Clinical Trial 21667

• Overview

  Study 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).

  Objective:

  The primary objective is to evaluate the safety of VAC85135 administered with ipilimumab in participants withMPNs. Key secondary endpoints are to evaluate the immunogenicity and anti-tumor clinical activity

• Treatments

  Therapies:

  Antibody-Drug Conjugate; Vaccine

  Medications:

  Ipilimumab (); VAC85135 (); Yervoy (Ipilimumab)

• Inclusion Criteria

  Inclusion Criteria:
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 or 2
  • Have the following hematologic laboratory values: Leukocytes greater than or equal to (>=) 1.5*10^9 per liter, Neutrophils >=1.0*10^9 per liter, Platelets >=20*10^9 per liter, Hemoglobin greater than (>) 7 gram per deciliter (g/dL) Have the following chemistry laboratory values: Alanine aminotransferase (ALT): less than or equal to (=40 milliliter per minute (mL/min)
  • A female participant of childbearing potential must agree to all the following during the study and for 6 months after the last dose of study treatment: use a barrier method of contraception, use a highly effective preferably user-independent method of contraception, not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction, not plan to become pregnant, not to breast-feed
  • A male participant must agree to all the following during the study and for 90 days after the last dose of study treatment: wear a condom when engaging in any activity that allows for passage of ejaculate to another person, not to father a child, not to donate sperm or freeze for future use for the purpose of reproduction.
  • Other criteria apply

• Exclusion Criteria

  Exclusion Criteria:
  • History of any significant medical condition per investigators judgment (example: severe asthma/chronic obstructive pulmonary disease (COPD), poorly regulated heart condition, insulin dependent diabetes mellitus)
  • Serious known clinically relevant allergies or earlier anaphylactic reactions
  • Currently pregnant or breastfeeding
  • Prior treatment with any Janus kinase 2 (JAK2) inhibitor
  • Known sensitivity or contraindications to the use of Ipilimumab per local prescribing information
  • Other criteria may apply

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