GVAX vs mKRASvax for Pancreatic Cancer

Recruiting in Palo Alto (17 mi)

Overseen byEric Christenson, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eric Christenson, MD

Principal Investigator

SKCCC • Johns Hopkins Medical Institution

Eligibility Criteria

This trial is for individuals with surgically removable pancreatic cancer. Participants must meet certain health standards, but specific inclusion criteria are not listed here. People with conditions that could interfere with the study or pose a risk to their safety based on the treatments being tested may be excluded.

Inclusion Criteria

I am fully active or can carry out light work.

My organ and bone marrow functions meet the required levels.

Women of childbearing potential (WOCBP) must have a negative serum pregnancy test

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Exclusion Criteria

I have not received a live vaccine in the last 28 days.

History of severe hypersensitivity reaction to any monoclononal antibody

I have active tuberculosis.

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Treatment Details

Interventions

AGEN2373 (Virus Therapy)
Balstilimab (Monoclonal Antibodies)
GVAX (Cancer Vaccine)
mKRASvax (Cancer Vaccine)

Trial OverviewThe study aims to find a safe dose of AGEN2373 and assess its effectiveness alongside balstilimab and either GVAX (Arm 1) or mKRASvax (Arm 2). These combinations are being tested as pre/post-surgery treatments for pancreatic cancer.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Arm 2 - AGEN2373/Balstilimab/mKRASvax (1.8mg total peptides +0.5mg each poly-ICLC)Experimental Treatment3 Interventions

Group II: Arm 1 - AGEN2373/Balstilimab/Cyclophosphamide/GVAXExperimental Treatment4 Interventions