Trial of Vemurafenib and Cobimetinib in Patients With Advanced BRAFV600 Mutant Melanoma

Withdrawn before enrolling · Phase 3

Conditions studied: Melanoma

In brief

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.

Key facts

Study ID

NCT02427893

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

0

Starts

2015-08-01

Expected to finish

2016-11-01

Last updated by the study team

2016-11-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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