NCT04673448

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

Phase IB Trial of Niraparib and Dostarlimab (TSR-042) in Patients With BRCA-Mutated Breast, Pancreas or Ovary Cancer

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OUTLINE: Patients receive niraparib orally (PO) once daily (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 computed tomography (CT) or magnetic resonance imaging (MRI) throughout the study. After completion of study treatment, patients are followed up for 30 days, every 6 months for 2 years, and then annually for up to 5 years.

Conditions

• Anatomic Stage III Breast Cancer AJCC v8
• Anatomic Stage IV Breast Cancer AJCC v8
• BRCA-Associated Malignant Neoplasm
• BRCA Hereditary Ovarian Carcinoma
• 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

Interventions

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

Timeline

• Start date: 2021-10-18
• Primary completion: 2025-12-31
• Completion: 2026-09-30
• First posted: 2020-12-17
• Last updated: 2026-01-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study