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

Johns Hopkins Medicine

Status and phase: Begins enrollment this month; Phase 2; Phase 1

Conditions: Pancreatic Cancer

Treatments: Drug: Balstilimab; Drug: mKRASvax; Drug: Cyclophosphamide; Drug: AGEN2373; Drug: GVAX; Drug: AGEN2373 (RP2D)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06782932

IRB00465956 (Other Identifier)

J24146

Details and patient eligibility

About

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.

Enrollment: 38 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Arm 1 - AGEN2373/Balstilimab/Cyclophosphamide/GVAX

Experimental group

Treatment:

Drug: GVAX

Drug: Cyclophosphamide

Drug: Balstilimab

Drug: AGEN2373

Drug: Balstilimab

Arm 2 - AGEN2373/Balstilimab/mKRASvax (1.8mg total peptides +0.5mg each poly-ICLC)

Experimental group

Treatment:

Drug: AGEN2373 (RP2D)

Drug: Balstilimab

Drug: mKRASvax

Drug: Balstilimab