab combination
Other Name: TSR-042

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. Progression Free Survival [ Time Frame: 1 and 3 years ]
    Measured using Kaplan Meier Curves from time of treatment start until time of progression

  3. Overall Survival [ Time Frame: 5 years ]
    Measured using Kaplan Meier Curves from diagnosis until time of death

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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

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United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
Trisha Wise-Draper
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Principal Investigator: Trisha Wise-Draper, MD, PhD University of Cincinnati
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Responsible Party: Trisha Wise-Draper, Principal Investigator, University of Cincinnati
ClinicalTrials.gov Identifier: NCT04313504    
Other Study ID Numbers: UCCI-HN-19-03
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents