A Study of Vemurafenib in Metastatic Melanoma Participants With Brain Metastases

NCT ID: NCT01378975

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2015-07-31

Brief Summary

This open-label, single-arm, multicenter study will evaluate the efficacy and safety in participants with metastatic melanoma who developed brain metastases. Participants may or may not have received prior systemic treatment for metastatic melanoma [except treatment with v-raf murine sarcoma viral oncogene homolog B (BRAF) or mitogen-activated protein kinase (MEK) inhibitors]. Participants will receive oral doses of 960 mg vemurafenib twice daily until disease progression, unacceptable toxicity or consent withdrawal.

Conditions

Malignant Melanoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1: Previously Untreated Participants

Participants who had not received previous treatment for brain metastases \[i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases\] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant's safety, death, reasons deemed by the investigator, or study termination by the Sponsor.

Group Type: EXPERIMENTAL

Vemurafenib

Intervention Type: DRUG

960 mg oral doses twice daily until disease progression, unacceptable toxicity or consent withdrawal.

Cohort 2: Previously treated Participants

Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant's safety, death, reasons deemed by the investigator, or study termination by the Sponsor.

Group Type: EXPERIMENTAL

Vemurafenib

Intervention Type: DRUG

960 mg oral doses twice daily until disease progression, unacceptable toxicity or consent withdrawal.

Interventions

Vemurafenib

960 mg oral doses twice daily until disease progression, unacceptable toxicity or consent withdrawal.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adult participants, >/= 18 years of age
• Histologically confirmed metastatic melanoma (Stage IV, American Joint Committee on Cancer) with BRAF V600 mutation (cobas 4800 BRAF V600 Mutation Test)
• Measurable brain metastases, defined as lesions that were accurately measured in at least one dimension (longest diameter to be recorded) as ≥0.5 cm in the brain MRI with contrast, treated or untreated
• Participants may or may not have received prior systemic therapy for metastatic melanoma and either a) have received no prior treatment for brain metastases or b) have received prior treatment for brain metastases and have progressed
• Participants may or may not have symptoms related to their brain metastases
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Participants must have recovered from all side effects of their most recent systemic or local treatment for metastatic melanoma

Exclusion Criteria

• Increasing corticosteroid dose during the 7 days prior to first dose of study drug
• Leptomeningeal involvement in participants with no prior treatment for brain metastases
• Previous malignancy requiring active treatment within the past 2 years, except for treated and controlled basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix
• Concurrent administration of any anticancer therapies other than those administered in the study
• Treatment with any cytotoxic, investigational drug or targeted therapy 4 weeks prior to first dose of study drug. Radiation therapy ≤1 week prior to first administration of vemurafenib; and stereotactic radiotherapy ≤1 day prior to prior to first administration of vemurafenib
• Prior treatment with BRAF or MEK inhibitors
• Clinically significant cardiovascular disease or event within the 6 months prior to first dose of study drug

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Los Angeles, California, United States

Aurora, Colorado, United States

Tampa, Florida, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Detroit, Michigan, United States

Rochester, Minnesota, United States

St Louis, Missouri, United States

Charlotte, North Carolina, United States

Dallas, Texas, United States

Seattle, Washington, United States

Wentworthville, New South Wales, Australia

Melbourne, Victoria, Australia

Toronto, Ontario, Canada

Bordeaux, , France

Nice, , France

Paris, , France

Paris, , France

Essen, , Germany

Frankfurt, , Germany

Kiel, , Germany

Mannheim, , Germany

Münster, , Germany

Tübingen, , Germany

Tel Litwinsky, , Israel

Milan, Lombardy, Italy

Siena, Tuscany, Italy

Amsterdam, , Netherlands

Groningen, , Netherlands

Pamplona, Navarre, Spain

Barcelona, , Spain

Madrid, , Spain

Northwood, , United Kingdom

Countries

United States; Australia; Canada; France; Germany; Israel; Italy; Netherlands; Spain; United Kingdom

Other Identifiers

MO25743

Identifier Type: -

Identifier Source: org_study_id