GVAX versus a mutated-KRAS peptide vaccine plus immune antibodies before and after surgery for resectable pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.