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Study of Chemotherapy Followed by Olaparib and Pembrolizumab for Metastatic Pancreatic Cancer

This study is looking at a new treatment approach for people with metastatic pancreatic cancer (cancer that has spread to other parts of the body) who have not yet received treatment. It combines a multi-drug, low-dose chemotherapy regimen called GAX-CI (using nab-paclitaxel, gemcitabine, capecitabine, cisplatin, and irinotecan) with two other drugs, olaparib and pembrolizumab. Researchers want to see how safe and effective this combination is. You might be eligible if you are 18 or older and have either stable disease or progressive disease after initial GAX-CI treatment. The main goal is to see how long people live without their cancer getting worse after 6 months. This study plans to enroll 38 participants, but its current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 38 participants. It is evaluating a specific treatment sequence for metastatic pancreatic cancer.
What's involved
You would receive nab-paclitaxel, gemcitabine, cisplatin, and irinotecan intravenously (into a vein) on Day 1 and Day 15 of each 28-day cycle. Capecitabine would be taken orally (by mouth) twice a day on days 1-7 and 15-21 of each 28-day cycle.
Compensation
Not stated in the trial record.
Follow-up
The study measures how long you live without your cancer getting worse after 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04753879

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

Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatment
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
~38 participants
Updated 2026-06-03 on ClinicalTrials.gov
What's tested:Nab-paclitaxelGemcitabineCisplatinIrinotecanCapecitabinePembrolizumab

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free Survival (PFS) after 6 months according to RECIST 1.1 criteria.
Measured over 6 Months
+1 more outcome measured

Conditions

Metastatic Pancreatic Cancer

Explore related trials

Pancreatic Carcinoma

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Dung Le, MD · PRINCIPAL_INVESTIGATOR · SKCCC Johns Hopkins Medical Institution

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Cohort 1 - Subject has stable disease as measured by RECIST 1.1 or iRECIST after 6 cycles of GAX-CI.
Cohort 2 - Subject has progressive disease as measured by RECIST 1.1 and iRECIST prior to 6 cycles of GAX-CI.
Ability to understand and willingness to sign a written informed consent document.
Age ≥18 years.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Have metastatic histologically or cytologically-proven ductal pancreatic cancer.
Patients must not have received prior treatment for pancreatic cancer.
Have measurable disease based on RECIST 1.1.
Willing to have to a tumor biopsy.
Patients must have adequate organ and marrow function defined by study - specified laboratory tests.
Woman of childbearing potential must have a negative pregnancy test and follow contraceptive guidelines as defined per protocol.
Men must use acceptable form of birth control while on study.
Participant understands the study regimen, its requirements, risks and discomforts, competent to report AE, understand the drug dosing schedule and use of medications to control AE.

Exclusion

Patients who will be considered for surgery are ineligible.
Had chemotherapy within 5 years prior to study treatment.
Have received any investigational drugs within 28 days prior to study treatment.
Had surgery within 28 days of dosing of investigational agent.
Has history of central nervous system (CNS) metastases and/or carcinomatous meningitis.
Require any antineoplastic therapy.
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent.
Has received prior therapy with gemcitabine, nab-paclitaxel, capecitabine, cisplatin, irinotecan, or PARP inhibitor.
Hypersensitivity reaction to any monoclonal antibody.
Is taking a moderate or strong CYP3A inhibitor.
Has uncontrolled acute or chronic medical illness.
Has known additional malignancy that is progressing and requires active treatment.
Has received radiotherapy for pancreatic cancer.
Have received any live vaccine or live-attenuated, any allergen hyposensitization therapy, growth factors or major surgery within 30 days prior to study treatment.
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
Has active autoimmune disease.
Has an active known or suspected autoimmune disease or is receiving chronic systemic steroid therapy within 7 days prior to the first dose of study drug.
Prior tissue or organ allograft or allogeneic bone marrow transplantation.
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Requirement for daily supplemental oxygen.
Patients with a history of (non-infectious) pneumonitis/interstitial lung disease that requires steroids.
Subject with clinically significant wound.
Has a confirmed history of encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent.
Infection with HIV.
Has active Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or Hepatitis C virus (defined as hepatitis C virus (HCV) RNA \[qualitative\] is detected) infection. Patients who are Hepatitis C antibody positive and viral load negative will be permitted to enroll.
Has uncontrolled infection.
Unwilling to have blood drawn.
Has known psychiatric or substance use disorder that would interfere with cooperation with the requirements of the trial.
Woman who are pregnant or breastfeeding.

What this trial measures

  • Progression-free Survival (PFS) after 6 months according to RECIST 1.1 criteria.6 Months

    PFS is defined as the 6 month from the date of randomization to disease progression (progressive disease \[PD\] or relapse from complete response \[CR\] as assessed using RECIST 1.1 criteria) or death due to any cause. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =\>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is \>20% increase in sum of diameters of target lesions, Stable Disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions.

  • Progression-free Survival (PFS) after 6 months according to IRECIST criteria.6 months

    PFS is defined as the 6 month from the date of randomization to disease progression (progressive disease \[PD\] or relapse from complete response \[CR\] as assessed using iRECIST criteria) or death due to any cause. Per iRECIST criteria, CR = disappearance of all target lesions, Partial Response (PR) is =\>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is \>20% increase in sum of diameters of target lesions, Stable Disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions.