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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Abramson Cancer Center at Penn Medicine
Study ID
NCT06747845
Phase
PHASE2
Status
Recruiting
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Conditions

  • Pancreatic Adenocarcinoma Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Niraparib — DRUG
    Niraparib 200mg PO daily on days 1-21 of each 21-day cycle.
  • FOLFIRI — DRUG
    Standard chemotherapy FOLFIRI (5-fluorouracil, folinic acid, and irinotecan) will be administered intravenously every 14 days of a 28-day cycle.
  • Ipilimumab — DRUG
    Ipilimumab 3mg/kg IV day 1 of each cycle, for the first 4 cycles only.

Study Details

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

Key Dates

Start date
May 7, 2025
Status verified
Sep 2025
Primary completion
Jun 30, 2028
Completion
Jan 30, 2029

Study Design

Enrollment
68 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Niraparib + Ipilimumab (Arm A)
    niraparib + ipilimumab
  • Other: FOLFIRI (Arm B)
    standard chemotherapy FOLFIRI

Primary Outcome Measure

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. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215
Kaitlyn Ramsey, MSCR
[email protected]
857-215-2352
Lauren Brais, MPH
[email protected]
(617) 632-6758
Brandon Huffman, MD (PRINCIPAL_INVESTIGATOR)
Brian Wolpin, MD, MPH (SUB_INVESTIGATOR)
University of Pennsylvania, Abramson Cancer CenterPhiladelphiaPennsylvania19104
Camilo Henao, MPH
[email protected]
215-220-9671
Asal Kareem
[email protected]
267-879-6644
Kim Reiss Binder, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Dana-Farber Cancer Institute· Boston, MAUniversity of Pennsylvania, Abramson Cancer Center· Philadelphia, PA

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