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

Launched by SIDNEY KIMMEL COMPREHENSIVE CANCER CENTER AT JOHNS HOPKINS · Jan 14, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for patients with surgically removable pancreatic cancer. The study aims to find the best and safest dose of a drug called AGEN2373 when combined with two other treatments: balstilimab and a pancreatic cancer vaccine (GVAX). Participants will be assigned to one of two groups: one will receive the GVAX vaccine and the other will receive a different vaccine called mKRASvax, both alongside the other medications. The researchers want to see how safe and effective these combinations are in helping treat the cancer.

To participate in this trial, you need to have a newly diagnosed pancreatic cancer that can be surgically removed. You must also be willing to have a tumor biopsy and be in good overall health, with a performance status that indicates you can carry out daily activities. Women who can become pregnant will need to take a pregnancy test and use birth control during the study. It’s important to know that if you've had other cancer treatments before or have certain health conditions, you might not be eligible to join. The study is not currently recruiting participants, but it could be a potential option for those who qualify in the future.

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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