NCT06782932
Comparing Neoadjuvant/Adjuvant GVAX vs a mKRASvax Given With Anti-PD-1 and Anti-CD137 for Surgically Resectable Pancreatic Cancer
Recruiting · Phase 1, Phase 2 · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · registry updated 2025-12-03
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- 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.
Exclusion
- 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.