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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT04753879
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Metastatic Pancreatic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nab-paclitaxel — DRUG
    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 — DRUG
    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 — DRUG
    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 — DRUG
    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 — DRUG
    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 — DRUG
    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 — DRUG
    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

Study Details

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.

Key Dates

Start date
Sep 29, 2021
Status verified
Jun 2026
Primary completion
Jul 1, 2026
Completion
Jul 1, 2026

Study Design

Enrollment
38 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nab-paclitaxel, Gemcitabine , Cisplatin, Irinotecan, Capecitabine
    Maintenance of Pembrolizumab and Olaparib

Primary Outcome Measure

Progression-free Survival (PFS) after 6 months according to RECIST 1.1 criteria. [ Time Frame: 6 Months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21231-

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By research site
Sidney Kimmel Comprehensive Cancer Center· Baltimore, MD

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