- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03768063
A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (IMbrella B)
March 17, 2024 updated by: Hoffmann-La Roche
An Open Label, Multicenter Extension Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (IMbrella B)
This is an open-label, multicenter, extension study.
Patients who are receiving clinical benefit from atezolizumab monotherapy or atezolizumab in combination with other agent(s) or comparator agent(s) during participation in a Genentech or Roche-sponsored study (the parent study), who are eligible to continue treatment and who do not have access to the study treatment locally, may continue to receive study treatment in this extension study following roll-over from the parent study.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
1000
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Reference Study ID Number: BO40729 https://forpatients.roche.com/
- Phone Number: 888-662-6728 (U.S. and Canada)
- Email: global-roche-genentech-trials@gene.com
Study Locations
-
-
New South Wales
-
Camperdown, New South Wales, Australia, 2050
- Withdrawn
- Chris O'Brien Lifehouse
-
Darlinghurst, New South Wales, Australia, 2010
- Active, not recruiting
- St Vincent's Hospital
-
-
Queensland
-
Chermside, Queensland, Australia, 4032
- Withdrawn
- The Prince Charles Hospital; Oncology Dept.
-
Douglas, Queensland, Australia, 4814
- Withdrawn
- The Townsville Hospital
-
Townsville, Queensland, Australia, 4810
- Active, not recruiting
- Townsville Hospital
-
-
Victoria
-
Malvern, Victoria, Australia, 3144
- Withdrawn
- Cabrini Hospital Malvern
-
-
-
-
-
Brussel, Belgium, 1090
- Active, not recruiting
- UZ Brussel
-
Bruxelles, Belgium, 1000
- Active, not recruiting
- Institut Jules Bordet
-
Gent, Belgium, 9000
- Withdrawn
- Universitair Ziekenhuis Gent; Oncology
-
Leuven, Belgium, 3000
- Active, not recruiting
- UZ Leuven
-
-
-
-
GO
-
Goiania, GO, Brazil, 74605-070?
- Active, not recruiting
- Hospital Araujo Jorge; Patologia
-
-
RJ
-
Rio de Janeiro, RJ, Brazil, 20560-120
- Active, not recruiting
- Instituto Nacional de Cancer - INCa; Oncologia
-
-
RS
-
Porto Alegre, RS, Brazil, 90035-903
- Active, not recruiting
- Hospital das Clinicas - UFRGS
-
-
SP
-
Sao Paulo, SP, Brazil, 01246-000
- Active, not recruiting
- Instituto do Cancer do Estado de Sao Paulo - ICESP
-
-
-
-
-
Plovdiv, Bulgaria, 4004
- Terminated
- Multiprofile Hospital for Active Treatment Central Onco Hospital OOD; Dept. of Medical Oncology
-
Sofia, Bulgaria, 1632
- Withdrawn
- Multiprofile Hospital for Active Treatment Serdika EOOD; Medical Oncology Department
-
-
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5Z 4E6
- Active, not recruiting
- BC Cancer ? Vancouver
-
-
Ontario
-
Oshawa, Ontario, Canada, L1G 2B9
- Withdrawn
- Lakeridge Health Oshawa
-
Toronto, Ontario, Canada, M5G 1Z5
- Active, not recruiting
- Princess Margaret Cancer Center
-
-
-
-
-
Santiago, Chile, 8330032
- Active, not recruiting
- Pontificia Universidad Catolica de Chile; Centro Del Cáncer
-
-
-
-
-
Brno, Czechia, 656 53
- Active, not recruiting
- Masaryk?v onkologický ústav; Klinika komplexní onkologické pé?e
-
Olomouc, Czechia, 779 00
- Active, not recruiting
- Fakultni nemocnice Olomouc; Onkologicka klinika
-
-
-
-
-
København Ø, Denmark, 2100
- Withdrawn
- Rigshospitalet; Hæmatologisk Klinik
-
København Ø, Denmark, 2100
- Terminated
- Rigshospitalet
-
-
-
-
-
Bordeaux, France, 33076
- Completed
- Institut Bergonie; Oncologie
-
Lille, France, 59037
- Completed
- Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez
-
Lyon, France, 69008
- Completed
- Centre Leon Berard
-
Marseille, France, 13005
- Active, not recruiting
- CHU Timone; Centre d'Essais Précoces en Cancérologie de Marseille (CEPCM)
-
Paris, France, 75475
- Withdrawn
- APHP - Hospital Saint Louis
-
Saint-Mande, France, 94160
- Completed
- Hopital d'Instruction des Armees de Begin
-
Toulon, France, 83000
- Withdrawn
- Hôpital d'Instruction des Armées de Sainte Anne; Service de Pneumologie
-
Toulouse, France, 31059
- Active, not recruiting
- Institut Claudius Regaud; Departement Oncologie Medicale
-
Toulouse, France, 31100
- Withdrawn
- IUCT Oncopole
-
Villejuif, France, 94805
- Active, not recruiting
- Institut Gustave Roussy
-
-
-
-
-
Frankfurt am Main, Germany, 60487
- Withdrawn
- St. Elisabethen Krankenhaus
-
Freiburg, Germany, 79106
- Active, not recruiting
- Universitätsklinikum Freiburg;Klinik für Innere Medizin I
-
Gauting, Germany, 82131
- Active, not recruiting
- Asklepios-Fachklinik Muenchen-Gauting; Klinik Für Pneumologie
-
Gera, Germany, 07548
- Active, not recruiting
- SRH Wald-Klinikum Gera; Zentrum fur klinische Studien (ZKS)
-
Hamburg, Germany, 22767
- Recruiting
- HOPA MVZ GmbH
-
Hamburg, Germany, 20246
- Withdrawn
- Universitätsklinikum Hamburg-Eppendorf
-
Heidelberg, Germany, 69120
- Active, not recruiting
- Universitatsklinikum Heidelberg
-
Heilbronn, Germany, 74078
- Withdrawn
- SLK-Kliniken Heilbronn GmbH; Klinik für Innere Medizin III; Schwerpunkt Häma./Onko./Palliativm.
-
Immenhausen, Germany, 34376
- Active, not recruiting
- Lungenfachklinik Immenhausen; Zentrum fur Pneumologie
-
München, Germany, 81377
- Withdrawn
- Klinikum d.Universität München Campus Großhadern
-
Regensburg, Germany, 93049
- Active, not recruiting
- Krankenhaus Barmherzige Bruder Regensburg
-
Tübingen, Germany, 72076
- Active, not recruiting
- Universitaets-Hautklinik Tuebingen
-
Tübingen, Germany, 72076
- Active, not recruiting
- Universitätsklinik Tübingen; Frauenklinik & Poliklinik
-
-
-
-
-
Athens, Greece, 115 27
- Active, not recruiting
- Laiko General Hospital Athen
-
Athens, Greece, 115 28
- Withdrawn
- Alexandras Hospital; Dept. of Clin. Therapeutics, Athens Uni School of Medicine
-
Athens, Greece, 185 47
- Active, not recruiting
- Metropolitan Hospital
-
Athens, Greece, 11522
- Completed
- Anticancer Hospital Ag. Savas
-
Larissa, Greece
- Withdrawn
- University Hospital of Larissa; Oncology
-
-
-
-
-
Guatemala City, Guatemala, 01015
- Active, not recruiting
- Grupo Angeles
-
-
-
-
-
Hong Kong, Hong Kong, 999077
- Completed
- Queen Mary Hospital
-
-
-
-
-
Budapest, Hungary, 1122
- Withdrawn
- Orszagos Onkologiai Intezet; "C" Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály
-
Budapest, Hungary
- Withdrawn
- Szegedi Tudomanyegyetem, AOK
-
Budapest, Hungary, 1122
- Active, not recruiting
- Orszagos Onkologiai Intezet; Borgyogyaszati Osztaly
-
Budapest, Hungary, 1122
- Completed
- Országos Onkológiai Intézet; Onkológiai Képalkotó és Invazív Diagnosztikai Központ
-
Gyor, Hungary, 9024
- Withdrawn
- Petz Aladar Megyei Oktato Korhaz; Pulmonologiai Osztaly
-
Pecs, Hungary, 7632
- Completed
- Pecsi Tudomanyegyetem AOK; Borgyogyaszati Klinika
-
Szeged, Hungary, 6720
- Completed
- Szegedi Tudományegyetem; Onkoterápiás Klinika
-
Szekesfehervar, Hungary, 8001
- Completed
- Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz; Pulmonologiai Osztaly
-
-
-
-
Lombardia
-
Milano, Lombardia, Italy, 20133
- Completed
- Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica
-
-
-
-
-
Aichi, Japan, 466-8560
- Recruiting
- Nagoya University Hospital
-
Ehime, Japan, 791-0280
- Recruiting
- National Hospital Organization Shikoku Cancer Center
-
Fukuoka, Japan, 812-8582
- Recruiting
- Kyushu University Hospital
-
Fukuoka, Japan, 810-8563
- Active, not recruiting
- National Hospital Organization Kyushu Medical Center
-
Hokkaido, Japan, 060-8648
- Recruiting
- Hokkaido University Hospital
-
Ibaraki, Japan, 305-8576
- Recruiting
- University of tsukuba hospital
-
Ishikawa, Japan, 920-8641
- Active, not recruiting
- Kanazawa University Hospital
-
Iwate, Japan, 028-3695
- Completed
- Iwate Medical University Hospital
-
Kanagawa, Japan, 252-0375
- Completed
- Kitasato University Hospital
-
Niigata, Japan, 951-8520
- Completed
- Niigata University Medical & Dental Hospital
-
Niigata, Japan, 951-8520
- Active, not recruiting
- Niigata University Medical & Dental Hospital
-
Okayama, Japan, 700-8558
- Recruiting
- Okayama University Hospital
-
Osaka, Japan, 583-8588
- Recruiting
- Osaka Habikino Medical Center
-
Saitama, Japan, 362-0806
- Active, not recruiting
- Saitama Cancer Center
-
Sakai-shi, Japan, 591-8555
- Recruiting
- National Hospital Organization Kinki-Chuo Chest Medical Center
-
-
-
-
-
Seoul, Korea, Republic of, 03080
- Active, not recruiting
- Seoul National University Hospital
-
Seoul, Korea, Republic of, 06351
- Active, not recruiting
- Samsung Medical Center
-
Seoul, Korea, Republic of, 03722
- Terminated
- Severance Hospital
-
Seoul, Korea, Republic of, 138-736
- Active, not recruiting
- Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology
-
Seoul, Korea, Republic of, 138-736
- Active, not recruiting
- Asan Medical Center; Internal Dept / Gastorenterology
-
Seoul, Korea, Republic of
- Active, not recruiting
- Seoul National University College of Medicine, Liver Research Institute
-
-
-
-
-
Riga, Latvia, LV-1079
- Active, not recruiting
- Riga's East Hosp Latvian Oncol; Medical Oncology
-
-
-
-
-
Mexico City, Mexico, 06700
- Active, not recruiting
- Centro Medico Dalinde
-
Toluca de Lerdo, Mexico, 50090
- Active, not recruiting
- Phylasis Clinicas Research S de RL de CV; Sucursal Toluca
-
-
Nuevo LEON
-
Monterrey, Nuevo LEON, Mexico, 64020
- Withdrawn
- Centro Universitario Contra El Cancer
-
-
-
-
-
Førde, Norway, 6800
- Withdrawn
- Førde sentralsjukehus
-
-
-
-
-
Gdansk, Poland, 80-214
- Withdrawn
- Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
-
Konin, Poland, 62-500
- Withdrawn
- Przychodnia Lekarska KOMED, Roman Karaszewski
-
Kraków, Poland, 30-688
- Withdrawn
- Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii
-
Olsztyn, Poland, 10-357
- Withdrawn
- Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii
-
Otwock, Poland, 05-400
- Active, not recruiting
- Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii
-
Otwock, Poland, 05-400
- Active, not recruiting
- Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii
-
Pozna?, Poland, 60-780
- Active, not recruiting
- Uniwersytecki Szpital Kliniczny w Poznaniu
-
Poznan, Poland, 60-693
- Withdrawn
- Med-Polonia Sp. z o.o.
-
Warszawa, Poland, 02-781
- Active, not recruiting
- Narodowy Instytut Onkologii im. Marii Sk?odowskiej-Curie - Pa?stwowy Instytut Badawczy
-
-
-
-
-
Porto, Portugal, 4099-001
- Withdrawn
- Centro Hospitalar do Porto ? Hospital de Santo António; Oncologia
-
-
-
-
-
Cluj Napoca, Romania, 400015
- Terminated
- Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca; Oncologie Medicala
-
Craiova, Romania, 200347
- Active, not recruiting
- Centrul de Oncologie Sfantul Nectarie
-
Iasi, Romania, 700483
- Active, not recruiting
- Institutul Regional de Oncologie Iasi; Clinica de Hematologie
-
Timisoara, Romania, 300239
- Active, not recruiting
- Centrul de Oncologie Oncohelp
-
-
-
-
-
Ivanovo, Russian Federation, 153013
- Active, not recruiting
- Ivanovo Regional Oncology Dispensary; Chemotherapy Department
-
-
Arhangelsk
-
Arkhangelsk, Arhangelsk, Russian Federation, 163045
- Active, not recruiting
- Arkhangelsk Regional Clinical Oncology Dispensary
-
-
Moskovskaja Oblast
-
Moscow, Moskovskaja Oblast, Russian Federation, 115478
- Active, not recruiting
- Russian Oncology Research Center n.a. N.N. Blokhin
-
Moscow, Moskovskaja Oblast, Russian Federation, 125248
- Recruiting
- P.A. Herzen Oncological Inst. ; Oncology
-
-
Sankt Petersburg
-
Saint-Petersburg, Sankt Petersburg, Russian Federation
- Completed
- FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"
-
St. Petersburg, Sankt Petersburg, Russian Federation, 197758
- Withdrawn
- Scientific Research Institute of Oncology n.a. N.N. Petrov; Department of Oncogynecology
-
-
-
-
-
Singapore, Singapore, 117599
- Active, not recruiting
- National University Hospital
-
-
-
-
-
Bratislava, Slovakia, 826 06
- Active, not recruiting
- University Hospital Bratislava; Department of Oncology
-
Bratislava, Slovakia, 833 10
- Completed
- Narodny Onkologicky Ustav; Oddelenie klinickej onkologie A
-
-
-
-
-
Barcelona, Spain, 08035
- Withdrawn
- Hospital Universitari Vall d'Hebron
-
Barcelona, Spain, 08028
- Active, not recruiting
- Hospital Universitario Quiron Dexeus
-
Barcelona, Spain, 08036
- Active, not recruiting
- Hospital Clinic de Barcelona
-
Lugo, Spain, 27003
- Withdrawn
- Hospital Lucus Augusti; Servicio de Oncologia
-
Madrid, Spain, 28009
- Withdrawn
- Hospital General Universitario Gregorio Mara
-
Madrid, Spain, 28050
- Withdrawn
- Centro Integral Oncologico Clara Campal; Servicio de Oncología
-
Madrid, Spain, 28050
- Active, not recruiting
- HM Sanchinarro ? CIOCC; Servicio de Oncologia
-
Madrid, Spain, 28027
- Withdrawn
- Clinica Universidad de Navarra-Madrid
-
Malaga, Spain, 29010
- Active, not recruiting
- Hospital Regional Universitario Carlos Haya
-
Valencia, Spain, 46010
- Withdrawn
- Hospital Clínico Universitario de Valencia
-
Valencia, Spain, 46010
- Active, not recruiting
- Hospital Clínico Universitario de Valencia; Medical Oncology
-
-
Barcelona
-
Sabadell, Barcelona, Spain, 8208
- Active, not recruiting
- Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
-
-
Islas Baleares
-
Palma de Mallorca, Islas Baleares, Spain, 07010
- Withdrawn
- Hospital Universitario Son Espases
-
-
Navarra
-
Pamplona, Navarra, Spain, 31620
- Completed
- Clínica Universidad de Navarra
-
-
-
-
-
Fribourg, Switzerland, 1708
- Completed
- Freiburger Spital; Onkologie
-
-
-
-
-
Putzu, Taiwan, 613
- Active, not recruiting
- Chang Gung Memorial Hospital Chiayi
-
Taichung, Taiwan, 40705
- Recruiting
- Taichung Veterans General Hospital
-
Taipei City, Taiwan, 11259
- Active, not recruiting
- Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
-
-
-
-
-
Bangkok, Thailand, 10700
- Recruiting
- Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
-
-
-
-
-
Kiev, Ukraine, 36022
- Terminated
- National Cancer Institute MOH of Ukraine
-
Kryvyi Rih, Ukraine, 50048
- Terminated
- ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council; Chemotherapy Department
-
Lutsk, Ukraine, 43018
- Active, not recruiting
- Volyn Regional Oncology Dispensary
-
Sumy, Ukraine, 40022
- Terminated
- Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary; Sumy State Uni, Med Inst
-
-
KIEV Governorate
-
Uzhhorod, KIEV Governorate, Ukraine, 88000
- Completed
- Uzhhorod Central City Clinical Hospital
-
-
Kharkiv Governorate
-
Kharkiv, Kharkiv Governorate, Ukraine, 61070
- Active, not recruiting
- Communal Non profit Enterprise Regional Center of Oncology; Oncosurgical dept of thoracic organs
-
-
Podolia Governorate
-
Vinnytsia, Podolia Governorate, Ukraine, 21029
- Completed
- Municipal Institution Podilskiy Regional Center of Oncology; Department of Chemotherapy
-
-
Volhynian Governorate
-
Lviv, Volhynian Governorate, Ukraine, 79031
- Withdrawn
- MI of the Lviv Regional Council Lviv Oncology Regional Treatment and Diagnostic Centre; Chemotherapy
-
-
-
-
-
London, United Kingdom, E1 2AT
- Active, not recruiting
- Barts Cancer Institute
-
London, United Kingdom, SW17 0RE
- Withdrawn
- St Georges University Hospitals NHS Foundation Trust
-
-
-
-
Alabama
-
Birmingham, Alabama, United States, 352331912
- Withdrawn
- Univ of Alabama at Birmingham; UAB Comprehensive Cancer Ctr
-
-
Arizona
-
Scottsdale, Arizona, United States, 85258
- Active, not recruiting
- HonorHealth Research Institute - Pima - Virginia G. Piper Cancer Care Network
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72205
- Withdrawn
- University of Arkansas for Medical Sciences; Winthrop Rockefeller Cancer Institute
-
-
California
-
Duarte, California, United States, 91010
- Withdrawn
- City of Hope
-
Los Angeles, California, United States, 90095
- Active, not recruiting
- UCLA Hematology / Oncology Clinic
-
Palo Alto, California, United States, 94304
- Withdrawn
- Stanford University Medical Center
-
San Diego, California, United States, 92108
- Withdrawn
- Kaiser Permanente - Bellflower
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Active, not recruiting
- University of Colorado Cancer Center
-
Aurora, Colorado, United States, 80045
- Withdrawn
- University of Colorado; Anschutz Cancer Pavilion
-
-
Connecticut
-
New Haven, Connecticut, United States, 06510
- Withdrawn
- Smilow Cancer Hospital at Yale New Haven
-
New Haven, Connecticut, United States, 06520
- Withdrawn
- Yale Cancer Center
-
North Haven, Connecticut, United States, 06473
- Withdrawn
- Smilow Cancer Center
-
Trumbull, Connecticut, United States, 06611
- Active, not recruiting
- Yale University School Of Medicine; Yale Cancer Center
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20007
- Active, not recruiting
- MedStar Georgetown University Hospital
-
-
Florida
-
Fort Myers, Florida, United States, 33916
- Withdrawn
- SCRI Florida Cancer Specialists South
-
Miami, Florida, United States, 33133
- Withdrawn
- Mercy Hospital, a Campus of Plantation General Hospital
-
Orlando, Florida, United States, 32804
- Recruiting
- Advent Health Orlando
-
Port Saint Lucie, Florida, United States, 34952
- Withdrawn
- Hematology Oncology Associates of the Treasure Coast
-
Saint Petersburg, Florida, United States, 33705
- Withdrawn
- SCRI Florida Cancer Specialists North; Research Office North Region.
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- Completed
- University Of Chicago Medical Center; Section Of Hematology/Oncology
-
-
Indiana
-
Fort Wayne, Indiana, United States, 46804
- Active, not recruiting
- Fort Wayne Medical Oncology and Hematology, Inc
-
-
Maine
-
Detroit, Maine, United States, 48201-2013
- Withdrawn
- Barbara Ann Karmanos Cancer Institute
-
Scarborough, Maine, United States, 04074
- Withdrawn
- New England Cancer Specialists
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Active, not recruiting
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Withdrawn
- Dana Farber Cancer Institute
-
Boston, Massachusetts, United States, 02215
- Active, not recruiting
- Beth Israel Deaconess Medical Center
-
Boston, Massachusetts, United States, 02215
- Active, not recruiting
- Dana Farber Cancer Institute
-
Boston, Massachusetts, United States, 02114
- Withdrawn
- Massachusetts General Hospital
-
Boston, Massachusetts, United States, 02114-2621
- Active, not recruiting
- Massachusetts General Hospital
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48106
- Withdrawn
- St. Joseph Mercy Hospital; Cancer Care Center.
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Withdrawn
- Washington University School of Medicine
-
-
New York
-
Bronx, New York, United States, 10467
- Withdrawn
- Montefiore Medical Center
-
New York, New York, United States, 10016
- Withdrawn
- New York University School of Medicine
-
New York, New York, United States, 10065
- Withdrawn
- Memorial Sloan Kettering - Basking Ridge
-
-
North Carolina
-
Charlotte, North Carolina, United States, 28204
- Active, not recruiting
- Levine Cancer Institute-Carolinas Medical Center
-
Huntersville, North Carolina, United States, 28078
- Active, not recruiting
- Carolina BioOncology Institute, PLCC
-
-
Ohio
-
Cincinnati, Ohio, United States, 45242
- Withdrawn
- Oncology Hematology Care Inc
-
Columbus, Ohio, United States, 43210
- Withdrawn
- Ohio State University; Hemat/Onc
-
-
Pennsylvania
-
Bethlehem, Pennsylvania, United States, 18015
- Active, not recruiting
- St. Luke's Cancer Care Associates
-
Philadelphia, Pennsylvania, United States, 19111
- Withdrawn
- Fox Chase Cancer Center
-
Pittsburgh, Pennsylvania, United States, 15232
- Withdrawn
- University of Pittsburgh Medical Center Cancer Center; Investigational Drug Service
-
-
Tennessee
-
Chattanooga, Tennessee, United States, 37404
- Withdrawn
- SCRI Tennessee Oncology Chattanooga
-
Nashville, Tennessee, United States, 37203
- Active, not recruiting
- Sarah Cannon Research Institute
-
Nashville, Tennessee, United States, 37203
- Withdrawn
- Sarah Cannon Research Institute
-
Nashville, Tennessee, United States, 37203
- Withdrawn
- SCRI-Tennessee Oncology
-
-
Texas
-
Houston, Texas, United States, 77030-4009
- Active, not recruiting
- The University of Texas MD Anderson Cancer Center
-
San Antonio, Texas, United States, 78229
- Active, not recruiting
- University of Texas Health Sciences Center in San Antonio
-
-
Washington
-
Everett, Washington, United States, 98201
- Withdrawn
- Providence Regional Cancer Partnership
-
Seattle, Washington, United States, 98109
- Withdrawn
- University of Washington - Seattle Cancer Care Alliance; Medical Oncology
-
Seattle, Washington, United States, 98109
- Active, not recruiting
- University of Washington - Seattle Cancer Care Alliance; Medical Oncology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Eligible for continuing atezolizumab-based therapy at the time of roll-over from the parent study, as per the parent study protocol or
- Eligible for continuing the comparator agent(s) in a Genentech- or Roche-sponsored study as per the parent study protocol, with no access to commercially available comparator agent
- Time between the last dose of treatment received in parent study and first dose in extension study is no longer than the interruption period allowed in the parent study. First dose of study treatment in this 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 roll-over from the parent study as assessed by the investigator
- Negative serum pregnancy test within 7 days prior to start of study treatment in women of childbearing potential
- For women of childbearing potential: agreement to remain abstinent or use contraceptive methods, and agreement to refrain from donating eggs
- For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm
Exclusion Criteria:
- Meet any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment in this extension study
- Study treatment or comparator agent is commercially marketed in the patient's country for the patient-specific disease and is accessible to the patient
- Treatment with any anti-cancer treatment during the time between last treatment in the parent study and the first dose of study treatment in this 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 this extension study (if applicable)
- Ongoing serious adverse event(s) that has not resolved to baseline level or Grade ≤1 from the parent study or during the time between the last treatment in the parent study and the first dose of study treatment in this extension study
- Any condition that, in the opinion of the investigator, would interfere with the interpretation of patient safety or place the patient at high risk for treatment-related complications
- Concurrent participation in any therapeutic clinical trial (other than the parent study)
- Pregnant or lactating, or intending to become pregnant during this extension study and for the period after the last dose of study treatment specified in the designated referenced safety information (RSI)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Atezolizumab Monotherapy
Participants will receive atezolizumab by intravenous infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
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:
|
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.
|
Bevacizumab will be administered as directed per the parent study.
Other Names:
Pemetrexed will be administered as directed per the parent study.
Paclitaxel will be administered as directed per the parent study.
Enzalutamide 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:
Alectinib will be administered as directed per the parent study.
Other Names:
Cobimetinib will be administered as directed per the parent study.
Other Names:
Vemurafenib will be administered as directed per the parent study.
Other Names:
FAP IL2V will be administered as directed per the parent study.
Other Names:
Venetoclax will be administered as directed per the parent study.
Other Names:
Niraparib will be administered as directed per the parent study.
Other Names:
Cabozantinib will be administered as directed per the parent study.
Other Names:
Emactuzumab will be administered as directed per the parent study.
Rucaparib will be administered as directed per the parent study.
|
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.
|
Pemetrexed will be administered as directed per the parent study.
Paclitaxel will be administered as directed per the parent study.
Enzalutamide will be administered as directed per the parent study.
Other Names:
Cobimetinib will be administered as directed per the parent study.
Other Names:
Vemurafenib will be administered as directed per the parent study.
Other Names:
Venetoclax will be administered as directed per the parent study.
Other Names:
Niraparib will be administered as directed per the parent study.
Other Names:
Pembrolizumab will be administered as directed per the parent study.
Other Names:
Sunitinib will be administered as directed per the parent study.
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
|
Day 1 up to maximum 10 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of Participants With Serious Adverse Events (SAEs) According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Time Frame: Day 1 up to 90 days after last dose of study treatment (last dose=until 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)
|
Day 1 up to 90 days after last dose of study treatment (last dose=until 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)
|
Percentage of Participants With Adverse Events of Special Interest Determined According to NCI CTCAE Version 5.0
Time Frame: Day 1 up to 90 days after last dose of study treatment (last dose=until 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)
|
Day 1 up to 90 days after last dose of study treatment (last dose=until 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)
|
Treatment Duration
Time Frame: Day 1 up to 90 days after last dose of study treatment (last dose=until 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)
|
Day 1 up to 90 days after last dose of study treatment (last dose=until 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)
|
Total Dose Received
Time Frame: Day 1 up to 90 days after last dose of study treatment (last dose=until 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)
|
Day 1 up to 90 days after last dose of study treatment (last dose=until 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)
|
Number of Treatment Cycles
Time Frame: Day 1 up to 90 days after last dose of study treatment (last dose=until 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)
|
Day 1 up to 90 days after last dose of study treatment (last dose=until 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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 28, 2019
Primary Completion (Estimated)
July 5, 2028
Study Completion (Estimated)
July 5, 2028
Study Registration Dates
First Submitted
November 30, 2018
First Submitted That Met QC Criteria
December 5, 2018
First Posted (Actual)
December 7, 2018
Study Record Updates
Last Update Posted (Estimated)
March 19, 2024
Last Update Submitted That Met QC Criteria
March 17, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Protein Kinase Inhibitors
- Poly(ADP-ribose) Polymerase Inhibitors
- Immune Checkpoint Inhibitors
- Folic Acid Antagonists
- Tyrosine Kinase Inhibitors
- Sunitinib
- Venetoclax
- Bevacizumab
- Pembrolizumab
- Niraparib
- Rucaparib
- Pemetrexed
- Atezolizumab
- Vemurafenib
- Alectinib
Other Study ID Numbers
- BO40729
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
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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