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Checkpoint Inhibitor

Neoantigen Vaccine + Ipilimumab for Myeloproliferative Disorder

Phase 1

Recruiting

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have an Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 or 2

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 24, 48 and eot (64 weeks)

Awards & highlights

Study Summary

This trial is testing a new drug, VAC85135, to see if it is safe to use with another drug, ipilimumab, to treat MPNs.

Who is the study for?

This trial is for adults with myeloproliferative neoplasms who are generally in good health (ECOG grade 0-2) and have certain blood and chemistry lab values within specific ranges. Participants must agree to use contraception during the study and for a period after its conclusion. Those with severe medical conditions, pregnant or breastfeeding women, individuals allergic to Ipilimumab, or those previously treated with JAK2 inhibitors cannot join.Check my eligibility

What is being tested?

The study tests the safety of VAC85135 combined with Ipilimumab in treating myeloproliferative neoplasms. It aims to see how well patients tolerate this neoantigen vaccine regimen when given alongside an established immunotherapy drug.See study design

What are the potential side effects?

Possible side effects include typical reactions associated with vaccines such as soreness at injection site, fever, fatigue, along with Ipilimumab-related risks like immune system-related inflammation affecting various organs, skin rash, digestive issues and endocrine disorders.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and perform daily activities.

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My liver and kidney functions are within the required ranges.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 24, 48 and eot (64 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 24, 48 and eot (64 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 24, 48 and eot (64 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Number of Participants With Dose-limiting Toxicity (DLT)

Secondary outcome measures

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

Number of Participants With Antigen-specific T-cell response

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

+5 more

Side effects data

From 2017 Phase 3 trial • 1289 Patients • NCT01285609

38%

Alopecia

36%

Anaemia

32%

Nausea

31%

Decreased appetite

31%

Diarrhoea

30%

Fatigue

25%

Constipation

23%

Neutropenia

20%

Dyspnoea

19%

Vomiting

19%

Pyrexia

18%

Rash

17%

Asthenia

17%

Cough

16%

Pruritus

16%

Thrombocytopenia

16%

Arthralgia

15%

Peripheral sensory neuropathy

14%

Myalgia

13%

Insomnia

13%

Neuropathy peripheral

11%

Hypokalaemia

10%

Platelet count decreased

Pain in extremity

Weight decreased

Leukopenia

Alanine aminotransferase increased

Hyponatraemia

Pneumonia

Haemoglobin decreased

Neutrophil count decreased

Dizziness

Malignant neoplasm progression

Aspartate aminotransferase increased

Bone pain

Haemoptysis

Back pain

Headache

Hypomagnesaemia

Stomatitis

Abdominal pain upper

Oedema peripheral

White blood cell count decreased

Chest pain

Dehydration

Abdominal pain

Febrile neutropenia

Paraesthesia

Musculoskeletal pain

Colitis

Death

Lung infection

Pulmonary embolism

Mucosal inflammation

Lung neoplasm malignant

Multi-organ failure

Cerebrovascular accident

Lung abscess

General physical health deterioration

Interstitial lung disease

Liver function test abnormal

Sudden death

Chronic obstructive pulmonary disease

Metastases to central nervous system

Blood creatinine increased

Atrial fibrillation

Cardio-respiratory arrest

Confusional state

Intestinal perforation

Pulmonary haemorrhage

Drug hypersensitivity

Infection

Pneumothorax

Renal failure

Lower respiratory tract infection

Pain

Respiratory failure

Syncope

Hyperglycaemia

Sepsis

Acute kidney injury

Hypersensitivity

Urinary tract infection

Disease progression

Pneumonitis

100%

80%

60%

40%

20%

Study treatment Arm

10 MG/KG Ipilimumab + Paclitaxel/ Carbop

Placebo + Paclitaxel/ Carboplatin

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose ExpansionExperimental Treatment2 Interventions

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).

Group II: Dose EscalationExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ipilimumab

2014

Completed Phase 3

~2620

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

976 Previous Clinical Trials

6,384,632 Total Patients Enrolled

Bristol-Myers SquibbIndustry Sponsor

2,641 Previous Clinical Trials

4,130,004 Total Patients Enrolled

Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC

746 Previous Clinical Trials

3,960,218 Total Patients Enrolled

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05444530 — Phase 1

Myeloproliferative Neoplasms Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT05444530 — Phase 1

Myeloproliferative Neoplasms Research Study Groups: Dose Escalation, Dose Expansion

Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05444530 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any US-based medical facilities administering this experiment?

"Currently, 8 research sites are admitting patients. These locations include Birmingham, Philadelphia and Nashville as well as 5 other cities in close proximity. In order to reduce any travel expenses associated with the trial, it is advisable to choose a site located within convenient reach of your home."

Answered by AI

How many volunteers are partaking in this research endeavor?

"In order to proceed, this medical trial requires 60 participants that meet its inclusion criteria. The sponsor of the study is Bristol-Myers Squibb, and it will be held at various sites including The University of Alabama in Birmingham and the University of Pennsylvania in Philadelphia."

Answered by AI

Are there any spots available in this clinical research program?

"Affirmative. According to clinicaltrials.gov, this investigation is presently seeking enrolment and was originally posted on July 21st 2022. Subsequently, it was revised the most recent time being November 3rd 2022. 8 medical facilities are needed in order to recruit a total of 60 individuals for participation."

Answered by AI

Does Ipilimumab present significant risks to human health?

"Our team at Power believes that the safety of Ipilimumab is measured as a 1 due to its early stage trials, leaving limited data on efficacy and safety."

Answered by AI

What are the core aims of this trial?

"This trial will be closely monitored from the onset, which is Day 1, to the 78th day of the study. The primary aim is to evaluate adverse and serious adverse events during this period. Secondary objectives include measuring antigen-specific T-cell response, time until initiation of next therapy for myeloproliferative neoplasms (MPNs), and overall responses using criteria established by IWG-MRT and ELN consensus report on myelofibrosis (MF)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "A Study of VAC85135, a Neoantigen Vaccine Regimen, Concurrently Administered With Ipilimumab for the Treatment of Myeloproliferative Neoplasms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05444530.

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