A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study

Cancer Clinical Trial

— IMbrella B  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03768063
• Other study ID #: BO40729
• Status: Recruiting
• Phase: Phase 3
• Start date: February 28, 2019
• Est. completion date: July 5, 2028

Study information

• Verified date: June 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
• 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)

Related Conditions & MeSH terms

• Cancer

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	Institut Régional du Cancer de Montpellier	Montpellier
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 General Hospital of Larissa	Larissa
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	CHA Bundang Medical Center	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si
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
Korea, Republic of	Pusan National University Yangsan Hospital; hemato-oncology	Yangsan
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	Sarah Cannon Research Institute / Tennessee Oncology	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 / Tennessee Oncology	Nashville	Tennessee
United States	SCRI Oncology Partners	Nashville	Tennessee
United States	SCRI Oncology Partners	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)