NCT04753879

Multi-agent Low Dose Chemotherapy GAX-CI Followed by Olaparib and Pembro in Metastatic Pancreatic Ductal Cancer.

Multi-agent Low Dose Chemotherapy (Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, Irinotecan) Followed by Maintenance Olaparib and Pembrolizumab in Untreated Metastatic Pancreatic Ductal Adenocarcinoma.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	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
DRUG	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
DRUG	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
DRUG	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
DRUG	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
DRUG	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
DRUG	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

Timeline

• Start date: 2021-09-29
• Primary completion: 2026-12-01
• Completion: 2029-12-01
• First posted: 2021-02-15
• Last updated: 2025-12-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study