Neoantigen Vaccine + Ipilimumab for Myeloproliferative Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new vaccine, VAC85135, combined with ipilimumab, an immunotherapy, to determine their safety in treating myeloproliferative neoplasms (MPNs), which are rare blood disorders. The study consists of two parts: some participants will receive only the vaccine initially, while others will receive both the vaccine and ipilimumab. It targets individuals with specific genetic mutations linked to these blood disorders that impact daily life. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that VAC85135, a new type of vaccine, is generally safe. Earlier studies found that its side effects were similar to those of ipilimumab, a well-known cancer treatment, indicating no unexpected safety issues from VAC85135 alone.
Ipilimumab is commonly used to treat certain cancers. Its side effects, which can range from mild to serious, are well understood due to its use in other treatments.
This trial is in its early stages and primarily aims to assess the safety of using these treatments together. So far, the side effects from combining VAC85135 and ipilimumab resemble those expected from ipilimumab alone. This suggests a predictable safety pattern, but ongoing trials will provide more detailed information.12345Why are researchers excited about this trial's treatments?
Unlike the standard treatments for myeloproliferative disorders, which often include medications like hydroxyurea or ruxolitinib, this new approach combines a neoantigen vaccine (VAC85135) with ipilimumab, an immune checkpoint inhibitor. This combination is unique because it aims to boost the body's immune system to specifically target cancer cells by presenting them with neoantigens—unique markers found on tumor cells. Researchers are excited about this treatment because it has the potential to enhance the immune response more effectively than current options, which primarily focus on managing symptoms rather than targeting the cancer itself. Additionally, the use of ipilimumab introduces the possibility of modulating immune checkpoints, potentially offering a more targeted and lasting response.
What evidence suggests that this trial's treatments could be effective for myeloproliferative neoplasms?
Research shows that ipilimumab may help treat certain blood cancers, such as myeloproliferative neoplasms (MPNs). Studies have found benefits like reduced spleen size and improved symptoms when used alone or with other treatments. In this trial, participants in the Dose Escalation arm will initially receive the VAC85135 vaccine alone, with subsequent cohorts receiving it alongside ipilimumab. Participants in the Dose Expansion arm will receive VAC85135 with ipilimumab at doses determined by the study evaluation team. VAC85135 is a vaccine designed to help the immune system identify and destroy cancer cells. However, early results suggest that the vaccine, whether used alone or with ipilimumab, might not have generated a strong immune response. These treatments aim to enhance the body's ability to fight cancer, but further research is needed to confirm their effectiveness.12567
Who Is on the Research Team?
Janssen Research & Development, LLC Clinical Trial
Principal Investigator
Janssen Research & Development, LLC
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
Interventions
- Ipilimumab
- VAC85135
Trial Overview
The study tests the safety of VAC85135 combined with Ipilimumab in treating myeloproliferative neoplasms. It aims to see how well patients tolerate this neoantigen vaccine regimen when given alongside an established immunotherapy drug.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants with polycythemia vera (PV) or post-polycythemia vera myelofibrosis, ET and MF will receive VAC85135 target dose IM injection with ipilimumab IV infusion at the dose(s) determined by study evaluation team (SET).
Participants with essential thrombocythemia (ET) and myelofibrosis (MF) will receive VAC85135 target dose intramuscular (IM) injection in the safety lead-in cohort (Cohort 0). Participants in subsequent cohorts will receive VAC85135 target dose IM injection along with ipilimumab intravenous (IV) infusion. Ipilimumab dose may be escalated based on dose limiting toxicity (DLT) observations.
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
Joaquin Duato
Janssen Research & Development, LLC
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen Research & Development, LLC
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University
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
Published Research Related to This Trial
Citations
Immunotherapy in Myeloproliferative Diseases - PMC
The most common treatment-related adverse events (TRAEs) included thrombocytopenia, anemia, headache, and hypoalbuminemia, whereas thrombocytopenia and anemia ...
NCT05444530 | A Study of VAC85135, a Neoantigen ...
The purpose of this study is to evaluate the safety of VAC85135 administered with ipilimumab for the treatment of myeloproliferative neoplasms (MPNs).
A study of VAC85135, a neoantigen vaccine regimen, ...
The goal of the vaccine is to train the immune system to attack the cancer cells that express these abnormal proteins. The study is designed to ...
Neoantigen Vaccine + Ipilimumab for Myeloproliferative ...
This trial is testing a new drug (VAC85135) with an existing one (ipilimumab) in patients with a type of blood cancer (MPNs).
5.
mpnresearchfoundation.org
mpnresearchfoundation.org/wp-content/uploads/2023/09/2023_MPN_Summer-Newsletter.pdfIN MPNS
The phase 2 results showed significant spleen volume reduction, symptom response, anemia benefit, and fibrosis reversion as monotherapy or in combination with ...
A study of VAC85135, a neoantigen vaccine regimen ...
Myeloproliferative neoplasms (MPNs) are a group of blood cancers in which the bone marrow makes too many red/white blood cells or platelets or develops scarring ...
Myelofibrosis | Blood | American Society of Hematology
MF is a myeloproliferative neoplasm (MPN) with a clinical phenotype dominated by splenomegaly, constitutional symptoms, a variety of blood cell alterations.
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