Myeloproliferative Neoplasms Clinical Trial

A 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).

View Eligibility Criteria

Eligibility 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

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 1

Estimated Enrollment:

60

Study ID:

NCT05444530

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 17 Locations for this study

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The University of Alabama at Birmingham
Birmingham Alabama, 35233, United States
Mayo Clinic Cancer Center-Scottsdale
Phoenix Arizona, 85054, United States
City of Hope
Duarte California, 91010, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
Mayo Clinic Rochester
Rochester Minnesota, 55902, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Vanderbilt University Medical Center (VUMC) - Vanderbilt-Ingram Cancer Center (VICC)
Nashville Tennessee, 37232, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
University Health Network (UHN) Princess Margaret Cancer Centre
Toronto Ontario, M5G 1, Canada
Hopital Saint-Louis
Paris , 75010, France
Clinica Univ. de Navarra
Pamplona , 31008, Spain
Hosp. Clinico Univ. de Salamanca
Salamanca , 37007, Spain
Hosp. Clinico Univ. de Valencia
Valencia , 46010, Spain
Guy's and St Thomas' Hospital
London , SE1 9, United Kingdom
The Christie NHS Foundation Trust - Christie Hospital
Manchester , M20 4, United Kingdom
Churchill Hospital
Oxford , OX3 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 1

Estimated Enrollment:

60

Study ID:

NCT05444530

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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