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| ID | Type | Description | Link |
|---|---|---|---|
| VAC85135MPN1001 | Other Identifier | Janssen Research & Development, LLC | |
| 2021-006033-20 | EudraCT Number | ||
| 2022-501913-30-00 | Registry Identifier | EUCT number |
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental | 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. |
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| Dose Expansion | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VAC85135 | Biological | Participants will receive VAC85135 as IM injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose-limiting Toxicity (DLT) | 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. | Baseline (Day 1) up to Day 78 |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. | Up to 79 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Antigen-specific T-cell response | Number of participants with antigen-specific T-cell response will be reported. | Up to end of treatment (EOT) (Up to 64 weeks) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| Moffitt Cancer Center |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| Ipilimumab | Drug | Participants will receive Ipilimumab as IV infusion. |
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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). |
| Up to 79 weeks |
| Number of Participants Disease Response at Weeks 24, 48 and End of Treatment (EOT) per Modified IWG-MRT Criteria | Number of participants with disease response as per the modified IWG-MRT criteria will be reported. | Weeks 24, 48 and EOT (64 weeks) |
| Number of Participants With Peripheral Blood Mutant Calreticulin (mutCALR) and Janus Kinase 2 With V617F Mutation (JAK2V617F) Allele Burden | Number of participants with peripheral blood mutCALR and JAK2V617F allele burden will be reported. | Up to end of treatment (EOT) (Up to 64 weeks) |
| Number of Participants With Transfusion Burden | Number of participants with transfusion burden will be reported. | Up to end of treatment (EOT) (Up to 64 weeks) |
| Number of Participants With Patient-reported Symptoms on Therapy | Number of participants with patient-reported symptoms on therapy will be reported. | Up to end of treatment (EOT) (Up to 64 weeks) |
| Time to Progression of Myeloproliferative Neoplasms (MPNs) | Time to progression of MPNs (polycythemiavera [PV], essential thrombocythemia [ET], and primary myelofibrosis [PMF]) will be reported. | Up to end of treatment (EOT) (Up to 64 weeks) |
| Time to Initiation of Next Therapy | Time to initiation of next therapy for myeloproliferative neoplasms (MPNs) will be reported. | Up to 79 weeks |
| Tampa |
| Florida |
| 33612 |
| United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Guy's and St Thomas' Hospital | London | SE1 9RT | United Kingdom |
| The Christie NHS Foundation Trust Christie Hospital | Manchester | M20 4BX | United Kingdom |
| Churchill Hospital | Oxford | OX3 7LE | United Kingdom |
| ID | Term |
|---|---|
| D009196 | Myeloproliferative Disorders |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000074324 | Ipilimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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