A Study of VAC85135, a Neoantigen Vaccine Regimen, Concurrently Administered With Ipilimumab for the Treatment of Myeloproliferative Neoplasms
NCT ID: NCT05444530
Last Updated: 2025-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
14 participants
INTERVENTIONAL
2022-07-21
2025-06-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation
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.
VAC85135
Participants will receive VAC85135 as IM injection.
Ipilimumab
Participants will receive Ipilimumab as IV infusion.
Dose Expansion
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).
VAC85135
Participants will receive VAC85135 as IM injection.
Ipilimumab
Participants will receive Ipilimumab as IV infusion.
Interventions
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VAC85135
Participants will receive VAC85135 as IM injection.
Ipilimumab
Participants will receive Ipilimumab as IV infusion.
Eligibility Criteria
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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
* 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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City of Hope
Duarte, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
Cleveland Clinic
Cleveland, Ohio, United States
MD Anderson Cancer Center
Houston, Texas, United States
Guy's and St Thomas' Hospital
London, , United Kingdom
The Christie NHS Foundation Trust Christie Hospital
Manchester, , United Kingdom
Churchill Hospital
Oxford, , United Kingdom
Countries
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Other Identifiers
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VAC85135MPN1001
Identifier Type: OTHER
Identifier Source: secondary_id
2021-006033-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2022-501913-30-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CR109149
Identifier Type: -
Identifier Source: org_study_id
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