Clinical trial NCT06782932: Comparing Neoadjuvant/Adjuvant GVAX vs a mKRASvax Given With Anti-PD-1 and Anti-CD137 for Surgically Resectable Pancreatic Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Pancreatic Cancer
Keywords: Balstilimab
AGEN2373
KRAS peptide vaccine
peptide vaccine
Poly-ICLC
GVAX
Cyclophosphamide
Immunotherapy
Anti-PD-1 (anti-check point inhibitor)
PD-L1 (check point inhibitor)
Anti-CD137
Cancer vaccine
Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
Adenocarcinoma
Carcinoma
Pancreas
mKRASvax
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: Agenus Inc.
name: Lustgarten Foundation
name: Oncovir, Inc.
First posted: 2025-01-20
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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 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

Primary outcomes:
measure: Dose Limiting Toxicities in Phase I participants
timeFrame: 1 month
measure: Number of participants experiencing Grade 3 or Higher study drug-related toxicities
timeFrame: 2 years
measure: Number of participants who form Intratumoral tertiary lymphoid structures (TLS)
timeFrame: 2 weeks
Secondary outcomes:
measure: Pathologic overall response rate (pORR)
timeFrame: evaluated at time of surgery, approximately 2 weeks from first dose of study drug
measure: CD3+CD8+CD137+ T cell density in Tumor Tissue
timeFrame: evaluated at time of surgery, approximately 2 weeks from first dose of study drug
measure: Change in peripheral interferon-gamma (IFNγ) producing mutant KRAS-specific T cells
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
state: Maryland
Study officials:
affiliation: SKCCC • Johns Hopkins Medical Institution
name: Eric Christenson, MD
role: PRINCIPAL_INVESTIGATOR
References: