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.
Abramson Cancer Center at Penn Medicine
Lead sponsor
Lustgarten Foundation
Collaborator
GlaxoSmithKline
Collaborator
Bristol-Myers Squibb
Collaborator