Expired Study
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Baltimore, Maryland 21231


This trial explores the immunologic effects of vemurafenib (BRAF inhibitor) and cobimetinib (MEK inhibitor), administered alone and in combination, to patients with advanced BRAF V600E/K mutant melanoma.


Inclusion Criteria: - Signed informed consent - 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 systemic infection - 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



Primary Contact:

Principal Investigator
Evan J Lipson, MD
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Backup Contact:


Location Contact:

Baltimore, Maryland 21231
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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