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

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.

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

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

Sponsors & Collaborators

• GlaxoSmithKline

  collaborator INDUSTRY

• University of Washington

  lead OTHER

Principal Investigators

• Elizabeth M. Swisher · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-10-18

Primary Completion

2025-12-31

Completion

2026-09-30

FDA Drug

Yes

Countries

• United States

Study Locations