Comparing Neoadjuvant/Adjuvant GVAX vs a mKRASvax Given With Anti-PD-1 and Anti-CD137 for Surgica… (NCT06782932) | Clinical Trial Compass
RecruitingPhase 1/2
Comparing Neoadjuvant/Adjuvant GVAX vs a mKRASvax Given With Anti-PD-1 and Anti-CD137 for Surgically Resectable Pancreatic Cancer
United States38 participantsStarted 2025-05-27
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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 dis…
What they're measuring
1
Dose Limiting Toxicities in Phase I participants
Timeframe: 1 month
2
Number of participants experiencing Grade 3 or Higher study drug-related toxicities
Timeframe: 2 years
3
Number of participants who form Intratumoral tertiary lymphoid structures (TLS)
Timeframe: 2 weeks
Trial details
NCT IDNCT06782932
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins