A Study in Participants Previously Enrolled in a Genentech- and/or F. Hoffmann-La Roche Ltd-Sponsored Atezolizumab Study (IMbrella A)
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
2 other identifiers
interventional
382
31 countries
168
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 cancer
Started Sep 2017
Longer than P75 for phase_3 cancer
168 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2017
CompletedFirst Posted
Study publicly available on registry
May 11, 2017
CompletedStudy Start
First participant enrolled
September 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 6, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 6, 2030
April 13, 2026
April 1, 2026
12.5 years
May 9, 2017
April 10, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Continued Access to Atezolizumab-Based Therapy and/or Comparator Agent(s)
Day 1 up to maximum 10 years
Secondary Outcomes (3)
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)
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)
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 or until the sponsor stop)
Study Arms (3)
Atezolizumab Monotherapy
EXPERIMENTALParticipants will continue to receive atezolizumab monotherapy 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.
Combined Agents with Atezolizumab
EXPERIMENTALParticipants will receive treatment of atezolizumab with combined agent(s) as directed per the parent study. Participants will receive agent(s) in combination with atezolizumab at the same dose and schedule, and with the same administration guidelines that were in effect at the time of participant discontinuation from the parent study.
Comparator Treatment
ACTIVE COMPARATORParticipants will receive comparator treatment administration as directed per the parent study. Participants will receive comparator treatment at the same dose and schedule, and with the same administration guidelines that were in effect at the time of participant discontinuation from the parent study.
Interventions
Bevacizumab will be administered as directed per the parent study.
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (170)
HonorHealth Research Institute ? Bisgrove
Scottsdale, Arizona, 85258, United States
Angeles Clinic & Rsch Inst
Los Angeles, California, 90025, United States
UCLA
Los Angeles, California, 90095, United States
Kaiser Permanente - San Diego (Zion Ave)
San Marcos, California, 92078, United States
University Of Colorado
Aurora, Colorado, 80045, United States
Rocky Mountain Cancer Ctr - Denver (Williams)
Denver, Colorado, 80218, United States
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, 06510, United States
Georgetown University Medical Center Lombardi Cancer Center
Washington D.C., District of Columbia, 20057, United States
Florida Cancer Specialists - Fort Myers (Broadway)
Fort Myers, Florida, 33901, United States
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, 34952, United States
Florida Cancer Specialists.
St. Petersburg, Florida, 33705, United States
H. Lee Moffitt Cancer Center and Research Inst.
Tampa, Florida, 33612, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta, Georgia, 30060, United States
Northwestern University
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612-3244, United States
University Of Chicago Medical Center
Chicago, Illinois, 60637, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
Illinois Cancer Care
Peoria, Illinois, 61615, United States
New England Cancer Specialists
Westbrook, Maine, 04092, United States
Johns Hopkins Univ Med Center
Baltimore, Maryland, 21231, United States
Maryland Oncology Hematology, P.A.
Columbia, Maryland, 21044, United States
Massachusetts General Hospital.
Boston, Massachusetts, 02114, United States
Beth Israel Medical Center
Boston, Massachusetts, 02215, United States
Dana Farber Cancer Inst.
Boston, Massachusetts, 02215, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
US oncology research at Minnesota Oncology
Saint Louis Park, Minnesota, 55416, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Comprehensive Cancer Centers of Nevada - Eastern Avenue
Las Vegas, Nevada, 89169, United States
Summit Medical Center
Florham Park, New Jersey, 07932, United States
New York Oncology Hematology, P.C.
Albany, New York, 12206, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Carolina BioOncology Institute, PLCC
Huntersville, North Carolina, 28078, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Oncology Associates of Oregon, P.C
Eugene, Oregon, 97401, United States
Northwest Cancer Specialists - Portland (N Broadway)
Portland, Oregon, 97227, United States
Penn State Hershey Cancer Institute
Hershey, Pennsylvania, 17033, United States
Allegheny Cancer Center
Pittsburgh, Pennsylvania, 15212, United States
Sarah Cannon Res Inst
Nashville, Tennessee, 37203, United States
Texas Oncology - DFW
Dallas, Texas, 75246, United States
Tyler Cancer Center
Tyler, Texas, 75702, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Blue Ridge Cancer Care
Roanoke, Virginia, 24014, United States
University of Washington Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
Northwest Medical Specialties
Tacoma, Washington, 98405, United States
Fundación CENIT para la Investigación en Neurociencias
Buenos Aires, C1125ABD, Argentina
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050, Australia
Princess AleXandra Hospital
Woolloongabba, Queensland, 4102, Australia
Klinik Penzing
Vienna, 1140, Austria
Krankenhaus Nord - Klinik Floridsdorf
Vienna, 1210, Austria
AZ Glorieux- vzw Werken Glorieux
Ronse, 9600, Belgium
ZAS Sint Augustinus Wilrijk
Wilrijk, 2610, Belgium
Hospital de Cancer de Barretos
Barretos, São Paulo, 14784-400, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, 01246-000, Brazil
Fundacao Antonio Prudente
São Paulo, São Paulo, 01509-900, Brazil
Multiprofile Hospital for Active Treatment Serdika EOOD
Sofia, 1303, Bulgaria
Royal Victoria Hospital
Barrie, Ontario, L4M 6M2, Canada
William Osler Health Centre
Brampton, Ontario, L6R 3J7, Canada
Lakeridge Health Corporation-Oshawa
Oshawa, Ontario, L1G 2B9, Canada
Sunnybrook Odette Cancer Centre
Toronto, Ontario, M4N 3M5, Canada
Princess Margaret Cancer Center
Toronto, Ontario, M5G 1Z5, Canada
Cite de La Sante de Laval
Laval, Quebec, H7M 3L9, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Bradford Hill Centro de Investigaciones Clinicas
Recoleta, 8420383, Chile
Masarykuv onkologicky ustav
Brno, 656 53, Czechia
Thomayerova nemocnice
Praha 4 - Krc, 140 59, Czechia
Hopital Jean Minjoz
Besançon, 25030, France
Chu Grenoble - Hopital Albert Michallon
Grenoble, 38043, France
Centre Leon Berard
Lyon, 69373, France
Hopital Nord
Marseille, 13915, France
Centre René Gauducheau - cancer Nantes - Atlantique
Nantes, 44805, France
Centre Antoine Lacassagne, Centre de Lutte Contre le Cancer (CLCC) de Nice
Nice, 06189, France
Hopital Saint Louis
Paris, 75475, France
GH Paris Saint Joseph
Paris, 75674, France
Hopital Tenon
Paris, 75970, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
CH de Saint Quentin
Saint-Quentin, 2100, France
Centre Medico-Chirurgical Foch
Suresnes, 92151, France
CHU de Toulouse - Hôpital Larrey
Toulouse, 31059, France
Institut Gustave Roussy
Villejuif, 94805, France
Klinikum d.Universität München Campus Großhadern
München, 81377, Germany
Semmelweis Egyetem X
Budapest, 1083, Hungary
Református Pulmonológiai Centrum
Törökbálint, 2045, Hungary
Belinson Medical Center
Petah Tikva, 4922297, Israel
Azienda Osp Uni Seconda Università Degli Studi Di Napoli
Naples, Campania, 80131, Italy
Azienda Ospedaliera A. Cardarelli
Naples, Campania, 80131, Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
Naples, Campania, 80131, Italy
A.O. Universitaria Policlinico Di Modena
Modena, Emilia-Romagna, 41100, Italy
Università Cattolica Del S Cuore
Rome, Lazio, 00168, Italy
IRCCS AOU San Martino - IST
Genoa, Liguria, 16132, Italy
ASL 3 Genovese
Genoa, Liguria, 16149, Italy
Irccs Istituto Nazionale Dei Tumori (Int)
Milan, Lombardy, 20133, Italy
Irccs Istituto Europeo Di Oncologia (IEO)
Milan, Lombardy, 20141, Italy
Asst Di Monza
Monza, Lombardy, 20900, Italy
A.O.U. Maggiore della Carità
Novara, Piedmont, 28100, Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Orbassano, Piedmont, 10043, Italy
Policlinico Vittorio Emanuele
Catania, Sicily, 95123, Italy
Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato
Arezzo, Tuscany, 52100, Italy
A.O. Universitaria Pisana-Ospedale Cisanello
Pisa, Tuscany, 56124, Italy
Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica
Siena, Tuscany, 53100, Italy
Ospedale Santa Maria Della
Perugia, Umbria, 06129, Italy
IOV - Istituto Oncologico Veneto - IRCCS
Padova, Veneto, 35128, Italy
Shikoku Cancer Center
Ehime, 791-0280, Japan
Sendai Kousei Hospital
Miyagi, 981-0914, Japan
Niigata Cancer Center Hospital
Niigata, 951-8566, Japan
Iwate Medical University Hospital
Numakunai, 028-3695, Japan
Okayama University Hospital
Okayama, 700-8558, Japan
Toranomon Hospital
Tokyo, 105-8470, Japan
The Cancer Institute Hospital of JFCR, Respiratory Medicine
Tokyo, 135-8550, Japan
Wakayama Medical University Hospital
Wakayama, 641-8510, Japan
NKI/AvL
Amsterdam, 1066 CX, Netherlands
Auckland city hospital
Auckland, 1023, New Zealand
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
Gdansk, 80-952, Poland
Oddzia? Onkologii Klinicznej i Chemioterapii Szpitala ELBL?SKA
Warsaw, 01-748, Poland
Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad
Warsaw, 02-781, Poland
Hospital de Santa Maria
Lisbon, 1649-035, Portugal
Centro Hospitalar do Porto ? Hospital de Santo António
Porto, 4099-001, Portugal
Institut Oncologic Ion Chiricuta
Cluj-Napoca, 400015, Romania
ONCOMED - Medical Centre
Timișoara, 300239, Romania
Moscow City Oncology Hospital #62
Moscovskaya Oblast, Moscow Oblast, 143423, Russia
Clinic for Pulmonology, Clinical Center of Serbia
Belgrade, 11000, Serbia
University Hospital Medical Center Bezanijska kosa
Belgrade, 11080, Serbia
Institute of Oncology Ljubljana
Ljubljana, 1000, Slovenia
National Cancer Center
Gyeonggi-do, 10408, South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, 13620, South Korea
Chonnam National University Hwasun Hospital
Jeollanam-do, 58128, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Hospital Son Llatzer
Palma de Mallorca, Balearic Islands, 07198, Spain
Hospital Universitario Reina Sofia
Córdoba, Cordoba, 14004, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
A Coruña, LA Coruna, 15006, Spain
Hospital Universitario Materno Infantil de Gran Canaria
Las Palmas de Gran Canaria, LAS Palmas, 35016, Spain
Clinica Universitaria de Navarra
Pamplona, Navarre, 31008, Spain
Hospital del Mar
Barcelona, 08003, Spain
Vall d'Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, 08035, Spain
Hospital Clinic de Barcelona. Unidad de Nuevas Terapias
Barcelona, 08036, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041, Spain
Institut Catala d Oncologia Hospital Duran i Reynals
Barcelona, 08908, Spain
Hospital Universitari Germans Trias i Pujol
Barcelona, 08916, Spain
Hospital San Pedro De Alcantara
Cáceres, 10003, Spain
Complejo Hospitalario de Jaen
Jaén, 23007, Spain
Hospital Lucus Augusti
Lugo, 27003, Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28007, Spain
Hospital Ramon y Cajal
Madrid, 28034, Spain
Hospital Universitario Clínico San Carlos
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital de Madrid Norte Sanchinarro- Centro Integral Oncologico Clara Campal
Madrid, 28050, Spain
Hospital Regional Universitario Carlos Haya
Málaga, 29010, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Hospital General Universitario de Valencia
Valencia, 46014, Spain
Hospital NisA 9 de Octubre
Valencia, 46015, Spain
CHUV
Lausanne, 1011, Switzerland
Changhua Christian Hospital
Changhua, 500, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
National Taiwan Uni Hospital
Taipei, 100, Taiwan
Chulalongkorn Hospital
Bangkok, 10330, Thailand
Ramathibodi Hospital
Bangkok, 10400, Thailand
Faculty of Med. Siriraj Hosp.
Bangkok, 10700, Thailand
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
Edirne, 22030, Turkey (Türkiye)
Istanbul Uni Cerrahpasa Medical Faculty Hospital
Istanbul, 34300, Turkey (Türkiye)
Hacettepe Uni Medical Faculty Hospital
S?hhiye, Ankara, 06100, Turkey (Türkiye)
Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU
Dnipropetrovsk, 49102, Ukraine
Barts & London School of Med
London, EC1A 7BE, United Kingdom
Royal Free Hospital
London, NW3 2QG, United Kingdom
St George's Hospital
London, SW17 0QT, United Kingdom
Royal Marsden Hospital - London
London, SW3 6JJ, United Kingdom
Charing Cross Hospital
London, W6 8RF, United Kingdom
Christie Hospital NHS Trust
Manchester, M20 4BX, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Metropolitan Borough of Wirral, L63 4JY, United Kingdom
Nottingham City Hospital
Nottingham, NG5 1PB, United Kingdom
Royal Marsden Hospital - Surrey
Surrey, SM2 5PT, United Kingdom
Related Publications (1)
Reck M, Dziadziuszko R, Sugawara S, Kao S, Hochmair M, Huemer F, de Castro G Jr, Havel L, Bernabe Caro R, Losonczy G, Lee JS, Kowalski DM, Andric Z, Califano R, Veatch A, Gerstner G, Batus M, Morris S, Kaul M, Cuchelkar V, Li H, Danner BJ, Nabet BY, Liu SV. Five-year survival in patients with extensive-stage small cell lung cancer treated with atezolizumab in the Phase III IMpower133 study and the Phase III IMbrella A extension study. Lung Cancer. 2024 Oct;196:107924. doi: 10.1016/j.lungcan.2024.107924. Epub 2024 Aug 10.
PMID: 39306923DERIVED
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2017
First Posted
May 11, 2017
Study Start
September 20, 2017
Primary Completion (Estimated)
March 6, 2030
Study Completion (Estimated)
March 6, 2030
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing