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 (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03148418
Collaborator
(none)
389
Enrollment
173
Locations
1
Arm
149.5
Anticipated Duration (Months)
2.2
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
389 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 20, 2017
Anticipated Primary Completion Date :
Mar 6, 2030
Anticipated Study Completion Date :
Mar 6, 2030

Arms and Interventions

ArmIntervention/Treatment
Experimental: Atezolizumab

Participants will continue to receive atezolizumab monotherapy or atezolizumab combined with other agent(s) or comparator agent(s) 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 monotherapy or combined with other agent(s) or comparator agent(s) in a Genentech or Roche-sponsored study (the parent study). Dosing regimen will be in accordance with the parent study and local prescribing information.
Other Names:
  • RO5541267
  • 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) 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)]

    2. 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)]

    3. 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)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1HonorHealth Research Institute - BisgroveScottsdaleArizonaUnited States85258
    2UCLALos AngelesCaliforniaUnited States90024
    3Angeles Clinic & Rsch InstLos AngelesCaliforniaUnited States90025
    4Kaiser Permanente - San Diego (Zion Ave)San MarcosCaliforniaUnited States92078
    5University Of ColoradoAuroraColoradoUnited States80045
    6Rocky Mountain Cancer Ctr - Denver (Williams)DenverColoradoUnited States80218
    7Smilow Cancer Hospital at Yale New HavenNew HavenConnecticutUnited States06510
    8Georgetown University Medical Center Lombardi Cancer CenterWashingtonDistrict of ColumbiaUnited States20007
    9Florida Cancer Specialists - Fort Myers (Broadway)Fort MyersFloridaUnited States33901
    10Hematology Oncology Associates of the Treasure CoastPort Saint LucieFloridaUnited States34952
    11Florida Cancer Specialists.Saint PetersburgFloridaUnited States33705
    12H. Lee Moffitt Cancer Center and Research Inst.TampaFloridaUnited States33612
    13Northwest Georgia Oncology Centers, a Service of Wellstar Cobb HospitalCarrolltonGeorgiaUnited States30117
    14Northwestern University; Robert H. Lurie Comp Can CtrChicagoIllinoisUnited States60611
    15Rush University Medical CenterChicagoIllinoisUnited States60612-3244
    16University Of Chicago Medical Center; Section Of Hematology/OncologyChicagoIllinoisUnited States60637
    17Ingalls Memorial HospitalHarveyIllinoisUnited States60426
    18Illinois Cancer CarePeoriaIllinoisUnited States61615
    19New England Cancer SpecialistsScarboroughMaineUnited States04074
    20Johns Hopkins Univ Med CenterBaltimoreMarylandUnited States21231
    21Maryland Oncology Hematology, P.A.ColumbiaMarylandUnited States21044
    22Massachusetts General Hospital.BostonMassachusettsUnited States02114
    23Dana Farber Cancer Inst. ; Dept. of Medical OncologyBostonMassachusettsUnited States02115
    24Karmanos Cancer InstituteDetroitMichiganUnited States48201
    25US oncology research at Minnesota OncologySaint PaulMinnesotaUnited States55102
    26Washington University School of MedicineSaint LouisMissouriUnited States63110
    27Comprehensive Cancer Centers of Nevada - Eastern AvenueLas VegasNevadaUnited States89169
    28Summit Medical CenterFlorham ParkNew JerseyUnited States07932
    29New York Oncology Hematology, P.C.AlbanyNew YorkUnited States12206
    30Memorial Sloan-Kettering Cancer CenterCommackNew YorkUnited States11725
    31Beth Israel Medical Center; Division of Digestive DiseasesNew YorkNew YorkUnited States10003
    32Carolina BioOncology Institute, PLCCHuntersvilleNorth CarolinaUnited States28078
    33Cleveland ClinicClevelandOhioUnited States44106
    34Oncology Associates of Oregon, P.CEugeneOregonUnited States97401
    35Northwest Cancer Specialists - Portland (N Broadway)PortlandOregonUnited States97227
    36Penn State Hershey Cancer InstituteHersheyPennsylvaniaUnited States17033
    37Allegheny Cancer CenterPittsburghPennsylvaniaUnited States15212
    38Sarah Cannon Res Inst; TN OncNashvilleTennesseeUnited States37203
    39Vanderbilt Univ Medical CtrNashvilleTennesseeUnited States37203
    40Texas Oncology-Baylor Sammons Cancer CenterDallasTexasUnited States75246
    41Tyler Cancer CenterFort WorthTexasUnited States76177
    42Virginia Oncology Associates - Lake Wright Cancer CenterNorfolkVirginiaUnited States23502
    43Blue Ridge Cancer CareRoanokeVirginiaUnited States24014
    44University of Washington Seattle Cancer Care AllianceSeattleWashingtonUnited States98195
    45Northwest Medical SpecialtiesTacomaWashingtonUnited States98405
    46Fundación CENIT para la Investigación en NeurocienciasBuenos AiresArgentinaC1125ABD
    47Chris O'Brien LifehouseCamperdownNew South WalesAustralia2050
    48Princess AleXandra Hospital; Department of Medical OncologyWoolloongabbaQueenslandAustralia4102
    49SMZ - Baumgartner Hohe, Otto-Wagner-Spital; 2.Interne LungenabteilungWienAustria1140
    50Krankenhaus Nord - Klinik Floridsdorf; Abteilung PulmologieWienAustria1210
    51AZ Glorieux- vzw Werken GlorieuxRonseBelgium9600
    52Sint Augustinus WilrijkWilrijkBelgium2610
    53Hospital de Cancer de BarretosBarretosSPBrazil14784-400
    54Instituto do Cancer do Estado de Sao Paulo - ICESPSao PauloSPBrazil01246-000
    55Fundacao Antonio PrudenteSao PauloSPBrazil01509-900
    56Multiprofile Hospital for Active Treatment Serdika EOOD; Medical Oncology DepartmentSofiaBulgaria1632
    57Royal Victoria HospitalBarrieOntarioCanadaL4M 6M2
    58William Osler Health CentreEtobicokeOntarioCanadaM9V 1R8
    59Lakeridge Health Corporation-Oshawa; Oncology clinicOshawaOntarioCanadaL1G 2B9
    60Sunnybrook Odette Cancer Centre; Clinical TrialsTorontoOntarioCanadaM4N 3M5
    61Princess Margaret Cancer CenterTorontoOntarioCanadaM5G 1Z5
    62Cite de La Sante de Laval; Hemato-OncologieLavalQuebecCanadaH7M 3L9
    63Jewish General HospitalMontrealQuebecCanadaH3T 1E2
    64Bradford Hill Centro de Investigaciones Clinicas; Bradford Hill Centro de Investigaciones ClinicasRecoletaChile8420383
    65Masarykuv onkologicky ustavBrnoCzechia656 53
    66Thomayerova nemocnicePraha 4 - KrcCzechia140 59
    67Hopital Jean Minjoz; PneumologieBesanconFrance25030
    68Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-HematologieGrenobleFrance38043
    69Centre Leon Berard; Departement Oncologie MedicaleLyonFrance69373
    70Hopital Nord; Service d'Oncologie Multidisciplinaire et Innovation ThérapeutiqueMarseilleFrance13915
    71Centre René Gauducheau - cancer Nantes - Atlantique; Service Oncologie MédicaleNantesFrance44805
    72Centre Antoine Lacassagne, Centre de Lutte Contre le Cancer (CLCC) de NiceNiceFrance06189
    73Hopital Saint Louis; Oncologie MedicaleParisFrance75475
    74GH Paris Saint Joseph; PneumologieParisFrance75674
    75Hopital Tenon;PneumologieParisFrance75970
    76Centre Hospitalier Lyon SudPierre BeniteFrance69495
    77CH de Saint QuentinSaint QuentinFrance2100
    78Centre Medico-Chirurgical Foch; Service de PneumologieSuresnesFrance92151
    79CHU de Toulouse - Hôpital Larrey; Service de pneumologie et oncologie pneumologiqueToulouse cedex 9France31100
    80Institut Gustave Roussy; SitepVILLEJUIF CedexFrance94805
    81Klinikum d.Universität München Campus GroßhadernMünchenGermany81377
    82Semmelweis Egyetem X; Pulmonologiai KlinikaBudapestHungary1083
    83Tudogyogyintezet TorokbalintTorokbalintHungary2045
    84Belinson Medical CenterPetah TikvaIsrael4922297
    85Azienda Osp Uni Seconda Università Degli Studi Di Napoli; Unità Operativa Oncologia MedicaNapoliCampaniaItaly80131
    86Azienda Ospedaliera A. Cardarelli; Dip. OncopneumoematologicoNapoliCampaniaItaly80131
    87Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. PascaleNapoliCampaniaItaly80131
    88A.O. Universitaria Policlinico Di Modena; OncologiaModenaEmilia-RomagnaItaly41100
    89Università Cattolica Del S CuoreRomaLazioItaly00168
    90ASL 3 GenoveseGenovaLiguriaItaly16125
    91IRCCS AOU San Martino - ISTGenovaLiguriaItaly16132
    92Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1MilanoLombardiaItaly20133
    93Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2MilanoLombardiaItaly20133
    94Irccs Istituto Europeo Di Oncologia (IEO); Oncologia MedicaMilanoLombardiaItaly20141
    95ASST DI MONZA; Oncologia MedicaMonzaLombardiaItaly20900
    96A.O.U. Maggiore della CaritàNovaraPiemonteItaly28100
    97Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo OncologicoOrbassanoPiemonteItaly10043
    98Policlinico Vittorio EmanueleCataniaSiciliaItaly95123
    99Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. OncologiaArezzoToscanaItaly52100
    100A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia IiPisaToscanaItaly56124
    101Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia OncologicaSienaToscanaItaly53100
    102Ospedale Santa Maria Della; Misericordia Di Perugia; Farmacia OspedalieraPerugiaUmbriaItaly06129
    103IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica IIPadovaVenetoItaly35128
    104Shikoku Cancer CenterEhimeJapan791-0280
    105Iwate Medical University Hospital; UrologyIwateJapan028-3695
    106Sendai Kousei HospitalMiyagiJapan980-0873
    107Niigata Cancer Center HospitalNiigataJapan951-8566
    108Okayama University Hospital; Respiratory and Allergy MedicineOkayamaJapan700-8558
    109Toranomon Hospital; Medical OncologyTokyoJapan105-8470
    110The Cancer Institute Hospital of JFCR, Respiratory MedicineTokyoJapan135-8550
    111Wakayama Medical University HospitalWakayamaJapan641-8510
    112National Cancer CenterGoyang-siKorea, Republic of10408
    113Chonnam National University Hwasun HospitalJeollanam-doKorea, Republic of58128
    114Seoul National University Bundang HospitalSeongnam-siKorea, Republic of13605
    115Samsung Medical CenterSeoulKorea, Republic of06351
    116NKI/AvLAmsterdamNetherlands1066 CX
    117Auckland city hospital; Auckland Regional Cancer Centre and Blood ServiceAucklandNew Zealand1023
    118Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i RadioterapiiGdanskPoland80-214
    119Oddział Onkologii Klinicznej i Chemioterapii Szpitala ELBLĄSKAWarszawaPoland01-748
    120Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki PiersWarszawaPoland02-781
    121Hospital de Santa Maria; Servico de Oncologia MedicaLisboaPortugal1649-035
    122Centro Hospitalar do Porto - Hospital de Santo António; OncologiaPortoPortugal4099-001
    123Institut Oncologic Ion Chiricuta; Departament RadioterapieCluj-napocaRomania400015
    124ONCOMED - Medical CentreTimisoaraRomania300239
    125Moscow City Oncology Hospital #62Moscovskaya OblastMoskovskaja OblastRussian Federation143423
    126Clinic for Pulmonology, Clinical Center of SerbiaBelgradeSerbia11000
    127University Hospital Medical Center Bezanijska kosaBelgradeSerbia11080
    128Institute of Oncology LjubljanaLjubljanaSlovenia1000
    129Hospital Universitari Germans Trias i Pujol; Servicio de OncologiaBadalonaBarcelonaSpain08916
    130Hospital Universitario Reina Sofia; Servicio de OncologiaCórdobaCordobaSpain14004
    131Hospital Son Llatzer; Servicio de OncologiaPalma de MallorcaIslas BalearesSpain07198
    132Hospital Universitario Materno Infantil de Gran Canaria; Servicio de OncologiaLas Palmas de Gran CanariaLAS PalmasSpain35016
    133Clinica Universitaria de Navarra; Servicio de OncologiaPamplonaNavarraSpain31008
    134Hospital del Mar; Servicio de OncologiaBarcelonaSpain08003
    135Hospital Univ Vall d'Hebron; Servicio de OncologiaBarcelonaSpain08035
    136Hospital Clinic de Barcelona. Unidad de Nuevas Terapias;Oncology DepartmentBarcelonaSpain08036
    137Hospital de la Santa Creu i Sant Pau; Servicio de OncologiaBarcelonaSpain08041
    138Institut Catala d Oncologia Hospital Duran i ReynalsBarcelonaSpain08908
    139Hospital San Pedro De Alcantara; Servicio de OncologiaCaceresSpain10003
    140Complejo Hospitalario de JaenJaenSpain23007
    141Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), OncologíaLa CoruñaSpain15006
    142Hospital Lucus Augusti; Servicio de OncologiaLugoSpain27003
    143Hospital General Universitario Gregorio Marañon; Servicio de OncologiaMadridSpain28007
    144Hospital Ramon y Cajal; Servicio de OncologiaMadridSpain28034
    145Hospital Universitario Clínico San Carlos; Servicio de OncologiaMadridSpain28040
    146Hospital Universitario 12 de Octubre; Servicio de OncologiaMadridSpain28041
    147Hospital Universitario La Paz; Servicio de OncologiaMadridSpain28046
    148HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de OncologiaMadridSpain28050
    149Hospital Regional Universitario Carlos Haya; Servicio de OncologiaMalagaSpain29011
    150Hospital Universitario Virgen del Rocio; Servicio de OncologiaSevillaSpain41013
    151Hospital General Universitario de Valencia; Servicio de oncologiaValenciaSpain46014
    152Hospital NisA 9 de OctubreValenciaSpain46015
    153CHUV; Departement d'OncologieLausanneSwitzerland1011
    154Changhua Christian Hospital; Internal MedicineChanghuaTaiwan500
    155China Medical University Hospital; UrologyTaichungTaiwan40447
    156National Taiwan Uni Hospital; Dept of OncologyTaipeiTaiwan100
    157Chulalongkorn Hospital; Medical OncologyBangkokThailand10330
    158Ramathibodi Hospital; Medicine/OncologyBangkokThailand10400
    159Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. OncologyBangkokThailand10700
    160Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan YerleskesiEdirneTurkey22030
    161Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical OncologyIstanbulTurkey34300
    162Hacettepe Uni Medical Faculty Hospital; Oncology DeptSihhiye/AnkaraTurkey06230
    163Municipal Institution Podilskiy Regional Center of Oncology; Department of ChemotherapyVinnytsiaPodolia GovernorateUkraine21029
    164Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU; Chair of Oncology and Medical RadiologyDnipropetrovskUkraine49102
    165The Clatterbridge Cancer Centre NHS Foundation TrustLiverpoolUnited KingdomL7 8YA
    166Barts & London School of Med; Medical OncologyLondonUnited KingdomEC1A 7BE
    167Royal Free Hospital; Oncology & HaematologyLondonUnited KingdomNW3 2QG
    168St George's Hospital; OncologyLondonUnited KingdomSW17 0QT
    169Royal Marsden Hospital - LondonLondonUnited KingdomSW3 6JJ
    170Charing Cross Hospital; Medical Oncology.LondonUnited KingdomW6 8RF
    171Christie Hospital NHS TrustManchesterUnited KingdomM20 4BX
    172Nottingham City Hospital; OncologyNottinghamUnited KingdomNG5 1PB
    173Royal Marsden Hospital - SurreySurreyUnited KingdomSM2 5PT

    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:
    NCT03148418
    Other Study ID Numbers:
    • BO39633
    • 2016-005189-75
    First Posted:
    May 11, 2017
    Last Update Posted:
    Nov 22, 2021
    Last Verified:
    Nov 1, 2021
    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 22, 2021