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

Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Jun 30, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called VAC85135, which is a type of vaccine designed to help the immune system fight against a group of blood disorders known as myeloproliferative neoplasms (MPNs). The vaccine is given together with another medication called ipilimumab. The main goal of the study is to see if this combination is safe for patients with MPNs.

To participate in the trial, individuals must have specific genetic mutations related to their condition, such as a CALR or JAK2 mutation. They should also have certain blood test results that meet the study requirements. Participants in the trial can expect to be closely monitored for their health and any side effects from the treatment. It’s important to note that both men and women of childbearing age must take precautions to prevent pregnancy during the study. This trial is currently active, but it is not recruiting new participants at this time.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Be positive for a CALR (calreticulin) mutation: Type 1 or Type 2; Type 1-like, or Type 2-like may be considered with Sponsor approval; or positive for the JAK2V617F (Janus kinase 2 with valine 617 to phenylalanine mutation) mutation with HLA-A02:01 (human leukocyte antigens) per medical history or local testing
• • 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 (\<=) 3\*upper limit of normal (ULN), Aspartate aminotransferase (AST): \<=3\*ULN, Total bilirubin: \<=1.5\*ULN, and glomerular filtration rate \>=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
• 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 1/2 (JAK1/2) inhibitor
• • Known sensitivity or contraindications to the use of Ipilimumab per local prescribing information