NCT06782932RecruitingPhase 1/2
Comparing Neoadjuvant/Adjuvant GVAX vs a mKRASvax Given With Anti-PD-1 and Anti-CD137 for Surgically Resectable Pancreatic Cancer
A Pilot Study Comparing Neoadjuvant and Adjuvant GVAX vs a Mutated KRAS Peptide Vaccine Given With Anti-PD-1 and Anti-CD137 for the Treatment of Surgically Resectable Pancreatic Adenocarcinoma
Source: ClinicalTrials.gov · Last updated 3 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 38 (estimated)
- First submitted
- 14 Jan 2025
- Start date
- 27 May 2025
- Primary completion date
- Dec 2028
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Diseases
- Pancreatic cancer
- NCT number
- NCT06782932
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 38
- From 27 May 2025 to the primary completion date, Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received any anti-pancreatic cancer therapy (symptomatic therapies are allowed), or any prior anti-cancer immunotherapy.
- Systemic steroid therapy (\> 10mg daily prednisone equivalent) or immunosuppressive therapy within 14 days of first dose of study drug administration.
- 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.
- Concurrent participation in another therapeutic clinical study
Other illness
- 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.
- 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.
- History of severe hypersensitivity reaction to any monoclonal antibody
Other
- Pregnant or breastfeeding
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.