Back to search results

Comparing GVAX vs mKRASvax with AGEN2373 and Balstilimab for Pancreatic Cancer

This study is testing different combinations of treatments for pancreatic cancer that can be surgically removed. Researchers want to find the safest and most effective dose of a drug called AGEN2373 when it's given with balstilimab and either GVAX or mKRASvax. These treatments are a type of immunotherapy, which helps your body's immune system fight cancer. The study will look at how safe these combinations are and how well they work. To join, you must have newly diagnosed pancreatic cancer that can be removed by surgery and be at least 18 years old. The study aims to enroll 38 participants, but its current status is unclear.

Study design
This interventional study plans to enroll 38 participants. It will test different doses of AGEN2373 in combination with other drugs.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will monitor for drug-related toxicities for up to 2 years and look for specific immune structures for 2 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06782932

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
~38 participants
Updated 2025-12-03 on ClinicalTrials.gov
What's tested:AGEN2373BalstilimabCyclophosphamideGVAXAGEN2373 (RP2D)mKRASvax

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose Limiting Toxicities in Phase I participants
Measured over 1 month
+2 more outcomes measured

Conditions

Pancreatic Cancer

Explore related trials

Pancreatic Carcinoma

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Eric Christenson, MD · PRINCIPAL_INVESTIGATOR · SKCCC • Johns Hopkins Medical Institution

Who to contact

Colleen Apostol, RN
[email protected]
410-614-3644
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Dose Limiting Toxicities in Phase I participants1 month

    Phase I participants will be evaluated for dose limiting toxicities (DLTs) during the first 14 day cycle and 14 days post-operatively for the purpose of determining the recommended phase II dose of AGEN2373 when given concurrently with balstilimab and cancer vaccination.

  • Number of participants experiencing Grade 3 or Higher study drug-related toxicities2 years

    Number of participants experiencing study drug-related adverse events Grade 3 or higher as defined by CTCAE v5.0

  • Number of participants who form Intratumoral tertiary lymphoid structures (TLS)2 weeks

    Number of participants who form at least one tertiary lymphoid structure (TLS) following one cycle of study drugs. The presence of at least 50 CD20+ B cells and 50 CD3+ T cells in a ≥50 µM area of surgical tissue is considered "positive" for TLS.