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

Last updated: May 22, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Not Recruiting

Phase

1

Condition

Neoplasms

Red Blood Cell Disorders

White Cell Disorders

Treatment

Ipilimumab

VAC85135

Clinical Study ID

NCT05444530
CR109149
2021-006033-20
2022-501913-30-00
VAC85135MPN1001
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Be positive for a CALR (calreticulin) mutation: Type 1 or Type 2; Type 1-like, orType 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 1or 2

  • Have the following hematologic laboratory values: Leukocytes greater than or equalto (>=) 1.510^9 per liter, Neutrophils >=1.010^9 per liter, Platelets >=20*10^9per liter, Hemoglobin greater than (>) 7 gram per deciliter (g/dL)

  • Have the following chemistry laboratory values: Alanine aminotransferase (ALT): lessthan or equal to (<=) 3upper limit of normal (ULN), Aspartate aminotransferase (AST): <=3ULN, Total bilirubin: <=1.5*ULN, and glomerular filtration rate >=40milliliter per minute (mL/min)

  • A female participant of childbearing potential must agree to all the followingduring the study and for 6 months after the last dose of study treatment: use abarrier method of contraception, use a highly effective preferably user-independentmethod of contraception, not to donate eggs (ova, oocytes) or freeze for future usefor the purposes of assisted reproduction, not plan to become pregnant, not tobreast-feed

  • A male participant must agree to all the following during the study and for 90 daysafter the last dose of study treatment: wear a condom when engaging in any activitythat allows for passage of ejaculate to another person, not to father a child, notto donate sperm or freeze for future use for the purpose of reproduction

Exclusion

Exclusion Criteria:

  • History of any significant medical condition per investigators judgment (example:severe asthma/chronic obstructive pulmonary disease (COPD), poorly regulated heartcondition, 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 localprescribing information

Study Design

Total Participants: 14
Treatment Group(s): 2
Primary Treatment: Ipilimumab
Phase: 1
Study Start date:
July 21, 2022
Estimated Completion Date:
October 10, 2025

Connect with a study center

  • University Health Network (UHN) Princess Margaret Cancer Centre

    Toronto, Ontario M5G 1Z5
    Canada

    Site Not Available

  • Hopital Saint-Louis

    Paris, 75010
    France

    Site Not Available

  • Clinica Univ. de Navarra

    Pamplona, 31008
    Spain

    Site Not Available

  • Hosp. Clinico Univ. de Salamanca

    Salamanca, 37007
    Spain

    Site Not Available

  • Hosp. Clinico Univ. de Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • Guy's and St Thomas' Hospital

    London, SE1 9RT
    United Kingdom

    Site Not Available

  • The Christie NHS Foundation Trust - Christie Hospital

    Manchester, M20 4BX
    United Kingdom

    Active - Recruiting

  • The Christie NHS Foundation Trust Christie Hospital

    Manchester, M20 4BX
    United Kingdom

    Site Not Available

  • Churchill Hospital

    Oxford, OX3 7LE
    United Kingdom

    Site Not Available

  • The University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Mayo Clinic Cancer Center-Scottsdale

    Phoenix, Arizona 85054
    United States

    Site Not Available

  • City of Hope

    Duarte, California 91010
    United States

    Site Not Available

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Mayo Clinic Rochester

    Rochester, Minnesota 55902
    United States

    Site Not Available

  • Rutgers University

    Newark, New Jersey 07103
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Vanderbilt University Medical Center (VUMC) - Vanderbilt-Ingram Cancer Center (VICC)

    Nashville, Tennessee 37232-0021
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.