Niraparib + Dostarlimab for Pancreatic Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on certain treatments like chemotherapy, radiotherapy, or investigational drugs, you may need to stop or adjust them before joining the trial. It's best to discuss your specific medications with the trial team.
Is the combination of Niraparib and Dostarlimab safe for humans?
Dostarlimab (also known as Jemperli) has been approved for use in certain types of cancer, showing it is generally considered safe for humans. Niraparib (Zejula) is also approved for use in ovarian and related cancers, indicating it is generally safe. However, specific safety data for the combination of these drugs in pancreatic cancer is not provided in the available research.12345
How is the drug combination of Niraparib and Dostarlimab unique for treating pancreatic cancer?
The combination of Niraparib and Dostarlimab is unique for pancreatic cancer as it involves a PARP inhibitor (Niraparib) and a PD-1 inhibitor (Dostarlimab), which work together to target cancer cells by preventing DNA repair and enhancing the immune system's ability to attack cancer, offering a novel approach compared to traditional chemotherapy.678910
What is the purpose of this trial?
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.
Research Team
Robert R. McWilliams, M.D.
Principal Investigator
Mayo Clinic in Rochester
Eligibility Criteria
This trial is for adults with metastatic pancreatic cancer that has specific genetic mutations (BRCA1/2 or PALB2). Participants should have had no more than two prior chemotherapy treatments, including a platinum agent, and must be in fairly good health with an ECOG performance status of 0 or 1. Pregnant individuals, those who've had certain immune conditions or severe reactions to immunotherapy, and anyone unwilling to use contraception are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive niraparib orally once daily on days 1-21 and dostarlimab intravenously on day 1 every 3 weeks for cycles 1-4 and every 6 weeks for subsequent cycles. Cycles repeat every 21 days for up to 2 years.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-ups at 30 days, every 3 months until progressive disease, and then every 6 months for up to 5 years.
Treatment Details
Interventions
- Dostarlimab
- Niraparib
Dostarlimab is already approved in European Union, United States for the following indications:
- Mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer
- dMMR/MSI-H recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen
- Adults with dMMR recurrent or advanced solid tumors who have progressed on or following prior treatment and lack satisfactory alternative treatment options
- Primary advanced or recurrent dMMR endometrial cancer in combination with carboplatin and paclitaxel
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
National Cancer Institute (NCI)
Collaborator