RECRUITING

Comparing Neoadjuvant/Adjuvant GVAX vs a mKRASvax Given With Anti-PD-1 and Anti-CD137 for Surgically Resectable Pancreatic Cancer

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Conditions

Pancreatic CancerBalstilimabAGEN2373KRAS peptide vaccinepeptide vaccinePoly-ICLCGVAXCyclophosphamideImmunotherapyAnti-PD-1 (anti-check point inhibitor)PD-L1 (check point inhibitor)Anti-CD137Cancer vaccinePancreatic Ductal Adenocarcinoma (PDAC)AdenocarcinomaCarcinomaPancreasmKRASvax

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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 determine the optimal dose of AGEN2373 that is safe when given in combination with balstilimab and Pancreatic GVAX Whole Cell Vaccine and evaluate the safety and clinical activity of balstilimab and AGEN2373 in combination with GVAX (Arm 1) or mKRASvax (Arm 2) in surgically resectable pancreatic adenocarcinoma.

Official Title

A Pilot Study Comparing Neoadjuvant and Adjuvant GVAX vs a Mutated KRAS Peptide Vaccine Given With Anti-PD-1 and Anti-CD137 for the Treatment of Surgically Resectable Pancreatic Adenocarcinoma

Quick Facts

Study Start:2025-05-27
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06782932

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 CriteriaExclusion Criteria
  1. * Have a newly diagnosed, biopsy-proven adenocarcinoma of the pancreas.
  2. * Tumor must be deemed resectable by the study team
  3. * Patient's acceptance to have a tumor biopsy.
  4. * Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.
  5. * Patients must have adequate organ and marrow function defined by study-specified laboratory tests and procedures.
  6. * Women of childbearing potential (WOCBP) must have a negative serum pregnancy test.
  7. * For both Women and Men, must use acceptable form of birth control while on study.
  1. * Received any anti-pancreatic cancer therapy (symptomatic therapies are allowed), or any prior anti-cancer immunotherapy.
  2. * Diagnosed with another cancer whose natural history or treatment could interfere with safety or efficacy assessments on this study.
  3. * Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness/social situations that would limit compliance with study requirements.
  4. * Active autoimmune disease.
  5. * Systemic steroid therapy (\> 10mg daily prednisone equivalent) or immunosuppressive therapy within 14 days of first dose of study drug administration.
  6. * Active infection requiring systemic therapy.
  7. * Known history of human immunodeficiency virus (HIV).
  8. * Active or chronic hepatitis B or hepatitis C.
  9. * Known active tuberculosis.
  10. * History of interstitial lung disease, non-infectious pneumonitis or uncontrolled lung diseases including pulmonary fibrosis, acute lung diseases, chronic obstructive pulmonary disease (COPD), asthma requiring medication, etc.
  11. * Prior allogeneic stem cell transplantation or organ transplantation.
  12. * Any major surgical procedure requiring general anesthesia ≤ 28 days before first dose of study drug.
  13. * Received a live vaccine ≤ 28 days before first dose of study drug.
  14. * History of severe hypersensitivity reaction to any monoclonal antibody
  15. * Concurrent participation in another therapeutic clinical study
  16. * Pregnant or breastfeeding

Contacts and Locations

Study Contact

Colleen Apostol, RN
CONTACT
410-614-3644
GIClinicalTrials@jhmi.edu
Joann Santmeyer, RN
CONTACT
410-614-3644
GIClinicalTrials@jhmi.edu

Principal Investigator

Eric Christenson, MD
PRINCIPAL_INVESTIGATOR
SKCCC • Johns Hopkins Medical Institution

Study Locations (Sites)

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21287
United States

Collaborators and Investigators

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  • Eric Christenson, 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 Date2025-05-27
Study Completion Date2028-12

Study Record Updates

Study Start Date2025-05-27
Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

  • Balstilimab
  • AGEN2373
  • KRAS peptide vaccine
  • peptide vaccine
  • Poly-ICLC
  • GVAX
  • Cyclophosphamide
  • Immunotherapy
  • Anti-PD-1 (anti-check point inhibitor)
  • PD-L1 (check point inhibitor)
  • Anti-CD137
  • Cancer vaccine
  • Pancreatic Cancer
  • Pancreatic Ductal Adenocarcinoma (PDAC)
  • Adenocarcinoma
  • Carcinoma
  • Pancreas
  • mKRASvax

Additional Relevant MeSH Terms

  • Pancreatic Cancer