A phase II study of Cobimetnib + Atezolizmab in patients with tumours
Research type
Research Study
Full title
A PHASE II, OPEN-LABEL, MULTICENTER, MULTI-COHORT STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF COBIMETINIB PLUS ATEZOLIZUMAB IN PATIENTS WITH SOLID TUMORS
IRAS ID
227637
Contact name
Thomas Powles
Contact email
Sponsor organisation
F. Hoffman-La Roche Ltd.
Eudract number
2017-000794-37
Duration of Study in the UK
2 years, 11 months, 3 days
Research summary
The purpose of this study is to evaluate the safety and effectiveness of cobimetinib plus atezolizumab, in patients with cancer that has spread to other parts of the body (metastatic), and cannot be removed by surgery (unresectable).\nCobimetinib (Cotellic®) is a type of drug called a MEK inhibitor. A MEK inhibitor can be used to block pathways of certain enzymes that can be overactive in some cancers. Cobimetinib is approved in the United States, Europe, and other countries for the treatment of metastatic melanoma when used together with vemurafenib (Zelboraf®). For all other cancers, cobimetinib is still considered an experimental drug. This means health authorities have not approved cobimetinib either alone or in combination with any drug for the treatment of solid tumours.\nAtezolizumab is a type of drug called a programmed death ligand receptor-1 (PD-L1) blocker. A PD-L1 blocker can inhibit PD-L1 from suppressing the immune system in certain conditions like cancer. Atezolizumab (Tecentriq®) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of metastatic urothelial bladder cancer and metastatic non-small cell lung cancer. For all other cancers, atezolizumab is still considered an experimental drug. \nThis research study is also looking to evaluate the anti-cancer activity of cobimetinib plus atezolizumab in you and your cancer and to evaluate the safety (side effects) of this drug combination and to test for the amount of study drug in your blood in order to understand how it affects your body\n
REC name
South Central - Oxford A Research Ethics Committee
REC reference
17/SC/0319
Date of REC Opinion
22 Sep 2017
REC opinion
Further Information Favourable Opinion