Clinical trial NCT03148418: A Study in Participants Previously Enrolled in a Genentech- and/or F. Hoffmann-La Roche Ltd-Sponsored Atezolizumab Study (IMbrella A)
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2017-05-11
Enrollment: 382
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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

Primary outcomes:
measure: Number of Participants With Continued Access to Atezolizumab-Based Therapy and/or Comparator Agent(s)
timeFrame: Day 1 up to maximum 10 years
Secondary outcomes:
measure: 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
timeFrame: 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)
measure: Percentage of Participants With Adverse Events of Special Interest by Severity Determined According to NCI CTCAE Version 4.0
timeFrame: 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)
measure: Time from Randomization or Treatment Initiation to Death due to any Cause for IMpower133 Participants Only
timeFrame: Day 1 (as indicated in parent study protocol) until death due to any cause (up to maximum 10 years)
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: HonorHealth Research Institute ? Bisgrove
state: Arizona
city: Los Angeles
country: United States
facility: Angeles Clinic & Rsch Inst
state: California
city: Los Angeles
country: United States
facility: UCLA
state: California
city: San Marcos
country: United States
facility: Kaiser Permanente - San Diego (Zion Ave)
state: California
city: Aurora
country: United States
facility: University Of Colorado
state: Colorado
city: Denver
country: United States
facility: Rocky Mountain Cancer Ctr - Denver (Williams)
state: Colorado
city: New Haven
country: United States
facility: Smilow Cancer Hospital at Yale New Haven
state: Connecticut
city: Washington
country: United States
facility: Georgetown University Medical Center Lombardi Cancer Center
state: District of Columbia
city: Fort Myers
country: United States
facility: Florida Cancer Specialists - Fort Myers (Broadway)
state: Florida
city: Port Saint Lucie
country: United States
facility: Hematology Oncology Associates of the Treasure Coast
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists.
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Inst.
state: Florida
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University Of Chicago Medical Center
state: Illinois
city: Harvey
country: United States
facility: Ingalls Memorial Hospital
state: Illinois
city: Peoria
country: United States
facility: Illinois Cancer Care
state: Illinois
city: Scarborough
country: United States
facility: New England Cancer Specialists
state: Maine
city: Baltimore
country: United States
facility: Johns Hopkins Univ Med Center
state: Maryland
city: Columbia
country: United States
facility: Maryland Oncology Hematology, P.A.
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital.
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Inst.
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Saint Louis Park
country: United States
facility: US oncology research at Minnesota Oncology
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada - Eastern Avenue
state: Nevada
city: Florham Park
country: United States
facility: Summit Medical Center
state: New Jersey
city: Albany
country: United States
facility: New York Oncology Hematology, P.C.
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Huntersville
country: United States
facility: Carolina BioOncology Institute, PLCC
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Eugene
country: United States
facility: Oncology Associates of Oregon, P.C
state: Oregon
city: Portland
country: United States
facility: Northwest Cancer Specialists - Portland (N Broadway)
state: Oregon
city: Hershey
country: United States
facility: Penn State Hershey Cancer Institute
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Cancer Center
state: Pennsylvania
city: Nashville
country: United States
facility: Sarah Cannon Res Inst
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Univ Medical Ctr
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology - DFW
state: Texas
city: Tyler
country: United States
facility: Tyler Cancer Center
state: Texas
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Roanoke
country: United States
facility: Blue Ridge Cancer Care
state: Virginia
city: Seattle
country: United States
facility: University of Washington Seattle Cancer Care Alliance
state: Washington
city: Tacoma
country: United States
facility: Northwest Medical Specialties
state: Washington
city: Buenos Aires
country: Argentina
facility: Fundación CENIT para la Investigación en Neurociencias
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
state: New South Wales
city: Woolloongabba
country: Australia
facility: Princess AleXandra Hospital
state: Queensland
city: Wien
country: Austria
facility: Klinik Penzing
city: Wien
country: Austria
facility: Krankenhaus Nord - Klinik Floridsdorf
city: Ronse
country: Belgium
facility: AZ Glorieux- vzw Werken Glorieux
city: Wilrijk
country: Belgium
facility: Sint Augustinus Wilrijk
city: Barretos
country: Brazil
facility: Hospital de Cancer de Barretos
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo - ICESP
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Fundacao Antonio Prudente
state: São Paulo
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Serdika EOOD
city: Barrie
country: Canada
facility: Royal Victoria Hospital
state: Ontario
city: Brampton
country: Canada
facility: William Osler Health Centre
state: Ontario
city: Oshawa
country: Canada
facility: Lakeridge Health Corporation-Oshawa
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Odette Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Center
state: Ontario
city: Laval
country: Canada
facility: Cite de La Sante de Laval
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Recoleta
country: Chile
facility: Bradford Hill Centro de Investigaciones Clinicas
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav
city: Praha 4 - Krc
country: Czechia
facility: Thomayerova nemocnice
city: Besancon
country: France
facility: Hopital Jean Minjoz
city: Grenoble
country: France
facility: Chu Grenoble - Hopital Albert Michallon
city: Lyon
country: France
facility: Centre Leon Berard
city: Marseille
country: France
facility: Hopital Nord
city: Nantes
country: France
facility: Centre René Gauducheau - cancer Nantes - Atlantique
city: Nice
country: France
facility: Centre Antoine Lacassagne, Centre de Lutte Contre le Cancer (CLCC) de Nice
city: Paris
country: France
facility: Hopital Saint Louis
city: Paris
country: France
facility: GH Paris Saint Joseph
city: Paris
country: France
facility: Hopital Tenon
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud
city: Saint Quentin
country: France
facility: CH de Saint Quentin
city: Suresnes
country: France
facility: Centre Medico-Chirurgical Foch
city: Toulouse Cedex 9
country: France
facility: CHU de Toulouse - Hôpital Larrey
city: VILLEJUIF Cedex
country: France
facility: Institut Gustave Roussy
city: München
country: Germany
facility: Klinikum d.Universität München Campus Großhadern
city: Budapest
country: Hungary
facility: Semmelweis Egyetem X
city: Törökbálint
country: Hungary
facility: Református Pulmonológiai Centrum
city: Petah Tikva
country: Israel
facility: Belinson Medical Center
city: Napoli
country: Italy
facility: Azienda Osp Uni Seconda Università Degli Studi Di Napoli
state: Campania
city: Napoli
country: Italy
facility: Azienda Ospedaliera A. Cardarelli
state: Campania
city: Napoli
country: Italy
facility: Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
state: Campania
city: Modena
country: Italy
facility: A.O. Universitaria Policlinico Di Modena
state: Emilia-Romagna
city: Roma
country: Italy
facility: Università Cattolica Del S Cuore
state: Lazio
city: Genova
country: Italy
facility: IRCCS AOU San Martino - IST
state: Liguria
city: Genova
country: Italy
facility: ASL 3 Genovese
state: Liguria
city: Milano
country: Italy
facility: Irccs Istituto Nazionale Dei Tumori (Int)
state: Lombardia
city: Milano
country: Italy
facility: Irccs Istituto Europeo Di Oncologia (IEO)
state: Lombardia
city: Monza
country: Italy
facility: Asst Di Monza
state: Lombardia
city: Novara
country: Italy
facility: A.O.U. Maggiore della Carità
state: Piemonte
city: Orbassano
country: Italy
facility: Az. Osp. S. Luigi Gonzaga
state: Piemonte
city: Catania
country: Italy
facility: Policlinico Vittorio Emanuele
state: Sicilia
city: Arezzo
country: Italy
facility: Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato
state: Toscana
city: Pisa
country: Italy
facility: A.O. Universitaria Pisana-Ospedale Cisanello
state: Toscana
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica
state: Toscana
city: Perugia
country: Italy
facility: Ospedale Santa Maria Della
state: Umbria
city: Padova
country: Italy
facility: IOV - Istituto Oncologico Veneto - IRCCS
state: Veneto
city: Ehime
country: Japan
facility: Shikoku Cancer Center
city: Iwate
country: Japan
facility: Iwate Medical University Hospital
city: Miyagi
country: Japan
facility: Sendai Kousei Hospital
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Tokyo
country: Japan
facility: Toranomon Hospital
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR, Respiratory Medicine
city: Wakayama
country: Japan
facility: Wakayama Medical University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Jeollanam-do
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Amsterdam
country: Netherlands
facility: NKI/AvL
city: Auckland
country: New Zealand
facility: Auckland city hospital
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
city: Warszawa
country: Poland
facility: Oddzia? Onkologii Klinicznej i Chemioterapii Szpitala ELBL?SKA
city: Warszawa
country: Poland
facility: Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad
city: Lisboa
country: Portugal
facility: Hospital de Santa Maria
city: Porto
country: Portugal
facility: Centro Hospitalar do Porto ? Hospital de Santo António
city: Cluj-napoca
country: Romania
facility: Institut Oncologic Ion Chiricuta
city: Timisoara
country: Romania
facility: ONCOMED - Medical Centre
city: Moscovskaya Oblast
country: Russian Federation
facility: Moscow City Oncology Hospital #62
state: Moskovskaja Oblast
city: Belgrade
country: Serbia
facility: Clinic for Pulmonology, Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: University Hospital Medical Center Bezanijska kosa
city: Ljubljana
country: Slovenia
facility: Institute of Oncology Ljubljana
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia
state: Cordoba
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llatzer
state: Islas Baleares
city: La Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
state: LA Coruna
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario Materno Infantil de Gran Canaria
state: LAS Palmas
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
state: Navarra
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Vall d'Hebron Institute of Oncology (VHIO), Barcelona
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona. Unidad de Nuevas Terapias
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Institut Catala d Oncologia Hospital Duran i Reynals
city: Barcelona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Caceres
country: Spain
facility: Hospital San Pedro De Alcantara
city: Jaen
country: Spain
facility: Complejo Hospitalario de Jaen
city: Lugo
country: Spain
facility: Hospital Lucus Augusti
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital de Madrid Norte Sanchinarro- Centro Integral Oncologico Clara Campal
city: Malaga
country: Spain
facility: Hospital Regional Universitario Carlos Haya
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital NisA 9 de Octubre
city: Lausanne
country: Switzerland
facility: CHUV
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan Uni Hospital
city: Bangkok
country: Thailand
facility: Chulalongkorn Hospital
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
city: Bangkok
country: Thailand
facility: Faculty of Med. Siriraj Hosp.
city: Edirne
country: Turkey
facility: Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
city: Istanbul
country: Turkey
facility: Istanbul Uni Cerrahpasa Medical Faculty Hospital
city: S?hhiye, Ankara
country: Turkey
facility: Hacettepe Uni Medical Faculty Hospital
city: Dnipropetrovsk
country: Ukraine
facility: Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU
city: London
country: United Kingdom
facility: Barts & London School of Med
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: St George's Hospital
city: London
country: United Kingdom
facility: Royal Marsden Hospital - London
city: London
country: United Kingdom
facility: Charing Cross Hospital
city: Manchester
country: United Kingdom
facility: Christie Hospital NHS Trust
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
city: Surrey
country: United Kingdom
facility: Royal Marsden Hospital - Surrey
city: Wirral
country: United Kingdom
facility: The Clatterbridge Cancer Centre NHS Foundation Trust
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: