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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
68
Niraparib 200mg PO daily on days 1-21 of each 21-day cycle.
Standard chemotherapy FOLFIRI (5-fluorouracil, folinic acid, and irinotecan) will be administered intravenously every 14 days of a 28-day cycle.
Ipilimumab 3mg/kg IV day 1 of each cycle, for the first 4 cycles only.
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
NOT_YET_RECRUITINGUniversity of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, United States
RECRUITINGProgression-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.
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.
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
Time frame: From first restaging assessment through completion of study treatment (maximum 42 months)
Overall survival (OS) in the experimental arm
Time from randomization to death from any cause in Arm A
Time frame: From Cycle 1 (each cycle in Arm A is 21 days) Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first
Disease Control in the experimental arm
Achieving stable disease (SD), partial response (PR), or complete response (CR) per RECIST v1.1, in Arm A
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..
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
Time frame: From Cycle 1 (each cycle in Arm A is 21 days) Day 1 through 90 days after patient End of Treatment Visit
PFS in the control 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 secondary outcome measure, PFS will be assessed in Arm B.
Time frame: From Cycle 1 (each cycle in Arm B is 28 days) Day 1 to disease progression, loss to follow-up or death from any cause, whichever came first, assessed up to 42 months.
OS in the control arm
Time from randomization until death from any cause or last follow-up in Arm B
Time frame: From Cycle 1 (each cycle in Arm B is 28 days) Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first
Overall response in evaluable patients within the control arm
The proportion of patients who achieve a complete or partial response, as determined by RECIST v1.1, in Arm B
Time frame: From first restaging assessment through completion of study treatment (maximum 42 months)
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