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

PHASE2RecruitingINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

September 29, 2021

Primary Completion Date

December 1, 2025

Study Completion Date

December 1, 2029

Conditions
Metastatic Pancreatic Cancer
Interventions
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"

Trial Locations (1)

21231

RECRUITING

Sidney Kimmel Comprehensive Cancer Center, Baltimore

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER