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

https://www.facingourrisk.org/research-clinical-trials/study/135/treating-metastatic-pancreatic-cancer-with-an-inherited-or-tumor-brca12-or-palb2-mutation-with-niraparib-and-dostarlimab

Clinicaltrials.gov identifier:
NCT04493060 (https://clinicaltrials.gov/show/NCT04493060)

Treatment

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        


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.

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:

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

Florida

Minnesota

 


This Study is Open To:

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

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:


About FORCE

FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.