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Treating Metastatic Pancreatic Cancer with an Inherited or Tumor BRCA1/2 or PALB2 Mutation with Niraparib and Dostarlimab

Treating Metastatic Pancreatic Cancer with an Inherited or Tumor BRCA1/2 or PALB2 Mutation with Niraparib and Dostarlimab

Clinicaltrials.gov identifier:
NCT04493060

Treatment:
Pancreatic

Study Contact Information:

Contact the Mayo Clinic Clinical Trials Referral Office  by phone  855-776-0015  or by email.

Principal Investigator: Robert R. McWilliams, MD        


Treating Metastatic Pancreatic Cancer with an Inherited or Tumor BRCA1/2 or PALB2 Mutation with Niraparib and Dostarlimab

About the Study

This study looks at how well the PARP inhibitor niraparib and the immunotherapy drug dostarlimab work together in treating patients with metastatic pancreatic cancer, who also have an inherited or tumor mutation in one of the following genes: BRCA1, BRCA2, PALB2, BARD1, RAD51c, or RAD51d.

  • Niraparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
  • Immunotherapy 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.

Type of Study

This is an open label, single-group study. In a single group assignment study, all participants will receive the same therapy (including dosage, frequency, and how the drug is given) during the study.

What the Study Entails:

All patients enrolled in this study will receive:

  • Niraparib orally once per day on days 1-21
  • Dostarlimab intravenously (IV) over 30 minutes 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 in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days, every 3 months until progressive disease (PD), and then every 6 months for up to 5 years.

Study Sites

Arizona

  • Scottsdale: Mayo Clinic Arizona
    Contact: Clinical Trials Referral Office by phone 855-776-0015 or by email    
    Principal Investigator: Daniel Ahn, D.O.        

Florida

  • Jacksonville: Mayo Clinic
    Contact: Clinical Trials Referral Office by phone 855-776-0015 or by email    
    Principal Investigator: Kabir Mody, M.D.        

Minnesota

  • Rochester: Mayo Clinic in Rochester
    Contact: Clinical Trials Referral Office by phone 855-776-0015 or by email 
    Principal Investigator: Robert R. McWilliams, MD        

 

This Study is Open To:

Men and women age 18 years or older can participate if they meet the following criteria:

  • Have either an inherited mutation or a tumor mutation in any one of the following genes: BRCA1, BRCA2, PALB2, BARD1, RAD51c, or RAD51d.
  • Have a diagnosis of metastatic pancreatic cancer
  • Have had at least one but no more than two prior lines of systemic therapy for metastatic disease
  • Received a platinum chemotherapy agent as part of first- or second-line treatment
  • Have a life expectancy of >= 3 months
  • Are willing to undergo repeat biopsies of tumor lesions

Note: Participants who previously received a PARP inhibitor or immunotherapy as a single agent may still be eligible. 

This Study is Not Open To:

The study is not open to the following patients:

  • Patients having had prior treatment with the combination of a PARP inhibitor and immunotherapy are not eligible. Participants who previously received a PARP inhibitor or immunotherapy as a single agent may still be eligible. 
  • Patients who experienced serious ( >= grade 3) immune-related adverse events with prior immunotherapy treatment
  • Patients with untreated brain metastases, uncontrolled seizure disorder, active neurologic disease, uncontrolled medical disorder, active infection or a mental disorder
  • Those with a known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
  • Participant with active hepatitis B, hepatitis C, or TB (tuberculosis)
  • Patient is pregnant or lactating