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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03768063
Other study ID # BO40729
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date February 28, 2019
Est. completion date July 5, 2028

Study information

Verified date March 2024
Source Hoffmann-La Roche
Contact Reference Study ID Number: BO40729 https://forpatients.roche.com
Phone 888-662-6728 (U.S. and Canada)
Email global-roche-genentech-trials@gene.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date July 5, 2028
Est. primary completion date July 5, 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Atezolizumab
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).
Bevacizumab
Bevacizumab will be administered as directed per the parent study.
Alectinib
Alectinib will be administered as directed per the parent study.
Cobimetinib
Cobimetinib will be administered as directed per the parent study.
Vemurafenib
Vemurafenib will be administered as directed per the parent study.
FAP IL2V
FAP IL2V will be administered as directed per the parent study.
Venetoclax
Venetoclax will be administered as directed per the parent study.
Enzalutamide
Enzalutamide will be administered as directed per the parent study.
Pembrolizumab
Pembrolizumab will be administered as directed per the parent study.
Sunitinib
Sunitinib will be administered as directed per the parent study.
Niraparib
Niraparib will be administered as directed per the parent study.
Cabozantinib
Cabozantinib will be administered as directed per the parent study.
Pemetrexed
Pemetrexed will be administered as directed per the parent study.
Paclitaxel
Paclitaxel will be administered as directed per the parent study.
Emactuzumab
Emactuzumab will be administered as directed per the parent study.
Rucaparib
Rucaparib will be administered as directed per the parent study.

Locations

Country Name City State
Australia Chris O'Brien Lifehouse Camperdown New South Wales
Australia The Prince Charles Hospital; Oncology Dept. Chermside Queensland
Australia St Vincent'S Hospital Darlinghurst New South Wales
Australia The Townsville Hospital Douglas Queensland
Australia Cabrini Hospital Malvern Malvern Victoria
Australia Townsville Hospital Townsville Queensland
Belgium UZ Brussel Brussel
Belgium Institut Jules Bordet Bruxelles
Belgium Universitair Ziekenhuis Gent; Oncology Gent
Belgium UZ Leuven Leuven
Brazil Hospital Araujo Jorge; Patologia Goiania GO
Brazil Hospital das Clinicas - UFRGS Porto Alegre RS
Brazil Instituto Nacional de Cancer - INCa; Oncologia Rio de Janeiro RJ
Brazil Instituto do Cancer do Estado de Sao Paulo - ICESP Sao Paulo SP
Bulgaria Multiprofile Hospital for Active Treatment Central Onco Hospital OOD; Dept. of Medical Oncology Plovdiv
Bulgaria Multiprofile Hospital for Active Treatment Serdika EOOD; Medical Oncology Department Sofia
Canada Lakeridge Health Oshawa Oshawa Ontario
Canada Princess Margaret Cancer Center Toronto Ontario
Canada BC Cancer ? Vancouver Vancouver British Columbia
Chile Pontificia Universidad Catolica de Chile; Centro Del Cáncer Santiago
Czechia Masaryk?v onkologický ústav; Klinika komplexní onkologické pé?e Brno
Czechia Fakultni nemocnice Olomouc; Onkologicka klinika Olomouc
Denmark Rigshospitalet København Ø
Denmark Rigshospitalet; Hæmatologisk Klinik København Ø
France Institut Bergonie; Oncologie Bordeaux
France Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez Lille
France Centre Leon Berard Lyon
France CHU Timone; Centre d'Essais Précoces en Cancérologie de Marseille (CEPCM) Marseille
France APHP - Hospital Saint Louis Paris
France Hopital d'Instruction des Armees de Begin Saint-Mande
France Hôpital d'Instruction des Armées de Sainte Anne; Service de Pneumologie Toulon
France Institut Claudius Regaud; Departement Oncologie Medicale Toulouse
France IUCT Oncopole Toulouse
France Institut Gustave Roussy Villejuif
Germany St. Elisabethen Krankenhaus Frankfurt am Main
Germany Universitätsklinikum Freiburg;Klinik für Innere Medizin I Freiburg
Germany Asklepios-Fachklinik Muenchen-Gauting; Klinik Für Pneumologie Gauting
Germany SRH Wald-Klinikum Gera; Zentrum fur klinische Studien (ZKS) Gera
Germany HOPA MVZ GmbH Hamburg
Germany Universitätsklinikum Hamburg-Eppendorf Hamburg
Germany Universitätsklinikum Heidelberg Heidelberg
Germany SLK-Kliniken Heilbronn GmbH; Klinik für Innere Medizin III; Schwerpunkt Häma./Onko./Palliativm. Heilbronn
Germany Lungenfachklinik Immenhausen; Zentrum fur Pneumologie Immenhausen
Germany Klinikum d.Universität München Campus Großhadern München
Germany Krankenhaus Barmherzige Bruder Regensburg Regensburg
Germany Universitaets-Hautklinik Tuebingen Tübingen
Germany Universitätsklinik Tübingen; Frauenklinik & Poliklinik Tübingen
Greece Alexandras Hospital; Dept. of Clin. Therapeutics, Athens Uni School of Medicine Athens
Greece Anticancer Hospital Ag. Savas Athens
Greece Laiko General Hospital Athen Athens
Greece Metropolitan Hospital Athens
Greece University Hospital of Larissa; Oncology Larissa
Guatemala Grupo Angeles Guatemala City
Hong Kong Queen Mary Hospital Hong Kong
Hungary Orszagos Onkologiai Intezet; "C" Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály Budapest
Hungary Orszagos Onkologiai Intezet; Borgyogyaszati Osztaly Budapest
Hungary Országos Onkológiai Intézet; Onkológiai Képalkotó és Invazív Diagnosztikai Központ Budapest
Hungary Szegedi Tudomanyegyetem, AOK Budapest
Hungary Petz Aladar Megyei Oktato Korhaz; Pulmonologiai Osztaly Gyor
Hungary Pecsi Tudomanyegyetem AOK; Borgyogyaszati Klinika Pecs
Hungary Szegedi Tudományegyetem; Onkoterápiás Klinika Szeged
Hungary Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz; Pulmonologiai Osztaly Szekesfehervar
Italy Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica Milano Lombardia
Japan Nagoya University Hospital Aichi
Japan National Hospital Organization Shikoku Cancer Center Ehime
Japan Kyushu University Hospital Fukuoka
Japan National Hospital Organization Kyushu Medical Center Fukuoka
Japan Hokkaido University Hospital Hokkaido
Japan University of Tsukuba Hospital Ibaraki
Japan Kanazawa University Hospital Ishikawa
Japan Iwate Medical University Hospital Iwate
Japan Kitasato University Hospital Kanagawa
Japan Niigata University Medical & Dental Hospital Niigata
Japan Niigata University Medical & Dental Hospital Niigata
Japan Okayama University Hospital Okayama
Japan Osaka Habikino Medical Center Osaka
Japan Saitama Cancer Center Saitama
Japan National Hospital Organization Kinki-Chuo Chest Medical Center Sakai-shi
Korea, Republic of Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology Seoul
Korea, Republic of Asan Medical Center; Internal Dept / Gastorenterology Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University College of Medicine, Liver Research Institute Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Severance Hospital Seoul
Latvia Riga's East Hosp Latvian Oncol; Medical Oncology Riga
Mexico Centro Medico Dalinde Mexico City
Mexico Centro Universitario Contra El Cancer Monterrey Nuevo LEON
Mexico Phylasis Clinicas Research S de RL de CV; Sucursal Toluca Toluca de Lerdo
Norway Førde sentralsjukehus Førde
Poland Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii Gdansk
Poland Przychodnia Lekarska KOMED, Roman Karaszewski Konin
Poland Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii Kraków
Poland Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii Olsztyn
Poland Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii Otwock
Poland Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii Otwock
Poland Uniwersytecki Szpital Kliniczny w Poznaniu Pozna?
Poland Med-Polonia Sp. z o.o. Poznan
Poland Narodowy Instytut Onkologii im. Marii Sk?odowskiej-Curie - Pa?stwowy Instytut Badawczy Warszawa
Portugal Centro Hospitalar do Porto ? Hospital de Santo António; Oncologia Porto
Romania Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca; Oncologie Medicala Cluj Napoca
Romania Centrul de Oncologie Sfantul Nectarie Craiova
Romania Institutul Regional de Oncologie Iasi; Clinica de Hematologie Iasi
Romania Centrul de Oncologie Oncohelp Timisoara
Russian Federation Arkhangelsk Regional Clinical Oncology Dispensary Arkhangelsk Arhangelsk
Russian Federation Ivanovo Regional Oncology Dispensary; Chemotherapy Department Ivanovo
Russian Federation P.A. Herzen Oncological Inst. ; Oncology Moscow Moskovskaja Oblast
Russian Federation Russian Oncology Research Center n.a. N.N. Blokhin Moscow Moskovskaja Oblast
Russian Federation FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov" Saint-Petersburg Sankt Petersburg
Russian Federation Scientific Research Institute of Oncology n.a. N.N. Petrov; Department of Oncogynecology St. Petersburg Sankt Petersburg
Singapore National University Hospital Singapore
Slovakia Narodny Onkologicky Ustav; Oddelenie klinickej onkologie A Bratislava
Slovakia University Hospital Bratislava; Department of Oncology Bratislava
Spain Hospital Clinic de Barcelona Barcelona
Spain Hospital Universitari Vall d'Hebron Barcelona
Spain Hospital Universitario Quiron Dexeus Barcelona
Spain Hospital Lucus Augusti; Servicio de Oncologia Lugo
Spain Centro Integral Oncologico Clara Campal; Servicio de Oncología Madrid
Spain Clinica Universidad de Navarra-Madrid Madrid
Spain HM Sanchinarro ? CIOCC; Servicio de Oncologia Madrid
Spain Hospital General Universitario Gregorio Mara Madrid
Spain Hospital Regional Universitario Carlos Haya Malaga
Spain Hospital Universitario Son Espases Palma de Mallorca Islas Baleares
Spain Clínica Universidad de Navarra Pamplona Navarra
Spain Corporacio Sanitaria Parc Tauli; Servicio de Oncologia Sabadell Barcelona
Spain Hospital Clinico Universitario de Valencia Valencia
Spain Hospital Clínico Universitario de Valencia; Medical Oncology Valencia
Switzerland Freiburger Spital; Onkologie Fribourg
Taiwan Chang Gung Memorial Hospital Chiayi Putzu
Taiwan Taichung Veterans General Hospital Taichung
Taiwan Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology Taipei City
Thailand Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology Bangkok
Ukraine Communal Non profit Enterprise Regional Center of Oncology; Oncosurgical dept of thoracic organs Kharkiv Kharkiv Governorate
Ukraine National Cancer Institute MOH of Ukraine Kiev
Ukraine ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council; Chemotherapy Department Kryvyi Rih
Ukraine Volyn Regional Oncology Dispensary Lutsk
Ukraine MI of the Lviv Regional Council Lviv Oncology Regional Treatment and Diagnostic Centre; Chemotherapy Lviv Volhynian Governorate
Ukraine Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary; Sumy State Uni, Med Inst Sumy
Ukraine Uzhhorod Central City Clinical Hospital Uzhhorod KIEV Governorate
Ukraine Municipal Institution Podilskiy Regional Center of Oncology; Department of Chemotherapy Vinnytsia Podolia Governorate
United Kingdom Barts Cancer Institute London
United Kingdom St Georges University Hospitals NHS Foundation Trust London
United States St. Joseph Mercy Hospital; Cancer Care Center. Ann Arbor Michigan
United States University of Colorado Cancer Center Aurora Colorado
United States University of Colorado; Anschutz Cancer Pavilion Aurora Colorado
United States Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Baltimore Maryland
United States St. Luke's Cancer Care Associates Bethlehem Pennsylvania
United States Univ of Alabama at Birmingham; UAB Comprehensive Cancer Ctr Birmingham Alabama
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Dana Farber Cancer Institute Boston Massachusetts
United States Dana Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Montefiore Medical Center Bronx New York
United States Levine Cancer Institute-Carolinas Medical Center Charlotte North Carolina
United States SCRI Tennessee Oncology Chattanooga Chattanooga Tennessee
United States University Of Chicago Medical Center; Section Of Hematology/Oncology Chicago Illinois
United States Oncology Hematology Care Inc Cincinnati Ohio
United States Ohio State University; Hemat/Onc Columbus Ohio
United States Barbara Ann Karmanos Cancer Institute Detroit Maine
United States City of Hope Duarte California
United States Providence Regional Cancer Partnership Everett Washington
United States SCRI Florida Cancer Specialists South Fort Myers Florida
United States Fort Wayne Medical Oncology and Hematology, Inc Fort Wayne Indiana
United States The University of Texas MD Anderson Cancer Center Houston Texas
United States Carolina BioOncology Institute, PLCC Huntersville North Carolina
United States University of Arkansas for Medical Sciences; Winthrop Rockefeller Cancer Institute Little Rock Arkansas
United States UCLA Hematology / Oncology Clinic Los Angeles California
United States Mercy Hospital, a Campus of Plantation General Hospital Miami Florida
United States Sarah Cannon Research Institute Nashville Tennessee
United States Sarah Cannon Research Institute Nashville Tennessee
United States SCRI-Tennessee Oncology Nashville Tennessee
United States Smilow Cancer Hospital at Yale New Haven New Haven Connecticut
United States Yale Cancer Center New Haven Connecticut
United States Memorial Sloan Kettering - Basking Ridge New York New York
United States New York University School of Medicine New York New York
United States Smilow Cancer Center North Haven Connecticut
United States Advent Health Orlando Orlando Florida
United States Stanford University Medical Center Palo Alto California
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States University of Pittsburgh Medical Center Cancer Center; Investigational Drug Service Pittsburgh Pennsylvania
United States Hematology Oncology Associates of the Treasure Coast Port Saint Lucie Florida
United States Washington University School of Medicine Saint Louis Missouri
United States SCRI Florida Cancer Specialists North; Research Office North Region. Saint Petersburg Florida
United States University of Texas Health Sciences Center in San Antonio San Antonio Texas
United States Kaiser Permanente - Bellflower San Diego California
United States New England Cancer Specialists Scarborough Maine
United States HonorHealth Research Institute - Pima - Virginia G. Piper Cancer Care Network Scottsdale Arizona
United States University of Washington - Seattle Cancer Care Alliance; Medical Oncology Seattle Washington
United States University of Washington - Seattle Cancer Care Alliance; Medical Oncology Seattle Washington
United States Yale University School Of Medicine; Yale Cancer Center Trumbull Connecticut
United States Medstar Georgetown University Hospital Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  Czechia,  Denmark,  France,  Germany,  Greece,  Guatemala,  Hong Kong,  Hungary,  Italy,  Japan,  Korea, Republic of,  Latvia,  Mexico,  Norway,  Poland,  Portugal,  Romania,  Russian Federation,  Singapore,  Slovakia,  Spain,  Switzerland,  Taiwan,  Thailand,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Continued Access to Atezolizumab-Based Therapy and/or Comparator Agent(s) Day 1 up to maximum 10 years
Secondary Percentage of Participants With Serious Adverse Events (SAEs) According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 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)
Secondary Percentage of Participants With Adverse Events of Special Interest Determined According to NCI CTCAE Version 5.0 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)
Secondary Treatment Duration 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)
Secondary Total Dose Received 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)
Secondary Number of Treatment Cycles 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)
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