Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
KRAS peptide vaccine · 1 trial · 2 indications
Number of participants experiencing study drug-related adverse events Grade 3 or higher as defined by CTCAE v5.0
Evaluated by the fold change in interferon-producing mutant-KRAS-specific CD8 and CD4 T cells after vaccination at 16 weeks compare to pre-vaccination baseline.
| Arm | Type | Description |
|---|---|---|
| Treatment Phase | EXPERIMENTAL | KRAS Vaccine Peptide, Nivolumab and Ipilimumab |
| Reinduction Treatment Phase | EXPERIMENTAL | KRAS Vaccine Peptide, Nivolumab and Ipilimumab |
| Name | Type | Description |
|---|---|---|
| KRAS peptide vaccine | DRUG | 1. KRAS peptide vaccine will be administered on cycle 1 (days 1, 8, 15) and R-Cycle 2 Day 1 (R-C2D1). Boost vaccinations with will be administered every 28 days at Reinduction cycle 5, 7, 9, 13. Extended vaccinations will be administered on Reinduction cycles 15 to 18, 19 and beyond (180 days ± 30 days for a total of 5 years on study. 2. Drug: up to 1.8 mg KRAS peptide vaccine + 0.5mg Poly-ICLC |
| Nivolumab | DRUG | 1. Nivolumab will be administered as a 30 minute IV infusion (-10min/+15min) on Day 1 of each 21 day cycle. Boost Phase will be administered every 28 days on cycles 5 thru 14. 2. Drug: 3mg/kg IV, 480 mg IV |
| Ipilimumab | DRUG | 1. Ipilimumab (1 mg/kg) will be administered as a 30 minute IV infusion (-10min/+15min) on Day 1 of Cycles 1 and 3 of the study. 2. Drug: 1mg/kg IV |
Inclusion Criteria: PDAC or metastatic MSS CRC Cohort: * Have histologically or cytologically - proven cancer of the pancreas (PDA) or MSS colorectal (CRC) in one of the following categories: * PDAC must have no evidence of disease and last dose of neoadjuvant and/or adjuvant chemotherapy/radia...
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KRAS peptide vaccine is an investigational cancer vaccine being studied for use in colorectal cancer. It is designed to target tumors that have mutations in the KRAS gene. The vaccine is currently in Phase 1 clinical development and has not been approved by the FDA.
KRAS peptide vaccine is a therapeutic vaccine that targets mutant KRAS proteins, which are found in certain cancers. By presenting these mutated peptides to the immune system, the vaccine aims to stimulate an immune response against cancer cells carrying the KRAS mutation. This mechanism is being evaluated in clinical trials.
KRAS peptide vaccine is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY. The company is conducting clinical trials to evaluate the vaccine's safety and efficacy in patients with colorectal cancer.
KRAS peptide vaccine is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trial is evaluating the vaccine in combination with other immunotherapies for patients with resected colorectal and pancreatic cancer.
KRAS peptide vaccine is being studied in one active clinical trial, NCT04117087. This Phase 1 trial is evaluating the vaccine combined with nivolumab and ipilimumab in patients with resected mismatch repair proficient colorectal and pancreatic cancer. The trial is enrolling 27 participants in the United States.
Yes, KRAS peptide vaccine is also referred to as a pooled mutant KRAS-targeted long peptide vaccine. In clinical trial NCT04117087, it is described as a KRAS-targeted long peptide vaccine, indicating that it is designed to target multiple KRAS mutations.