RECRUITING

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

Study Overview

Study Details

Study overview

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.

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

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

Condition
Pancreatic Cancer
Intervention / Treatment

-

Contacts and Locations

Baltimore

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Have a newly diagnosed, biopsy-proven adenocarcinoma of the pancreas.
  • * Tumor must be deemed resectable by the study team
  • * Patient's acceptance to have a tumor biopsy.
  • * Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.
  • * Patients must have adequate organ and marrow function defined by study-specified laboratory tests and procedures.
  • * Women of childbearing potential (WOCBP) must have a negative serum pregnancy test.
  • * For both Women and Men, must use acceptable form of birth control while on study.
  • * Received any anti-pancreatic cancer therapy (symptomatic therapies are allowed), or any prior anti-cancer immunotherapy.
  • * Diagnosed with another cancer whose natural history or treatment could interfere with safety or efficacy assessments on this study.
  • * 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.
  • * Active autoimmune disease.
  • * Systemic steroid therapy (\> 10mg daily prednisone equivalent) or immunosuppressive therapy within 14 days of first dose of study drug administration.
  • * Active infection requiring systemic therapy.
  • * Known history of human immunodeficiency virus (HIV).
  • * Active or chronic hepatitis B or hepatitis C.
  • * Known active tuberculosis.
  • * 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.
  • * Prior allogeneic stem cell transplantation or organ transplantation.
  • * Any major surgical procedure requiring general anesthesia ≤ 28 days before first dose of study drug.
  • * Received a live vaccine ≤ 28 days before first dose of study drug.
  • * History of severe hypersensitivity reaction to any monoclonal antibody
  • * Concurrent participation in another therapeutic clinical study
  • * Pregnant or breastfeeding

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,

Eric Christenson, MD, PRINCIPAL_INVESTIGATOR, SKCCC • Johns Hopkins Medical Institution

Study Record Dates

2028-12