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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
179
Locations
1
Arm
112.2
Anticipated Duration (Months)
5.6
Patients Per Site
0
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 Disease Intervention/Treatment Phase
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

Arm Intervention/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

    Site City State Country Postal Code
    1 Univ of Alabama at Birmingham; UAB Comprehensive Cancer Ctr Birmingham Alabama United States 352331912
    2 HonorHealth Research Institute - Pima - Virginia G. Piper Cancer Care Network Scottsdale Arizona United States 85258
    3 University of Arkansas for Medical Sciences; Winthrop Rockefeller Cancer Institute Little Rock Arkansas United States 72205
    4 Kaiser Permanente - Bellflower Bellflower California United States 90706
    5 City of Hope Duarte California United States 91010
    6 UCLA Hematology / Oncology Clinic Los Angeles California United States 90095
    7 Stanford University Medical Center Palo Alto California United States 94304
    8 University of Colorado Cancer Center Aurora Colorado United States 80045
    9 University of Colorado; Anschutz Cancer Pavilion Aurora Colorado United States 80045
    10 Smilow Cancer Hospital at Yale New Haven New Haven Connecticut United States 06510
    11 Yale Cancer Center New Haven Connecticut United States 06520
    12 Smilow Cancer Center North Haven Connecticut United States 06473
    13 Yale University School Of Medicine; Yale Cancer Center Trumbull Connecticut United States 06611
    14 Medstar Georgetown University Hospital Washington District of Columbia United States 20007
    15 SCRI Florida Cancer Specialists South Fort Myers Florida United States 33916
    16 Mercy Hospital, a Campus of Plantation General Hospital Miami Florida United States 33133
    17 Hematology Oncology Associates of the Treasure Coast Port Saint Lucie Florida United States 34952
    18 SCRI Florida Cancer Specialists North; Research Office North Region. Saint Petersburg Florida United States 33705
    19 University Of Chicago Medical Center; Section Of Hematology/Oncology Chicago Illinois United States 60637
    20 Fort Wayne Medical Oncology and Hematology, Inc Fort Wayne Indiana United States 46804
    21 New England Cancer Specialists Scarborough Maine United States 04074
    22 Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Baltimore Maryland United States 21287
    23 Massachusetts General Hospital Boston Massachusetts United States 02114-2621
    24 Massachusetts General Hospital Boston Massachusetts United States 02114
    25 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    26 Dana Farber Cancer Institute Boston Massachusetts United States 02215
    27 Dana Farber Cancer Institute Boston Massachusetts United States 02215
    28 St. Joseph Mercy Hospital; Cancer Care Center. Ann Arbor Michigan United States 48106
    29 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201
    30 Montefiore Medical Center Bronx New York United States 10467
    31 New York University School of Medicine New York New York United States 10016
    32 Memorial Sloan Kettering - Basking Ridge New York New York United States 10065
    33 Levine Cancer Institute-Carolinas Medical Center; Levine Cancer Institute-Carolinas Medical Center Charlotte North Carolina United States 28204
    34 Carolina BioOncology Institute, PLCC Huntersville North Carolina United States 28078
    35 Oncology Hematology Care Inc Cincinnati Ohio United States 45242
    36 Ohio State University; Hemat/Onc Columbus Ohio United States 43210
    37 St. Luke's Cancer Care Associates Bethlehem Pennsylvania United States 18015
    38 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
    39 University of Pittsburgh Medical Center Cancer Center; Investigational Drug Service Pittsburgh Pennsylvania United States 15232
    40 SCRI Tennessee Oncology Chattanooga Chattanooga Tennessee United States 37404
    41 Sarah Cannon Research Institute Nashville Tennessee United States 37203
    42 Sarah Cannon Research Institute Nashville Tennessee United States 37203
    43 SCRI-Tennessee Oncology Nashville Tennessee United States 37203
    44 The University of Texas MD Anderson Cancer Center Houston Texas United States 77030-4009
    45 University of Texas Health Sciences Center in San Antonio San Antonio Texas United States 78229
    46 Providence Regional Cancer Partnership Everett Washington United States 98201
    47 University of Washington - Seattle Cancer Care Alliance; Medical Oncology Seattle Washington United States 98109
    48 University of Washington - Seattle Cancer Care Alliance; Medical Oncology Seattle Washington United States 98109
    49 Chris O'Brien Lifehouse Camperdown New South Wales Australia 2050
    50 St Vincent'S Hospital Darlinghurst New South Wales Australia 2010
    51 The Prince Charles Hospital; Oncology Dept. Chermside Queensland Australia 4032
    52 The Townsville Hospital Douglas Queensland Australia 4814
    53 Townsville Hospital Townsville Queensland Australia 4810
    54 Cabrini Hospital Malvern Malvern Victoria Australia 3144
    55 Institut Jules Bordet Bruxelles Belgium 1000
    56 Universitair Ziekenhuis Gent; Oncology Gent Belgium 9000
    57 UZ Leuven Leuven Belgium 3000
    58 Hospital Araujo Jorge; Patologia Goiania GO Brazil 74605-070
    59 Instituto Nacional de Cancer - INCa; Oncologia Rio de Janeiro RJ Brazil 20560-120
    60 Hospital das Clinicas - UFRGS Porto Alegre RS Brazil 90035-903
    61 Instituto do Cancer do Estado de Sao Paulo - ICESP Sao Paulo SP Brazil 01246-000
    62 Multiprofile Hospital for Active Treatment Central Onco Hospital OOD; Dept. of Medical Oncology Plovdiv Bulgaria 4004
    63 Multiprofile Hospital for Active Treatment Serdika EOOD; Medical Oncology Department Sofia Bulgaria 1632
    64 BC Cancer - Vancouver Vancouver British Columbia Canada V5Z 4E6
    65 Lakeridge Health Oshawa Oshawa Ontario Canada L1G 2B9
    66 Princess Margaret Cancer Center Toronto Ontario Canada M5G 1Z5
    67 Pontificia Universidad Catolica de Chile; Centro Del Cáncer Santiago Chile 8330032
    68 Masarykův onkologický ústav; Klinika komplexní onkologické péče Brno Czechia 656 53
    69 Fakultni nemocnice Olomouc; Onkologicka klinika Olomouc Czechia 779 00
    70 Rigshospitalet; Hæmatologisk Klinik København Ø Denmark 2100
    71 Rigshospitalet København Ø Denmark 2100
    72 Institut Bergonie; Oncologie Bordeaux France 33076
    73 Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez Lille France 59037
    74 Centre Leon Berard Lyon France 69008
    75 CHU Timone; Centre d'Essais Précoces en Cancérologie de Marseille (CEPCM) Marseille France 13005
    76 APHP - Hospital Saint Louis Paris France 75475
    77 Hopital d'Instruction des Armees de Begin Saint-Mande France 94160
    78 Hôpital d'Instruction des Armées de Sainte Anne; Service de Pneumologie Toulon France 83000
    79 Institut Claudius Regaud; Departement Oncologie Medicale Toulouse France 31059
    80 IUCT Oncopole Toulouse France 31100
    81 Institut Gustave Roussy Villejuif France 94805
    82 St. Elisabethen Krankenhaus Frankfurt am Main Germany 60487
    83 Universitätsklinikum Freiburg;Klinik für Innere Medizin I Freiburg Germany 79106
    84 Asklepios-Fachklinik Muenchen-Gauting; Klinik Für Pneumologie Gauting Germany 82131
    85 SRH Wald-Klinikum Gera; Zentrum fur klinische Studien (ZKS) Gera Germany 07548
    86 HOPA MVZ GmbH Hamburg Germany 22767
    87 Universitätsklinikum Heidelberg Heidelberg Germany 69120
    88 SLK-Kliniken Heilbronn GmbH; Klinik für Innere Medizin III; Schwerpunkt Häma./Onko./Palliativm. Heilbronn Germany 74078
    89 Lungenfachklinik Immenhausen; Zentrum fur Pneumologie Immenhausen Germany 34376
    90 Krankenhaus Barmherzige Bruder Regensburg Regensburg Germany 93049
    91 Universitaets-Hautklinik Tuebingen Tübingen Germany 72076
    92 Universitätsklinik Tübingen; Frauenklinik & Poliklinik Tübingen Germany 72076
    93 Laiko General Hospital Athen Athens Greece 115 27
    94 Alexandras Hospital; Dept. of Clin. Therapeutics, Athens Uni School of Medicine Athens Greece 115 28
    95 Anticancer Hospital Ag. Savas Athens Greece 11522
    96 Metropolitan Hospital Athens Greece 185 47
    97 University Hospital of Larissa; Oncology Λαρισα Greece 413 35
    98 Grupo Angeles Guatemala City Guatemala 01015
    99 Queen Mary Hospital Hong Kong Hong Kong
    100 Orszagos Onkologiai Intezet; "C" Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály Budapest Hungary 1122
    101 Orszagos Onkologiai Intezet; Borgyogyaszati Osztaly Budapest Hungary 1122
    102 Országos Onkológiai Intézet; Onkológiai Képalkotó és Invazív Diagnosztikai Központ Budapest Hungary 1122
    103 Szegedi Tudomanyegyetem, AOK Budapest Hungary
    104 Petz Aladar Megyei Oktato Korhaz; Pulmonologiai Osztaly Gyor Hungary 9024
    105 Pecsi Tudomanyegyetem AOK; Borgyogyaszati Klinika Pecs Hungary 7632
    106 Szegedi Tudományegyetem; Onkoterápiás Klinika Szeged Hungary 6720
    107 Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz; Pulmonologiai Osztaly Szekesfehervar Hungary 8001
    108 Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica Milano Lombardia Italy 20133
    109 Nagoya University Hospital Aichi Japan 466-8560
    110 National Hospital Organization Shikoku Cancer Center Ehime Japan 791-0280
    111 National Hospital Organization Kyushu Medical Center Fukuoka Japan 810-8563
    112 Kyushu University Hospital Fukuoka Japan 812-8582
    113 Iwate Medical University Hospital Iwate Japan 028-3695
    114 Kitasato University Hospital Kanagawa Japan 252-0375
    115 Niigata University Medical & Dental Hospital Niigata Japan 951-8520
    116 Osaka Habikino Medical Center Osaka Japan 583-8588
    117 Saitama Cancer Center Saitama Japan 362-0806
    118 National Hospital Organization Kinki-Chuo Chest Medical Center Sakai-shi Japan 591-8555
    119 Seoul National University Hospital Seoul Korea, Republic of 03080
    120 Severance Hospital Seoul Korea, Republic of 03722
    121 Samsung Medical Center Seoul Korea, Republic of 06351
    122 Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology Seoul Korea, Republic of 138-736
    123 Asan Medical Center; Internal Dept / Gastorenterology Seoul Korea, Republic of 138-736
    124 Seoul National University College of Medicine, Liver Research Institute Seoul Korea, Republic of
    125 Riga's East Hosp Latvian Oncol; Medical Oncology Riga Latvia LV-1079
    126 Centro Medico Dalinde Mexico City Mexico 06700
    127 Centro Universitario Contra El Cancer Monterrey Mexico 64020
    128 Phylasis Clinicas Research S de RL de CV; Sucursal Toluca Toluca de Lerdo Mexico 50090
    129 Førde sentralsjukehus Førde Norway 6800
    130 Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii Gdańsk Poland 80-214
    131 Przychodnia Lekarska KOMED, Roman Karaszewski Konin Poland 62-500
    132 Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii Kraków Poland 30-688
    133 Warminsko-Mazurskie Centrum Chorób Płuc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii Olsztyn Poland 10-357
    134 Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii Otwock Poland 05-400
    135 Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii Otwock Poland 05-400
    136 Med-Polonia Sp. z o.o. Poznan Poland 60-693
    137 Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu. Poznań Poland 60-780
    138 Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy Warszawa Poland 02-781
    139 Centro Hospitalar do Porto - Hospital de Santo António; Oncologia Porto Portugal 4099-001
    140 Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca; Oncologie Medicala Cluj Napoca Romania 400015
    141 Centrul de Oncologie Sfantul Nectarie Craiova Romania 200347
    142 Institutul Regional de Oncologie Iasi; Clinica de Hematologie Iasi Romania 700483
    143 Centrul de Oncologie Oncohelp Timisoara Romania 300239
    144 Arkhangelsk Regional Clinical Oncology Dispensary Arkhangelsk Arhangelsk Russian Federation 163045
    145 Ivanovo Regional Oncology Dispensary; Chemotherapy Department Ivanovo Russian Federation 153013
    146 Russian Oncology Research Center n.a. N.N. Blokhin Moscow Russian Federation 115478
    147 P.A. Herzen Oncological Inst. ; Oncology Moscow Russian Federation 125284
    148 FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov" Saint-Petersburg Russian Federation
    149 National University Hospital Singapore Singapore 119074
    150 University Hospital Bratislava; Department of Oncology Bratislava Slovakia 826 06
    151 Narodny Onkologicky Ustav; Oddelenie klinickej onkologie A Bratislava Slovakia 833 10
    152 Corporacio Sanitaria Parc Tauli; Servicio de Oncologia Sabadell Barcelona Spain 8208
    153 Hospital Universitario Son Espases Palma de Mallorca Islas Baleares Spain 07010
    154 Clínica Universidad de Navarra Pamplona Navarra Spain 31620
    155 Hospital Universitario Quiron Dexeus Barcelona Spain 08028
    156 Hospital Universitari Vall d'Hebron Barcelona Spain 08035
    157 Hospital Clinic de Barcelona Barcelona Spain 08036
    158 Hospital Lucus Augusti; Servicio de Oncologia Lugo Spain 27003
    159 Hospital General Universitario Gregorio Mara Madrid Spain 28009
    160 Clinica Universidad de Navarra-Madrid Madrid Spain 28027
    161 Centro Integral Oncologico Clara Campal; Servicio de Oncología Madrid Spain 28050
    162 HM Sanchinarro - CIOCC; Servicio de Oncologia Madrid Spain 28050
    163 Hospital Regional Universitario Carlos Haya Malaga Spain 29010
    164 Hospital Clinico Universitario de Valencia Valencia Spain 46010
    165 Freiburger Spital; Onkologie Fribourg Switzerland 1708
    166 Chang Gung Memorial Hospital Chiayi Putzu Taiwan 613
    167 Taichung Veterans General Hospital Taichung Taiwan 40705
    168 Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology Taipei City Taiwan 11259
    169 MI Dnipropetrovsk City Multifield Clinical Hospital 4 of Dnipropetrovsk Regional Council Dnipropetrovsk Katerynoslav Governorate Ukraine 49102
    170 Communal Non profit Enterprise Regional Center of Oncology; Oncosurgical dept of thoracic organs Kharkiv Kharkiv Governorate Ukraine 61070
    171 Uzhhorod Central City Clinical Hospital Uzhhorod KIEV Governorate Ukraine 88000
    172 Municipal Institution Podilskiy Regional Center of Oncology; Department of Chemotherapy Vinnytsia Podolia Governorate Ukraine 21029
    173 MI of the Lviv Regional Council Lviv Oncology Regional Treatment and Diagnostic Centre; Chemotherapy Lviv Volhynian Governorate Ukraine 79031
    174 National Cancer Institute MOH of Ukraine Kiev Ukraine 36022
    175 ME Kryviy Rih Oncology Dispensary of Dnipropetrovs'k Regional Council; Chemotherapy Department Kryvyi Rih Ukraine 50048
    176 Volyn Regional Oncology Dispensary Lutsk Ukraine 43018
    177 Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary; Sumy State Uni, Med Inst Sumy Ukraine 40022
    178 Barts Cancer Institute London United Kingdom E1 2AT
    179 St Georges University Hospitals NHS Foundation Trust London United Kingdom SW17 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:
    Aug 18, 2022
    Last Verified:
    Aug 1, 2022
    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:
    Atezolizumab

    Study Results

    No Results Posted as of Aug 18, 2022