Niraparib + Dostarlimab + RT in Pancreatic Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT04409002
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Niraparib — DRUG
    Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment
  • Dostarlimab — DRUG
    Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study
  • Radiation — RADIATION
    Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1

Study Details

This research is being done to see how the combination of dostarlimab, niraparib, and radiation therapy works in controlling metastatic pancreatic cancer.

Key Dates

Start date
Jul 23, 2020
Status verified
Aug 2025
Primary completion
Jan 19, 2022
Completion
Feb 25, 2022

Study Design

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

Arms

  • Experimental: Niraparib+Dostarlimab + Radiation
    Each study treatment cycle lasts 21 days * Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment * Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study * Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1

Primary Outcome Measure

Disease Control Rate With RECIST 1.1 Criteria [ Time Frame: up to 17 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114-

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