CO39262 - Atezolizumab in patients with untreated advanced melanoma
Research type
Research Study
Full title
A phase III, double-blinded, randomized, placebo-controlled study of atezolizumab plus cobimetinib and vemurafenib versus placebo plus cobimetinib and vemurafenib in previously untreated BRAFv600 mutation−positive patients with unresectable locally advanced or metastatic melanoma
IRAS ID
215840
Contact name
Jeff Evans
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2016-002482-54
Duration of Study in the UK
3 years, 0 months, 22 days
Research summary
Despite recent therapeutic advances, metastatic melanoma continues to be one of the most deadly cancers, with a relative 5-year survival rate of 15%−17%. In 2012, there were around 232,000 new cases and 55,000 deaths from melanoma worldwide. The number of melanoma cases worldwide is increasing faster than any other cancer, especially in fair-skinned, Caucasian populations.
Approximately half of all cutaneous melanomas have a mutation in BRAF, a major driver of cell signalling. More than 40 BRAF mutations have been described, the most common of which is known as V600E.In the past several years new agents have been approved for the treatment of BRAFV600 mutation-positive advanced melanoma in the European Union, these include: targeted therapies (BRAK and MEK inhibitors), immunotherapies and vaccines. Combined targeted therapy has improved effectiveness (as compared with monotherapy with a BRAF inhibitor), with response rates of approximately 70% and progression-free survival of 11−14 months across trials.
Combination immunotherapy has demonstrated an increased overall response rate and improved progression free survival but results in challenging toxicity.
Despite advances in treatments for patients with advanced melanoma, a significant unmet medical for more efficacious treatment options remains.Atezolizumab shows anti-tumour activity in both nonclinical models and cancer patients and is being investigated as a potential therapy in a wide variety of malignancies. Atezolizumab is being studied as a single agent in the advanced cancer and adjuvant therapy settings, as well as in combination with chemotherapy, targeted therapy, and cancer immunotherapy.
The aim of this study is to evaluate the efficacy of placebo, cobimetinib and vemurafenib (Arm A) with atezolizumab, cobimetinib and vemurafenib (Arm B) as measured by investigator-assessed Progression Free Survival.
Patients will be treated in 28 day cycles and randomised (1:1).
A planned 500 patients will be enrolled globally with 30 patients in the UK across 7 sites.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
16/EM/0512
Date of REC Opinion
20 Jan 2017
REC opinion
Further Information Favourable Opinion