Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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11 May 2015 |
Main ID: |
NCT02095652 |
Date of registration:
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17/03/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Study for the Evaluation of Vemurafenib ( Zelboraf® ) and Ipilimumab ( Yervoy® ) in Combination With DNE3 Therapy to Patients With Metastatic Melanoma
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Scientific title:
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Phase 1/2 Study for the Evaluation of Vemurafenib ( Zelboraf® ) and Ipilimumab ( Yervoy® ) in Combination With DNE3 Therapy to Patients With Metastatic Melanoma |
Date of first enrolment:
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September 2013 |
Target sample size:
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95 |
Recruitment status: |
Terminated |
URL:
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http://clinicaltrials.gov/show/NCT02095652 |
Study type:
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Interventional |
Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Belarus
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Germany
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Russian Federation
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Ukraine
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Contacts
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Name:
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Valentina Kolesnik |
Address:
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Telephone:
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Email:
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Affiliation:
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Cancer Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Previously untreated, metastatic melanoma with activating V600
Serine/threonine-protein kinase B-Raf (BRAF) mutation
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
Exclusion Criteria:
- Autoimmune disease
- Active Brain Metastases (with symptoms or requiring corticosteroid treatment)
- Prior therapy with immunosuppressive agents (within the past 2 years) and any
anti-cancer therapy
- Active pneumonitis or interstitial lung disease
- Lactating female
- History of another malignancy (Exception: Subjects who have been disease-free for 3
years, or subjects with a history of completely resected non-melanoma skin cancer or
successfully treated in situ carcinoma are eligible)
- Any serious and/or unstable pre-existing medical, psychiatric disorder or other
conditions that could interfere with subject's safety, obtaining informed consent or
compliance to the study procedures
- Any prohibited medication
- Administration of an investigational study treatment within 28 days or 5 half-lives,
whichever is longer, preceding the first dose of study treatment(s) in this study
Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs
chemically related to the study treatments, their excipients, and/or dimethyl
sulfoxide (DMSO)
- Unwillingness or inability to follow the procedures outlined in the protocol
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Melanoma
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Metastatic Melanoma
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Intervention(s)
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Drug: Vemurafenib 960 mg tablet by mouth (oral) twice daily
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Drug: Ipilimumab 10 mg/kg Intravenous (IV) injection
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Biological: DNE3 0.2?g/kg of body weight
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Primary Outcome(s)
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To assess the safety of DNE3 in combination with Vemurafenib and Ipilimumab and select the optimal dose of DNE3 for the phase II portion in patients with metastasis melanoma (Phase I)
[Time Frame: up to approximately 3 years]
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Secondary Outcome(s)
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Overall survival (Phase II)
[Time Frame: From date of registration to date of death due to any cause, assessed up to 5 years]
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Secondary ID(s)
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PTC-293-72
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XTPTC-293-72
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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