Cancer Vaccine + Nivolumab + Ipilimumab for Pancreatic and Colorectal Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications before starting, such as systemic steroids, chemotherapy, and investigational drugs. If you're on these, you may need to stop them 2 to 4 weeks before the trial begins.
What data supports the effectiveness of the treatment involving Cancer Vaccine, Nivolumab, and Ipilimumab for pancreatic and colorectal cancer?
Research shows that a mutant ras peptide vaccine can induce immune responses in pancreatic cancer patients, leading to prolonged survival for those who respond. Additionally, combining cancer vaccines with immune checkpoint inhibitors like Nivolumab may enhance the immune system's ability to fight tumors, potentially improving outcomes in patients with pancreatic cancer.12345
Is the combination of cancer vaccine, Nivolumab, and Ipilimumab safe for humans?
The combination of cancer vaccines with Nivolumab has been generally well-tolerated in clinical trials for pancreatic cancer, with no severe adverse events reported. This suggests that the treatment is generally safe in humans, although specific data on the combination with Ipilimumab is not provided.36789
How is the treatment with Cancer Vaccine, Nivolumab, and Ipilimumab different from other treatments for pancreatic and colorectal cancer?
This treatment is unique because it combines a cancer vaccine targeting specific cancer mutations with two immune checkpoint inhibitors, Nivolumab and Ipilimumab, which help the immune system recognize and attack cancer cells. This approach aims to enhance the body's immune response against cancer, potentially offering a new option for patients with limited treatment choices.1341011
What is the purpose of this trial?
This trial tests a special vaccine combined with immune-boosting drugs for patients with advanced pancreatic or colorectal cancer who have had extensive prior treatments. The goal is to train and enhance the immune system to better fight cancer. The vaccine has been used in previous studies to help the immune system recognize cancer cells in pancreatic cancer patients.
Research Team
Nilofer Azad, MD
Principal Investigator
Johns Hopkins Medical Institution
Eligibility Criteria
Adults over 18 with certain types of pancreatic or colorectal cancer that's been surgically removed and who've had previous chemotherapy can join. They must be in good health, have a life expectancy over 6 months, and use birth control. People can't join if they're on high-dose steroids, had recent radiation or chemo, prior immunotherapy, severe allergies to antibodies, active autoimmune diseases, serious infections including HIV/hepatitis B/C, brain metastases or need oxygen therapy.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the KRAS Vaccine Peptide, Nivolumab, and Ipilimumab
Reinduction Treatment
Participants may receive additional doses of KRAS Vaccine Peptide, Nivolumab, and Ipilimumab
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Ipilimumab
- KRAS peptide vaccine
- Nivolumab
Ipilimumab is already approved in United States, European Union for the following indications:
- Advanced melanoma
- Stage III unresectable melanoma
- Stage IV metastatic melanoma
- Advanced melanoma
- Stage III unresectable melanoma
- Stage IV metastatic melanoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
Bristol-Myers Squibb
Industry Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania
National Cancer Institute (NCI)
Collaborator
National Institutes of Health (NIH)
Collaborator