IMbrella B: A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03768063
Collaborator
(none)
1,000
Enrollment
175
Locations
1
Arm
112.2
Anticipated Duration (Months)
5.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an open-label, multicenter, extension study. Patients who are receiving clinical benefit from atezolizumab monotherapy or atezolizumab in combination with other agent(s) or comparator agent(s) during participation in a Genentech or Roche-sponsored study (the parent study), who are eligible to continue treatment and who do not have access to the study treatment locally, may continue to receive study treatment in this extension study following roll-over from the parent study.

Condition or DiseaseIntervention/TreatmentPhase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1000 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open Label, Multicenter Extension Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (IMbrella B)
Actual Study Start Date :
Feb 28, 2019
Anticipated Primary Completion Date :
Jul 5, 2028
Anticipated Study Completion Date :
Jul 5, 2028

Arms and Interventions

ArmIntervention/Treatment
Experimental: Atezolizumab

Participants will continue to receive atezolizumab monotherapy or atezolizumab with other agent(s) or comparator agent(s) as per parent protocol, until disease progression, loss of clinical benefit as judged by the investigator, death, withdrawl of study consent, unacceptable toxicity, pregnancy, patient 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) or comparator 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
  • Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Continued Access to Atezolizumab-Based Therapy and/or Comparator Agent(s) [Day 1 up to maximum 10 years]

    Secondary Outcome Measures

    1. Percentage of Participants With Serious Adverse Events (SAEs) According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 [Day 1 up to 90 days after last dose of study treatment (last dose=until 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)]

    2. Percentage of Participants With Adverse Events of Special Interest Determined According to NCI CTCAE Version 5.0 [Day 1 up to 90 days after last dose of study treatment (last dose=until 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)]

    3. Treatment Duration [Day 1 up to 90 days after last dose of study treatment (last dose=until 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)]

    4. Total Dose Received [Day 1 up to 90 days after last dose of study treatment (last dose=until 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)]

    5. Number of Treatment Cycles [Day 1 up to 90 days after last dose of study treatment (last dose=until 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)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Eligible for continuing atezolizumab-based therapy at the time of roll-over from the parent study, as per the parent study protocol or

    • Eligible for continuing the comparator agent(s) in a Genentech- or Roche-sponsored study as per the parent study protocol, with no access to commercially available comparator agent

    • Time between the last dose of treatment received in parent study and first dose in extension study is no longer than the interruption period allowed in the parent study. First dose of study treatment in this 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 roll-over from the parent study as assessed by the investigator

    • Negative serum pregnancy test within 7 days prior to start of study treatment in women of childbearing potential

    • For women of childbearing potential: agreement to remain abstinent or use contraceptive methods, and agreement to refrain from donating eggs

    • For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm

    Exclusion Criteria:
    • Meet any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment in this extension study

    • Study treatment or comparator agent is commercially marketed in the patient's country for the patient-specific disease and is accessible to the patient

    • Treatment with any anti-cancer treatment during the time between last treatment in the parent study and the first dose of study treatment in this 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 this extension study (if applicable)

    • Ongoing serious adverse event(s) that has not resolved to baseline level or Grade ≤1 from the parent study or during the time between the last treatment in the parent study and the first dose of study treatment in this extension study

    • Any condition that, in the opinion of the investigator, would interfere with the interpretation of patient safety or place the patient at high risk for treatment-related complications

    • Concurrent participation in any therapeutic clinical trial (other than the parent study)

    • Pregnant or lactating, or intending to become pregnant during this extension study and for the period after the last dose of study treatment specified in the designated referenced safety information (RSI)

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Univ of Alabama at Birmingham; UAB Comprehensive Cancer CtrBirminghamAlabamaUnited States352331912
    2HonorHealth Research Institute - Pima - Virginia G. Piper Cancer Care NetworkScottsdaleArizonaUnited States85258
    3University of Arkansas for Medical Sciences; Winthrop Rockefeller Cancer InstituteLittle RockArkansasUnited States72205
    4Kaiser Permanente - BellflowerBellflowerCaliforniaUnited States90706
    5City of HopeDuarteCaliforniaUnited States91010
    6UCLA Hematology / Oncology ClinicLos AngelesCaliforniaUnited States90095
    7Stanford University Medical CenterStanfordCaliforniaUnited States94305-5236
    8University of Colorado Cancer CenterAuroraColoradoUnited States80045
    9University of Colorado; Anschutz Cancer PavilionAuroraColoradoUnited States80045
    10Smilow Cancer Hospital at Yale New HavenNew HavenConnecticutUnited States06510
    11Yale Cancer CenterNew HavenConnecticutUnited States06520
    12Smilow Cancer CenterNorth HavenConnecticutUnited States06473
    13Yale University School Of Medicine; Yale Cancer CenterTrumbullConnecticutUnited States06611
    14Medstar Georgetown University HospitalWashingtonDistrict of ColumbiaUnited States20007
    15SCRI Florida Cancer Specialists SouthFort MyersFloridaUnited States33916
    16Mercy Hospital, a Campus of Plantation General HospitalMiamiFloridaUnited States33133
    17Hematology Oncology Associates of the Treasure CoastPort Saint LucieFloridaUnited States34952
    18SCRI Florida Cancer Specialists North; Research Office North Region.Saint PetersburgFloridaUnited States33705
    19University Of Chicago Medical Center; Section Of Hematology/OncologyChicagoIllinoisUnited States60637
    20Fort Wayne Medical Oncology and Hematology, IncFort WayneIndianaUnited States46804
    21New England Cancer SpecialistsScarboroughMaineUnited States04074
    22Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimoreMarylandUnited States21287
    23Massachusetts General HospitalBostonMassachusettsUnited States02114
    24Massachusetts General HospitalBostonMassachusettsUnited States02114
    25Beth Israel Deaconess Medical CenterBostonMassachusettsUnited States02215
    26Dana Farber Cancer InstituteBostonMassachusettsUnited States02215
    27Dana Farber Cancer InstituteBostonMassachusettsUnited States02215
    28St. Joseph Mercy Hospital; Cancer Care Center.Ann ArborMichiganUnited States48106
    29Barbara Ann Karmanos Cancer InstituteDetroitMichiganUnited States48201
    30Montefiore Medical CenterBronxNew YorkUnited States10467
    31New York University School of MedicineNew YorkNew YorkUnited States10016
    32Memorial Sloan Kettering - Basking RidgeNew YorkNew YorkUnited States10065
    33Levine Cancer Institute-Carolinas Medical Center; Levine Cancer Institute-Carolinas Medical CenterCharlotteNorth CarolinaUnited States28204
    34Carolina BioOncology Institute, PLCCHuntersvilleNorth CarolinaUnited States28078
    35Oncology Hematology Care IncCincinnatiOhioUnited States45242
    36Ohio State University; Hemat/OncColumbusOhioUnited States43210
    37St. Luke's Cancer Care AssociatesBethlehemPennsylvaniaUnited States18015
    38Fox Chase Cancer CenterPhiladelphiaPennsylvaniaUnited States19111
    39University of Pittsburgh Medical Center Cancer Center; Investigational Drug ServicePittsburghPennsylvaniaUnited States15232
    40SCRI Tennessee Oncology ChattanoogaChattanoogaTennesseeUnited States37404
    41Sarah Cannon Research InstituteNashvilleTennesseeUnited States37203
    42Sarah Cannon Research InstituteNashvilleTennesseeUnited States37203
    43SCRI-Tennessee OncologyNashvilleTennesseeUnited States37203
    44The University of Texas MD Anderson Cancer CenterHoustonTexasUnited States77030-4009
    45University of Texas Health Sciences Center in San AntonioSan AntonioTexasUnited States78229
    46Providence Regional Cancer PartnershipEverettWashingtonUnited States98201
    47University of Washington - Seattle Cancer Care Alliance; Medical OncologySeattleWashingtonUnited States98109
    48University of Washington - Seattle Cancer Care Alliance; Medical OncologySeattleWashingtonUnited States98109
    49Chris O'Brien LifehouseCamperdownNew South WalesAustralia2050
    50St Vincent'S HospitalDarlinghurstNew South WalesAustralia2010
    51The Prince Charles Hospital; Oncology Dept.ChermsideQueenslandAustralia4032
    52The Townsville HospitalDouglasQueenslandAustralia4814
    53Townsville HospitalTownsvilleQueenslandAustralia4810
    54Cabrini Hospital MalvernMalvernVictoriaAustralia3144
    55Institut Jules BordetBruxellesBelgium1000
    56Universitair Ziekenhuis Gent; OncologyGentBelgium9000
    57UZ LeuvenLeuvenBelgium3000
    58Hospital Araujo Jorge; PatologiaGoianiaGOBrazil74605-070
    59Instituto Nacional de Cancer - INCa; OncologiaRio de JaneiroRJBrazil20560-120
    60Hospital das Clinicas - UFRGSPorto AlegreRSBrazil90035-903
    61Instituto do Cancer do Estado de Sao Paulo - ICESPSao PauloSPBrazil01246-000
    62Multiprofile Hospital for Active Treatment Central Onco Hospital OOD; Dept. of Medical OncologyPlovdivBulgaria4004
    63Multiprofile Hospital for Active Treatment Serdika EOOD; Medical Oncology DepartmentSofiaBulgaria1632
    64BC Cancer - VancouverVancouverBritish ColumbiaCanadaV5Z 4E6
    65Lakeridge Health OshawaOshawaOntarioCanadaL1G 2B9
    66Princess Margaret Cancer CenterTorontoOntarioCanadaM5G 1Z5
    67Pontificia Universidad Catolica de Chile; Centro Del CáncerSantiagoChile8330032
    68Fakultni nemocnice Olomouc; Onkologicka klinikaOlomoucCzechia779 00
    69Rigshospitalet; Hæmatologisk KlinikKøbenhavn ØDenmark2100
    70RigshospitaletKøbenhavn ØDenmark2100
    71Institut Bergonie; OncologieBordeauxFrance33076
    72Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude HuriezLilleFrance59037
    73Centre Leon BerardLyonFrance69008
    74CHU Timone; Centre d'Essais Précoces en Cancérologie de Marseille (CEPCM)MarseilleFrance13005
    75APHP - Hospital Saint LouisParisFrance75475
    76Hopital d'Instruction des Armees de BeginSaint-MandeFrance94160
    77Hôpital d'Instruction des Armées de Sainte Anne; Service de PneumologieToulonFrance83000
    78Institut Claudius Regaud; Departement Oncologie MedicaleToulouseFrance31059
    79IUCT OncopoleToulouseFrance31100
    80Institut Gustave RoussyVillejuifFrance94805
    81St. Elisabethen KrankenhausFrankfurt am MainGermany60487
    82Universitätsklinikum Freiburg;Klinik für Innere Medizin IFreiburgGermany79106
    83SRH Wald-Klinikum Gera; Zentrum fur klinische Studien (ZKS)GeraGermany07548
    84Universitätsklinikum HeidelbergHeidelbergGermany69120
    85SLK-Kliniken Heilbronn GmbH; Klinik für Innere Medizin III; Schwerpunkt Häma./Onko./Palliativm.HeilbronnGermany74078
    86Lungenfachklinik Immenhausen; Zentrum fur PneumologieImmenhausenGermany34376
    87Krankenhaus Barmherzige Bruder RegensburgRegensburgGermany93049
    88Universitaets-Hautklinik TuebingenTübingenGermany72076
    89Universitätsklinik Tübingen; Frauenklinik & PoliklinikTübingenGermany72076
    90Laiko General Hospital AthenAthensGreece115 27
    91Alexandras Hospital; Dept. of Clin. Therapeutics, Athens Uni School of MedicineAthensGreece115 28
    92Anticancer Hospital Ag. SavasAthensGreece11522
    93Metropolitan HospitalAthensGreece185 47
    94University Hospital of Larissa; OncologyΛαρισαGreece413 35
    95Grupo AngelesGuatemala CityGuatemala01015
    96Queen Mary HospitalHong KongHong Kong
    97Orszagos Onkologiai Intezet; "C" Belgyógyászati-Onkológiai és Klinikai Farmakológiai OsztályBudapestHungary1122
    98Orszagos Onkologiai Intezet; Borgyogyaszati OsztalyBudapestHungary1122
    99Országos Onkológiai Intézet; Onkológiai Képalkotó és Invazív Diagnosztikai KözpontBudapestHungary1122
    100Szegedi Tudomanyegyetem, AOKBudapestHungary
    101Petz Aladar Megyei Oktato Korhaz; Pulmonologiai OsztalyGyorHungary9024
    102Pecsi Tudomanyegyetem AOK; Borgyogyaszati KlinikaPecsHungary7632
    103Szegedi Tudományegyetem; Onkoterápiás KlinikaSzegedHungary6720
    104Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz; Pulmonologiai OsztalySzekesfehervarHungary8001
    105Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e GinecologicaMilanoLombardiaItaly20133
    106Nagoya University HospitalAichiJapan466-8560
    107National Hospital Organization Shikoku Cancer CenterEhimeJapan791-0280
    108National Hospital Organization Kyushu Medical CenterFukuokaJapan810-8563
    109Kyushu University HospitalFukuokaJapan812-8582
    110Iwate Medical University HospitalIwateJapan028-3695
    111Kitasato University HospitalKanagawaJapan252-0375
    112Niigata University Medical & Dental HospitalNiigataJapan951-8520
    113Osaka Habikino Medical CenterOsakaJapan583-8588
    114Saitama Cancer CenterSaitamaJapan362-0806
    115National Hospital Organization Kinki-Chuo Chest Medical CenterSakai-shiJapan591-8555
    116Seoul National University HospitalSeoulKorea, Republic of03080
    117Severance HospitalSeoulKorea, Republic of03722
    118Samsung Medical CenterSeoulKorea, Republic of06351
    119Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/OncologySeoulKorea, Republic of138-736
    120Asan Medical Center; Internal Dept / GastorenterologySeoulKorea, Republic of138-736
    121Seoul National University College of Medicine, Liver Research InstituteSeoulKorea, Republic of
    122Riga's East Hosp Latvian Oncol; Medical OncologyRigaLatviaLV-1079
    123Centro Medico DalindeMexico CityMexico06700
    124Centro Universitario Contra El CancerMonterreyMexico64020
    125Førde sentralsjukehusFørdeNorway6800
    126Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i RadioterapiiGdańskPoland80-214
    127Przychodnia Lekarska KOMED, Roman KaraszewskiKoninPoland62-500
    128Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki OnkologiiKrakówPoland30-688
    129Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc; Oddzial onkologii z pododdzialem chemioterapiiOlsztynPoland10-357
    130Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika OnkologiiOtwockPoland05-400
    131Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial IiiOtwockPoland05-400
    132Med-Polonia Sp. z o.o.PoznanPoland60-693
    133Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu.PoznańPoland60-780
    134Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut BadawczyWarszawaPoland02-781
    135Centro Hospitalar do Porto - Hospital de Santo António; OncologiaPortoPortugal4099-001
    136Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca; Oncologie MedicalaCluj NapocaRomania400015
    137Centrul de Oncologie Sfantul NectarieCraiovaRomania200347
    138Institutul Regional de Oncologie Iasi; Clinica de HematologieIasiRomania700483
    139Centrul de Oncologie OncohelpTimisoaraRomania300239
    140Arkhangelsk Regional Clinical Oncology DispensaryArkhangelskArhangelskRussian Federation163045
    141Ivanovo Regional Oncology Dispensary; Chemotherapy DepartmentIvanovoRussian Federation153013
    142Russian Oncology Research Center n.a. N.N. BlokhinMoscowRussian Federation115478
    143P.A. Herzen Oncological Inst. ; OncologyMoscowRussian Federation125284
    144FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"Saint-PetersburgRussian Federation
    145National University HospitalSingaporeSingapore119074
    146University Hospital Bratislava; Department of OncologyBratislavaSlovakia826 06
    147Narodny Onkologicky Ustav; Oddelenie klinickej onkologie ABratislavaSlovakia833 10
    148Corporacio Sanitaria Parc Tauli; Servicio de OncologiaSabadellBarcelonaSpain8208
    149Hospital Universitario Son EspasesPalma de MallorcaIslas BalearesSpain07010
    150Clínica Universidad de NavarraPamplonaNavarraSpain31620
    151Hospital Universitario Quiron DexeusBarcelonaSpain08028
    152Hospital Universitari Vall d'HebronBarcelonaSpain08035
    153Hospital Clinic de BarcelonaBarcelonaSpain08036
    154Hospital Lucus Augusti; Servicio de OncologiaLugoSpain27003
    155Hospital General Universitario Gregorio MaraMadridSpain28009
    156Clinica Universidad de Navarra-MadridMadridSpain28027
    157Centro Integral Oncologico Clara Campal; Servicio de OncologíaMadridSpain28050
    158HM Sanchinarro - CIOCC; Servicio de OncologiaMadridSpain28050
    159Hospital Regional Universitario de Málaga - Hospital GeneralMalagaSpain29010
    160Hospital Clinico Universitario de ValenciaValenciaSpain46010
    161Freiburger Spital; OnkologieFribourgSwitzerland1708
    162Chang Gung Memorial Hospital ChiayiPutzuTaiwan613
    163Taichung Veterans General HospitalTaichungTaiwan40705
    164Koo Foundation Sun Yat-Sen Cancer Center; Hemato-OncologyTaipei CityTaiwan11259
    165MI Dnipropetrovsk City Multifield Clinical Hospital 4 of Dnipropetrovsk Regional CouncilDnipropetrovskKaterynoslav GovernorateUkraine49102
    166Communal Non profit Enterprise Regional Center of Oncology; Oncosurgical dept of thoracic organsKharkivKharkiv GovernorateUkraine61070
    167Uzhhorod Central City Clinical HospitalUzhhorodKIEV GovernorateUkraine88000
    168Municipal Institution Podilskiy Regional Center of Oncology; Department of ChemotherapyVinnytsiaPodolia GovernorateUkraine21029
    169MI of the Lviv Regional Council Lviv Oncology Regional Treatment and Diagnostic Centre; ChemotherapyLvivVolhynian GovernorateUkraine79031
    170National Cancer Institute MOH of UkraineKievUkraine36022
    171ME Kryviy Rih Oncology Dispensary of Dnipropetrovs'k Regional Council; Chemotherapy DepartmentKryvyi RihUkraine50048
    172Volyn Regional Oncology DispensaryLutskUkraine43018
    173Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary; Sumy State Uni, Med InstSumyUkraine40022
    174Barts Cancer InstituteLondonUnited KingdomE1 2AT
    175St Georges University Hospitals NHS Foundation TrustLondonUnited KingdomSW17 0RE

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT03768063
    Other Study ID Numbers:
    • BO40729
    First Posted:
    Dec 7, 2018
    Last Update Posted:
    Nov 16, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 16, 2021