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

April 10, 2026 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

382

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1125ABD
        • Fundación Cenit para la Investigación en Neurociencias
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Chris O'Brien Lifehouse
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
  • Austria
      • Vienna, Austria, 1140
        • Klinik Penzing
      • Vienna, Austria, 1210
        • Krankenhaus Nord - Klinik Floridsdorf
  • Belgium
      • Ronse, Belgium, 9600
        • AZ Glorieux- vzw Werken Glorieux
      • Wilrijk, Belgium, 2610
        • ZAS Sint Augustinus Wilrijk
  • Brazil
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784-400
        • Hospital de Cancer de Barretos
      • São Paulo, São Paulo, Brazil, 01246-000
        • Instituto do Cancer do Estado de Sao Paulo - ICESP
      • São Paulo, São Paulo, Brazil, 01509-900
        • Fundacao Antonio Prudente
  • Bulgaria
      • Sofia, Bulgaria, 1303
        • Multiprofile Hospital for Active Treatment Serdika EOOD
  • Canada
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
        • Royal Victoria Hospital
      • Brampton, Ontario, Canada, L6R 3J7
        • William Osler Health Centre
      • Oshawa, Ontario, Canada, L1G 2B9
        • Lakeridge Health Corporation-Oshawa
      • Toronto, Ontario, Canada, M5G 1Z5
        • Princess Margaret Cancer Center
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Odette Cancer Centre
    • Quebec
      • Laval, Quebec, Canada, H7M 3L9
        • Cite de La Sante de Laval
      • Montreal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital
  • Chile
      • Recoleta, Chile, 8420383
        • Bradford Hill Centro de Investigaciones Clinicas
  • Czechia
      • Brno, Czechia, 656 53
        • Masarykuv Onkologicky Ustav
      • Praha 4 - Krc, Czechia, 140 59
        • Thomayerova nemocnice
  • France
      • Besançon, France, 25030
        • Hôpital Jean Minjoz
      • Grenoble, France, 38043
        • Chu Grenoble - Hopital Albert Michallon
      • Lyon, France, 69373
        • Centre Leon Berard
      • Marseille, France, 13915
        • Hopital Nord
      • Nantes, France, 44805
        • Centre René Gauducheau - cancer Nantes - Atlantique
      • Nice, France, 06189
        • Centre Antoine Lacassagne, Centre de Lutte Contre le Cancer (CLCC) de Nice
      • Paris, France, 75970
        • Hôpital Tenon
      • Paris, France, 75475
        • Hopital Saint Louis
      • Paris, France, 75674
        • GH Paris Saint Joseph
      • Pierre-Bénite, France, 69495
        • Centre Hospitalier Lyon Sud
      • Saint-Quentin, France, 2100
        • CH de Saint Quentin
      • Suresnes, France, 92151
        • Centre Médico-Chirurgical Foch
      • Toulouse, France, 31059
        • CHU de Toulouse - Hopital Larrey
      • Villejuif, France, 94805
        • Institut Gustave Roussy
  • Germany
      • München, Germany, 81377
        • Klinikum d.Universität München Campus Großhadern
  • Hungary
      • Budapest, Hungary, 1083
        • Semmelweis Egyetem X
      • Törökbálint, Hungary, 2045
        • Reformatus Pulmonologiai Centrum
  • Israel
      • Petah Tikva, Israel, 4922297
        • Belinson Medical Center
  • Italy
    • Campania
      • Naples, Campania, Italy, 80131
        • Azienda Osp Uni Seconda Università Degli Studi Di Napoli
      • Naples, Campania, Italy, 80131
        • Azienda Ospedaliera A. Cardarelli
      • Naples, Campania, Italy, 80131
        • Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
    • Emilia-Romagna
      • Modena, Emilia-Romagna, Italy, 41100
        • A.O. Universitaria Policlinico Di Modena
    • Lazio
      • Rome, Lazio, Italy, 00168
        • Università Cattolica Del S Cuore
    • Liguria
      • Genoa, Liguria, Italy, 16132
        • IRCCS AOU San Martino - IST
      • Genoa, Liguria, Italy, 16149
        • ASL 3 Genovese
    • Lombardy
      • Milan, Lombardy, Italy, 20133
        • Irccs Istituto Nazionale Dei Tumori (Int)
      • Milan, Lombardy, Italy, 20141
        • Irccs Istituto Europeo Di Oncologia (IEO)
      • Monza, Lombardy, Italy, 20900
        • Asst Di Monza
    • Piedmont
      • Novara, Piedmont, Italy, 28100
        • A.O.U. Maggiore della Carità
      • Orbassano, Piedmont, Italy, 10043
        • Azienda Ospedaliero-Universitaria San Luigi Gonzaga
    • Sicily
      • Catania, Sicily, Italy, 95123
        • Policlinico Vittorio Emanuele
    • Tuscany
      • Arezzo, Tuscany, Italy, 52100
        • Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato
      • Pisa, Tuscany, Italy, 56124
        • A.O. Universitaria Pisana-Ospedale Cisanello
      • Siena, Tuscany, Italy, 53100
        • Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica
    • Umbria
      • Perugia, Umbria, Italy, 06129
        • Ospedale Santa Maria Della
    • Veneto
      • Padova, Veneto, Italy, 35128
        • IOV - Istituto Oncologico Veneto - IRCCS
  • Japan
      • Ehime, Japan, 791-0280
        • Shikoku Cancer Center
      • Miyagi, Japan, 981-0914
        • Sendai Kousei Hospital
      • Niigata, Japan, 951-8566
        • Niigata Cancer Center Hospital
      • Numakunai, Japan, 028-3695
        • Iwate Medical University Hospital
      • Okayama, Japan, 700-8558
        • Okayama University Hospital
      • Tokyo, Japan, 135-8550
        • The Cancer Institute Hospital of JFCR, Respiratory Medicine
      • Tokyo, Japan, 105-8470
        • Toranomon Hospital
      • Wakayama, Japan, 641-8510
        • Wakayama Medical University Hospital
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • NKI/AvL
  • New Zealand
      • Auckland, New Zealand, 1023
        • Auckland City Hospital
  • Poland
      • Gdansk, Poland, 80-952
        • Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
      • Warsaw, Poland, 02-781
        • Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad
      • Warsaw, Poland, 01-748
        • Oddzia? Onkologii Klinicznej i Chemioterapii Szpitala ELBL?SKA
  • Portugal
      • Lisbon, Portugal, 1649-035
        • Hospital de Santa Maria
      • Porto, Portugal, 4099-001
        • Centro Hospitalar do Porto ? Hospital de Santo António
  • Romania
      • Cluj-Napoca, Romania, 400015
        • Institut Oncologic Ion Chiricuta
      • Timișoara, Romania, 300239
        • ONCOMED - Medical Centre
  • Russia
    • Moscow Oblast
      • Moscovskaya Oblast, Moscow Oblast, Russia, 143423
        • Moscow City Oncology Hospital #62
  • Serbia
      • Belgrade, Serbia, 11000
        • Clinic for Pulmonology, Clinical Center of Serbia
      • Belgrade, Serbia, 11080
        • University Hospital Medical Center Bezanijska kosa
  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Institute of Oncology Ljubljana
  • South Korea
      • Gyeonggi-do, South Korea, 13620
        • Seoul National University Bundang Hospital
      • Gyeonggi-do, South Korea, 10408
        • National Cancer Center
      • Jeollanam-do, South Korea, 58128
        • Chonnam National University Hwasun Hospital
      • Seoul, South Korea, 06351
        • Samsung Medical Center
  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08908
        • Institut Catala d Oncologia Hospital Duran i Reynals
      • Barcelona, Spain, 08041
        • Hospital De La Santa Creu I Sant Pau
      • Barcelona, Spain, 08916
        • Hospital Universitari Germans Trias i Pujol
      • Barcelona, Spain, 08035
        • Vall d'Hebron Institute of Oncology (VHIO), Barcelona
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona. Unidad de Nuevas Terapias
      • Cáceres, Spain, 10003
        • Hospital San Pedro de Alcantara
      • Jaén, Spain, 23007
        • Complejo Hospitalario de Jaén
      • Lugo, Spain, 27003
        • Hospital Lucus Augusti
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañón
      • Madrid, Spain, 28040
        • Hospital Universitario Clinico San Carlos
      • Madrid, Spain, 28050
        • Hospital de Madrid Norte Sanchinarro- Centro Integral Oncologico Clara Campal
      • Málaga, Spain, 29010
        • Hospital Regional Universitario Carlos Haya
      • Seville, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Valencia, Spain, 46014
        • Hospital General Universitario de Valencia
      • Valencia, Spain, 46015
        • Hospital NisA 9 de Octubre
    • Balearic Islands
      • Palma de Mallorca, Balearic Islands, Spain, 07198
        • Hospital Son Llatzer
    • Cordoba
      • Córdoba, Cordoba, Spain, 14004
        • Hospital Universitario Reina Sofía
    • LA Coruna
      • A Coruña, LA Coruna, Spain, 15006
        • Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
    • LAS Palmas
      • Las Palmas de Gran Canaria, LAS Palmas, Spain, 35016
        • Hospital Universitario Materno Infantil de Gran Canaria
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Clinica Universitaria de Navarra
  • Switzerland
      • Lausanne, Switzerland, 1011
        • CHUV
  • Taiwan
      • Changhua, Taiwan, 500
        • Changhua Christian Hospital
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Taipei, Taiwan, 100
        • National Taiwan Uni Hospital
  • Thailand
      • Bangkok, Thailand, 10330
        • Chulalongkorn Hospital
      • Bangkok, Thailand, 10400
        • Ramathibodi Hospital
      • Bangkok, Thailand, 10700
        • Faculty of Med. Siriraj Hosp.
  • Turkey (Türkiye)
      • Edirne, Turkey (Türkiye), 22030
        • Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
      • Istanbul, Turkey (Türkiye), 34300
        • Istanbul Uni Cerrahpasa Medical Faculty Hospital
      • S?hhiye, Ankara, Turkey (Türkiye), 06100
        • Hacettepe Uni Medical Faculty Hospital
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49102
        • Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU
  • United Kingdom
      • London, United Kingdom, Nw3 2QG
        • Royal Free Hospital
      • London, United Kingdom, SW17 0QT
        • St George's Hospital
      • London, United Kingdom, W6 8RF
        • Charing Cross Hospital
      • London, United Kingdom, SW3 6JJ
        • Royal Marsden Hospital - London
      • London, United Kingdom, EC1A 7BE
        • Barts & London School of Med
      • Manchester, United Kingdom, M20 4BX
        • Christie Hospital Nhs Trust
      • Metropolitan Borough of Wirral, United Kingdom, L63 4JY
        • The Clatterbridge Cancer Centre NHS Foundation Trust
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham City Hospital
      • Surrey, United Kingdom, SM2 5PT
        • Royal Marsden Hospital - Surrey
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • HonorHealth Research Institute ? Bisgrove
    • California
      • Los Angeles, California, United States, 90095
        • UCLA
      • Los Angeles, California, United States, 90025
        • Angeles Clinic & Rsch Inst
      • San Marcos, California, United States, 92078
        • Kaiser Permanente - San Diego (Zion Ave)
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Ctr - Denver (Williams)
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Smilow Cancer Hospital at Yale New Haven
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20057
        • Georgetown University Medical Center Lombardi Cancer Center
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Florida Cancer Specialists - Fort Myers (Broadway)
      • Port Saint Lucie, Florida, United States, 34952
        • Hematology Oncology Associates of the Treasure Coast
      • St. Petersburg, Florida, United States, 33705
        • Florida Cancer Specialists.
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center and Research Inst.
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
      • Chicago, Illinois, United States, 60612-3244
        • Rush University Medical Center
      • Harvey, Illinois, United States, 60426
        • Ingalls Memorial Hospital
      • Peoria, Illinois, United States, 61615
        • Illinois Cancer Care
    • Maine
      • Westbrook, Maine, United States, 04092
        • New England Cancer Specialists
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Johns Hopkins Univ Med Center
      • Columbia, Maryland, United States, 21044
        • Maryland Oncology Hematology, P.A.
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital.
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Medical Center
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Inst.
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55416
        • US oncology research at Minnesota Oncology
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Comprehensive Cancer Centers of Nevada - Eastern Avenue
    • New Jersey
      • Florham Park, New Jersey, United States, 07932
        • Summit Medical Center
    • New York
      • Albany, New York, United States, 12206
        • New York Oncology Hematology, P.C.
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center
    • North Carolina
      • Huntersville, North Carolina, United States, 28078
        • Carolina BioOncology Institute, PLCC
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Oncology Associates of Oregon, P.C
      • Portland, Oregon, United States, 97227
        • Northwest Cancer Specialists - Portland (N Broadway)
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Hershey Cancer Institute
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Res Inst
    • Texas
      • Dallas, Texas, United States, 75246
        • Texas Oncology - DFW
      • Tyler, Texas, United States, 75702
        • Tyler Cancer Center
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates
      • Roanoke, Virginia, United States, 24014
        • Blue Ridge Cancer Care
    • Washington
      • Seattle, Washington, United States, 98109
        • University of Washington Seattle Cancer Care Alliance
      • Tacoma, Washington, United States, 98405
        • Northwest Medical Specialties

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combined Agents with Atezolizumab
Participants 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.
Drug: Bevacizumab
Bevacizumab will be administered as directed per the parent study.
Other Names:
  • Avastin
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).
Other Names:
  • Tecentriq
  • RO5541267
Active Comparator: Comparator Treatment
Participants 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.
Drug: Bevacizumab
Bevacizumab will be administered as directed per the parent study.
Other Names:
  • Avastin
Experimental: Atezolizumab Monotherapy
Participants 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.
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).
Other Names:
  • Tecentriq
  • RO5541267

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Continued Access to Atezolizumab-Based Therapy and/or Comparator Agent(s)
Time Frame: Day 1 up to maximum 10 years
Day 1 up to maximum 10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 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)
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
Time Frame: 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)
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
Time Frame: Day 1 (as indicated in parent study protocol) until death due to any cause (up to maximum 10 years or until the sponsor stop)
Day 1 (as indicated in parent study protocol) until death due to any cause (up to maximum 10 years or until the sponsor stop)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2017

Primary Completion (Estimated)

March 6, 2030

Study Completion (Estimated)

March 6, 2030

Study Registration Dates

First Submitted

May 9, 2017

First Submitted That Met QC Criteria

May 9, 2017

First Posted (Actual)

May 11, 2017

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BO39633
  • 2016-005189-75 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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