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KRAS peptide vaccine

Phase 1

Colorectal Cancer | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Jul 27, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment27

FDA Designations

No designations recorded

Clinical trial landscape

KRAS peptide vaccine · 1 trial · 2 indications

Phase 1 1
NCT04117087Pooled Mutant KRAS-Targeted Long Peptide Vaccine Combined With Nivolumab and Ipilimumab for Patients With Resected Mismatch Repair Protein (MMR-p) Colorectal and Pancreatic CancerColorectal Cancer
ACTIVE NOT_RECRUITING27 Analytics
PHASE1ACTIVE NOT_RECRUITING
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
Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants experiencing study drug-related toxicities
2 years

Number of participants experiencing study drug-related adverse events Grade 3 or higher as defined by CTCAE v5.0

Fold change in interferon-producing mutant-KRAS-specific cytotoxic (CD8) and helper (CD4) T cells at 16 weeks
Baseline, 16 weeks

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.

Secondary Endpoints

Disease Free Survival (DFS)
4 years
Percentage change of interferon (IFN)-γ-producing mutant-KRAS-specific CD8 and CD4 T cells
2 years
Objective Response Rate (ORR) per RECIST 1.1
4 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment PhaseEXPERIMENTALKRAS Vaccine Peptide, Nivolumab and Ipilimumab
Reinduction Treatment PhaseEXPERIMENTALKRAS Vaccine Peptide, Nivolumab and Ipilimumab

Interventions

NameTypeDescription
KRAS peptide vaccineDRUG1. 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
NivolumabDRUG1. 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
IpilimumabDRUG1. 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
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

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...

Countries:United States
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Frequently asked questions about KRAS peptide vaccine

What is KRAS peptide vaccine used for?

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.

How does KRAS peptide vaccine work?

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.

Who is developing KRAS peptide vaccine?

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.

What phase is KRAS peptide vaccine in?

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.

What clinical trials is KRAS peptide vaccine in?

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.

Is KRAS peptide vaccine the same as a KRAS-targeted vaccine?

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.