NCT03625141 - A Study Evaluating the Safety and Efficacy of Cobimetinib Plus Atezolizumab in BRAFV600 Wild-type Melanoma With Central Nervous System Metastases and Cobimetinib Plus Atezolizumab and Vemurafenib in BRAFV600 Mutation-positive Melanoma With Central Nervous System Metastases | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

December 13, 2018

Primary Completion Date

June 7, 2021

Study Completion Date

April 13, 2023

Conditions

Metastatic Melanoma

Interventions

DRUG

Cobimetinib

60 mg (three tablets of 20 mg each) orally (PO) once a day (QD) on Days 1-21 of each 28-day cycle.

DRUG

Atezolizumab

"Atezolizumab will be given at a fixed dose of 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.~Only for cohort 2, no dose of atezolizumab will be given during the run-in period (cycle 1)."

DRUG

Vemurafenib

Participants will receive vemurafenib 960 mg (four 240 mg tablets) orally (PO) twice daily (BID) on days 1-21 of the run-in period (cycle 1); thereafter, they will receive vemurafenib 720 mg dose (three 240 mg tablets) PO BID on days 22-28 of cycle 1 and on days 1-28 of all subsequent cycles.

Trial Locations (22)

1122

Orszagos Onkologiai Intezet; Borgyogyaszati Osztaly, Budapest

8091

Universitätsspital Zürich; USZ Flughafen / H13-7-609, Zurich

16132

IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A, Genoa

20014

Onkologikoa - Instituto Oncológico de Donostia, Donostia / San Sebastian

20141

Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica, Milan

28007

Hospital General Universitario Gregorio Marañon; Servicio de Oncologia, Madrid

31059

Institut Claudius Regaud; Departement Oncologie Medicale, Toulouse

35128

IOV - Istituto Oncologico Veneto IRCCS, Padua

41009

Hospital Universitario Virgen Macarena; Servicio de Oncologia, Seville

44093

CHU de Nantes; Cancéro-dermatologie, Nantes

46014

Hospital General Universitario de Valencia; Servicio de oncologia, Valencia

56126

Azienda Ospedaliero - Universitaria Pisana U.O. Oncologia Medica 2 Universitaria ? Polo Oncologico, Pisa

80131

IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica B, Napoli

94805

Institut Gustave Roussy; Dermatologie, Villejuif

20560-120

Instituto Nacional de Cancer - INCa; Oncologia, Rio de Janeiro

98700-000

Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda, Ijuí

90035-903

Hospital das Clinicas - UFRGS, Porto Alegre

01307

"Universitätsklinikum Carl Gustav Carus; Klinik und Poliklinik fur Dermatologie", Dresden

00167

Istituto Dermopatico dell'Immacolata (IDI)-IRCCS; IV Divisione Oncologica e Dermatologia Oncologica, Rome

LV-1079

Riga East Clinical University Hospital Latvian Oncology Centre, Riga

08036

Hospital Clínic i Provincial; Servicio de Hematología y Oncología, Barcelona

08908

Institut Catala d Oncologia Hospital Duran i Reynals, Barcelona

All Listed Sponsors

lead

Hoffmann-La Roche

INDUSTRY