Niraparib + Ipilimumab or Nivolumab in Progression Free Pancreatic Adenocarcinoma After Platinum-Based Chemotherapy
NCT03404960 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 104
Last updated 2025-10-10
Summary
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.
Conditions
- Pancreatic Adenocarcinoma
Interventions
- DRUG
-
Niraparib + Nivolumab
Niraparib 200mg PO daily on days 1-28 of each 28-day cycle. Nivolumab 480mg IV day 1 of each cycle.
- DRUG
-
Niraparib + Ipilimumab
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.
Sponsors & Collaborators
- collaborator INDUSTRY
- collaborator INDUSTRY
- lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-01-31
- Primary Completion
- 2022-04-05
- Completion
- 2024-10-09
- FDA Drug
- Yes
Countries
- United States
Study Locations
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