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Multi-agent Low Dose Chemotherapy GAX-CI Followed by Olaparib and Pembro in Metastatic Pancreatic Ductal Cancer.
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Summary
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.
Official title: Multi-agent Low Dose Chemotherapy (Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, Irinotecan) Followed by Maintenance Olaparib and Pembrolizumab in Untreated Metastatic Pancreatic Ductal Adenocarcinoma.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
38
Start Date
2021-09-29
Completion Date
2029-12-01
Last Updated
2025-12-04
Healthy Volunteers
No
Conditions
Interventions
Nab-paclitaxel
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
Gemcitabine
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
Cisplatin
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
Irinotecan
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
Capecitabine
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
Pembrolizumab
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
Olaparib
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
Locations (1)
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States