A Study of Vemurafenib in Participants With Metastatic Melanoma

Roche

Status and phase: Completed; Phase 3

Conditions: Malignant Melanoma

Treatments: Drug: Vemurafenib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01307397

2010-023526-21 (EudraCT Number)

MO25515

Details and patient eligibility

About

This multi-center study evaluates the safety and efficacy of vemurafenib in participants with BRAF V600 mutation-positive, surgically incurable, and unresectable Stage IIIC or IV (American Joint Committee on Cancer [AJCC]) metastatic melanoma.

Enrollment: 3,219 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with Histologically confirmed metastatic melanoma (surgically incurable and unresectable Stage IIIC or Stage IV; AJCC) with BRAF V 600 mutation determined by Cobas 4800 BRAF Mutation Test. Unresectable Stage IIIC disease must have had confirmation from a surgical oncologist
• Participants with either measurable or non-measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1
• Participants may or may not have received prior systemic therapy for metastatic melanoma
• Eastern Cooperative Oncology Group (ECOG) performance status between 0 to 2
• Adequate hematologic, renal and liver function

Exclusion criteria

• Evidence of symptomatic central nervous system (CNS) lesions, use of steroids or anti-seizure medications for treatment of brain metastases prior to the first administration of vemurafenib
• Previous malignancy (other than melanoma) 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 anti-cancer therapies other than those administered in the study
• Clinically significant cardiovascular disease or event within the 6 months prior to first administration of study drug
• Refractory nausea or vomiting, external biliary shunt, or significant bowel resection that would preclude adequate absorption

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3,219 participants in 1 patient group

Vemurafenib

Experimental group

Description:

Participants will receive vemurafenib at a dose of 960 milligrams (mg) twice daily (bid) until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant's safety, death, or study termination by the Sponsor, whichever occurs first.

Treatment:

Drug: Vemurafenib