Actively Recruiting
Multi-agent Low Dose Chemotherapy GAX-CI Followed by Olaparib and Pembro in Metastatic Pancreatic Ductal Cancer.
Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2025-12-04
38
Participants Needed
1
Research Sites
426 weeks
Total Duration
On this page
Sponsors
S
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Multi-agent Low Dose Chemotherapy GAX-CI Followed by Olaparib and Pembro in Metastatic Pancreatic Ductal Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject has stable disease as measured by RECIST 1.1 or iRECIST after 6 cycles of GAX-CI (Cohort 1) or progressive disease prior to 6 cycles (Cohort 2).
- Ability to understand and willingness to sign informed consent.
- Age 18 years or older.
- ECOG performance status of 0 or 1.
- Metastatic histologically or cytologically-proven ductal pancreatic cancer.
- No prior treatment for pancreatic cancer.
- Measurable disease based on RECIST 1.1.
- Willingness to have a tumor biopsy.
- Adequate organ and marrow function per laboratory tests.
- Negative pregnancy test and adherence to contraceptive guidelines for women of childbearing potential.
- Use of acceptable birth control for men during the study.
- Understanding of the study regimen, risks, and ability to report adverse events.
You will not qualify if you...
- Candidates for surgery.
- Chemotherapy within 5 years prior to study treatment.
- Use of investigational drugs within 28 days prior to study treatment.
- Surgery within 28 days of investigational agent dosing.
- History of CNS metastases or carcinomatous meningitis.
- Requirement for any antineoplastic therapy.
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2 agents.
- Prior therapy with gemcitabine, nab-paclitaxel, capecitabine, cisplatin, irinotecan, or PARP inhibitors.
- Hypersensitivity to monoclonal antibodies.
- Taking moderate or strong CYP3A inhibitors.
- Uncontrolled acute or chronic illness.
- Additional progressing malignancy requiring treatment.
- Prior radiotherapy for pancreatic cancer.
- Live vaccine, allergen therapy, growth factors, or major surgery within 30 days prior to study.
- Participation in investigational studies or devices within 4 weeks prior to first dose.
- Active or suspected autoimmune disease or recent systemic steroid use.
- Prior tissue/organ allograft or bone marrow transplantation.
- Conditions or therapies interfering with study participation.
- Requirement for daily supplemental oxygen.
- History of pneumonitis/interstitial lung disease requiring steroids.
- Clinically significant wound.
- History of encephalitis, meningitis, or uncontrolled seizures within 1 year.
- HIV infection.
- Active Hepatitis B or C infection (except antibody positive and viral load negative).
- Uncontrolled infection.
- Unwillingness to have blood drawn.
- Psychiatric or substance use disorder interfering with study cooperation.
- Pregnancy or breastfeeding.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21231
Actively Recruiting
Research Team
C
Colleen Apostal, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here