Niraparib + Ipilimumab or Nivolumab in Progression Free Pancreatic Adenocarcinoma After Platinum-Based Chemotherapy

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT03404960
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Niraparib + Nivolumab — DRUG
    Niraparib 200mg PO daily on days 1-28 of each 28-day cycle. Nivolumab 480mg IV day 1 of each cycle.
  • Niraparib + Ipilimumab — DRUG
    Niraparib 200mg PO daily on days 1-21 of each 21-day cycle. Ipilimumab 3mg/kg IV day 1 of each cycle, for the first 4 cycles only.

Study Details

The main purpose of this study is to look at the effectiveness, safety, and anti-tumor activity (preventing growth of the tumor) of the drugs Niraparib with either Ipilimumab or Nivolumab on patients and their pancreatic cancer.

Key Dates

Start date
Jan 31, 2018
Status verified
Sep 2025
Primary completion
Apr 5, 2022
Completion
Oct 9, 2024

Study Design

Enrollment
104 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Niraparib + Nivolumab
  • Experimental: Arm B
    Niraparib + Ipilimumab

Primary Outcome Measure

Rate of Progression-free Survival at 6 Months (PFS6) [ Time Frame: 6 months after initiation of study therapy ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Pennsylvania, Abramson Cancer CenterPhiladelphiaPennsylvania19104-

Find similar trials in Philadelphia, PA

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
University of Pennsylvania, Abramson Cancer Center· Philadelphia, PA

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