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Spots Global Cancer Trial Database for A Study to Investigate Efficacy and Safety of Cobimetinib Plus Atezolizumab and Atezolizumab Monotherapy Versus Regorafenib in Participants With Metastatic Colorectal Adenocarcinoma (COTEZO IMblaze370)

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Trial Identification

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

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Clinical Trials

Affiliation: Hoffmann-La Roche

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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