Niraparib + Dostarlimab for Pancreatic Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen ByRobert R McWilliams

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Mayo Clinic

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

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.

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

My diagnosis of pancreatic cancer was confirmed through tissue or cell testing.

Provide written informed consent

Negative pregnancy test done =< 7 days prior to registration for persons of childbearing potential

+10 more

Exclusion Criteria

I do not have stomach or intestine problems affecting medicine absorption.

I am still recovering from side effects or complications of my last surgery or treatment.

Known hypersensitivity to any component of study treatments

+18 more

Participant Groups

The trial is testing the combination of Niraparib, which blocks enzymes needed for tumor growth, and Dostarlimab, an antibody that may help the immune system fight cancer. It's a phase II study designed to see how well these drugs work together in treating patients whose pancreatic cancer has spread.

1Treatment groups

Experimental Treatment

Group I: Treatment (niraparib, dostarlimab)Experimental Treatment2 Interventions

Patients receive niraparib PO QD on days 1-21. Patients also receive dostarlimab IV over 30 minutes on day 1 Q3W for cycles 1-4 and Q6W for subsequent cycles. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Dostarlimab is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Jemperli for:

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

🇺🇸 Approved in United States as Jemperli for:

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