22 Participants Needed

Niraparib + Dostarlimab for Pancreatic Cancer

Recruiting at 2 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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

RR

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

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
See 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
See 18 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

Up to 2 years
Every 3 weeks for cycles 1-4, then every 6 weeks

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.

Up to 5 years
30 days post-treatment, then every 3 months, then every 6 months

Treatment Details

Interventions

  • Dostarlimab
  • Niraparib
Trial Overview 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.
Participant Groups
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

Dostarlimab is a monoclonal antibody that targets the PD-1 receptor and has been approved for treating adult patients with mismatch repair deficient recurrent or advanced endometrial cancer based on promising results from the GARNET trial.
The approval of dostarlimab in the EU and USA marks a significant milestone in cancer treatment, highlighting its potential efficacy in targeting specific cancer types.
Dostarlimab: First Approval.Markham, A.[2021]
Dostarlimab (JEMPERLI) is a PD-1 monoclonal antibody that has received rapid FDA approval for treating adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, showing promising tumor response rates.
A clinical trial (NCT04165772) reported a remarkable 100% remission rate for rectal cancer patients treated with Dostarlimab, highlighting the potential of matching tumor genetics with targeted therapies, and the trial is ongoing for other cancer types like gastric, prostate, and pancreatic cancers.
Dostarlimab: A Review.Costa, B., Vale, N.[2022]
Niraparib (Zejula) is effective for treating recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, providing a targeted therapy option for these specific cancer types.
Ocrelizumab (Ocrevus) has shown efficacy in managing both relapsing and primary progressive multiple sclerosis, while dupilumab (Dupixent) is effective for patients with moderate-to-severe atopic dermatitis, highlighting its role in managing chronic inflammatory skin conditions.
Pharmaceutical Approval Update.Choy, M.[2020]

References

Dostarlimab: First Approval. [2021]
Dostarlimab: A Review. [2022]
Pharmaceutical Approval Update. [2020]
New Drug for Mismatch Repair Deficient Endometrial Cancer and Solid Tumors. [2023]
Clinical Activity and Safety of Cediranib and Olaparib Combination in Patients with Metastatic Pancreatic Ductal Adenocarcinoma without BRCA Mutation. [2022]
Dual Inhibition of IGF-1R and ErbB3 Enhances the Activity of Gemcitabine and Nab-Paclitaxel in Preclinical Models of Pancreatic Cancer. [2022]
A phase 3 randomized, double-blind, placebo-controlled trial of ganitumab or placebo in combination with gemcitabine as first-line therapy for metastatic adenocarcinoma of the pancreas: the GAMMA trial. [2022]
Nab-paclitaxel plus gemcitabine with or without capecitabine and cisplatin in metastatic pancreatic adenocarcinoma (PACT-19): a randomised phase 2 trial. [2022]
Nimotuzumab Plus Gemcitabine for K-Ras Wild-Type Locally Advanced or Metastatic Pancreatic Cancer. [2023]
Efficacy and safety comparison of nabpaclitaxel plus S-1 and gemcitabine plus S-1 as first-line chemotherapy for metastatic pancreatic cancer. [2022]
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