KRAS-Targeted Vaccine With Nivolumab and Ipilimumab for Patients With NSCLC
Status:
Not yet recruiting
Trial end date:
2026-04-01
Target enrollment:
Participant gender:
Summary
This is a single institution, Phase 1 study for patients with Stage III/IV unresectable
Kirsten rat sarcoma (KRAS) mutated NSCLC to evaluate safety of the pooled mutant-KRAS peptide
vaccine (KRAS peptide vaccine) with polyinosinic-polycytidylic acid (poly-ICLC) adjuvant in
combination with nivolumab and ipilimumab in the first line treatment setting. The primary
objectives of this study are to determine the safety and feasibility of administering the
KRAS peptide vaccine with poly-ICLC adjuvant in combination with nivolumab and ipilimumab.
The secondary objectives are to estimate the progression free survival (PFS) of pooled
mutant-KRAS long peptide vaccine with poly-ICLC adjuvant in combination with Ipilimumab +
Nivolumab for the first line treatment of patients with unresectable Stage III/IV NSCLC whose
tumors harbor selected KRAS mutations (KRAS glycine-to-cysteine substitution at codon 12
(G12C), KRAS glycine-to-valine substitution at codon 12 (G12V), KRAS
glycine-to-Detoxglyphosate substitution at codon 12 (G12D), KRAS glycine-to-arginine
substitution at codon 12 (G12A), KRAS glycine-to-Aspartic Acid "D" at codon 13 (G13D) or KRAS
G12R) and to assess the impact of predicted KRAS mutations on mutant-KRAS specific T cell
responses in the peripheral blood of these patients. Exploratory objectives will assess the
impact of predicted KRAS mutations on mutant-KRAS specific T cell responses in the peripheral
blood, as well as changes in circulating tumor deoxyribonucleic acid (ctDNA). Approximately
15 subjects will be enrolled to have 12 evaluable subjects for T cell response assessment.
Safety analysis will include all enrolled patients who receive at least one dose of vaccine.
The evaluable population for T cell response will consist of all patients who receive at
least one dose of vaccine and have baseline and post-treatment T cell measures in the
peripheral blood at 12 weeks.
Phase:
Phase 1
Details
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins