GVAX versus a mutated-KRAS peptide vaccine plus immune antibodies before and after surgery for resectable pancreatic cancer
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
This trial tests whether giving AGEN2373 and the immune antibody balstilimab together with either GVAX or a mutated-KRAS peptide vaccine is safe and helpful for people with newly diagnosed, surgically resectable pancreatic cancer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Academic / other |
| Drugs / interventions | immunotherapy, prednisone, balstilimab |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT06782932 on ClinicalTrials.gov |
What this trial studies
This Phase 1/2 study enrolls patients with newly diagnosed, biopsy-proven resectable pancreatic adenocarcinoma to find a safe dose of AGEN2373 when combined with balstilimab and to compare two vaccine strategies given around surgery. It starts with a dose-escalation to identify the recommended Phase 2 dose of AGEN2373 plus balstilimab (with low-dose cyclophosphamide support) and then treats patients with either GVAX (arm 1) or a mutated-KRAS peptide vaccine (mKRASvax, arm 2) in the neoadjuvant and adjuvant settings. Patients must agree to tumor biopsies and undergo careful safety monitoring; endpoints include safety, immune responses, and clinical activity related to surgery. The trial is run at Johns Hopkins and combines standard surgical care with investigational immunotherapy regimens.
Who should consider this trial
Good fit: Adults with newly diagnosed, biopsy-proven, surgically resectable pancreatic adenocarcinoma who are ECOG 0–1, have adequate organ function, can undergo tumor biopsy, and agree to contraception if applicable.
Not a fit: Patients who have received prior anti-cancer therapy or prior immunotherapy, those with unresectable or metastatic disease, or those with poor performance status or significant uncontrolled medical problems are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could boost anti-tumor immunity around the time of surgery and potentially reduce recurrence risk and improve outcomes after resection.
How similar studies have performed: Prior attempts to combine cancer vaccines and checkpoint antibodies in pancreatic cancer have had limited clinical success, although early-phase KRAS-targeted vaccines and GVAX approaches have produced immune responses in small studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Baltimore, Maryland
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Eric Christenson, MD — SKCCC • Johns Hopkins Medical Institution
- Study coordinator: Colleen Apostol, RN
- Email: GIClinicalTrials@jhmi.edu
- Phone: 410-614-3644
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.