RecruitingPhase 2NCT06747845

Maintenance Niraparib Plus Ipilimumab in Patients With Metastatic Pancreatic Adenocarcinoma Whose Disease Has Not Progressed on Platinum-Based Chemotherapy

ParpVax2: A Phase II Study Of Maintenance Niraparib Plus Ipilimumab In Patients With Metastatic Pancreatic Cancer Whose Disease Has Not Progressed On Platinum-Based Therapy


Sponsor

Abramson Cancer Center at Penn Medicine

Enrollment

68 participants

Start Date

May 7, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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. The main questions the study aims to answer are: * Does niraparib plus ipilimumab slow down tumor growth in patients with pancreatic cancer? * What medical problems do participants have when taking niraparib plus ipilimumab? Participants will: * Undergo screening procedures to evaluate their cancer, overall health, and suitability for the study * After passing screening, will be randomized to Arm A or B and be scheduled to receive niraparib plus ipilimumab (Arm A) or chemotherapy (Arm B) * Receive niraparib plus ipilimumab every 3 weeks (Arm A) * Receive chemotherapy every 2 weeks (Arm B) * Visit the clinic for regular checkups and tests


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — niraparib (a PARP inhibitor that targets DNA repair in cancer cells) and ipilimumab (an immunotherapy drug) — as a maintenance treatment for people with metastatic pancreatic cancer whose disease has stabilized or responded to initial platinum-based chemotherapy. **You may be eligible if...** - You are 18 or older - You have been diagnosed with metastatic pancreatic adenocarcinoma (pancreatic cancer that has spread) - You completed 8–12 cycles of first-line platinum-based chemotherapy (such as FOLFIRINOX or NALIRIFOX) with stable or improving disease - You stopped oxaliplatin due to side effects but completed the rest of chemotherapy **You may NOT be eligible if...** - Your cancer progressed during initial chemotherapy - You have not yet received first-line treatment - You have conditions that prevent safe use of these medications (e.g., severe autoimmune disease, poor organ function) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNiraparib

Niraparib 200mg PO daily on days 1-21 of each 21-day cycle.

DRUGFOLFIRI

Standard chemotherapy FOLFIRI (5-fluorouracil, folinic acid, and irinotecan) will be administered intravenously every 14 days of a 28-day cycle.

DRUGIpilimumab

Ipilimumab 3mg/kg IV day 1 of each cycle, for the first 4 cycles only.


Locations(2)

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

University of Pennsylvania, Abramson Cancer Center

Philadelphia, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

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NCT06747845


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