CO39722 - Cobimetinib and atezolizumab v's pembrolizumab in melanoma
Research type
Research Study
Full title
A phase III, open-label, multicenter, two-arm, randomized study to investigate the efficacy and safety of cobimetinib plus atezolizumab versus pembrolizumab in patients with previously untreated advanced brafv600 wild-type melanoma
IRAS ID
229212
Contact name
Guy Faust
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2016-004387-18
Clinicaltrials.gov Identifier
CANC 34606, Portfolio
Duration of Study in the UK
6 years, 8 months, 1 days
Research summary
Melanoma is a potentially deadly form of skin cancer, the clinical outcome is highly dependent on the stage at presentation. In the metastatic setting, high rates of mortality and disease-related morbidity have improved significantly with recent therapeutic advances. In 2012, there were approximately 232,000 new cases and 55,000 deaths from melanoma worldwide, with more than 100,000 new cases and 22,000 deaths in Europe. Moreover, the number of melanoma cases worldwide is increasing faster than any other cancer. Estimates suggest a doubling of the incidence of melanoma every 10−20 years. Until recently, treatment options for metastatic melanoma were limited.
In recent years, targeting of the MAPK pathway has emerged as an effective treatment strategy in BRAFV600-mutated melanoma. Both single-agent and combination immunotherapy with pembrolizumab, ipilimumab, and/or nivolumab have demonstrated an increased overall response rate (ORR) and improved progression free survival for the treatment of BRAF wild-type unresectable or metastatic melanoma with prolonged duration of responses (DORs).
Treatment options are limited for patients with advanced BRAFV600 wild-type melanoma whose disease is unresectable or metastatic. Given the unmet need in this indication, the efficacy and safety data for cobimetinib and atezolizumab given as single agents and in combination in advanced melanoma, suggest that the effects of cobimetinib on tumour immune contexture may sensitize tumors to anti−PD-1 and anti−PD-L1 agents. With a potentially much improved tolerated safety profile and the extent of safety monitoring proposed, the potential benefits for patients with this indication outweigh the potential risks.
The aim of this study is to evaluate the efficacy of cobimetinib and atezolizumab (Arm A) with pembrolizumab (Arm B) as measured by investigator-assessed Progression Free Survival.Patients will be randomised 1:1 to each of the study arms.
A planned 450 patients will be enrolled globally with 35 patients in the UK across 13 sites.REC name
London - London Bridge Research Ethics Committee
REC reference
17/LO/1656
Date of REC Opinion
7 Nov 2017
REC opinion
Further Information Favourable Opinion