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

• Status: Not yet recruiting
• Trial end date: 2026-01-16
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Collaborator: Bristol-Myers Squibb
• Treatments: Ipilimumab

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 (<=) 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 2 (JAK2) inhibitor

• Known sensitivity or contraindications to the use of Ipilimumab per local prescribing information