- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03148418
A Study in Participants Previously Enrolled in a Genentech- and/or F. Hoffmann-La Roche Ltd-Sponsored Atezolizumab Study (IMbrella A)
An Open-Label, Multicenter Extension and Long-Term Observational Study in Patients Previously Enrolled in a Genentech- and/or F. Hoffmann-La Roche Ltd-Sponsored Atezolizumab Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Buenos Aires, Argentina, C1125ABD
- Fundación CENIT para la Investigación en Neurociencias
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New South Wales
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Camperdown, New South Wales, Australia, 2050
- Chris O'Brien Lifehouse
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Queensland
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Woolloongabba, Queensland, Australia, 4102
- Princess AleXandra Hospital; Department of Medical Oncology
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Wien, Austria, 1210
- Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie
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Wien, Austria, 1140
- Klinik Penzing; Abteilung für Atemwegs- und Lungenkrankheiten
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Ronse, Belgium, 9600
- AZ Glorieux- vzw Werken Glorieux
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Wilrijk, Belgium, 2610
- Sint Augustinus Wilrijk
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SP
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Barretos, SP, Brazil, 14784-400
- Hospital de Cancer de Barretos
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Sao Paulo, SP, Brazil, 01246-000
- Instituto do Cancer do Estado de Sao Paulo - ICESP
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Sao Paulo, SP, Brazil, 01509-900
- Fundacao Antonio Prudente
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Sofia, Bulgaria, 1632
- Multiprofile Hospital for Active Treatment Serdika EOOD; Medical Oncology Department
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Ontario
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Barrie, Ontario, Canada, L4M 6M2
- Royal Victoria Hospital
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Etobicoke, Ontario, Canada, M9V 1R8
- William Osler Health Centre
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Oshawa, Ontario, Canada, L1G 2B9
- Lakeridge Health Corporation-Oshawa; Oncology clinic
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Toronto, Ontario, Canada, M5G 1Z5
- Princess Margaret Cancer Center
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Odette Cancer Centre; Clinical Trials
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Quebec
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Laval, Quebec, Canada, H7M 3L9
- Cite de La Sante de Laval; Hemato-Oncologie
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Montreal, Quebec, Canada, H3T 1E2
- Jewish General Hospital
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Recoleta, Chile, 8420383
- Bradford Hill Centro de Investigaciones Clinicas
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Brno, Czechia, 656 53
- Masarykuv onkologicky ustav
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Praha 4 - Krc, Czechia, 140 59
- Thomayerova Nemocnice
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Besancon, France, 25030
- Hopital Jean Minjoz; Pneumologie
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Grenoble, France, 38043
- Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie
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Lyon, France, 69373
- Centre Leon Berard; Departement Oncologie Medicale
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Marseille, France, 13915
- Hopital Nord; Service d'Oncologie Multidisciplinaire et Innovation Thérapeutique
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Nantes, France, 44805
- Centre René Gauducheau - cancer Nantes - Atlantique; Service Oncologie Médicale
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Nice, France, 06189
- Centre Antoine Lacassagne, Centre de Lutte Contre le Cancer (CLCC) de Nice
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Paris, France, 75970
- Hopital Tenon;Pneumologie
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Paris, France, 75475
- Hopital Saint Louis; Oncologie Medicale
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Paris, France, 75674
- GH Paris Saint Joseph; Pneumologie
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Pierre Benite, France, 69495
- Centre Hospitalier Lyon Sud
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Saint Quentin, France, 2100
- CH de Saint Quentin
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Suresnes, France, 92151
- Centre Medico-Chirurgical Foch; Service de Pneumologie
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Toulouse cedex 9, France, 31100
- CHU de Toulouse - Hôpital Larrey; Service de pneumologie et oncologie pneumologique
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VILLEJUIF Cedex, France, 94805
- Institut Gustave Roussy; Sitep
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München, Germany, 81377
- Klinikum d.Universität München Campus Großhadern
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Budapest, Hungary, 1083
- Semmelweis Egyetem X; Pulmonologiai Klinika
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Torokbalint, Hungary, 2045
- Tüdőgyógyintézet Törökbálint
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Petah Tikva, Israel, 4922297
- Belinson Medical Center
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Campania
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Napoli, Campania, Italy, 80131
- Azienda Osp Uni Seconda Università Degli Studi Di Napoli; Unità Operativa Oncologia Medica
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Napoli, Campania, Italy, 80131
- Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
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Napoli, Campania, Italy, 80131
- Azienda Ospedaliera A. Cardarelli; Dip. Oncopneumoematologico
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Emilia-Romagna
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Modena, Emilia-Romagna, Italy, 41124
- A.O. Universitaria Policlinico Di Modena; Oncologia
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Lazio
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Roma, Lazio, Italy, 00168
- Università Cattolica Del S Cuore
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Liguria
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Genova, Liguria, Italy, 16132
- Irccs Aou San Martino - Ist
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Genova, Liguria, Italy, 16125
- ASL 3 Genovese
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Lombardia
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Milano, Lombardia, Italy, 20133
- Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
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Milano, Lombardia, Italy, 20141
- Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
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Milano, Lombardia, Italy, 20133
- Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
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Monza, Lombardia, Italy, 20900
- ASST DI MONZA; Oncologia Medica
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Piemonte
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Novara, Piemonte, Italy, 28100
- A.O.U. Maggiore della Carità
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Orbassano, Piemonte, Italy, 10043
- Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico
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Sicilia
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Catania, Sicilia, Italy, 95123
- Policlinico Vittorio Emanuele
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Toscana
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Arezzo, Toscana, Italy, 52100
- Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia
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Pisa, Toscana, Italy, 56124
- A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii
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Siena, Toscana, Italy, 53100
- Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica
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Umbria
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Perugia, Umbria, Italy, 06129
- Ospedale Santa Maria Della; Misericordia Di Perugia; Farmacia Ospedaliera
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Veneto
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Padova, Veneto, Italy, 35128
- IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
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Ehime, Japan, 791-0280
- Shikoku Cancer Center
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Iwate, Japan, 028-3695
- Iwate Medical University Hospital; Urology
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Miyagi, Japan, 980-0873
- Sendai Kousei Hospital
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Niigata, Japan, 951-8566
- Niigata Cancer Center Hospital
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Okayama, Japan, 700-8558
- Okayama University Hospital; Respiratory and Allergy Medicine
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Tokyo, Japan, 105-8470
- Toranomon Hospital; Medical Oncology
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Tokyo, Japan, 135-8550
- The Cancer Institute Hospital of JFCR, Respiratory Medicine
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Wakayama, Japan, 641-8510
- Wakayama Medical University Hospital
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Goyang-si, Korea, Republic of, 10408
- National Cancer Center
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Jeollanam-do, Korea, Republic of, 58128
- Chonnam National University Hwasun Hospital
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Seongnam-si, Korea, Republic of, 463-707
- Seoul National University Bundang Hospital
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Seoul, Korea, Republic of, 06351
- Samsung Medical Center
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Amsterdam, Netherlands, 1066 CX
- NKI/AvL
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Auckland, New Zealand, 1023
- Auckland city hospital; Auckland Regional Cancer Centre and Blood Service
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Gdansk, Poland, 80-214
- Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
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Warszawa, Poland, 02-781
- Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers
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Warszawa, Poland, 01-748
- Oddzia? Onkologii Klinicznej i Chemioterapii Szpitala ELBL?SKA
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Lisboa, Portugal, 1649-035
- Hospital de Santa Maria; Servico de Oncologia Medica
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Porto, Portugal, 4099-001
- Centro Hospitalar do Porto ? Hospital de Santo António; Oncologia
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Cluj-napoca, Romania, 400015
- Institut Oncologic Ion Chiricuta; Departament Radioterapie
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Timisoara, Romania, 300239
- ONCOMED - Medical Centre
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Moskovskaja Oblast
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Moscovskaya Oblast, Moskovskaja Oblast, Russian Federation, 143423
- Moscow City Oncology Hospital #62
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Belgrade, Serbia, 11000
- Clinic for Pulmonology, Clinical Center of Serbia
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Belgrade, Serbia, 11080
- University Hospital Medical Center Bezanijska kosa
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Ljubljana, Slovenia, 1000
- Institute of Oncology Ljubljana
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Barcelona, Spain, 08003
- Hospital del Mar; Servicio de Oncologia
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Barcelona, Spain, 08908
- Institut Catala d Oncologia Hospital Duran i Reynals
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Barcelona, Spain, 08041
- Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
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Barcelona, Spain, 08036
- Hospital Clinic de Barcelona. Unidad de Nuevas Terapias;Oncology Department
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Caceres, Spain, 10003
- Hospital San Pedro De Alcantara; Servicio de Oncologia
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Jaen, Spain, 23007
- Complejo Hospitalario de Jaen
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La Coruña, Spain, 15006
- Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
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Lugo, Spain, 27003
- Hospital Lucus Augusti; Servicio de Oncologia
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Madrid, Spain, 28034
- Hospital Ramon y Cajal; Servicio de Oncologia
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Madrid, Spain, 28050
- HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
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Madrid, Spain, 28041
- Hospital Universitario 12 de Octubre; Servicio de Oncologia
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Madrid, Spain, 28040
- Hospital Universitario Clínico San Carlos; Servicio de Oncologia
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Madrid, Spain, 28007
- Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
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Madrid, Spain, 28046
- Hospital Universitario La Paz; Servicio de Oncologia
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Malaga, Spain, 29011
- Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
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Sevilla, Spain, 41013
- Hospital Universitario Virgen del Rocio; Servicio de Oncologia
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Valencia, Spain, 46014
- Hospital General Universitario de Valencia; Servicio de oncologia
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Valencia, Spain, 46015
- Hospital NisA 9 de Octubre
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Barcelona
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Badalona, Barcelona, Spain, 08916
- Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
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Sant Andreu de La Barca, Barcelona, Spain, 08740
- Hospital Univ Vall d'Hebron; Servicio de Oncologia
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Cordoba
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Córdoba, Cordoba, Spain, 14004
- Hospital Universitario Reina Sofia; Servicio de Oncologia
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Islas Baleares
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Palma de Mallorca, Islas Baleares, Spain, 07198
- Hospital Son Llatzer; Servicio de Oncologia
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LAS Palmas
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Las Palmas de Gran Canaria, LAS Palmas, Spain, 35016
- Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia
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Navarra
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Pamplona, Navarra, Spain, 31008
- Clinica Universitaria de Navarra; Servicio de Oncologia
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Lausanne, Switzerland, 1011
- CHUV; Departement d'Oncologie
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Changhua, Taiwan, 500
- Changhua Christian Hospital; Internal Medicine
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Taichung, Taiwan, 40447
- China Medical University Hospital; Urology
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Taipei, Taiwan, 100
- National Taiwan Uni Hospital; Dept of Oncology
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Bangkok, Thailand, 10330
- Chulalongkorn Hospital; Medical Oncology
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Bangkok, Thailand, 10700
- Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
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Bangkok, Thailand, 10400
- Ramathibodi Hospital; Medicine/Oncology
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Edirne, Turkey, 22030
- Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
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Istanbul, Turkey, 34300
- Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
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Sihhiye/Ankara, Turkey, 06230
- Hacettepe Uni Medical Faculty Hospital; Oncology Dept
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Dnipropetrovsk, Ukraine, 49102
- Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU; Chair of Oncology and Medical Radiology
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Podolia Governorate
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Vinnytsia, Podolia Governorate, Ukraine, 21029
- Municipal Institution Podilskiy Regional Center of Oncology; Department of Chemotherapy
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Liverpool, United Kingdom, L7 8YA
- The Clatterbridge Cancer Centre NHS Foundation Trust
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London, United Kingdom, SW3 6JJ
- Royal Marsden Hospital - London
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London, United Kingdom, W6 8RF
- Charing Cross Hospital; Medical Oncology.
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London, United Kingdom, EC1A 7BE
- Barts & London School of Med; Medical Oncology
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London, United Kingdom, NW3 2QG
- Royal Free Hospital; Oncology & Haematology
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London, United Kingdom, SW17 0QT
- St George's Hospital; Oncology
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Manchester, United Kingdom, M20 4BX
- Christie Hospital Nhs Trust
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Nottingham, United Kingdom, NG5 1PB
- Nottingham City Hospital; Oncology
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Surrey, United Kingdom, SM2 5PT
- Royal Marsden Hospital - Surrey
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Arizona
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Scottsdale, Arizona, United States, 85258
- HonorHealth Research Institute ? Bisgrove
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California
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Los Angeles, California, United States, 90024
- UCLA
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Los Angeles, California, United States, 90025
- Angeles Clinic & Rsch Inst
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San Marcos, California, United States, 92078
- Kaiser Permanente - San Diego (Zion Ave)
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado
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Denver, Colorado, United States, 80218
- Rocky Mountain Cancer Ctr - Denver (Williams)
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Connecticut
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New Haven, Connecticut, United States, 06510
- Smilow Cancer Hospital at Yale New Haven
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District of Columbia
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Washington, District of Columbia, United States, 20007
- Georgetown University Medical Center Lombardi Cancer Center
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Florida
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Fort Myers, Florida, United States, 33901
- Florida Cancer Specialists - Fort Myers (Broadway)
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Port Saint Lucie, Florida, United States, 34952
- Hematology Oncology Associates of the Treasure Coast
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Saint Petersburg, Florida, United States, 33705
- Florida Cancer Specialists.
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Tampa, Florida, United States, 33612
- H. Lee Moffitt Cancer Center and Research Inst.
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Georgia
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Carrollton, Georgia, United States, 30117
- Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
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Illinois
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Chicago, Illinois, United States, 60612-3244
- Rush University Medical Center
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Chicago, Illinois, United States, 60637
- University Of Chicago Medical Center; Section Of Hematology/Oncology
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Chicago, Illinois, United States, 60611
- Northwestern University; Robert H. Lurie Comp Can Ctr
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Harvey, Illinois, United States, 60426
- Ingalls Memorial Hospital
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Peoria, Illinois, United States, 61615
- Illinois Cancer Care
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Maine
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Scarborough, Maine, United States, 04074
- New England Cancer Specialists
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Maryland
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Baltimore, Maryland, United States, 21231
- Johns Hopkins Univ Med Center
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Columbia, Maryland, United States, 21044
- Maryland Oncology Hematology, P.A.
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital.
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Boston, Massachusetts, United States, 02115
- Dana Farber Cancer Inst. ; Dept. of Medical Oncology
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Michigan
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Detroit, Michigan, United States, 48201
- Karmanos Cancer Institute
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Minnesota
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Saint Paul, Minnesota, United States, 55102
- US oncology research at Minnesota Oncology
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
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Nevada
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Las Vegas, Nevada, United States, 89169
- Comprehensive Cancer Centers of Nevada - Eastern Avenue
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New Jersey
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Florham Park, New Jersey, United States, 07932
- Summit Medical Center
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New York
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Albany, New York, United States, 12206
- New York Oncology Hematology, P.C.
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Commack, New York, United States, 11725
- Memorial Sloan-Kettering Cancer Center
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New York, New York, United States, 10003
- Beth Israel Medical Center; Division of Digestive Diseases
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North Carolina
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Huntersville, North Carolina, United States, 28078
- Carolina BioOncology Institute, PLCC
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Ohio
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Cleveland, Ohio, United States, 44106
- Cleveland Clinic
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Oregon
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Eugene, Oregon, United States, 97401
- Oncology Associates of Oregon, P.C
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Portland, Oregon, United States, 97227
- Northwest Cancer Specialists - Portland (N Broadway)
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033
- Penn State Hershey Cancer Institute
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Pittsburgh, Pennsylvania, United States, 15212
- Allegheny Cancer Center
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Tennessee
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Nashville, Tennessee, United States, 37203
- Vanderbilt Univ Medical Ctr
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Nashville, Tennessee, United States, 37203
- Sarah Cannon Res Inst; TN Onc
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Texas
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Dallas, Texas, United States, 75246
- Texas Oncology - DFW
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Fort Worth, Texas, United States, 76177
- Tyler Cancer Center
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Virginia
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Norfolk, Virginia, United States, 23502
- Virginia Oncology Associates
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Roanoke, Virginia, United States, 24014
- Blue Ridge Cancer Care
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Washington
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Seattle, Washington, United States, 98195
- University of Washington Seattle Cancer Care Alliance
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Tacoma, Washington, United States, 98405
- Northwest Medical Specialties
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Specific criteria for patients who continue treatment as well as safety and survival follow-up in the extension study (and survival follow up for pattients who roll over from IMpower133):
- Eligible for continuing or crossing over to atezolizumab-based therapy at the time of the parent-study closure as per the parent study or eligible for continuing the comparator agent(s) in a Genentech- or Roche-sponsored study at the time of the parent-study closure as per the parent study, with no access to commercially available comparator agent
- First dose of study treatment in the extension study will be received within 7 days of the treatment interruption window allowed by the parent study
- Continue to benefit from atezolizumab-based study treatment or from the comparator at the time of parent-study closure as assessed by the investigator
- Negative serum pregnancy test within 7 days prior to start of study treatment in women of childbearing potential
Specific criteria for patients from the IMpower133 parent study only who do not continue treatment in the extension study and/or receive commercially available atezolizumab (Tecentriq) outside this extension study and continue safety and survival follow-up only in the extension study:
- Discontinuation of atezolizumab-based therapy in the IMpower133 parent study and in survival follow- up at the time of IMpower133 parent study closure, or eligible for continuing or crossing over to atezolizumab-based therapy as per the IMpower133 parent protocol and have access to commercially available atezolizumab (Tecentriq) outside this extension study at the time of the IMpower133 parent-study closure
Exclusion Criteria:
Specific criteria for patients who continue treatment as well as safety and survival follow-up in the extension study:
- Meet of any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment in the extension study
- Study treatment is commercially marketed in the patient's country for the patient specific disease and is accessible to the patient
- Time between the last dose of treatment received in parent study and first dose in extension study is longer than the interruption period (± 7 days) allowed in the parent study
- Treatment with any anti-cancer treatment (other than treatment permitted in the parent study) during the time between last treatment in the parent study and the first dose of study treatment in the extension study
- Permanent discontinuation of atezolizumab for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in the extension study (if applicable)
- Any unresolved or irreversible toxicities during the parent study that required permanent discontinuation of study treatment, in accordance to the parent study or local prescribing information
- Ongoing SAE(s) that has not resolved to baseline level or Grade less than or equal to (<=) 1 from the parent study or during the time between last treatment in the parent study and the first dose of study treatment in the extension study
- Any serious uncontrolled concomitant disease that would contraindicate the use of study treatment at the time of the extension study or that would place the participant at high risk for treatment-related complications
- Concurrent participation in any therapeutic clinical trial (other than the parent study)
Specific criteria for patients who do not continue treatment in the extension study and/or receive commercially available atezolizumab (Tecentriq) outside this extension study and continue safety and survival follow-up only in the extension study:
- Discontinuation of comparator in parent study and in survival follow-up at the time of parent study closure
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Combined Agents with Atezolizumab
Participants will receive treatment of atezolizumab with combined agent(s) as directed per the parent study.
Participants will receive agent(s) in combination with atezolizumab at the same dose and schedule, and with the same administration guidelines that were in effect at the time of participant discontinuation from the parent study.
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Bevacizumab will be administered as directed per the parent study.
Other Names:
Atezolizumab will be administered as a monotherapy or atezolizumab with other agent(s) as per parent protocol.
Dosing regimen will continue in accordance with the parent study or at equivalent dose (if applicable) and at the same schedule as the parent study, or switch to a fixed atezolizumab dose of 1200 mg every 3 weeks (Q3W).
Other Names:
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Active Comparator: Comparator Treatment
Participants will receive comparator treatment administration as directed per the parent study.
Participants will receive comparator treatment at the same dose and schedule, and with the same administration guidelines that were in effect at the time of participant discontinuation from the parent study.
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Bevacizumab will be administered as directed per the parent study.
Other Names:
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Experimental: Atezolizumab Monotherapy
Participants will continue to receive atezolizumab monotherapy in a Genentech or Roche-sponsored study (the parent study) in accordance with local prescribing information till the participant continues to derive clinical benefit or until death, withdrawal of study consent, unacceptable toxicity, pregnancy, participant non-compliance, or study termination by the Sponsor, whichever occurs first.
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Atezolizumab will be administered as a monotherapy or atezolizumab with other agent(s) as per parent protocol.
Dosing regimen will continue in accordance with the parent study or at equivalent dose (if applicable) and at the same schedule as the parent study, or switch to a fixed atezolizumab dose of 1200 mg every 3 weeks (Q3W).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants With Continued Access to Atezolizumab-Based Therapy and/or Comparator Agent(s)
Time Frame: Day 1 up to maximum 10 years
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Day 1 up to maximum 10 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of Participants With Serious Adverse Events (SAEs) by Severity Determined According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Time Frame: Day 1 up to 90 days after last dose of study treatment (last dose=till clinical benefit or until death, withdrawal of consent, unacceptable toxicity, pregnancy, non-compliance, or termination by Sponsor, whichever occurs first) (up to maximum 10 years)
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Day 1 up to 90 days after last dose of study treatment (last dose=till clinical benefit or until death, withdrawal of consent, unacceptable toxicity, pregnancy, non-compliance, or termination by Sponsor, whichever occurs first) (up to maximum 10 years)
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Percentage of Participants With Adverse Events of Special Interest by Severity Determined According to NCI CTCAE Version 4.0
Time Frame: Day 1 up to 90 days after last dose of study treatment (last dose=till clinical benefit or until death, withdrawal of consent, unacceptable toxicity, pregnancy, non-compliance, or termination by Sponsor, whichever occurs first) (up to maximum 10 years)
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Day 1 up to 90 days after last dose of study treatment (last dose=till clinical benefit or until death, withdrawal of consent, unacceptable toxicity, pregnancy, non-compliance, or termination by Sponsor, whichever occurs first) (up to maximum 10 years)
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Time from Randomization or Treatment Initiation to Death due to any Cause for IMpower133 Participants Only
Time Frame: Day 1 (as indicated in parent study protocol) until death due to any cause (up to maximum 10 years)
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Day 1 (as indicated in parent study protocol) until death due to any cause (up to maximum 10 years)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BO39633
- 2016-005189-75 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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