Actively Recruiting
Comparing Neoadjuvant/Adjuvant GVAX vs a mKRASvax Given With Anti-PD-1 and Anti-CD137 for Surgically Resectable Pancreatic Cancer
Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2025-12-03
38
Participants Needed
1
Research Sites
183 weeks
Total Duration
On this page
Sponsors
S
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
A
Agenus Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Comparing Neoadjuvant/Adjuvant GVAX vs a mKRASvax Given With Anti-PD-1 and Anti-CD137 for Surgically Resectable Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 must have a negative serum pregnancy test.
- Both women and men must use an acceptable form of birth control during the study.
You will not qualify if you...
- Received any anti-pancreatic cancer therapy (symptomatic therapies are allowed), or any prior anti-cancer immunotherapy.
- Diagnosed with another cancer that could interfere with safety or efficacy assessments.
- Uncontrolled illness including infection, heart failure, unstable angina, arrhythmia, metastatic cancer, or psychiatric/social issues limiting compliance.
- Active autoimmune disease.
- Systemic steroid therapy (> 10mg prednisone daily) or immunosuppressive therapy within 14 days before study drug.
- Active infection requiring systemic therapy.
- Known history of HIV.
- Active or chronic hepatitis B or C.
- Known active tuberculosis.
- History of interstitial lung disease, non-infectious pneumonitis, or uncontrolled lung diseases.
- Prior allogeneic stem cell or organ transplantation.
- Major surgery requiring general anesthesia within 28 days before first study drug dose.
- Received live vaccine within 28 days before first study drug dose.
- History of severe allergic reaction to any monoclonal antibody.
- Concurrent participation in another therapeutic clinical study.
- Pregnant or breastfeeding.
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Trial Site Locations
Total: 1 location
1
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
C
Colleen Apostol, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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