A Study in Participants Previously Enrolled in a Genentech- and/or F. Hoffmann-La Roche Ltd-Sponsored Atezolizumab Study (IMbrella A)

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03148418
• Other study ID #: BO39633
• Secondary ID: 2016-005189-75
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 20, 2017
• Est. completion date: March 6, 2030

Study information

• Verified date: May 2024
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label, multicenter, non-randomized extension and long-term observational study. Participants receiving atezolizumab monotherapy or atezolizumab combined with other agent(s) or comparator agent(s) in a Genentech or Roche-sponsored study (the parent study) and who continue to receive study treatment at the time of the parent-study closure and do not have access to the study treatment locally are eligible for continued treatment in the extension study. Dosing regimen for a given participant and indication will be the same or equivalent to the respective parent study protocol. Study treatment in the extension study can continue until disease progression or beyond if the patient continues to derive clinical benefit as judged by the investigator and if allowed by the parent study or local prescribing information until death; withdrawal of study consent; unacceptable toxicity; pregnancy; patient non-compliance; or study termination by the Sponsor, whichever occurs first.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 382
• Est. completion date: March 6, 2030
• Est. primary completion date: March 6, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

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.

Locations

Country	Name	City	State
Argentina	Fundación CENIT para la Investigación en Neurociencias	Buenos Aires
Australia	Chris O'Brien Lifehouse	Camperdown	New South Wales
Australia	Princess AleXandra Hospital; Department of Medical Oncology	Woolloongabba	Queensland
Austria	Klinik Penzing; Abteilung für Atemwegs- und Lungenkrankheiten	Wien
Austria	Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie	Wien
Belgium	AZ Glorieux- vzw Werken Glorieux	Ronse
Belgium	Sint Augustinus Wilrijk	Wilrijk
Brazil	Hospital de Cancer de Barretos	Barretos	SP
Brazil	Fundacao Antonio Prudente	Sao Paulo	SP
Brazil	Instituto do Cancer do Estado de Sao Paulo - ICESP	Sao Paulo	SP
Bulgaria	Multiprofile Hospital for Active Treatment Serdika EOOD; Medical Oncology Department	Sofia
Canada	Royal Victoria Hospital	Barrie	Ontario
Canada	William Osler Health Centre	Etobicoke	Ontario
Canada	Cite de La Sante de Laval; Hemato-Oncologie	Laval	Quebec
Canada	Jewish General Hospital	Montreal	Quebec
Canada	Lakeridge Health Corporation-Oshawa; Oncology clinic	Oshawa	Ontario
Canada	Princess Margaret Cancer Center	Toronto	Ontario
Canada	Sunnybrook Odette Cancer Centre; Clinical Trials	Toronto	Ontario
Chile	Bradford Hill Centro de Investigaciones Clinicas	Recoleta
Czechia	Masarykuv onkologicky ustav	Brno
Czechia	Thomayerova nemocnice	Praha 4 - Krc
France	Hopital Jean Minjoz; Pneumologie	Besancon
France	Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie	Grenoble
France	Centre Leon Berard; Departement Oncologie Medicale	Lyon
France	Hopital Nord; Service d'Oncologie Multidisciplinaire et Innovation Thérapeutique	Marseille
France	Centre René Gauducheau - cancer Nantes - Atlantique; Service Oncologie Médicale	Nantes
France	Centre Antoine Lacassagne, Centre de Lutte Contre le Cancer (CLCC) de Nice	Nice
France	GH Paris Saint Joseph; Pneumologie	Paris
France	Hopital Saint Louis; Oncologie Medicale	Paris
France	Hopital Tenon;Pneumologie	Paris
France	Centre Hospitalier Lyon Sud	Pierre Benite
France	CH de Saint Quentin	Saint Quentin
France	Centre Medico-Chirurgical Foch; Service de Pneumologie	Suresnes
France	CHU de Toulouse - Hôpital Larrey; Service de pneumologie et oncologie pneumologique	Toulouse cedex 9
France	Institut Gustave Roussy; Sitep	VILLEJUIF Cedex
Germany	Klinikum d.Universität München Campus Großhadern	München
Hungary	Semmelweis Egyetem X; Pulmonologiai Klinika	Budapest
Hungary	Református Pulmonológiai Centrum; Oncology Department	Törökbálint
Israel	Belinson Medical Center	Petah Tikva
Italy	Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia	Arezzo	Toscana
Italy	Policlinico Vittorio Emanuele	Catania	Sicilia
Italy	ASL 3 Genovese	Genova	Liguria
Italy	IRCCS AOU San Martino - IST	Genova	Liguria
Italy	Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica	Milano	Lombardia
Italy	Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1	Milano	Lombardia
Italy	Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2	Milano	Lombardia
Italy	A.O. Universitaria Policlinico Di Modena; Oncologia	Modena	Emilia-Romagna
Italy	ASST DI MONZA; Oncologia Medica	Monza	Lombardia
Italy	Azienda Osp Uni Seconda Università Degli Studi Di Napoli; Unità Operativa Oncologia Medica	Napoli	Campania
Italy	Azienda Ospedaliera A. Cardarelli; Dip. Oncopneumoematologico	Napoli	Campania
Italy	Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale	Napoli	Campania
Italy	A.O.U. Maggiore della Carità	Novara	Piemonte
Italy	Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico	Orbassano	Piemonte
Italy	IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II	Padova	Veneto
Italy	Ospedale Santa Maria Della; Misericordia Di Perugia; Farmacia Ospedaliera	Perugia	Umbria
Italy	A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii	Pisa	Toscana
Italy	Università Cattolica Del S Cuore	Roma	Lazio
Italy	Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica	Siena	Toscana
Japan	Shikoku Cancer Center	Ehime
Japan	Iwate Medical University Hospital; Urology	Iwate
Japan	Sendai Kousei Hospital	Miyagi
Japan	Niigata Cancer Center Hospital	Niigata
Japan	Okayama University Hospital; Respiratory and Allergy Medicine	Okayama
Japan	The Cancer Institute Hospital of JFCR, Respiratory Medicine	Tokyo
Japan	Toranomon Hospital; Medical Oncology	Tokyo
Japan	Wakayama Medical University Hospital	Wakayama
Korea, Republic of	National Cancer Center	Goyang-si
Korea, Republic of	Chonnam National University Hwasun Hospital	Jeollanam-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si
Korea, Republic of	Samsung Medical Center	Seoul
Netherlands	NKI/AvL	Amsterdam
New Zealand	Auckland city hospital; Auckland Regional Cancer Centre and Blood Service	Auckland
Poland	Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii	Gdansk
Poland	Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers	Warszawa
Poland	Oddzia? Onkologii Klinicznej i Chemioterapii Szpitala ELBL?SKA	Warszawa
Portugal	Hospital de Santa Maria; Servico de Oncologia Medica	Lisboa
Portugal	Centro Hospitalar do Porto ? Hospital de Santo António; Oncologia	Porto
Romania	Institut Oncologic Ion Chiricuta; Departament Radioterapie	Cluj-napoca
Romania	ONCOMED - Medical Centre	Timisoara
Russian Federation	Moscow City Oncology Hospital #62	Moscovskaya Oblast	Moskovskaja Oblast
Serbia	Clinic for Pulmonology, Clinical Center of Serbia	Belgrade
Serbia	University Hospital Medical Center Bezanijska kosa	Belgrade
Slovenia	Institute of Oncology Ljubljana	Ljubljana
Spain	Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia	Badalona	Barcelona
Spain	Hospital Clinic de Barcelona. Unidad de Nuevas Terapias;Oncology Department	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia	Barcelona
Spain	Hospital del Mar; Servicio de Oncologia	Barcelona
Spain	Institut Catala d Oncologia Hospital Duran i Reynals	Barcelona
Spain	Hospital San Pedro De Alcantara; Servicio de Oncologia	Caceres
Spain	Hospital Universitario Reina Sofia; Servicio de Oncologia	Córdoba	Cordoba
Spain	Complejo Hospitalario de Jaen	Jaen
Spain	Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología	La Coruña
Spain	Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia	Las Palmas de Gran Canaria	LAS Palmas
Spain	Hospital Lucus Augusti; Servicio de Oncologia	Lugo
Spain	HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia	Madrid
Spain	Hospital General Universitario Gregorio Marañon; Servicio de Oncologia	Madrid
Spain	Hospital Ramon y Cajal; Servicio de Oncologia	Madrid
Spain	Hospital Universitario 12 de Octubre; Servicio de Oncologia	Madrid
Spain	Hospital Universitario Clínico San Carlos; Servicio de Oncologia	Madrid
Spain	Hospital Universitario La Paz; Servicio de Oncologia	Madrid
Spain	Hospital Regional Universitario Carlos Haya; Servicio de Oncologia	Malaga
Spain	Hospital Son Llatzer; Servicio de Oncologia	Palma de Mallorca	Islas Baleares
Spain	Clinica Universitaria de Navarra; Servicio de Oncologia	Pamplona	Navarra
Spain	Hospital Univ Vall d'Hebron; Servicio de Oncologia	Sant Andreu de La Barca	Barcelona
Spain	Hospital Universitario Virgen del Rocio; Servicio de Oncologia	Sevilla
Spain	Hospital General Universitario de Valencia; Servicio de oncologia	Valencia
Spain	Hospital NisA 9 de Octubre	Valencia
Switzerland	CHUV; Departement d'Oncologie	Lausanne
Taiwan	Changhua Christian Hospital; Internal Medicine	Changhua
Taiwan	China Medical University Hospital; Urology	Taichung
Taiwan	National Taiwan Uni Hospital; Dept of Oncology	Taipei
Thailand	Chulalongkorn Hospital; Medical Oncology	Bangkok
Thailand	Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology	Bangkok
Thailand	Ramathibodi Hospital; Medicine/Oncology	Bangkok
Turkey	Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi	Edirne
Turkey	Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology	Istanbul
Turkey	Hacettepe Uni Medical Faculty Hospital; Oncology Dept	Sihhiye/Ankara
Ukraine	Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU; Chair of Oncology and Medical Radiology	Dnipropetrovsk
Ukraine	Municipal Institution Podilskiy Regional Center of Oncology; Department of Chemotherapy	Vinnytsia	Podolia Governorate
United Kingdom	The Clatterbridge Cancer Centre NHS Foundation Trust	Liverpool
United Kingdom	Barts & London School of Med; Medical Oncology	London
United Kingdom	Charing Cross Hospital; Medical Oncology.	London
United Kingdom	Royal Free Hospital; Oncology & Haematology	London
United Kingdom	Royal Marsden Hospital - London	London
United Kingdom	St George's Hospital; Oncology	London
United Kingdom	Christie Hospital NHS Trust	Manchester
United Kingdom	Nottingham City Hospital; Oncology	Nottingham
United Kingdom	Royal Marsden Hospital - Surrey	Surrey
United States	New York Oncology Hematology, P.C.	Albany	New York
United States	University Of Colorado	Aurora	Colorado
United States	Johns Hopkins Univ Med Center	Baltimore	Maryland
United States	Dana Farber Cancer Inst. ; Dept. of Medical Oncology	Boston	Massachusetts
United States	Massachusetts General Hospital.	Boston	Massachusetts
United States	Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital	Carrollton	Georgia
United States	Northwestern University; Robert H. Lurie Comp Can Ctr	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	University Of Chicago Medical Center; Section Of Hematology/Oncology	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	Maryland Oncology Hematology, P.A.	Columbia	Maryland
United States	Memorial Sloan-Kettering Cancer Center	Commack	New York
United States	Texas Oncology - DFW	Dallas	Texas
United States	Rocky Mountain Cancer Ctr - Denver (Williams)	Denver	Colorado
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	Oncology Associates of Oregon, P.C	Eugene	Oregon
United States	Summit Medical Center	Florham Park	New Jersey
United States	Florida Cancer Specialists - Fort Myers (Broadway)	Fort Myers	Florida
United States	Tyler Cancer Center	Fort Worth	Texas
United States	Ingalls Memorial Hospital	Harvey	Illinois
United States	Penn State Hershey Cancer Institute	Hershey	Pennsylvania
United States	Carolina BioOncology Institute, PLCC	Huntersville	North Carolina
United States	Comprehensive Cancer Centers of Nevada - Eastern Avenue	Las Vegas	Nevada
United States	Angeles Clinic & Rsch Inst	Los Angeles	California
United States	UCLA	Los Angeles	California
United States	Sarah Cannon Res Inst; TN Onc	Nashville	Tennessee
United States	Vanderbilt Univ Medical Ctr	Nashville	Tennessee
United States	Smilow Cancer Hospital at Yale New Haven	New Haven	Connecticut
United States	Beth Israel Medical Center; Division of Digestive Diseases	New York	New York
United States	Virginia Oncology Associates	Norfolk	Virginia
United States	Illinois Cancer Care	Peoria	Illinois
United States	Allegheny Cancer Center	Pittsburgh	Pennsylvania
United States	Hematology Oncology Associates of the Treasure Coast	Port Saint Lucie	Florida
United States	Northwest Cancer Specialists - Portland (N Broadway)	Portland	Oregon
United States	Blue Ridge Cancer Care	Roanoke	Virginia
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	US oncology research at Minnesota Oncology	Saint Paul	Minnesota
United States	Florida Cancer Specialists.	Saint Petersburg	Florida
United States	Kaiser Permanente - San Diego (Zion Ave)	San Marcos	California
United States	New England Cancer Specialists	Scarborough	Maine
United States	HonorHealth Research Institute ? Bisgrove	Scottsdale	Arizona
United States	University of Washington Seattle Cancer Care Alliance	Seattle	Washington
United States	Northwest Medical Specialties	Tacoma	Washington
United States	H. Lee Moffitt Cancer Center and Research Inst.	Tampa	Florida
United States	Georgetown University Medical Center Lombardi Cancer Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  Czechia,  France,  Germany,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Netherlands,  New Zealand,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Slovenia,  Spain,  Switzerland,  Taiwan,  Thailand,  Turkey,  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) by Severity Determined According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0		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)
Secondary	Percentage of Participants With Adverse Events of Special Interest by Severity Determined According to NCI CTCAE Version 4.0		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)
Secondary	Time from Randomization or Treatment Initiation to Death due to any Cause for IMpower133 Participants Only		Day 1 (as indicated in parent study protocol) until death due to any cause (up to maximum 10 years)