RECRUITING

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

Conditions

Metastatic Pancreatic Cancer PARP Gemcitabine Nab-paclitaxel Capecitabine Cisplatin Irinotecan Olaparib Pembrolizumab Immunotherapy PD-L1 (receptor blocking antibody)Anti-PD-L1 Monoclonal Antibodies

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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.

Quick Facts

Study Start:2021-09-29

Study Completion:2029-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04753879

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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.	* 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.

Inclusion Criteria

Exclusion Criteria

* 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.

* 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.

Contacts and Locations

Study Contact

Colleen Apostal, RN

CONTACT

410-614-3644

GIClinicaltrials@jhmi.edu

Joann Santmyer, RN

CONTACT

410-614-3644

jsantmy1@jhmi.edu

Principal Investigator

Dung Le, MD

PRINCIPAL_INVESTIGATOR

SKCCC Johns Hopkins Medical Institution

Study Locations (Sites)

Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21231

United States

Collaborators and Investigators

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-29

Study Completion Date2029-12-01

Study Record Updates

Study Start Date2021-09-29

Study Completion Date2029-12-01

Terms related to this study

Keywords Provided by Researchers

PARP
Gemcitabine
Nab-paclitaxel
Capecitabine
Cisplatin
Irinotecan
Olaparib
Pembrolizumab
Immunotherapy
PD-L1 (receptor blocking antibody)
Anti-PD-L1
Monoclonal Antibodies
Metastatic pancreatic cancer

Additional Relevant MeSH Terms

Metastatic Pancreatic Cancer