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

• Status: Withdrawn
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: Genentech, Inc.
• Treatments: Vemurafenib

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