The purpose of this study is to evaluate the safety and clinical activity of maintenance olaparib and pembrolizumab following multi-agent, low dose chemotherapy with gemcitabine, nab-paclitaxel, capecitabine, cisplatin, and irinotecan (GAX-CI) in patients with untreated metastatic pancreatic ductal cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
1. Patients will receive treatment Day 1 and Day 15 of each cycle (28 days). 2. Nab-paclitaxel (80 mg/m2) will be administered IV on Day 1 and Day 15 (28 day cycle). 3. Other Name: Abraxane
1. Patients will receive treatment Day 1 and Day 15 of each cycle (28 days). 2. Gemcitabine (500mg/m2) will be administered IV on Day 1 and Day 15 (28 day cycle). 3. Other Name: Gemzar
1. Patients will receive treatment Day 1 and Day 15 of each cycle (28 days). 2. Cisplatin (20mg/m2) will be administered IV on Day 1 and Day 15 (28 day cycle). 3. Other Name: N/A
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
RECRUITINGProgression-free Survival (PFS) after 6 months according to RECIST 1.1 criteria.
PFS is defined as the 6 month from the date of randomization to disease progression (progressive disease \[PD\] or relapse from complete response \[CR\] as assessed using RECIST 1.1 criteria) or death due to any cause. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =\>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is \>20% increase in sum of diameters of target lesions, Stable Disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions.
Time frame: 6 Months
Progression-free Survival (PFS) after 6 months according to IRECIST criteria.
PFS is defined as the 6 month from the date of randomization to disease progression (progressive disease \[PD\] or relapse from complete response \[CR\] as assessed using iRECIST criteria) or death due to any cause. Per iRECIST criteria, CR = disappearance of all target lesions, Partial Response (PR) is =\>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is \>20% increase in sum of diameters of target lesions, Stable Disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions.
Time frame: 6 months
Number of participants experiencing grade 3 or above drug-related toxicities
• When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v5.0) will be counted only once for a given subject. Estimation based on the Kaplan-Meier curve.
Time frame: 4 years
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1. Patients will receive treatment Day 1 and Day 15 of each cycle (28 days). 2. Irinotecan (20 mg/m2) will be administered IV on Day 1 and Day 15 (28 day cycle). 3. Other Name: N/A
1. Patients will receive treatment Day 1-7 and Day 15-21 of each cycle (28 days). 2. Capecitabine (500 mg) will be administered orally twice a day on days 1-7 and 15-21 of each cycle (28 days). 3. Other Name: Xeloda
1. Patients will receive treatment Day 1 every other cycle (every 6 weeks) (28 days) during maintenance phase. 2. Pembrolizumab (400 mg) will be administered IV on day 1 every other cycle (every 6 weeks). 3. Other Name: MK-3475; Keytruda
1. Patients will receive treatment on Days 1-21 during the maintenance phase. 2. Olaparib (300 mg) will be administered orally twice a day on Days 1- 21 of each cycle (28 days). 3. Other Name: Lynparza