Phase
Condition
Adenocarcinoma
Colon Cancer
Colorectal Cancer
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Disease-specific inclusion criteria:
Histologically confirmed adenocarcinoma originating from the colon or rectum (Stage 4American Joint Committee on Cancer [AJCC] 7th edition)
Experienced disease progression or was intolerant to at least two systemicchemotherapy regimens for metastatic colorectal cancer that must have includedfluroropyrimidines, irinotecan, and oxaliplatin; adjuvant regimen can be considered asone chemotherapy regimen for metastatic disease if the participant had diseaserecurrence within 6 months of completion; disease progression must have occurredwithin 3 months of the last systemic therapy administration General inclusion criteria:
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Anticipated life expectancy greater than or equal to (>=) 3 months
Adequate hematologic and end organ function
Women of childbearing potential must agree to appropriately use an effective form ofcontraception (failure rate of less than [<] 1 percent [%] per year) during thetreatment period, within 5 months after the last dose of atezolizumab, and within 3months after the last dose of cobimetinib and regorafenib
Men must agree not to donate sperm or have intercourse with a female partner withoutusing appropriate barrier contraception during the treatment period and for 3 monthsafter the last dose of either cobimetinib or regorafenib
Provide an archival or newly obtained tumor tissue sample
Exclusion
Exclusion Criteria:
After the approximate 5% cap for microsatellite (MSI)-high participants is reached,only MSI-stable participants will be eligible
Once the 50% cap for wild-type RAS has been reached, only extended RAS-mutantparticipants will be eligible
Major surgery or radiotherapy within 21 days prior to Cycle 1 Day 1 or anticipation ofneeding such procedure while receiving study treatment
Treatment with any anti-cancer agent within 14 days prior to Cycle 1 Day 1
Uncontrolled tumor-related pain. Participants requiring narcotic pain medication mustbe on a stable regimen at study entry
Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeateddrainage more than once every 28 days. Indwelling drainage catheters (e.g., PleurX®)are allowed
Active or untreated central nervous system (CNS) metastases are excluded
Prior therapy with any cancer immunotherapy, MEK inhibitor, or regorafenib
Participants with active malignancy (other than CRC) or a prior malignancy within thepast 3 years are excluded. Participants with completely resected cutaneous melanoma (early stage), basal cell carcinoma, cutaneous squamous cell carcinoma, cervicalcarcinoma in-situ, breast carcinoma in-situ, and localized prostate cancer areeligible
Unstable angina, new onset angina within last 3 months, myocardial infarction withinlast 6 months and current congestive heart failure New York Heart Association Class IIor higher
Left ventricular ejection fraction (LVEF) below institutional lower limit of normal orbelow 50%, whichever is lower
Poorly controlled hypertension, defined as a blood pressure consistently above 150/90millimeters of Mercury (mmHg) despite optimal medical management
Human immunodeficiency virus (HIV) infection
Active tuberculosis infection
Severe infections within 2 weeks prior to Cycle 1 Day 1
Active or chronic viral hepatitis B or C infection
History of or evidence of retinal pathology on ophthalmologic examination that isconsidered a risk factor for central serous retinopathy, retinal vein occlusion, orneovascular macular degeneration
Participants will be excluded if they currently have any of the risk factors asdefined in the study protocol for retinal vein occlusion
History of autoimmune disease
History of idiopathic pulmonary fibrosis, organizing pneumonia, bronchiolitisobliterans, drug-induced pneumonitis, or idiopathic pneumonitis
History of organ transplantation including allogeneic bone marrow transplantation
Inability to swallow medications
Malabsorption condition that would alter the absorption of orally administeredmedications
Pregnant, lactating, breastfeeding, or intending to become pregnant during the study
Administration of a live, attenuated vaccine within 4 weeks before randomization oranticipation of a live attenuated vaccine will be required during the study
Study Design
Connect with a study center
Bankstown Hospital; Medical Oncology
Bankstown, New South Wales 2200
AustraliaSite Not Available
Port Macquarie Base Hospital;North Coast Cancer Institute
Port Macquarie, New South Wales 2444
AustraliaSite Not Available
Northern Cancer Institute
St Leonards, New South Wales 2065
AustraliaSite Not Available
Sydney Adventist Hospital; Clinical Trial Unit
Sydney, New South Wales 2076
AustraliaSite Not Available
Monash Medical Centre; Oncology
Clayton, Victoria 3168
AustraliaSite Not Available
Monash Medical Centre; Oncology
East Bentleigh, Victoria VIC 3165
AustraliaSite Not Available
Peninsula and South Eastern Haematology and Oncology Group
Frankston, Victoria 3199
AustraliaSite Not Available
Austin Health; Cancer Clinical Trial Centre
Heidelberg, Victoria 3084
AustraliaSite Not Available
Imeldaziekenhuis
Bonheiden, 2820
BelgiumSite Not Available
Cliniques Universitaires St-Luc
Bruxelles, 1200
BelgiumSite Not Available
GHdC Site Notre Dame
Charleroi, 6000
BelgiumSite Not Available
AZ Groeninge
Kortrijk, 8500
BelgiumSite Not Available
UZ Leuven Gasthuisberg
Leuven, 3000
BelgiumSite Not Available
Tom Baker Cancer Centre-Calgary
Calgary, Alberta T2N 4N2
CanadaSite Not Available
Cross Cancer Institute; Clinical Trials
Edmonton, Alberta T6G 1Z2
CanadaSite Not Available
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia V5Z 4E6
CanadaSite Not Available
The Ottawa Hospital
Ottawa, Ontario K1H 8L6
CanadaSite Not Available
Sunnybrook Health Sciences Centre
Toronto, Ontario M4N 3M5
CanadaSite Not Available
Hopital du Sacre-Coeur
Montreal, Quebec J4B 5Z7
CanadaSite Not Available
McGill University Health Center, Cedar Cancer Center
Montreal, Quebec H3G 1A4
CanadaSite Not Available
CHU de Québec
Quebec City, Quebec G1J 1Z4
CanadaSite Not Available
Clinique Sainte Catherine
Avignon, 84082
FranceSite Not Available
Chr De Besancon - Hopital Jean Minjoz
Besancon, 25030
FranceSite Not Available
Institut Bergonie CLCC Bordeaux
Bordeaux, 33000
FranceSite Not Available
Centre Oscar Lambret
Lille, 59020
FranceSite Not Available
Centre Leon Berard
Lyon, 69008
FranceSite Not Available
Centre Antoine Lacassagne
Nice, 06189
FranceSite Not Available
European Hospital Georges Pompidou (HEGP)
Paris, 75908
FranceSite Not Available
ICO Rene Gauducheau; CEC
St Herblain, 44805
FranceSite Not Available
CHU de Toulouse - Hôpital Rangueil
Toulouse Cedex 09, 31059
FranceSite Not Available
Gemeinschaftspraxis Brudler/ Heinrich/ Bangerter
Augsburg, 86150
GermanySite Not Available
University Hospital Dresden Medizinische Klink I und Poliklinik I
Dresden, 01307
GermanySite Not Available
Krankenhaus Nordwest
Frankfurt am Main, 60488
GermanySite Not Available
Onkologische Schwerpunktpraxis Eppendorf
Hamburg, 20249
GermanySite Not Available
SLK-Kliniken Heilbronn GmbH
Heilbronn, 74078
GermanySite Not Available
Universitätsklinikum Mannheim, Tagestherapiezentrum, Interdisziplinäres Tumorzentrum
Mannheim, 68167
GermanySite Not Available
Klinikum am Steinenberg / Ermstalklinik
Reutlingen, 72764
GermanySite Not Available
Universitaetsklinikum Ulm
Ulm, 89081
GermanySite Not Available
Queen Mary Hospital; Dept. of Clinical Oncology
Hong Kong,
Hong KongSite Not Available
Tuen Mun Hospital; Clinical Oncology
Hong Kong,
Hong KongSite Not Available
Prince of Wales Hosp; Dept. Of Clinical Onc
Shatin,
Hong KongSite Not Available
Azienda Osp Uni Seconda Università Degli Studi Di Napoli; Unità Operativa Oncologia Medica
Napoli, Campania 80131
ItalySite Not Available
A.O. Universitaria Policlinico Di Modena; Oncologia
Modena, Emilia-Romagna 41100
ItalySite Not Available
Arcispedale Santa Maria Nuova; Oncologia
Reggio Emilia, Emilia-Romagna 42100
ItalySite Not Available
Istit. Naz. per la Ricerca sul Cancro - Az. Osped. S. Martino
Genova, Liguria 16132
ItalySite Not Available
Fondazione Poliambulanza Istituto Ospedaliero
Brescia, Lombardia 25124
ItalySite Not Available
Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
Milano, Lombardia 20162
ItalySite Not Available
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
Milano, Lombardia 20133
ItalySite Not Available
IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia
San Giovanni Rotondo, Puglia 71013
ItalySite Not Available
A.O. Universitaria Pisana; Oncologia
Pisa, Toscana 56100
ItalySite Not Available
Kyungpook National University Medical Center
Daegu, 41404
Korea, Republic ofSite Not Available
National Cancer Center
Gyeonggi-do, 10408
Korea, Republic ofSite Not Available
Chonnam National University Hwasun Hospital
Jeollanam-do, 58128
Korea, Republic ofSite Not Available
Asan Medical Center - Oncology
Seoul, 05505
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul, 06351
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofSite Not Available
Yonsei University Health System/Severance Hospital
Seoul, 120-752
Korea, Republic ofSite Not Available
Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy
Bydgoszcz, 85-796
PolandSite Not Available
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
Gdansk, 80-952
PolandSite Not Available
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
Gdańsk, 80-214
PolandSite Not Available
Szpitale Pomorskie Sp. z o. o.
Gdynia, 81-519
PolandSite Not Available
empty
Gdyr, 81-519
PolandSite Not Available
Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
Krakow, 31-531
PolandSite Not Available
Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii
Lodz, 93-513
PolandSite Not Available
Arkhangelsk Regional Clinical Oncology Dispensary
Arkhangelsk, 163045
Russian FederationSite Not Available
N.N.Burdenko Main Military Clinical Hospital; Oncology Dept
Moscow, 105229
Russian FederationSite Not Available
BHI of Omsk region Clinical Oncology Dispensary
Omsk, 644013
Russian FederationSite Not Available
Hospital Universitario Reina Sofia; Servicio de Oncologia
Córdoba, Cordoba 14004
SpainSite Not Available
empty
A Coruña, La Coruña 15706
SpainSite Not Available
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
Santiago de Compostela, La Coruña 15706
SpainSite Not Available
empty
Pamplona, Navarra 31008
SpainSite Not Available
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, 08035
SpainSite Not Available
Hospital Universitario Reina Sofia; Servicio de Oncologia
Cordoba, 14004
SpainSite Not Available
Hospital Clinico San Carlos; Servicio de Oncologia
Madrid, 28040
SpainSite Not Available
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid, 28034
SpainSite Not Available
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, 28041
SpainSite Not Available
Hospital de Navarra; Servicio de Oncologia
Navarra, 31008
SpainSite Not Available
Hospital Clínico Universitario de Valencia; Servicio de Oncología
Valencia, 46010
SpainSite Not Available
Birmingham Heartlands Hospital; Dept of Oncology
Birmingham, B9 5SS
United KingdomSite Not Available
St James Hospital; Dept of Oncology/Hematology
Leeds, LS9 7TF
United KingdomSite Not Available
Royal Marsden Hospital - Fulham; Oncology Department
London, SW3 6JJ
United KingdomSite Not Available
Maidstone & Tonbridge Wells Hospital; Kent Oncology Center
Maidstone, ME16 9QQ
United KingdomSite Not Available
The Christie; GI Research Office
Manchester, M20 4BX
United KingdomSite Not Available
Churchill Hospital; Department of Oncology
Oxford, OX3 7LE
United KingdomSite Not Available
Queen's Hospital
Romford, RM7 0AG
United KingdomSite Not Available
Scarborough General Hospital
Scarborough, YO12 6QL
United KingdomSite Not Available
Weston Park Hospital; Cancer Clinical Trials Centre
Sheffield, S10 2SJ
United KingdomSite Not Available
Royal Marsden Hospital; Dept of Medical Oncology
Sutton, SM2 5PT
United KingdomSite Not Available
City of Hope Comprehensive Cancer Center
Duarte, California 91010
United StatesSite Not Available
USC Norris Cancer Center
Los Angeles, California 90033
United StatesSite Not Available
Kaiser Permanente Of Colorado
Denver, Colorado 80205
United StatesSite Not Available
Yale Cancer Center; Medical Oncology
New Haven, Connecticut 06520
United StatesSite Not Available
Georgetown University
Washington, District of Columbia 20007
United StatesSite Not Available
Georgetown University
Washington, D.C., District of Columbia 20007
United StatesSite Not Available
Florida Cancer Specialists; SCRI
Fort Myers, Florida 33901
United StatesSite Not Available
Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)
Jacksonville, Florida 32256
United StatesSite Not Available
Florida Cancer Specialists.
Saint Petersburg, Florida 33705
United StatesSite Not Available
Florida Cancer Specialists.
St.Petersburg, Florida 33705
United StatesSite Not Available
Florida Cancer Specialists
West Palm Beach, Florida 33401
United StatesSite Not Available
Ingalls Cancer Research Center
Harvey, Illinois 60426
United StatesSite Not Available
empty
Fort Wayne, Indiana 46845
United StatesSite Not Available
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United StatesSite Not Available
Southdale Cancer Clinic U of M Medical Center, Fairview- Edina
Edina, Minnesota 55435
United StatesSite Not Available
Mayo Clinic - Rochester
Rochester, Minnesota 55905
United StatesSite Not Available
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
Washington University School of Medicine
St. Louis, Missouri 63110
United StatesSite Not Available
North Shore Hem Onc Associates
East Setauket, New York 11733
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesSite Not Available
INTEGRIS Cancer Inst of OK
Oklahoma City, Oklahoma 73142
United StatesSite Not Available
University of Pittsburgh Cancer Institute; Division of Medical Oncology
Pittsburgh, Pennsylvania 15232
United StatesSite Not Available
SCRI Tennessee Oncology Chattanooga
Chattanooga, Tennessee 37404
United StatesSite Not Available
Sarah Cannon Research Inst.
Nashville, Tennessee 37203
United StatesSite Not Available
MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
Medical Oncology Associates
Spokane, Washington 99208
United StatesSite Not Available
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