drugset / Trial / NCT04117087

Pooled Mutant KRAS-Targeted Long Peptide Vaccine Combined With Nivolumab and Ipilimumab for Patients With Resected Mismatch Repair Protein (MMR-p) Colorectal and Pancreatic Cancer

NCT04117087

Non-randomizedParallel-groupOpen-labelTreatment

Summary

Phase 1 study for patients with resected PDAC after neoadjuvant and/ or adjuvant chemotherapy and/or radiation, as well as patients with metastatic colorectal cancer who have exposure to 2 or more lines of chemotherapy, to evaluate safety and the immune response to pooled mutant-KRAS peptide vaccine (KRAS peptide vaccine) with poly-ICLC adjuvant in combination with nivolumab and ipilimumab.

Timeline

Start
2020-05-28
Primary completion
2027-06-01
Completion
2027-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Ipilimumab Monoclonal antibody 1 mg/kg Intravenous
Subject KRAS peptide vaccine Vaccine 1.8 mg
Subject Nivolumab Monoclonal antibody 3 mg/kg Intravenous
Subject Nivolumab Monoclonal antibody 480 mg Intravenous
Background Hiltonol Other / unclassified 0.5 mg