NCT06747845 · Abramson Cancer Center at Penn Medicine
Maintenance Niraparib Plus Ipilimumab in Patients With Metastatic Pancreatic Adenocarcinoma Whose Disease Has Not Progressed on Platinum-Based Chemotherapy
(ParpVax2)
What this study is about
The main goal of this study is to look at the effectiveness and anti-tumor activity (preventing growth of the tumor) of the drugs niraparib and ipilimumab, on the patients and their pancreatic cancer. This study will involve two different treatment treatment group$1. In treatment group$1 A, patients will receive niraparib plus ipilimumab.
View original scientific description
The main goal of this study is to look at the effectiveness and anti-tumor activity (preventing growth of the tumor) of the drugs niraparib and ipilimumab, on the patients and their pancreatic cancer. This study will involve two different treatment arms. In Arm A, patients will receive niraparib plus ipilimumab. In Arm B, patients will receive standard chemotherapy.
Interventions
DRUG
Niraparib
Niraparib 200mg PO daily on days 1-21 of each 21-day cycle.
DRUG
FOLFIRI
Standard chemotherapy FOLFIRI (5-fluorouracil, folinic acid, and irinotecan) will be administered intravenously every 14 days of a 28-day cycle.
DRUG
Ipilimumab
Ipilimumab 3mg/kg IV day 1 of each cycle, for the first 4 cycles only.
Primary outcome measures
Progression-free survival (PFS) in the experimental arm
Time frame: From Cycle 1 (each cycle in Arm A is 21 days) Day 1 to disease progression, loss to follow-up or death from any cause, whichever came first, assessed up to 42 months.
PFS is defined as the time from randomization to the occurrence of disease progression according to RECIST v1.1, as assessed by the investigator, or death from any cause. Median PFS and 95% confidence interval will be estimated from the Kaplan-Meier curve. In the primary outcome measure, PFS will be assessed in Arm A.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma with metastatic disease
- ≥18 years of age
- Patients must be able to understand the study procedures and agree to participate in the study by providing written informed consent
- Participants must have received 8-12 cycles (4-6 months) of first-line FOLFIRINOX or modified FOLFIRINOX for metastatic disease with stable disease or better. Patients treated with liposomal irinotecan with oxaliplatin, 5-fluorouracil and leucovorin (NALIRIFOX) are also eligible. Patients who were initially treated with FOLFIRINOX or NALIRIFOX but stopped oxaliplatin because of toxicity are eligible for the trial.
- Note: This requires at least stable imaging and a stable or decreasing tumor marker as applicable and as determined by the investigator.
- Measurable disease is not a requirement for study entry.
- Note: The study will require that at least 80% of enrolled patients (ie 55 of all patients)
Where
- Boston, Massachusetts
- Philadelphia, Pennsylvania
Collaborators
Lustgarten Foundation, GlaxoSmithKline, Bristol-Myers Squibb
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 16, 2025 · Source of record for eligibility and locations