296
Participants
Start Date
August 19, 2013
Primary Completion Date
January 13, 2017
Study Completion Date
May 5, 2017
Bevacizumab
Bevacizumab will be administered at a dose of 10 milligrams per kilogram (mg/kg) intravenous (IV) every 2 weeks (Q2W) throughout the study, with the exception of bevacizumab monotherapy prior to PD1, which will be given as 15 mg/kg IV every 3 weeks (Q3W).
Lomustine
Lomustine will be administered at a dose of 90 milligrams per square meter (mg/m\^2) orally (PO) every 6 weeks (Q6W), with a cap of 160 milligrams (mg) per dose. In the absence of hematologic toxicity following the first dose, the second and subsequent doses may be increased to 110 mg/m\^2 PO Q6W, with a cap of 200 mg per dose.
Placebo
Placebo will be administered via IV infusion, in a formulation matched to bevacizumab, Q2W after randomization.
Radiotherapy
Radiotherapy will be administered for a total dose of 60 Gray (Gy), administered in 2-Gy fractions, 5 days per week for 6 weeks during first-line treatment.
Temozolomide
Temozolomide will be administered orally (PO) as 75 mg/m\^2 per day for the first 6 weeks of first-line treatment (concurrent treatment), followed by 6 cycles (28 days each) as follows: 150 mg/m\^2 per day for the first 5 days of Cycle 1, then 200 mg/m\^2 per day (if permitted by the participant's hematological and non-hematological toxicity profile) for the first 5 days of Cycles 2-6.
SOC Agent
The choice of SOC agent will be at the discretion of investigator. The SOC agent will be administered during third-line treatment and subsequent lines, as per standard practice.
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie, Vienna
Kaiser-Franz-Josef-Spital; Neurologische Abteilung, Vienna
MBAL Serdika EOOD, Sofia
Kepler Universitätsklinikum GmbH - Neuromed Campus; Innere Medizin mit Neuroonkologie, Linz
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt., Salzburg
Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie, Innsbruck
Medizinische Universität Graz; Universitätsklinik für Neurologie, Graz
Clinical Hospital Centre Zagreb, Zagreb
Azienda Ospedaliera Le Molintte di Torino; Dipartimento Di Neurologia - Oncologia, Turin
Hopital de La Timone - CHU de Marseille; Service de neuro-oncologie - Hôpital Adultes - 12ème étage, Marseille
Hospital Universitario Reina Sofia; Servicio de Oncologia, Córdoba
Hopital Cote De Nacre; Unite Neurologie Generale, Caen
Agioi Anargyroi Anticancer Hospital; Radiotherapeutic Clinic, Kifissia
Hygeia Hospital, Marousi
IInstituto Oncologico de San Sebastian, Oncologikoa; Servicio de Oncologia, Donostia / San Sebastian
Fondazione IRCCS Istituto Neurologico C. Besta; Neuro-oncologia Sperimentale e Terapia Genica, Milan
Centre Georges Francois Leclerc; Oncologie 3, Dijon
HOPITAL JEAN MINJOZ; Oncologie, Besançon
Hospital Ramon y Cajal; Servicio de Oncologia, Madrid
Hosp. Clinico San Carlos, Madrid
Hospital Universitario 12 de Octubre; Servicio de Oncologia, Madrid
Hospital Universitario La Paz; Servicio de Oncologia, Madrid
HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia, Madrid
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia, Málaga
Hopital Purpan, Toulouse
Kocaeli University Faculty of Medicine; Medical oncology, İzmit
Hopital Saint Andre; Département de Radiothérapie Et D'Oncologie Médicale, Bordeaux
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda, Padua
Dokuz Eylul Uni ; Medical Oncology, Izmir
Hospital Clinico Universitario de Salamanca; Servicio de Oncologia, Salamanca
Ospedale Bellaria; U.O. Oncologia Medica, Bologna
Hospital de Cruces; Servicio de Oncologia, Bilbao
Tartu University Hospital; Clinic of Hematology and Oncology, Tartu
Hôpital Central; Departement de Neuro-Oncologie, Nancy
Universitetssjukhuset; Onkologkliniken, Linköping
Hopital Roger Salengro; Service de Neurologie, Lille
Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie, Bron
Akademiska sjukhuset, Onkologkliniken, Uppsala
Hopital Pitié Salpétrière - CHU; Service de neurologie 2 - Mazarin, Paris
Hopital Avicenne; Neurologie, Bobigny
Institut Oncologic Ion Chiricuta; Departament Radioterapie, Cluj-Napoca
Spital Clinic Judetean Mures; Oncologie, Târgu Mureş
Tom Baker Cancer Centre; Dept of Medicine, Calgary
McGill University; Montreal Neurological Institute; Oncology, Montreal
Papageorgiou General Hospital; Medical Oncology, Thessaloniki
IFO - Istituto Regina Elena; Oncologia Medica, Rome
Riga East Clinical University hospital, Clinic Gailezers, Dept of Neurosurgery, Riga
IPO de Coimbra; Servico de Oncologia Medica, Coimbra
Hospital de Santa Maria; Servico de Oncologia Medica, Lisbon
Hospital de Sao Joao; Servico de Oncologia, Porto
Institutul Oncologic Prof. Dr. Al. Trestioreanu Bucuresti, Bucharest
Hospital Universitario Son Espases; Servicio de Oncologia, Palma de Mallorca
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia, Badalona
Hospital Universitario Infanta Cristina; Servicio de Oncologia, Badajoz
Hospital del Mar; Servicio de Oncologia, Barcelona
Hospital Duran i Reynals; Oncologia, Barcelona
Norrlands Universitetssjukhus; Cancer Centrum, Umeå
Adana City Hospital, Medical Oncology, Adana
Baskent Universitesi Tıp Fakultesi; Ic Hastalıkları Anabilim Dalı Tıbbi Onkoloji Bilim Dalı, Ankara
Bristol Haematology and Oncology Centre, Bristol
Addenbrookes Hospital; Dept of Oncology, Cambridge
University College Hospital; Department of Oncology, London
Christie Hospital Nhs Trust; Medical Oncology, Manchester
Royal Marsden Hospital; Dept of Medical Oncology, Sutton
Hoffmann-La Roche
INDUSTRY