Clinical trialPhase 1 / Phase 2Completed
Niraparib + Ipilimumab or Nivolumab in Progression Free Pancreatic Adenocarcinoma After Platinum-Based Chemotherapy
PARPVAX: Parpvax: A Phase 1b/2, Open Label Study of Niraparib Plus Either Ipilimumab or Nivolumab in Patients With Advanced Pancreatic Cancer Whose Disease Has Not Progressed on Platinum-based Therapy
- Outcome
- Outcome unknown
- Phase
- Phase 1 / Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- 31 January 2018
- Expected end
- 9 October 2024
- Enrollment
- 104 participants
- Sites
- 1
- Primary outcomes
- Rate of Progression-free Survival at 6 Months (PFS6)
- Sponsor
- Other
- Results posted
- 2023-07-03
- Last update
- 10 October 2025
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Brief summary public domain (ClinicalTrials.gov)
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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Rate of Progression-free Survival at 6 Months (PFS6) [6 months after initiation of study therapy]. Number, percentage of participants with PFS (95% Confidence Interval). Niraparib + Nivolumab (Arm A) (n=44): 20.6 (8.3 to 32.9); Niraparib + Ipilimumab (Arm B) (n=40): 59.6 (44.3 to 74.9).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Objective Response Rate (ORR) Per RECIST v.1.1 as Assessed by Radiology Review [From first restaging assessment through completion of study treatment (maximum 42 months)]. Number, Percentage of participants (95% Confidence Interval). Niraparib + Nivolumab (Arm A) (n=44): 7.7 (1.5 to 19.5); Niraparib + Ipilimumab (Arm B) (n=40): 15.4 (5.9 to 30.5).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival (OS) [Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first]. Median, Months (95% Confidence Interval). Niraparib + Nivolumab (Arm A) (n=44): 13.2 (8.1 to 16.7); Niraparib + Ipilimumab (Arm B) (n=40): 17.3 (12.8 to 21.9).