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

Last updated: August 22, 2024
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Overall Status: Active - Recruiting

Phase

2

Condition

Digestive System Neoplasms

Metastatic Cancer

Treatment

Nab-paclitaxel

Gemcitabine

Cisplatin

Clinical Study ID

NCT04753879
J2112
IRB00267980
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Cohort 1 - Subject has stable disease as measured by RECIST 1.1 or iRECIST after 6cycles of GAX-CI.

  • Cohort 2 - Subject has progressive disease as measured by RECIST 1.1 and iRECISTprior 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 - specifiedlaboratory tests.

  • Woman of childbearing potential must have a negative pregnancy test and followcontraceptive 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 medicationsto control AE.

Exclusion

Exclusion Criteria:

  • 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 carcinomatousmeningitis.

  • 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 hyposensitizationtherapy, growth factors or major surgery within 30 days prior to study treatment.

  • Is currently participating in or has participated in a study of an investigationalagent or has used an investigational device within 4 weeks prior to the first doseof study treatment.

  • Has active autoimmune disease.

  • Has an active known or suspected autoimmune disease or is receiving chronic systemicsteroid 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 laboratoryabnormality that might confound the results of the study, interfere with thesubject's participation for the full duration of the study, or is not in the bestinterest 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 diseasethat requires steroids.

  • Subject with clinically significant wound.

  • Has a confirmed history of encephalitis, meningitis, or uncontrolled seizures in theyear prior to informed consent.

  • Infection with HIV.

  • Has active Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) orHepatitis C virus (defined as hepatitis C virus (HCV) RNA [qualitative] is detected)infection. Patients who are Hepatitis C antibody positive and viral load negativewill be permitted to enroll.

  • Has uncontrolled infection.

  • Unwilling to have blood drawn.

  • Has known psychiatric or substance use disorder that would interfere withcooperation with the requirements of the trial.

  • Woman who are pregnant or breastfeeding.

Study Design

Total Participants: 38
Treatment Group(s): 7
Primary Treatment: Nab-paclitaxel
Phase: 2
Study Start date:
September 29, 2021
Estimated Completion Date:
December 01, 2029

Connect with a study center

  • Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland 21231
    United States

    Active - Recruiting

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