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NCT Number: NCT06782932

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

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.

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Key information

Conditions

Pancreatic Cancer Adenocarcinoma Carcinoma Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21287, United States

Location status: Recruiting

Location contact

Colleen Apostol, RN

CONTACT

[email protected]

410-614-3644

Eric Christenson, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AGEN2373

Drug
  • Up to 3 doses (1 mg/kg, 3 mg/kg, and 10 mg/kg) will be tested in Phase I to determine the dose to be used in Phase II. AGEN2373 will be administered as a 60 minute IV infusion (-5/+15 min) on Day 1 of each cycle for a total of 6 cycles of treatment. Cycle 1 (14 days) is prior to surgical resection, Cycle 2 (14 days) is after surgery and prior to standard of care chemotherapy, and Cycles 3-6 (21 days) are given after completion of chemotherapy.
  • Drug: 1 mg/kg, 3 mg/kg, and 10 mg/kg IV

Balstilimab

Drug
  • 450 mg will be administered as a 30 minute IV Infusion (-5/+15 min) on day 1 of each cycle for a total of 6 cycles of treatment. Cycle 1 (14 days) is prior to surgical resection, Cycle 2 (14 days) is after surgery and prior to standard of care chemotherapy, and Cycles 3-6 (21 days) are given after completion of chemotherapy.
  • Drug: 450 mg IV

Other names: AGEN2034, anti-PD-1 antibody

Cyclophosphamide

Drug
  • 200 mg/m2 will be administered as a 30 minute IV infusion (-5/+15 min) on day 1 of each cycle for a total of 6 cycles of treatment. Cycle 1 (14 days) is prior to surgical resection, Cycle 2 (14 days) is after surgery and prior to standard of care chemotherapy, and Cycles 3-6 (21 days) are given after completion of chemotherapy.
  • Drug: 200 mg/m2 IV

Other names: Cy

GVAX

Drug
  • Vaccine (5 × 108 cells) will be administered on Day 2 of each cycle for a total of 6 cycles of treatment. Six intradermal injections will be given in the upper thighs and non-dominant arms. Cycle 1 (14 days) is prior to surgical resection, Cycle 2 (14 days) is after surgery and prior to standard of care chemotherapy, and Cycles 3-6 (21 days) are given after completion of chemotherapy.
  • Drug: GVAX

Other names: PANC 10.05 pcDNA-1/GM-Neo vaccine and PANC 6.03 pcDNA-1/GM-Neo vaccine

AGEN2373 (RP2D)

Drug
  • Drug: Up to 3 doses (1 mg/kg, 3 mg/kg, and 10 mg/kg) will be administered as a 60 minute IV. Infusion (-5/+15 min) on Day 1 of each cycle for a total of 6 cycles of treatment. Cycle 1 (14 days) is prior to surgical resection, Cycle 2 (14 days) is after surgery and prior to standard of care chemotherapy, and Cycles 3-6 (21 days) are given after completion of chemotherapy.
  • Drug: 1 mg/kg, 3 mg/kg, and 10 mg/kg IV

mKRASvax

Drug
  • mKRASvax will be administered on Day 1 of each cycle and on Day 8 of Cycle 1 only. mKRASvax is given as 5 subcutaneous injections administered in the upper thighs and arms. Cycle 1 (14 days) is prior to surgical resection, Cycle 2 (14 days) is after surgery and prior to standard of care chemotherapy, and Cycles 3-6 (21 days) are given after completion of chemotherapy.
  • 0.3 mg per peptide vaccine + 0.5mg Poly-ICLC

Other names: mutant KRAS peptide vaccine with Hiltonol® (Poly-ICLC)

Primary outcomes

  1. Dose Limiting Toxicities in Phase I participants

    Time frame: 1 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.

  2. Number of participants experiencing Grade 3 or Higher study drug-related toxicities

    Time frame: 2 years

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

  3. Number of participants who form Intratumoral tertiary lymphoid structures (TLS)

    Time frame: 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.

Secondary outcomes

  1. Pathologic overall response rate (pORR)

    Time frame: evaluated at time of surgery, approximately 2 weeks from first dose of study drug

    Number of participants who have a pathologic response to the first dose of study drug as determined using surgically resected tissue and the College of American Pathologists (CAP) scoring system. A pathologic response is defined as CAP grade of 0-2. Possible CAP grades include grade 0: Complete Response/ No viable residual tumor; grade 1: Marked Response/ minimal residual cancer with single cells or small groups of cancer cells; grade 2: Moderate Response/ residual cancer outgrown by fibrosis; and grade 3: Poor or No response/ extensive residual cancer.

  2. CD3+CD8+CD137+ T cell density in Tumor Tissue

    Time frame: evaluated at time of surgery, approximately 2 weeks from first dose of study drug

    Number of CD3+CD8+CD137+ T cells found in resected surgical tissue by Immunohistochemistry (IHC).

  3. Change in peripheral interferon-gamma (IFNγ) producing mutant KRAS-specific T cells

    Time frame: 13 weeks

    Percent change in the number of IFNγ producing T cells at Cycle 2 Day 14 when compared with baseline. Number of IFNγ T cells will be assessed by ELISPOT.

Study contacts

Contact information is provided by the study sponsor or research team.

Colleen Apostol, RN

CONTACT

[email protected]

410-614-3644

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Collaborators

  • Agenus Inc.
  • Lustgarten Foundation
  • Oncovir, Inc.

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 20, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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