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

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

May 28, 2020

Primary Completion Date

June 1, 2027

Study Completion Date

June 1, 2027

Conditions
Colorectal CancerPancreatic Cancer
Interventions
DRUG

KRAS peptide vaccine

"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"

DRUG

Nivolumab

"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"

DRUG

Ipilimumab

"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"

Trial Locations (1)

21231

Sidney Kimmel Comprehensive Cancer Center, Baltimore

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

collaborator

National Cancer Institute (NCI)

NIH

collaborator

National Institutes of Health (NIH)

NIH

lead

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER