Niraparib and Dostarlimab for the Treatment of Germline or Somatic BRCA1/2 and PALB2 Mutated Metastatic Pancreatic Cancer
NCT04493060 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22
Last updated 2025-08-07
Summary
This phase II trial studies how well niraparib and dostarlimab work in treating patients with germline or somatic BRCA1/2 and PALB2 mutated pancreatic cancer that has spread to other places in the body (metastatic). Niraparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as dostarlimab, 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 dostarlimab may kill more tumor cells.
Conditions
- Metastatic Pancreatic Ductal Adenocarcinoma
- Stage IV Pancreatic Cancer AJCC v8
Interventions
- BIOLOGICAL
-
Dostarlimab
Given IV
- DRUG
-
Niraparib
Given PO
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Robert R. McWilliams, M.D. · Mayo Clinic in Rochester
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-12-28
- Primary Completion
- 2023-12-07
- Completion
- 2025-06-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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