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
Phase 1
Active not recruiting
27 enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Bristol-Myers Squibb · collabNational Cancer Institute (NCI) · collabNational Institutes of Health (NIH) · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |