A Study of VAC85135, a Neoantigen Vaccine Regimen, Concurrently Administered With Ipilimumab for the Treatment of Myeloproliferative Neoplasms

Official Title

A Phase 1 Study of VAC85135, a Neoantigen Vaccine Regimen, Concurrently Administered With Ipilimumab for the Treatment of Myeloproliferative Neoplasms

Summary:

The purpose of this study is to evaluate the safety of VAC85135 administered with ipilimumab for the treatment of myeloproliferative neoplasms (MPNs).

Trial Description

Primary Outcome:

  • Number of Participants With Dose-limiting Toxicity (DLT)
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Secondary Outcome:
  • Number of Participants With Antigen-specific T-cell response
  • Number of Participants With Overall Response per Revised Response Criteria by the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) and European LeukemiaNet (ELN) Consensus Report
  • Number of Participants Disease Response at Weeks 24, 48 and End of Treatment (EOT) per Modified IWG-MRT Criteria
  • Number of Participants With Peripheral Blood Mutant Calreticulin (mutCALR) and Janus Kinase 2 With V617F Mutation (JAK2V617F) Allele Burden
  • Number of Participants With Transfusion Burden
  • Number of Participants With Patient-reported Symptoms on Therapy
  • Time to Progression of Myeloproliferative Neoplasms (MPNs)
  • Time to Initiation of Next Therapy

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society