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

PHASE3CompletedINTERVENTIONAL
Enrollment

363

Participants

Timeline

Start Date

July 5, 2016

Primary Completion Date

March 9, 2018

Study Completion Date

December 26, 2018

Conditions
Colorectal Cancer
Interventions
DRUG

Atezolizumab (MPDL3280A), an Engineered Anti-PDL1 Antibody

Participants will receive atezolizumab IV at 840 mg on Day 1 and Day 15 in a 28-day cycle as a combination therapy or at 1200 mg on Day 1 in a 21-day cycle as a monotherapy until disease progression according to RECIST Version 1.1, unacceptable toxicity, death, participant's or physician decision to withdraw, or pregnancy, whichever occurs first.

DRUG

Cobimetinib

Participants will receive cobimetinib 60 mg orally on Days 1 to 21 in a 28-day cycle as a combination therapy until disease progression according to RECIST Version 1.1, unacceptable toxicity, death, participant's or physician decision to withdraw, or pregnancy, whichever occurs first.

DRUG

Regorafenib

Participants will receive regorafenib 160 mg orally on Days 1 to 21 in a 28-day cycle until disease progression according to RECIST Version 1.1, unacceptable toxicity, death, participant's or physician decision to withdraw, or pregnancy, whichever occurs first.

Trial Locations (73)

1200

Cliniques Universitaires St-Luc, Brussels

2065

Northern Cancer Institute, St Leonards

2076

Sydney Adventist Hospital; Clinical Trial Unit, Sydney

2444

Port Macquarie Base Hospital;North Coast Cancer Institute, Port Macquarie

2820

Imeldaziekenhuis, Bonheiden

3000

UZ Leuven Gasthuisberg, Leuven

3084

Austin Health; Cancer Clinical Trial Centre, Heidelberg

3168

Monash Medical Centre; Oncology, Clayton

3199

Peninsula and South Eastern Haematology and Oncology Group, Frankston

6000

GHdC Site Notre Dame, Charleroi

8500

AZ Groeninge, Kortrijk

10065

Memorial Sloan Kettering Cancer Center, New York

10408

National Cancer Center, Gyeonggi-do

11733

North Shore Hem Onc Associates, East Setauket

15232

University of Pittsburgh Cancer Institute; Division of Medical Oncology, Pittsburgh

16132

Istit. Naz. per la Ricerca sul Cancro - Az. Osped. S. Martino, Genoa

20007

Georgetown University, Washington D.C.

20133

Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1, Milan

20162

Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia, Milan

28034

Hospital Ramon y Cajal; Servicio de Oncologia, Madrid

28040

Hospital Clinico San Carlos; Servicio de Oncologia, Madrid

28041

Hospital Universitario 12 de Octubre; Servicio de Oncologia, Madrid

31008

Hospital de Navarra; Servicio de Oncologia, Navarra

32256

Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy), Jacksonville

33705

Florida Cancer Specialists., St. Petersburg

33901

Florida Cancer Specialists; SCRI, Fort Myers

37203

Sarah Cannon Research Inst., Nashville

37404

SCRI Tennessee Oncology Chattanooga, Chattanooga

41100

A.O. Universitaria Policlinico Di Modena; Oncologia, Modena

46010

Hospital Clínico Universitario de Valencia; Servicio de Oncología, Valencia

55435

Southdale Cancer Clinic U of M Medical Center, Fairview- Edina, Edina

56100

A.O. Universitaria Pisana; Oncologia, Pisa

58128

Chonnam National University Hwasun Hospital, Jeollanam-do

60426

Ingalls Cancer Research Center, Harvey

63110

Washington University School of Medicine, St Louis

71013

IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia, San Giovanni Rotondo

73142

INTEGRIS Cancer Inst of OK, Oklahoma City

77030

MD Anderson Cancer Center, Houston

80131

Azienda Osp Uni Seconda Università Degli Studi Di Napoli; Unità Operativa Oncologia Medica, Napoli

91010

City of Hope Comprehensive Cancer Center, Duarte

99208

Medical Oncology Associates, Spokane

105229

N.N.Burdenko Main Military Clinical Hospital; Oncology Dept, Moscow

163045

Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk

644013

BHI of Omsk region Clinical Oncology Dispensary, Omsk

06520

Yale Cancer Center; Medical Oncology, New Haven

T2N 4N2

Tom Baker Cancer Centre-Calgary, Calgary

T6G 1Z2

Cross Cancer Institute; Clinical Trials, Edmonton

V5Z 4E6

BCCA-Vancouver Cancer Centre, Vancouver

K1H 8L6

The Ottawa Hospital, Ottawa

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

H3G 1A4

McGill University Health Center, Cedar Cancer Center, Montreal

J4B 5Z7

Hopital du Sacre-Coeur, Montreal

G1J 1Z4

CHU de Québec, Québec

Unknown

Queen Mary Hospital; Dept. of Clinical Oncology, Hong Kong

Tuen Mun Hospital; Clinical Oncology, Hong Kong

Prince of Wales Hosp; Dept. Of Clinical Onc, Shatin

85-796

Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy, Bydgoszcz

80-214

Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii, Gdansk

81-519

Szpitale Pomorskie Sp. z o. o., Gdynia

31-531

Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii, Krakow

93-513

Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii, Lodz

03080

Seoul National University Hospital, Seoul

05505

Asan Medical Center - Oncology, Seoul

06351

Samsung Medical Center, Seoul

120-752

Yonsei University Health System/Severance Hospital, Seoul

08035

Hospital Univ Vall d'Hebron; Servicio de Oncologia, Barcelona

B9 5SS

Birmingham Heartlands Hospital; Dept of Oncology, Birmingham

SW3 6JJ

Royal Marsden Hospital - Fulham; Oncology Department, London

M20 4BX

The Christie; GI Research Office, Manchester

OX3 7LE

Churchill Hospital; Department of Oncology, Oxford

RM7 0AG

Queen's Hospital, Romford

S10 2SJ

Weston Park Hospital; Cancer Clinical Trials Centre, Sheffield

SM2 5PT

Royal Marsden Hospital; Dept of Medical Oncology, Sutton

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02788279 - A Study to Investigate Efficacy and Safety of Cobimetinib Plus Atezolizumab and Atezolizumab Monotherapy Versus Regorafenib in Participants With Metastatic Colorectal Adenocarcinoma (COTEZO IMblaze370) | Biotech Hunter | Biotech Hunter