Trial of Vemurafenib and Cobimetinib in Patients With Advanced BRAFV600 Mutant Melanoma
NCT ID: NCT02427893
Last Updated: 2016-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2015-08-31
2016-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1
Ten patients begin Vemurafenib monotherapy, after 10 days, begin combination therapy by adding Cobimetinib.
Cobimetinib
A potent and highly selective inhibitor of MEK1 and MEK2, central components of the RAS/RAF pathway.
Vemurafenib
A low molecular weight, orally available inhibitor of the activated form of the BRAF serine-threonine kinase enzyme, which is commonly found in melanoma
Cohort 2
Ten patients begin Cobimetinib monotherapy, after 10 days, begin combination therapy by adding Vemurafenib.
Cobimetinib
A potent and highly selective inhibitor of MEK1 and MEK2, central components of the RAS/RAF pathway.
Vemurafenib
A low molecular weight, orally available inhibitor of the activated form of the BRAF serine-threonine kinase enzyme, which is commonly found in melanoma
Interventions
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Cobimetinib
A potent and highly selective inhibitor of MEK1 and MEK2, central components of the RAS/RAF pathway.
Vemurafenib
A low molecular weight, orally available inhibitor of the activated form of the BRAF serine-threonine kinase enzyme, which is commonly found in melanoma
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Signed HIV testing consent
* Life expectancy ≥ 12 weeks
* Able to swallow pills
* ECOG performance status 2 or less
* Adequate bone marrow function
* Adequate renal function
* Adequate liver function
* Negative urine pregnancy test within 7 days prior to commencement of dosing in premenopausal women
* Histological diagnosis of unresectable AJCC stage III or stage IV, BRAFV600E/K mutant melanoma
* Measurable disease
* Accessible tumor that can be biopsied
* Naive to targeted therapy (Prior immune-based therapy in the adjuvant setting or for advanced disease will be allowed if \>2 weeks from study entry)
Exclusion Criteria
* Active autoimmune disease or history of known or suspected autoimmune disease
* Active brain metastases or leptomeningeal metastases
* Treatment with any immunomodulatory medication within 4 weeks of initiation of study therapy.
* Positive test for hepatitis B virus
* Positive test for hepatitis C virus
* Positive test for human immunodeficiency virus (HIV)
* Pregnant, lactating or breast feeding women
* Localized radiation therapy within the last 14 days
* History of malabsorption
* No consumption of the following within 7 days prior to start of treatment:
* St. John's wort or hyperforin (potent cytochrome P450 CYP3A4 enzyme inducer)
* Grapefruit juice (potent cytochrome P450 CYP3A4 enzyme inhibitor
* History or evidence of cardiovascular risk
* History or evidence of retinal pathology
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
OTHER
Responsible Party
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Principal Investigators
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Evan J Lipson, MD
Role: PRINCIPAL_INVESTIGATOR
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Locations
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The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Countries
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Other Identifiers
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IRB00051085
Identifier Type: OTHER
Identifier Source: secondary_id
J1517
Identifier Type: -
Identifier Source: org_study_id