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
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.
Prior treatment with a PARP inhibitor, ipilimumab, or other cytotoxic T-lymphocyte-associated-4 protein (CTLA-4) inhibitor.
Patients who have demonstrated resistance to FOLFIRINOX are not eligible to participate in this study
Patients with known pathogenic/likely pathogenic germline or somatic alteration(s) in BRCA1, BRCA2, PALB2, RAD51C, or RAD51D.
Patients with known mismatch repair deficiency or microsatellite instability-high cancer.
Parallel
Niraparib
DrugNiraparib 200mg PO daily on days 1-21 of each 21-day cycle.
FOLFIRI
DrugStandard chemotherapy FOLFIRI (5-fluorouracil, folinic acid, and irinotecan) will be administered intravenously every 14 days of a 28-day cycle.
Ipilimumab
DrugIpilimumab 3mg/kg IV day 1 of each cycle, for the first 4 cycles only.
Progression-free survival (PFS) in the experimental arm
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.
Overall response rate (ORR) in the experimental arm
The proportion of patients who achieve a complete or partial response, as determined by RECIST v1.1, in Arm A
Overall survival (OS) in the experimental arm
Time from randomization to death from any cause in Arm A
Disease Control in the experimental arm
Achieving stable disease (SD), partial response (PR), or complete response (CR) per RECIST v1.1, in Arm A
Safety and tolerability of Niraparib plus Ipilimumab in the experimental arm
The incidence of adverse events (AEs), clinical laboratory abnormalities and dose modifications, as determined by CTCAE v5.0, in Arm A
Click on the lead sponsor to view all of their trials.
Abramson Cancer Center at Penn Medicine
Lead sponsor
Lustgarten Foundation
Collaborator
GlaxoSmithKline
Collaborator
Bristol-Myers Squibb
Collaborator
