Neoantigen Vaccine + Ipilimumab for Myeloproliferative Disorder
Trial Summary
What is the purpose of this trial?
This trial is testing a new drug (VAC85135) with an existing one (ipilimumab) in patients with a type of blood cancer (MPNs). The goal is to see if this combination can help the immune system fight the cancer more effectively. Ipilimumab has shown promising activity in various cancers including melanoma.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Neoantigen Vaccine + Ipilimumab for Myeloproliferative Disorder?
Research suggests that immune therapies, like vaccines targeting specific proteins such as PD-L1, can enhance the body's immune response against myeloproliferative disorders. Combining these vaccines with immune checkpoint inhibitors, like Ipilimumab, may improve the anti-tumor immune response, as seen in other cancer treatments.12345
How is the treatment Neoantigen Vaccine + Ipilimumab different from other treatments for myeloproliferative disorder?
This treatment is unique because it combines a neoantigen vaccine targeting specific mutations in the calreticulin gene with Ipilimumab, an immune checkpoint inhibitor, to enhance the body's immune response against cancer cells. This approach aims to specifically target and eliminate malignant cells in myeloproliferative disorders, which current treatments struggle to do effectively.24678
Research Team
Janssen Research & Development, LLC Clinical Trial
Principal Investigator
Janssen Research & Development, LLC
Eligibility Criteria
This trial is for adults with myeloproliferative neoplasms who are generally in good health (ECOG grade 0-2) and have certain blood and chemistry lab values within specific ranges. Participants must agree to use contraception during the study and for a period after its conclusion. Those with severe medical conditions, pregnant or breastfeeding women, individuals allergic to Ipilimumab, or those previously treated with JAK2 inhibitors cannot join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive VAC85135 and ipilimumab for the treatment of myeloproliferative neoplasms
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Ipilimumab
- VAC85135
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?
Janssen Research & Development, LLC
Lead Sponsor
Giacomo Salvadore
Janssen Research & Development, LLC
Chief Medical Officer since 2023
MD from the University of Rome, Tor Vergata
Ricardo Attar
Janssen Research & Development, LLC
Chief Executive Officer since 2008
PhD in Molecular Biology from the University of Buenos Aires
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