A Study of VAC85135, a Neoantigen Vaccine Regimen, Concurrently Administered With Ipilimumab for the Treatment of Myeloproliferative Neoplasms
Completed · Phase 1
Conditions studied: Myeloproliferative Neoplasms
In brief
The purpose of this study is to evaluate the safety of VAC85135 administered with ipilimumab for the treatment of myeloproliferative neoplasms (MPNs).
Key facts
- Study ID
- NCT05444530
- Run by
- Janssen Research & Development, LLC
- People needed
- 14
- Starts
- 2022-07-21
- Expected to finish
- 2025-06-24
- Last updated by the study team
- 2025-07-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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