Clinical trial NCT05444530: A Study of VAC85135, a Neoantigen Vaccine Regimen, Concurrently Administered With Ipilimumab for the Treatment of Myeloproliferative Neoplasms
Official title: A Phase 1 Study of VAC85135, a Neoantigen Vaccine Regimen, Concurrently Administered With Ipilimumab for the Treatment of Myeloproliferative Neoplasms
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Myeloproliferative Neoplasms
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2022-07-06
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Number of Participants With Dose-limiting Toxicity (DLT)
timeFrame: Baseline (Day 1) up to Day 78
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to 79 weeks
Secondary outcomes:
measure: Number of Participants With Antigen-specific T-cell response
timeFrame: Up to end of treatment (EOT) (Up to 64 weeks)
measure: 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
timeFrame: Up to 79 weeks
measure: Number of Participants Disease Response at Weeks 24, 48 and End of Treatment (EOT) per Modified IWG-MRT Criteria
timeFrame: Weeks 24, 48 and EOT (64 weeks)
measure: Number of Participants With Peripheral Blood Mutant Calreticulin (mutCALR) and Janus Kinase 2 With V617F Mutation (JAK2V617F) Allele Burden
timeFrame: Up to end of treatment (EOT) (Up to 64 weeks)
measure: Number of Participants With Transfusion Burden
timeFrame: Up to end of treatment (EOT) (Up to 64 weeks)
measure: Number of Participants With Patient-reported Symptoms on Therapy
timeFrame: Up to end of treatment (EOT) (Up to 64 weeks)
measure: Time to Progression of Myeloproliferative Neoplasms (MPNs)
timeFrame: Up to end of treatment (EOT) (Up to 64 weeks)
measure: Time to Initiation of Next Therapy
timeFrame: Up to 79 weeks
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: London
country: United Kingdom
facility: Guy's and St Thomas' Hospital
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust Christie Hospital
city: Oxford
country: United Kingdom
facility: Churchill Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: