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

Primary Purpose

Head and Neck Cancer

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Niraparib
Dostarlimab
Sponsored by
Trisha Wise-Draper
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Cincinnati Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Niraparib & Dostarlimab

Arm Description

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.

Outcomes

Primary Outcome Measures

Overall Response
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

Rate of all Adverse Events
As determined by CTCAE v5.0 in subjects with recurrent and/or metastatic HNSCC receiving combination of niraparib and dostarlimab.
Progression Free Survival
Measured using Kaplan Meier Curves from time of treatment start until time of progression
Overall Survival
Measured using Kaplan Meier Curves from diagnosis until time of death

Full Information

First Posted
March 16, 2020
Last Updated
January 31, 2023
Sponsor
Trisha Wise-Draper
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT04313504
Brief Title
Study Evaluating the Efficacy of Niraparib and Dostarlimab (TSR-042) in Recurrent/Metastatic HNSCC
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 4, 2020 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Trisha Wise-Draper
Collaborators
GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Niraparib & Dostarlimab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Niraparib
Other Intervention Name(s)
ZEJULA
Intervention Description
Niraparib & Dostarlimab combination
Intervention Type
Drug
Intervention Name(s)
Dostarlimab
Other Intervention Name(s)
TSR-042
Intervention Description
Niraparib & Dostarlimab combination
Primary Outcome Measure Information:
Title
Overall Response
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Rate of all Adverse Events
Description
As determined by CTCAE v5.0 in subjects with recurrent and/or metastatic HNSCC receiving combination of niraparib and dostarlimab.
Time Frame
30 days after completion of treatment
Title
Progression Free Survival
Description
Measured using Kaplan Meier Curves from time of treatment start until time of progression
Time Frame
1 and 3 years
Title
Overall Survival
Description
Measured using Kaplan Meier Curves from diagnosis until time of death
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trisha Wise-Draper, MD, PhD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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