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

NCT06747845 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2025-09-16

No results posted yet for this study

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

Conditions

  • Pancreatic Adenocarcinoma Metastatic

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-07
Primary Completion
2028-06-30
Completion
2029-01-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06747845 on ClinicalTrials.gov