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Completed

NCT Number: NCT05444530

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

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

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Key information

Conditions

Myeloproliferative Neoplasms Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Myeloproliferative Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Guy's and St Thomas' Hospital, London, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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 1/2 (JAK1/2) inhibitor
  • Known sensitivity or contraindications to the use of Ipilimumab per local prescribing information

Treatment and study plan

VAC85135

Biological

Participants will receive VAC85135 as IM injection.

Ipilimumab

Drug

Participants will receive Ipilimumab as IV infusion.

Primary outcomes

  1. Number of Participants With Dose-limiting Toxicity (DLT)

    Time frame: Baseline (Day 1) up to Day 78

    Number of participants with a DLT will be reported. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity. Toxicities will be graded for severity according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0.

  2. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Up to 79 weeks

    Number of participants with AEs will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical product. AEs will be graded as Grade 1: Mild- asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2: Moderate- minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL); Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living; Grade 4- Life-threatening consequences- urgent intervention indicated; Grade 5: Death related to AE.

Secondary outcomes

  1. Number of Participants With Antigen-specific T-cell response

    Time frame: Up to end of treatment (EOT) (Up to 64 weeks)

    Number of participants with antigen-specific T-cell response will be reported.

  2. Number of Participants With Overall Response per Revised Response Criteria by the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) and European LeukemiaNet (ELN) Consensus Report

    Time frame: Up to 79 weeks

    Overall response will be measured by complete remission, partial remission, clinical improvement, anemia response, spleen response, symptoms response, progressive disease, stable disease and relapse as per the revised IWG-MRT and ELN response criteria for myelofibrosis (MF).

  3. Number of Participants Disease Response at Weeks 24, 48 and End of Treatment (EOT) per Modified IWG-MRT Criteria

    Time frame: Weeks 24, 48 and EOT (64 weeks)

    Number of participants with disease response as per the modified IWG-MRT criteria will be reported.

  4. Number of Participants With Peripheral Blood Mutant Calreticulin (mutCALR) and Janus Kinase 2 With V617F Mutation (JAK2V617F) Allele Burden

    Time frame: Up to end of treatment (EOT) (Up to 64 weeks)

    Number of participants with peripheral blood mutCALR and JAK2V617F allele burden will be reported.

  5. Number of Participants With Transfusion Burden

    Time frame: Up to end of treatment (EOT) (Up to 64 weeks)

    Number of participants with transfusion burden will be reported.

  6. Number of Participants With Patient-reported Symptoms on Therapy

    Time frame: Up to end of treatment (EOT) (Up to 64 weeks)

    Number of participants with patient-reported symptoms on therapy will be reported.

  7. Time to Progression of Myeloproliferative Neoplasms (MPNs)

    Time frame: Up to end of treatment (EOT) (Up to 64 weeks)

    Time to progression of MPNs (polycythemiavera [PV], essential thrombocythemia [ET], and primary myelofibrosis [PMF]) will be reported.

  8. Time to Initiation of Next Therapy

    Time frame: Up to 79 weeks

    Time to initiation of next therapy for myeloproliferative neoplasms (MPNs) will be reported.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

A Phase 1 Study of VAC85135, a Neoantigen Vaccine Regimen, Concurrently Administered With Ipilimumab for the Treatment of Myeloproliferative Neoplasms

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 6, 2022
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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