Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Baltimore, Maryland 21231


Purpose:

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.


Criteria:

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


NCT ID:

NCT02427893


Primary Contact:

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


Backup Contact:

N/A


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

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.