Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06747845

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

Led by Abramson Cancer Center at Penn Medicine · Updated on 2025-09-16

68

Participants Needed

2

Research Sites

194 weeks

Total Duration

On this page

Sponsors

A

Abramson Cancer Center at Penn Medicine

Lead Sponsor

L

Lustgarten Foundation

Collaborating Sponsor

AI-Summary

What this Trial 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 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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of pancreatic adenocarcinoma with metastatic disease confirmed by tissue analysis
  • At least 18 years old
  • Able to understand study procedures and provide written informed consent
  • Received 8 to 12 cycles (4 to 6 months) of first-line FOLFIRINOX or modified FOLFIRINOX chemotherapy with stable disease or better
  • Patients treated with NALIRIFOX or who stopped oxaliplatin due to toxicity are eligible
  • Measurable disease not required for entry; at least 80% of patients must be biopsiable at enrollment
  • Willing to undergo pre-treatment and on-treatment tumor biopsies if medically feasible
  • Female participants of childbearing potential must have a negative pregnancy test within 24 hours before treatment and agree to avoid pregnancy from screening through 6 months after last dose
  • Male participants must agree to use contraception from first dose through 90 days after last dose
  • Adequate organ function based on lab tests within 7 days before starting study therapy
  • ECOG performance status of 0 to 1
Not Eligible

You will not qualify if you...

  • Prior treatment with PARP inhibitors, ipilimumab, or other CTLA-4 inhibitors
  • Resistance to FOLFIRINOX chemotherapy
  • Known pathogenic mutations in BRCA1, BRCA2, PALB2, RAD51C, or RAD51D
  • Known mismatch repair deficiency or microsatellite instability-high cancer
  • Uncontrolled malabsorption or gastrointestinal disorder affecting drug absorption
  • Uncontrolled hypertension (systolic >140 mmHg or diastolic >90 mmHg)
  • History of posterior reversible encephalopathy syndrome (PRES)
  • Acute infection requiring IV antibiotics, antivirals, or antifungals within 14 days before treatment
  • History or active autoimmune diseases except specified exceptions
  • History of interstitial lung disease or active non-infectious pneumonitis
  • Receipt of live vaccines within 4 weeks before treatment
  • Refusal to use effective contraception during the trial period
  • Systemic treatment for pancreatic cancer within 14 days before treatment
  • Use of systemic corticosteroids (>10 mg prednisone equivalent) or immunosuppressives within 14 days before treatment
  • Grade 3 or 4 anemia, neutropenia, or thrombocytopenia persisting over 4 weeks from prior chemotherapy
  • Recent surgery not fully recovered (minor <5 days, major <21 days before treatment)
  • Active drug or alcohol use interfering with compliance
  • Any condition increasing risk or interfering with study participation
  • History of myelodysplastic syndrome or acute myeloid leukemia
  • Enrollment in another therapeutic clinical trial
  • Radiotherapy within 4 weeks before treatment
  • Known hypersensitivity to niraparib or its components
  • Blood transfusion within 4 weeks before treatment
  • Treatment for a second active cancer, with some exceptions
  • Active hepatitis B or C infection
  • HIV infection with detectable viral load or unstable treatment
  • Known symptomatic brain or leptomeningeal metastases

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Not Yet Recruiting

2

University of Pennsylvania, Abramson Cancer Center

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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Research Team

K

Kim Reiss Binder, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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