NCT06782932 Comparing Neoadjuvant/Adjuvant GVAX vs a mKRASvax Given With Anti-PD-1 and Anti-CD137 for Surgically Resectable Pancreatic Cancer
| NCT ID | NCT06782932 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| Condition | Pancreatic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 38 participants |
| Start Date | 2025-05-27 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 38 participants in total. It began in 2025-05-27 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion 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. Exclusion Criteria: * 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
Contact & Investigator
Eric Christenson, MD
PRINCIPAL INVESTIGATOR
SKCCC • Johns Hopkins Medical Institution
Frequently Asked Questions
Who can join the NCT06782932 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06782932 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06782932 currently recruiting?
Yes, NCT06782932 is actively recruiting participants. Contact the research team at GIClinicalTrials@jhmi.edu for enrollment information.
Where is the NCT06782932 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT06782932 clinical trial?
NCT06782932 is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The principal investigator is Eric Christenson, MD at SKCCC • Johns Hopkins Medical Institution. The trial plans to enroll 38 participants.
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