Niraparib and TSR-042 for the Treatment of BRCA-Mutated Unresectable or Metastatic Breast, Pancreas, Ovary, Fallopian Tube, or Primary Peritoneal Cancer

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT04673448
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Anatomic Stage III Breast Cancer AJCC v8
  • Anatomic Stage IV Breast Cancer AJCC v8
  • BRCA Hereditary Ovarian Carcinoma
  • BRCA-Associated Malignant Neoplasm
  • Metastatic BRCA Hereditary Breast Carcinoma
  • Metastatic Breast Carcinoma
  • Metastatic Fallopian Tube Carcinoma
  • Metastatic Malignant Solid Neoplasm
  • Metastatic Ovarian Carcinoma
  • Metastatic Pancreatic Carcinoma
  • Metastatic Primary Peritoneal Carcinoma
  • Prognostic Stage III Breast Cancer AJCC v8
  • Prognostic Stage IV Breast Cancer AJCC v8
  • Stage III Fallopian Tube Cancer AJCC v8
  • Stage III Ovarian Cancer AJCC v8
  • Stage III Pancreatic Cancer AJCC v8
  • Stage III Primary Peritoneal Cancer AJCC v8
  • Stage IV Fallopian Tube Cancer AJCC v8
  • Stage IV Ovarian Cancer AJCC v8
  • Stage IV Pancreatic Cancer AJCC v8
  • Stage IV Primary Peritoneal Cancer AJCC v8
  • Unresectable Breast Carcinoma
  • Unresectable Fallopian Tube Carcinoma
  • Unresectable Malignant Solid Neoplasm
  • Unresectable Ovarian Carcinoma
  • Unresectable Pancreatic Carcinoma
  • Unresectable Primary Peritoneal Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dostarlimab — BIOLOGICAL
    Given IV
  • Niraparib — DRUG
    Given PO
  • Biopsy — PROCEDURE
    Undergo biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI

Study Details

This phase IB trial evaluates the effect of niraparib and TSR-042 in treating patients with BRCA-mutated breast, pancreas, ovary, fallopian tube, or primary peritoneal cancer that cannot be removed by surgery (unresectable) or has spread to other places in the body (metastatic). Niraparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Immunotherapy with monoclonal antibodies, such as TSR-042, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving niraparib and TSR-042 may kill more cancer cells.

Key Dates

Start date
Oct 18, 2021
Status verified
Jan 2026
Primary completion
Dec 31, 2025
Completion
Sep 30, 2026

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (niraparib, dostarlimab)
    Patients receive niraparib PO QD on days 1-28 of cycle 1. Beginning cycle 2, patients receive niraparib PO QD on days 1-21 and dostarlimab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning cycle 6, patients receive niraparib PO QD on days 1-42 and dostarlimab IV over 30 minutes on day 1. Cycles repeat every 42 days for up to 24 months in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo biopsy, blood sample collection, and CT or MRI throughout the study.

Primary Outcome Measure

Best objective response [ Time Frame: 5 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109-

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By research site
Fred Hutch/University of Washington Cancer Consortium· Seattle, WA

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