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Brief Title: A Study to Investigate Efficacy and Safety of Cobimetinib Plus Atezolizumab and Atezolizumab Monotherapy Versus Regorafenib in Participants With Metastatic Colorectal Adenocarcinoma (COTEZO IMblaze370)
Official Title: A Phase III, Open-Label, Multicenter, Three-Arm, Randomized Study to Investigate the Efficacy and Safety of Cobimetinib Plus Atezolizumab and Atezolizumab Monotherapy vs. Regorafenib in Patients With Previously Treated Unresectable Locally Advanced or Metastatic Colorectal Adenocarcinoma
Study ID: NCT02788279
Brief Summary: This is a Phase III, multicenter, open-label, three-arm, randomized study in participants with unresectable locally advanced or metastatic colorectal cancer (CRC) who have received at least two prior regimens of cytotoxic chemotherapy for metastatic disease. The study compares regorafenib, a standard of care therapy in this setting, to cobimetinib plus atezolizumab and atezolizumab monotherapy.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope Comprehensive Cancer Center, Duarte, California, United States
Yale Cancer Center; Medical Oncology, New Haven, Connecticut, United States
Georgetown University, Washington, District of Columbia, United States
Florida Cancer Specialists; SCRI, Fort Myers, Florida, United States
Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy), Jacksonville, Florida, United States
Florida Cancer Specialists., Saint Petersburg, Florida, United States
Ingalls Cancer Research Center, Harvey, Illinois, United States
Southdale Cancer Clinic U of M Medical Center, Fairview- Edina, Edina, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
North Shore Hem Onc Associates, East Setauket, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
INTEGRIS Cancer Inst of OK, Oklahoma City, Oklahoma, United States
University of Pittsburgh Cancer Institute; Division of Medical Oncology, Pittsburgh, Pennsylvania, United States
SCRI Tennessee Oncology Chattanooga, Chattanooga, Tennessee, United States
Sarah Cannon Research Inst., Nashville, Tennessee, United States
MD Anderson Cancer Center, Houston, Texas, United States
Medical Oncology Associates, Spokane, Washington, United States
Port Macquarie Base Hospital;North Coast Cancer Institute, Port Macquarie, New South Wales, Australia
Northern Cancer Institute, St Leonards, New South Wales, Australia
Sydney Adventist Hospital; Clinical Trial Unit, Sydney, New South Wales, Australia
Monash Medical Centre; Oncology, Clayton, Victoria, Australia
Peninsula and South Eastern Haematology and Oncology Group, Frankston, Victoria, Australia
Austin Health; Cancer Clinical Trial Centre, Heidelberg, Victoria, Australia
Imeldaziekenhuis, Bonheiden, , Belgium
Cliniques Universitaires St-Luc, Bruxelles, , Belgium
GHdC Site Notre Dame, Charleroi, , Belgium
AZ Groeninge, Kortrijk, , Belgium
UZ Leuven Gasthuisberg, Leuven, , Belgium
Tom Baker Cancer Centre-Calgary, Calgary, Alberta, Canada
Cross Cancer Institute; Clinical Trials, Edmonton, Alberta, Canada
BCCA-Vancouver Cancer Centre, Vancouver, British Columbia, Canada
The Ottawa Hospital, Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
McGill University Health Center, Cedar Cancer Center, Montreal, Quebec, Canada
Hopital du Sacre-Coeur, Montreal, Quebec, Canada
CHU de Québec, Quebec City, Quebec, Canada
Queen Mary Hospital; Dept. of Clinical Oncology, Hong Kong, , Hong Kong
Tuen Mun Hospital; Clinical Oncology, Hong Kong, , Hong Kong
Prince of Wales Hosp; Dept. Of Clinical Onc, Shatin, , Hong Kong
Azienda Osp Uni Seconda Università Degli Studi Di Napoli; Unità Operativa Oncologia Medica, Napoli, Campania, Italy
A.O. Universitaria Policlinico Di Modena; Oncologia, Modena, Emilia-Romagna, Italy
Istit. Naz. per la Ricerca sul Cancro - Az. Osped. S. Martino, Genova, Liguria, Italy
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1, Milano, Lombardia, Italy
Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia, Milano, Lombardia, Italy
IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia, San Giovanni Rotondo, Puglia, Italy
A.O. Universitaria Pisana; Oncologia, Pisa, Toscana, Italy
National Cancer Center, Gyeonggi-do, , Korea, Republic of
Chonnam National University Hwasun Hospital, Jeollanam-do, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Asan Medical Center - Oncology, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Yonsei University Health System/Severance Hospital, Seoul, , Korea, Republic of
Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy, Bydgoszcz, , Poland
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii, Gdańsk, , Poland
Szpitale Pomorskie Sp. z o. o., Gdynia, , Poland
Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii, Krakow, , Poland
Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii, Lodz, , Poland
Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, , Russian Federation
N.N.Burdenko Main Military Clinical Hospital; Oncology Dept, Moscow, , Russian Federation
BHI of Omsk region Clinical Oncology Dispensary, Omsk, , Russian Federation
Hospital Univ Vall d'Hebron; Servicio de Oncologia, Barcelona, , Spain
Hospital Ramon y Cajal; Servicio de Oncologia, Madrid, , Spain
Hospital Clinico San Carlos; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia, Madrid, , Spain
Hospital de Navarra; Servicio de Oncologia, Navarra, , Spain
Hospital Clínico Universitario de Valencia; Servicio de Oncología, Valencia, , Spain
Birmingham Heartlands Hospital; Dept of Oncology, Birmingham, , United Kingdom
Royal Marsden Hospital - Fulham; Oncology Department, London, , United Kingdom
The Christie; GI Research Office, Manchester, , United Kingdom
Churchill Hospital; Department of Oncology, Oxford, , United Kingdom
Queen's Hospital, Romford, , United Kingdom
Weston Park Hospital; Cancer Clinical Trials Centre, Sheffield, , United Kingdom
Royal Marsden Hospital; Dept of Medical Oncology, Sutton, , United Kingdom
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR