Niraparib and Dostarlimab for the Treatment of Germline or Somatic BRCA1/2 and PALB2 Mutated Metastatic Pancreatic Cancer

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT04493060
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Pancreatic Ductal Adenocarcinoma
  • Stage IV Pancreatic Cancer AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Dec 28, 2020
Status verified
Jan 2025
Primary completion
Dec 7, 2023
Completion
Jun 1, 2025

Study Design

Enrollment
22 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (niraparib, dostarlimab)
    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.

Primary Outcome Measure

Disease Control Rate at 12 Weeks (DCR12) [ Time Frame: At 12 weeks ]

Locations (3)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259-
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980-
Mayo Clinic in RochesterRochesterMinnesota55905-

Find similar trials in Scottsdale, AZ

By research site
Mayo Clinic in Arizona· Scottsdale, AZMayo Clinic in Florida· Jacksonville, FLMayo Clinic in Rochester· Rochester, MN

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