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Metastatic Pancreatic CancerPhase 2NCT04753879

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

A Phase 2 study testing Nab-paclitaxel, Gemcitabine and Cisplatin in people with Metastatic Pancreatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Pancreatic Cancer
What is being tested?
Nab-paclitaxel, Gemcitabine and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited States
Study dates
29 Sep 2021to 1 Jul 2026
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • Willing to have to a tumor biopsy.
  • Patients must have adequate organ and marrow function defined by study - specified laboratory tests.
  • Women 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.

Who cannot join

  • 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.
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  • 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.
  • Women who are pregnant or breastfeeding.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21231

Other trials in United States

About this study

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

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.

Keywords
PARP, Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, Irinotecan, Olaparib, Pembrolizumab, Immunotherapy, PD-L1 (receptor blocking antibody), Anti-PD-L1, Monoclonal Antibodies, Metastatic pancreatic cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nab-paclitaxelDrug

    Also called Abraxane

    Nab-paclitaxel (80 mg/m^2) will be administered IV on Day 1 and Day 15 of each Cycle for up to 6 Cycles during the GAX-CI Chemotherapy Phase. Each Cycle is 28 days.

  • GemcitabineDrug

    Also called Gemzar

    Gemcitabine (500mg/m^2) will be administered IV on Day 1 and Day 15 of each Cycle for up to 6 Cycles during the GAX-CI Chemotherapy Phase. Each Cycle is 28 days

  • CisplatinDrug

    Cisplatin (20mg/m^2) will be administered IV on Day 1 and Day 15 of each Cycle for up to 6 Cycles during the GAX-CI Chemotherapy Phase. Each Cycle is 28 days

  • IrinotecanDrug

    Irinotecan (20 mg/m^2) will be administered IV on Day 1 and Day 15 of each Cycle for up to 6 Cycles during the GAX-CI Chemotherapy Phase. Each Cycle is 28 days

  • CapecitabineDrug

    Also called Xeloda

    Capecitabine (500 mg) will be administered orally twice a day on Days 1-7 and 15-21 of each Cycle for up to 6 Cycles during the GAX-CI Chemotherapy Phase. Each Cycle is 28 days

  • PembrolizumabDrug

    Also called MK-3475; Keytruda

    Pembrolizumab (400 mg) will be administered IV on day 1 every other Cycle (every 6 weeks) during the Maintenance Phase for up to 2 years. Each Cycle is 28 days.

  • OlaparibDrug

    Also called Lynparza

    Olaparib (300 mg) will be administered orally twice a day on Days 1- 21 of each Cycle during the Maintenance Phase for up to 2 years. Each Cycle is 28 days.

Study groups in NCT04753879
Study groupRoleWhat they receive
GAX-CI Chemotherapy with Pembrolizumab and OlaparibExperimentalThe treatment period will consist of a chemotherapy phase with GAX-CI (gemcitabine, nab-paclitaxel, capecitabine, cisplatin, and irinotecan) followed by a maintenance phase with pembrolizumab and olaparib. The chemotherapy phase will consist of 6 cycles of GAX-CI. Post-GAX-CI treatment, patients will receive pembrolizumab and olaparib. Maintenance phase treatment may continue up to a maximum of 2 years. Patients who had stable disease or better post-GAX-CI treatment and develop clinical or radiographic progressive disease following initiation of maintenance therapy, or those who become intolerant of treatment with either pembrolizumab or olaparib, may be retreated with GAX-CI if the PI deems that the patient will derive meaningful clinical benefit.
Receives: Drug: Nab-paclitaxel; Drug: Gemcitabine; Drug: Cisplatin; Drug: Irinotecan; Drug: Capecitabine; Drug: Pembrolizumab; Drug: Olaparib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS) Rate at 6 Months

    The 6-month PFS rate is defined as the Kaplan-Meier estimate of the proportion of patients without disease progression or death at 6 months from the date of first dose of maintenance therapy (pembrolizumab and olaparib) after disease stabilization (SD, PR, or CR per RECIST 1.1 criteria) with 6 cycles of GAX-CI. 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.

    Measured: 6 Months

Secondary outcomes (1)

  1. Number of Participants Experiencing Grade 3 or Above Drug-related Toxicities

    When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v5.0) will be counted only once for a given subject.

    Measured: Up to 34 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2021
  2. Study start29 Sep 2021
  3. Primary completion7 May 2026
  4. Study completion1 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04753879
Sponsor's protocol ID
J2112
Other IDs
IRB00267980
Status last verified
Oct 2026
First submitted
9 Feb 2021
Last updated
4 Nov 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nab-paclitaxel, Gemcitabine and Cisplatin in people with Metastatic Pancreatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) Rate at 6 Months (time frame: 6 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04753879.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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