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

Status: Active, not recruiting
Location: See all (171) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: No
View:

⁃ 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

Locations
United States
Arizona
HonorHealth Research Institute - Bisgrove
Scottsdale
California
Angeles Clinic & Rsch Inst
Los Angeles
UCLA
Los Angeles
Kaiser Permanente - San Diego (Zion Ave)
San Marcos
Colorado
University Of Colorado
Aurora
Rocky Mountain Cancer Ctr - Denver (Williams)
Denver
Connecticut
Smilow Cancer Hospital at Yale New Haven
New Haven
Washington, D.c.
Georgetown University Medical Center Lombardi Cancer Center
Washington
Florida
Florida Cancer Specialists - Fort Myers (Broadway)
Fort Myers
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie
Florida Cancer Specialists.
Saint Petersburg
H. Lee Moffitt Cancer Center and Research Inst.
Tampa
Georgia
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Carrollton
Illinois
Northwestern University; Robert H. Lurie Comp Can Ctr
Chicago
Rush University Medical Center
Chicago
University Of Chicago Medical Center; Section Of Hematology/Oncology
Chicago
Ingalls Memorial Hospital
Harvey
Illinois Cancer Care
Peoria
Massachusetts
Dana Farber Cancer Inst. ; Dept. of Medical Oncology
Boston
Massachusetts General Hospital.
Boston
Maryland
Johns Hopkins Univ Med Center
Baltimore
Maryland Oncology Hematology, P.A.
Columbia
Maine
New England Cancer Specialists
Scarborough
Michigan
Karmanos Cancer Institute
Detroit
Minnesota
US oncology research at Minnesota Oncology
Saint Paul
Missouri
Washington University School of Medicine
Saint Louis
North Carolina
Carolina BioOncology Institute, PLCC
Huntersville
New Jersey
Summit Medical Center
Florham Park
Nevada
Comprehensive Cancer Centers of Nevada - Eastern Avenue
Las Vegas
New York
New York Oncology Hematology, P.C.
Albany
Memorial Sloan-Kettering Cancer Center
Commack
Beth Israel Medical Center; Division of Digestive Diseases
New York
Ohio
Cleveland Clinic
Cleveland
Oregon
Oncology Associates of Oregon, P.C
Eugene
Northwest Cancer Specialists - Portland (N Broadway)
Portland
Pennsylvania
Penn State Hershey Cancer Institute
Hershey
Allegheny Cancer Center
Pittsburgh
Tennessee
Sarah Cannon Res Inst; TN Onc
Nashville
Vanderbilt Univ Medical Ctr
Nashville
Texas
Texas Oncology-Baylor Sammons Cancer Center
Dallas
Tyler Cancer Center
Fort Worth
Virginia
Virginia Oncology Associates - Lake Wright Cancer Center
Norfolk
Blue Ridge Cancer Care
Roanoke
Washington
University of Washington Seattle Cancer Care Alliance
Seattle
Northwest Medical Specialties
Tacoma
Other Locations
Argentina
Fundación CENIT para la Investigación en Neurociencias
Buenos Aires
Australia
Chris O'Brien Lifehouse
Camperdown
Princess AleXandra Hospital; Department of Medical Oncology
Woolloongabba
Austria
Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie
Wien
SMZ - Baumgartner Hohe, Otto-Wagner-Spital; 2.Interne Lungenabteilung
Wien
Belgium
AZ Glorieux- vzw Werken Glorieux
Ronse
Sint Augustinus Wilrijk
Wilrijk
Brazil
Hospital de Cancer de Barretos
Barretos
Fundacao Antonio Prudente
Sao Paulo
Instituto do Cancer do Estado de Sao Paulo - ICESP
Sao Paulo
Bulgaria
Multiprofile Hospital for Active Treatment Serdika EOOD; Medical Oncology Department
Sofia
Canada
Royal Victoria Hospital
Barrie
William Osler Health Centre
Etobicoke
Cite de La Sante de Laval; Hemato-Oncologie
Laval
Jewish General Hospital
Montreal
Lakeridge Health Corporation-Oshawa; Oncology clinic
Oshawa
Princess Margaret Cancer Center
Toronto
Sunnybrook Odette Cancer Centre; Clinical Trials
Toronto
Chile
Bradford Hill Centro de Investigaciones Clinicas; Bradford Hill Centro de Investigaciones Clinicas
Recoleta
France
Hopital Jean Minjoz; Pneumologie
Besancon
Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie
Grenoble
Centre Leon Berard; Departement Oncologie Medicale
Lyon
Hopital Nord; Service d'Oncologie Multidisciplinaire et Innovation Thérapeutique
Marseille
Centre René Gauducheau - cancer Nantes - Atlantique; Service Oncologie Médicale
Nantes
Centre Antoine Lacassagne, Centre de Lutte Contre le Cancer (CLCC) de Nice
Nice
GH Paris Saint Joseph; Pneumologie
Paris
Hopital Saint Louis; Oncologie Medicale
Paris
Hopital Tenon;Pneumologie
Paris
Centre Hospitalier Lyon Sud
Pierre Benite
CH de Saint Quentin
Saint Quentin
Centre Medico-Chirurgical Foch; Service de Pneumologie
Suresnes
CHU de Toulouse - Hôpital Larrey; Service de pneumologie et oncologie pneumologique
Toulouse Cedex 9
Institut Gustave Roussy; Sitep
Villejuif Cedex
Germany
Klinikum d.Universität München Campus Großhadern
München
Hungary
Semmelweis Egyetem X; Pulmonologiai Klinika
Budapest
Tudogyogyintezet Torokbalint
Torokbalint
Israel
Belinson Medical Center
Petah Tikva
Italy
Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia
Arezzo
Policlinico Vittorio Emanuele
Catania
ASL 3 Genovese
Genova
IRCCS AOU San Martino - IST
Genova
Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
Milano
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
Milano
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
Milano
A.O. Universitaria Policlinico Di Modena; Oncologia
Modena
ASST DI MONZA; Oncologia Medica
Monza
Azienda Osp Uni Seconda Università Degli Studi Di Napoli; Unità Operativa Oncologia Medica
Napoli
Azienda Ospedaliera A. Cardarelli; Dip. Oncopneumoematologico
Napoli
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
Napoli
A.O.U. Maggiore della Carità
Novara
Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico
Orbassano
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
Padova
Ospedale Santa Maria Della; Misericordia Di Perugia; Farmacia Ospedaliera
Perugia
A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii
Pisa
Università Cattolica Del S Cuore
Roma
Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica
Siena
Japan
Shikoku Cancer Center
Ehime
Iwate Medical University Hospital; Urology
Iwate
Sendai Kousei Hospital
Miyagi
Niigata Cancer Center Hospital
Niigata
Okayama University Hospital; Respiratory and Allergy Medicine
Okayama
The Cancer Institute Hospital of JFCR, Respiratory Medicine
Tokyo
Toranomon Hospital; Medical Oncology
Tokyo
Wakayama Medical University Hospital
Wakayama
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
Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers
Warszawa
Oddział Onkologii Klinicznej i Chemioterapii Szpitala ELBLĄSKA
Warszawa
Portugal
Hospital de Santa Maria; Servico de Oncologia Medica
Lisboa
Centro Hospitalar do Porto - Hospital de Santo António; Oncologia
Porto
Republic of Korea
National Cancer Center
Goyang-si
Chonnam National University Hwasun Hospital
Jeollanam-do
Seoul National University Bundang Hospital
Seongnam-si
Samsung Medical Center
Seoul
Romania
Institut Oncologic Ion Chiricuta; Departament Radioterapie
Cluj-napoca
ONCOMED - Medical Centre
Timisoara
Russian Federation
Moscow City Oncology Hospital #62
Moscovskaya Oblast
Serbia
Clinic for Pulmonology, Clinical Center of Serbia
Belgrade
University Hospital Medical Center Bezanijska kosa
Belgrade
Slovenia
Institute of Oncology Ljubljana
Ljubljana
Spain
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
Badalona
Hospital Clinic de Barcelona. Unidad de Nuevas Terapias;Oncology Department
Barcelona
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
Barcelona
Hospital del Mar; Servicio de Oncologia
Barcelona
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona
Institut Catala d Oncologia Hospital Duran i Reynals
Barcelona
Hospital San Pedro De Alcantara; Servicio de Oncologia
Caceres
Hospital Universitario Reina Sofia; Servicio de Oncologia
Córdoba
Complejo Hospitalario de Jaen
Jaen
Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
La Coruña
Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia
Las Palmas De Gran Canaria
Hospital Lucus Augusti; Servicio de Oncologia
Lugo
HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
Madrid
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid
Hospital Universitario Clínico San Carlos; Servicio de Oncologia
Madrid
Hospital Universitario La Paz; Servicio de Oncologia
Madrid
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
Malaga
Hospital Son Llatzer; Servicio de Oncologia
Palma De Mallorca
Clinica Universitaria de Navarra; Servicio de Oncologia
Pamplona
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Sevilla
Hospital General Universitario de Valencia; Servicio de oncologia
Valencia
Hospital NisA 9 de Octubre
Valencia
Switzerland
CHUV; Departement d'Oncologie
Lausanne
Taiwan
Changhua Christian Hospital; Internal Medicine
Changhua
China Medical University Hospital; Urology
Taichung
National Taiwan Uni Hospital; Dept of Oncology
Taipei
Thailand
Chulalongkorn Hospital; Medical Oncology
Bangkok
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
Bangkok
Ramathibodi Hospital; Medicine/Oncology
Bangkok
Turkey
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
Edirne
Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
Istanbul
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
Municipal Institution Podilskiy Regional Center of Oncology; Department of Chemotherapy
Vinnytsia
United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool
Barts & London School of Med; Medical Oncology
London
Charing Cross Hospital; Medical Oncology.
London
Royal Free Hospital; Oncology & Haematology
London
Royal Marsden Hospital - London
London
St George's Hospital; Oncology
London
Christie Hospital NHS Trust
Manchester
Nottingham City Hospital; Oncology
Nottingham
Royal Marsden Hospital - Surrey
Surrey
Time Frame
Start Date: September 20, 2017
Estimated Completion Date: March 6, 2030
Participants
Target number of participants: 382
Treatments
Experimental: Atezolizumab
Participants will continue to receive atezolizumab monotherapy or atezolizumab combined with other agent(s) or comparator agent(s) in a Genentech or Roche-sponsored study (the parent study) in accordance with local prescribing information till the participant continues to derive clinical benefit or until death, withdrawal of study consent, unacceptable toxicity, pregnancy, participant non-compliance, or study termination by the Sponsor, whichever occurs first.
Sponsors
Leads: Hoffmann-La Roche

This content was sourced from clinicaltrials.gov