Clinical Trials Logo
  1. Home
  2. Head and Neck Cancer
  3. NCT04313504
  4. Details
NCT04313504 Clinical Trial

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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04313504
Other study ID # UCCI-HN-19-03
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date November 4, 2020
Est. completion date June 1, 2027

Study information
Verified date February 2024
Source University of Cincinnati
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 23
Est. completion date June 1, 2027
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Niraparib
Niraparib & Dostarlimab combination
• Dostarlimab
Niraparib & Dostarlimab combination

Locations
Country Name City State
United States University of Cincinnati Medical Center Cincinnati Ohio

Sponsors (2)
Lead Sponsor Collaborator
Trisha Wise-Draper GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 8 weeks
Secondary 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. 30 days after completion of treatment
Secondary Progression Free Survival Measured using Kaplan Meier Curves from time of treatment start until time of progression 1 and 3 years
Secondary Overall Survival Measured using Kaplan Meier Curves from diagnosis until time of death 5 years
See also
  Status Clinical Trial Phase
Recruiting NCT05808920 - The RESCUE Study: Survival and Functional Outcomes Following Salvage Surgery for RESidual or reCurrent sqUamous cEll Carcinoma of the Head and Neck
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Active, not recruiting NCT05060432 - Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT03997643 - Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT04700475 - Effect of Low Level Laser Therapy on Prevention of Radiotherapy Induced Xerostomia in Cancer Patients. N/A
Withdrawn NCT04058145 - AMD3100 Plus Pembrolizumab in Immune Checkpoint Blockade Refractory Head and Neck Squamous Cell Carcinoma Phase 2
Completed NCT02572869 - Functional and Aesthetic Outcomes After Mandible Reconstruction With Fibula Osteomyocutaneous Free Flaps
Active, not recruiting NCT04474470 - A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer Phase 1/Phase 2
Withdrawn NCT05073809 - Photoacoustic Imaging of Head and Neck Tumours
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Active, not recruiting NCT03651570 - Randomized Controlled Trial of a E-intervention to Help Patients Newly Diagnosed With Cancer Cope Better: Pilot Study N/A
Recruiting NCT04930432 - Study of MCLA-129, a Human Bispecific EGFR and cMet Antibody, in Patients With Advanced NSCLC and Other Solid Tumors Phase 1/Phase 2
Recruiting NCT06016699 - Immunological Function After Radiation With Either Proton or Photon Therapy
Terminated NCT03843554 - Commensal Oral Microbiota in Head and Neck Cancer N/A
Recruiting NCT05915572 - Mulligan Technique on Shoulder Dysfunction N/A
Completed NCT05897983 - Tens and Rocabado Exercises on TMJ Dysfunction N/A
Not yet recruiting NCT06289049 - Heavy Strength Training in Head and Neck Cancer Survivors Phase 2
Withdrawn NCT05263648 - Virtual Reality Software to Reduce Stress in Cancer Patients N/A
Withdrawn NCT03238638 - A Study of Epacadostat + Pembrolizumab in Head and Neck Cancer Patients, Who Failed Prior PD-1/PD-L1 Therapy Phase 2