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ACTIVE NOT RECRUITING

NCT03148418

PHASE3

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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

382

Start Date

2017-09-20

Completion Date

2030-03-06

Last Updated

2026-01-13

Healthy Volunteers

Conditions

Cancer

Interventions

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).

DRUG

Bevacizumab

Bevacizumab will be administered as directed per the parent study.

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

Locations (170)

HonorHealth Research Institute ? Bisgrove

Scottsdale, Arizona, United States

Angeles Clinic & Rsch Inst

Los Angeles, California, United States

UCLA

Los Angeles, California, United States

Kaiser Permanente - San Diego (Zion Ave)

San Marcos, California, United States

University Of Colorado

Aurora, Colorado, United States

Rocky Mountain Cancer Ctr - Denver (Williams)

Denver, Colorado, United States

Smilow Cancer Hospital at Yale New Haven

New Haven, Connecticut, United States

Georgetown University Medical Center Lombardi Cancer Center

Washington D.C., District of Columbia, United States

Florida Cancer Specialists - Fort Myers (Broadway)

Fort Myers, Florida, United States

Hematology Oncology Associates of the Treasure Coast

Port Saint Lucie, Florida, United States

Florida Cancer Specialists.

St. Petersburg, Florida, United States

H. Lee Moffitt Cancer Center and Research Inst.

Tampa, Florida, United States

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

Marietta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

University Of Chicago Medical Center

Chicago, Illinois, United States

Ingalls Memorial Hospital

Harvey, Illinois, United States

Illinois Cancer Care

Peoria, Illinois, United States

New England Cancer Specialists

Westbrook, Maine, United States

Johns Hopkins Univ Med Center

Baltimore, Maryland, United States

Maryland Oncology Hematology, P.A.

Columbia, Maryland, United States

Massachusetts General Hospital.

Boston, Massachusetts, United States

Beth Israel Medical Center

Boston, Massachusetts, United States

Dana Farber Cancer Inst.

Boston, Massachusetts, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

US oncology research at Minnesota Oncology

Saint Louis Park, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

Comprehensive Cancer Centers of Nevada - Eastern Avenue

Las Vegas, Nevada, United States

Summit Medical Center

Florham Park, New Jersey, United States

New York Oncology Hematology, P.C.

Albany, New York, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Carolina BioOncology Institute, PLCC

Huntersville, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Oncology Associates of Oregon, P.C

Eugene, Oregon, United States

Northwest Cancer Specialists - Portland (N Broadway)

Portland, Oregon, United States

Penn State Hershey Cancer Institute

Hershey, Pennsylvania, United States

Allegheny Cancer Center

Pittsburgh, Pennsylvania, United States

Sarah Cannon Res Inst

Nashville, Tennessee, United States

Texas Oncology - DFW

Dallas, Texas, United States

Tyler Cancer Center

Tyler, Texas, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

Blue Ridge Cancer Care

Roanoke, Virginia, United States

University of Washington Seattle Cancer Care Alliance

Seattle, Washington, United States

Northwest Medical Specialties

Tacoma, Washington, United States

Fundación CENIT para la Investigación en Neurociencias

Buenos Aires, Argentina

Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia

Princess AleXandra Hospital

Woolloongabba, Queensland, Australia

Klinik Penzing

Vienna, Austria

Krankenhaus Nord - Klinik Floridsdorf

Vienna, Austria

AZ Glorieux- vzw Werken Glorieux

Ronse, Belgium

ZAS Sint Augustinus Wilrijk

Wilrijk, Belgium

Hospital de Cancer de Barretos

Barretos, São Paulo, Brazil

Instituto do Cancer do Estado de Sao Paulo - ICESP

São Paulo, São Paulo, Brazil

Fundacao Antonio Prudente

São Paulo, São Paulo, Brazil

Multiprofile Hospital for Active Treatment Serdika EOOD

Sofia, Bulgaria

Royal Victoria Hospital

Barrie, Ontario, Canada

William Osler Health Centre

Brampton, Ontario, Canada

Lakeridge Health Corporation-Oshawa

Oshawa, Ontario, Canada

Sunnybrook Odette Cancer Centre

Toronto, Ontario, Canada

Princess Margaret Cancer Center

Toronto, Ontario, Canada

Cite de La Sante de Laval

Laval, Quebec, Canada

Jewish General Hospital

Montreal, Quebec, Canada

Bradford Hill Centro de Investigaciones Clinicas

Recoleta, Chile

Masarykuv onkologicky ustav

Brno, Czechia

Thomayerova nemocnice

Praha 4 - Krc, Czechia

Hopital Jean Minjoz

Besançon, France

Chu Grenoble - Hopital Albert Michallon

Grenoble, France

Centre Leon Berard

Lyon, France

Hopital Nord

Marseille, France

Centre René Gauducheau - cancer Nantes - Atlantique

Nantes, France

Centre Antoine Lacassagne, Centre de Lutte Contre le Cancer (CLCC) de Nice

Nice, France

Hopital Saint Louis

Paris, France

GH Paris Saint Joseph

Paris, France

Hopital Tenon

Paris, France

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

CH de Saint Quentin

Saint-Quentin, France

Centre Medico-Chirurgical Foch

Suresnes, France

CHU de Toulouse - Hôpital Larrey

Toulouse, France

Institut Gustave Roussy

Villejuif, France

Klinikum d.Universität München Campus Großhadern

München, Germany

Semmelweis Egyetem X

Budapest, Hungary

Református Pulmonológiai Centrum

Törökbálint, Hungary

Belinson Medical Center

Petah Tikva, Israel

Azienda Osp Uni Seconda Università Degli Studi Di Napoli

Naples, Campania, Italy

Azienda Ospedaliera A. Cardarelli

Naples, Campania, Italy

Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale

Naples, Campania, Italy

A.O. Universitaria Policlinico Di Modena

Modena, Emilia-Romagna, Italy

Università Cattolica Del S Cuore

Rome, Lazio, Italy

IRCCS AOU San Martino - IST

Genoa, Liguria, Italy

ASL 3 Genovese

Genoa, Liguria, Italy

Irccs Istituto Nazionale Dei Tumori (Int)

Milan, Lombardy, Italy

Irccs Istituto Europeo Di Oncologia (IEO)

Milan, Lombardy, Italy

Asst Di Monza

Monza, Lombardy, Italy

A.O.U. Maggiore della Carità

Novara, Piedmont, Italy

Azienda Ospedaliero-Universitaria San Luigi Gonzaga

Orbassano, Piedmont, Italy

Policlinico Vittorio Emanuele

Catania, Sicily, Italy

Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato

Arezzo, Tuscany, Italy

A.O. Universitaria Pisana-Ospedale Cisanello

Pisa, Tuscany, Italy

Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica

Siena, Tuscany, Italy

Ospedale Santa Maria Della

Perugia, Umbria, Italy

IOV - Istituto Oncologico Veneto - IRCCS

Padova, Veneto, Italy

Shikoku Cancer Center

Ehime, Japan

Sendai Kousei Hospital

Miyagi, Japan

Niigata Cancer Center Hospital

Niigata, Japan

Iwate Medical University Hospital

Numakunai, Japan

Okayama University Hospital

Okayama, Japan

Toranomon Hospital

Tokyo, Japan

The Cancer Institute Hospital of JFCR, Respiratory Medicine

Tokyo, Japan

Wakayama Medical University Hospital

Wakayama, Japan

NKI/AvL

Amsterdam, Netherlands

Auckland city hospital

Auckland, New Zealand

Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

Gdansk, Poland

Oddzia? Onkologii Klinicznej i Chemioterapii Szpitala ELBL?SKA

Warsaw, Poland

Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad

Warsaw, Poland

Hospital de Santa Maria

Lisbon, Portugal

Centro Hospitalar do Porto ? Hospital de Santo António

Porto, Portugal

Institut Oncologic Ion Chiricuta

Cluj-Napoca, Romania

ONCOMED - Medical Centre

Timișoara, Romania

Moscow City Oncology Hospital #62

Moscovskaya Oblast, Moscow Oblast, Russia

Clinic for Pulmonology, Clinical Center of Serbia

Belgrade, Serbia

University Hospital Medical Center Bezanijska kosa

Belgrade, Serbia

Institute of Oncology Ljubljana

Ljubljana, Slovenia

National Cancer Center

Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Gyeonggi-do, South Korea

Chonnam National University Hwasun Hospital

Jeollanam-do, South Korea

Samsung Medical Center

Seoul, South Korea

Hospital Son Llatzer

Palma de Mallorca, Balearic Islands, Spain

Hospital Universitario Reina Sofia

Córdoba, Cordoba, Spain

Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología

A Coruña, LA Coruna, Spain

Hospital Universitario Materno Infantil de Gran Canaria

Las Palmas de Gran Canaria, LAS Palmas, Spain

Clinica Universitaria de Navarra

Pamplona, Navarre, Spain

Hospital del Mar

Barcelona, Spain

Vall d'Hebron Institute of Oncology (VHIO), Barcelona

Barcelona, Spain

Hospital Clinic de Barcelona. Unidad de Nuevas Terapias

Barcelona, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Institut Catala d Oncologia Hospital Duran i Reynals

Barcelona, Spain

Hospital Universitari Germans Trias i Pujol

Barcelona, Spain

Hospital San Pedro De Alcantara

Cáceres, Spain

Complejo Hospitalario de Jaen

Jaén, Spain

Hospital Lucus Augusti

Lugo, Spain

Hospital General Universitario Gregorio Marañon

Madrid, Spain

Hospital Ramon y Cajal

Madrid, Spain

Hospital Universitario Clínico San Carlos

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital de Madrid Norte Sanchinarro- Centro Integral Oncologico Clara Campal

Madrid, Spain

Hospital Regional Universitario Carlos Haya

Málaga, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Hospital General Universitario de Valencia

Valencia, Spain

Hospital NisA 9 de Octubre

Valencia, Spain

CHUV

Lausanne, Switzerland

Changhua Christian Hospital

Changhua, Taiwan

China Medical University Hospital

Taichung, Taiwan

National Taiwan Uni Hospital

Taipei, Taiwan

Chulalongkorn Hospital

Bangkok, Thailand

Ramathibodi Hospital

Bangkok, Thailand

Faculty of Med. Siriraj Hosp.

Bangkok, Thailand

Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi

Edirne, Turkey (Türkiye)

Istanbul Uni Cerrahpasa Medical Faculty Hospital

Istanbul, Turkey (Türkiye)

Hacettepe Uni Medical Faculty Hospital

S?hhiye, Ankara, Turkey (Türkiye)

Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU

Dnipropetrovsk, Ukraine

Barts & London School of Med

London, United Kingdom

Royal Free Hospital

London, United Kingdom

St George's Hospital

London, United Kingdom

Royal Marsden Hospital - London

London, United Kingdom

Charing Cross Hospital

London, United Kingdom

Christie Hospital NHS Trust

Manchester, United Kingdom

The Clatterbridge Cancer Centre NHS Foundation Trust

Metropolitan Borough of Wirral, United Kingdom

Nottingham City Hospital

Nottingham, United Kingdom

Royal Marsden Hospital - Surrey

Surrey, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (170)