GO28141 PhIII Vemurafenib Vs Vemurafenib + GDC-0973 in Melanoma
Research type
Research Study
Full title
A Phase III, Double-Blind, Placebo-Controlled Study of Vemurafenib Versus Vemurafenib Plus GDC-0973 in previously untreated BRAFV600-Mutation Positive Patients with Unresectable Locally Advanced or Metastatic Melanoma
IRAS ID
115748
Contact name
James Michael George Larkin
Sponsor organisation
F.Hoffmann-La Roche Ltd
Eudract number
2012-003008-11
Clinicaltrials.gov Identifier
Research summary
This global study aims to evaluate the safety and efficacy of vemurafenib in combination with GDC-0973 or vemurafenib alone and how it can help prevent or delay the return of melanoma after surgical removal. It will assess whether vemurafenib or GDC-0973 causes side effects in patients, how it is processed by the body and look at the effect on proteins (biomarkers) in the blood, tumour or skin to provide information on response to treatment. Genes contain information to make protein. A large number of melanoma tumours have changes (mutations) in the BRAF gene. Vemurafenib works by preventing these changed BRAF proteins from working and therefore blocks the growth and spread of cancer cells. GDC-0973 works by blocking a protein called MEK that has been known to stimulate cells that also promote melanoma growth.Approximately 500 previously untreated BRAFV600 mutation-positive patients with unresectable locally advanced or metastatic melanoma will be randomly assigned in a 1:1 ratio to receive treatment with one of the following regimens:Vemurafenib ?? 960 mg twice each day, in 240mg tablets (4 tablets in the morning and 4 tablets in evening) GDC-0973 (or placebo) - 60 mg every day, in 20mg tablets (3 tablets in the morning), on Days 1 to 21 of each treatment cycle.This is a ??double-blind?? study neither the study doctors nor the patients will know which drug has been assigned.Study visits will occur on Days 1, and 15 of Cycles 1, 2 and 3 and on Day 1 of every subsequent treatment cycles (every 4 weeks). Patients may continue on study treatment until the development of progressive disease, unacceptable toxicity, and/or consent withdrawal. Patients who discontinue study treatment for any reason will be followed for SCC (squamous cell carcinoma), followed for disease progression and followed for survival until death, withdrawal of consent, or they are lost to follow-up.
REC name
London - Brent Research Ethics Committee
REC reference
12/LO/1876
Date of REC Opinion
6 Feb 2013
REC opinion
Further Information Favourable Opinion