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

NCT06782932 Phase 1/Phase 2 RECRUITING

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.

Details

Lead sponsor	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phase	Phase 1/Phase 2
Status	RECRUITING
Enrolment	38
Start date	2025-05-27
Completion	2028-12

Conditions

• Pancreatic Cancer

Interventions

• AGEN2373
• Balstilimab
• Cyclophosphamide
• GVAX
• AGEN2373 (RP2D)
• Balstilimab
• mKRASvax

Primary outcomes

• Dose Limiting Toxicities in Phase I participants — 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.
• Number of participants experiencing Grade 3 or Higher study drug-related toxicities — 2 years
  Number of participants experiencing study drug-related adverse events Grade 3 or higher as defined by CTCAE v5.0
• Number of participants who form Intratumoral tertiary lymphoid structures (TLS) — 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.

Countries

United States