Mutant KRAS vaccine with dual checkpoint blockade in resected pancreatic cancer: a phase I trial

In this phase I study, we test a pooled synthetic long peptide vaccine targeting the six KRAS mutations (G12V, G12A, G12R, G12C, G12D, G13D) with ipilimumab and nivolumab in resected pancreatic adenocarcinoma. Co-primary endpoints include safety and maximal percent change of IFNγ-producing mutant KRAS T cell responses in the blood within 17 weeks. Secondary endpoints include disease-free survival, overall survival, and maximal percent change of IFNγ-producing mutant KRAS T cell responses at any time after vaccination. Vaccine-related adverse events are grade 1-2. 11/12 and 10/12 patients generate a significant increase in average T cell response to 6 mutant KRAS antigens and tumor-specific response,…

• BS
  Bristol-Myers Squibb

  Award: P30 CA006973
• LF
  Lustgarten Foundation
• AS
  American Society of Clinical Oncology
• JH
  Johns Hopkins University

  Awards: P50CA062924, P30 CA006973
• NI
  National Institutes of Health

  Awards: R50 CA243627, P30 CA006973, U01CA253403, P50CA062924, CA006973
• SU
  Stand Up To Cancer
• NC
  National Cancer Institute

  Awards: F32CA271470-01, CA006973, R50 CA243627, P01CA247886, U01CA253403, K08CA248624, P50CA062924, P30 CA006973