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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)
382
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 Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
382 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

Arm Intervention/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

    Site City State Country Postal Code
    1 HonorHealth Research Institute - Bisgrove Scottsdale Arizona United States 85258
    2 UCLA Los Angeles California United States 90024
    3 Angeles Clinic & Rsch Inst Los Angeles California United States 90025
    4 Kaiser Permanente - San Diego (Zion Ave) San Marcos California United States 92078
    5 University Of Colorado Aurora Colorado United States 80045
    6 Rocky Mountain Cancer Ctr - Denver (Williams) Denver Colorado United States 80218
    7 Smilow Cancer Hospital at Yale New Haven New Haven Connecticut United States 06510
    8 Georgetown University Medical Center Lombardi Cancer Center Washington District of Columbia United States 20007
    9 Florida Cancer Specialists - Fort Myers (Broadway) Fort Myers Florida United States 33901
    10 Hematology Oncology Associates of the Treasure Coast Port Saint Lucie Florida United States 34952
    11 Florida Cancer Specialists. Saint Petersburg Florida United States 33705
    12 H. Lee Moffitt Cancer Center and Research Inst. Tampa Florida United States 33612
    13 Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital Carrollton Georgia United States 30117
    14 Northwestern University; Robert H. Lurie Comp Can Ctr Chicago Illinois United States 60611
    15 Rush University Medical Center Chicago Illinois United States 60612-3244
    16 University Of Chicago Medical Center; Section Of Hematology/Oncology Chicago Illinois United States 60637
    17 Ingalls Memorial Hospital Harvey Illinois United States 60426
    18 Illinois Cancer Care Peoria Illinois United States 61615
    19 New England Cancer Specialists Scarborough Maine United States 04074
    20 Johns Hopkins Univ Med Center Baltimore Maryland United States 21231
    21 Maryland Oncology Hematology, P.A. Columbia Maryland United States 21044
    22 Massachusetts General Hospital. Boston Massachusetts United States 02114
    23 Dana Farber Cancer Inst. ; Dept. of Medical Oncology Boston Massachusetts United States 02115
    24 Karmanos Cancer Institute Detroit Michigan United States 48201
    25 US oncology research at Minnesota Oncology Saint Paul Minnesota United States 55102
    26 Washington University School of Medicine Saint Louis Missouri United States 63110
    27 Comprehensive Cancer Centers of Nevada - Eastern Avenue Las Vegas Nevada United States 89169
    28 Summit Medical Center Florham Park New Jersey United States 07932
    29 New York Oncology Hematology, P.C. Albany New York United States 12206
    30 Memorial Sloan-Kettering Cancer Center Commack New York United States 11725
    31 Beth Israel Medical Center; Division of Digestive Diseases New York New York United States 10003
    32 Carolina BioOncology Institute, PLCC Huntersville North Carolina United States 28078
    33 Cleveland Clinic Cleveland Ohio United States 44106
    34 Oncology Associates of Oregon, P.C Eugene Oregon United States 97401
    35 Northwest Cancer Specialists - Portland (N Broadway) Portland Oregon United States 97227
    36 Penn State Hershey Cancer Institute Hershey Pennsylvania United States 17033
    37 Allegheny Cancer Center Pittsburgh Pennsylvania United States 15212
    38 Sarah Cannon Res Inst; TN Onc Nashville Tennessee United States 37203
    39 Vanderbilt Univ Medical Ctr Nashville Tennessee United States 37203
    40 Texas Oncology-Baylor Sammons Cancer Center Dallas Texas United States 75246
    41 Tyler Cancer Center Fort Worth Texas United States 76177
    42 Virginia Oncology Associates - Lake Wright Cancer Center Norfolk Virginia United States 23502
    43 Blue Ridge Cancer Care Roanoke Virginia United States 24014
    44 University of Washington Seattle Cancer Care Alliance Seattle Washington United States 98195
    45 Northwest Medical Specialties Tacoma Washington United States 98405
    46 Fundación CENIT para la Investigación en Neurociencias Buenos Aires Argentina C1125ABD
    47 Chris O'Brien Lifehouse Camperdown New South Wales Australia 2050
    48 Princess AleXandra Hospital; Department of Medical Oncology Woolloongabba Queensland Australia 4102
    49 SMZ - Baumgartner Hohe, Otto-Wagner-Spital; 2.Interne Lungenabteilung Wien Austria 1140
    50 Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie Wien Austria 1210
    51 AZ Glorieux- vzw Werken Glorieux Ronse Belgium 9600
    52 Sint Augustinus Wilrijk Wilrijk Belgium 2610
    53 Hospital de Cancer de Barretos Barretos SP Brazil 14784-400
    54 Instituto do Cancer do Estado de Sao Paulo - ICESP Sao Paulo SP Brazil 01246-000
    55 Fundacao Antonio Prudente Sao Paulo SP Brazil 01509-900
    56 Multiprofile Hospital for Active Treatment Serdika EOOD; Medical Oncology Department Sofia Bulgaria 1632
    57 Royal Victoria Hospital Barrie Ontario Canada L4M 6M2
    58 William Osler Health Centre Etobicoke Ontario Canada M9V 1R8
    59 Lakeridge Health Corporation-Oshawa; Oncology clinic Oshawa Ontario Canada L1G 2B9
    60 Sunnybrook Odette Cancer Centre; Clinical Trials Toronto Ontario Canada M4N 3M5
    61 Princess Margaret Cancer Center Toronto Ontario Canada M5G 1Z5
    62 Cite de La Sante de Laval; Hemato-Oncologie Laval Quebec Canada H7M 3L9
    63 Jewish General Hospital Montreal Quebec Canada H3T 1E2
    64 Bradford Hill Centro de Investigaciones Clinicas; Bradford Hill Centro de Investigaciones Clinicas Recoleta Chile 8420383
    65 Masarykuv onkologicky ustav Brno Czechia 656 53
    66 Thomayerova nemocnice Praha 4 - Krc Czechia 140 59
    67 Hopital Jean Minjoz; Pneumologie Besancon France 25030
    68 Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie Grenoble France 38043
    69 Centre Leon Berard; Departement Oncologie Medicale Lyon France 69373
    70 Hopital Nord; Service d'Oncologie Multidisciplinaire et Innovation Thérapeutique Marseille France 13915
    71 Centre René Gauducheau - cancer Nantes - Atlantique; Service Oncologie Médicale Nantes France 44805
    72 Centre Antoine Lacassagne, Centre de Lutte Contre le Cancer (CLCC) de Nice Nice France 06189
    73 Hopital Saint Louis; Oncologie Medicale Paris France 75475
    74 GH Paris Saint Joseph; Pneumologie Paris France 75674
    75 Hopital Tenon;Pneumologie Paris France 75970
    76 Centre Hospitalier Lyon Sud Pierre Benite France 69495
    77 CH de Saint Quentin Saint Quentin France 2100
    78 Centre Medico-Chirurgical Foch; Service de Pneumologie Suresnes France 92151
    79 CHU de Toulouse - Hôpital Larrey; Service de pneumologie et oncologie pneumologique Toulouse cedex 9 France 31100
    80 Institut Gustave Roussy; Sitep VILLEJUIF Cedex France 94805
    81 Klinikum d.Universität München Campus Großhadern München Germany 81377
    82 Semmelweis Egyetem X; Pulmonologiai Klinika Budapest Hungary 1083
    83 Tudogyogyintezet Torokbalint Torokbalint Hungary 2045
    84 Belinson Medical Center Petah Tikva Israel 4922297
    85 Azienda Osp Uni Seconda Università Degli Studi Di Napoli; Unità Operativa Oncologia Medica Napoli Campania Italy 80131
    86 Azienda Ospedaliera A. Cardarelli; Dip. Oncopneumoematologico Napoli Campania Italy 80131
    87 Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale Napoli Campania Italy 80131
    88 A.O. Universitaria Policlinico Di Modena; Oncologia Modena Emilia-Romagna Italy 41100
    89 Università Cattolica Del S Cuore Roma Lazio Italy 00168
    90 ASL 3 Genovese Genova Liguria Italy 16125
    91 IRCCS AOU San Martino - IST Genova Liguria Italy 16132
    92 Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1 Milano Lombardia Italy 20133
    93 Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2 Milano Lombardia Italy 20133
    94 Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica Milano Lombardia Italy 20141
    95 ASST DI MONZA; Oncologia Medica Monza Lombardia Italy 20900
    96 A.O.U. Maggiore della Carità Novara Piemonte Italy 28100
    97 Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico Orbassano Piemonte Italy 10043
    98 Policlinico Vittorio Emanuele Catania Sicilia Italy 95123
    99 Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia Arezzo Toscana Italy 52100
    100 A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii Pisa Toscana Italy 56124
    101 Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica Siena Toscana Italy 53100
    102 Ospedale Santa Maria Della; Misericordia Di Perugia; Farmacia Ospedaliera Perugia Umbria Italy 06129
    103 IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II Padova Veneto Italy 35128
    104 Shikoku Cancer Center Ehime Japan 791-0280
    105 Iwate Medical University Hospital; Urology Iwate Japan 028-3695
    106 Sendai Kousei Hospital Miyagi Japan 980-0873
    107 Niigata Cancer Center Hospital Niigata Japan 951-8566
    108 Okayama University Hospital; Respiratory and Allergy Medicine Okayama Japan 700-8558
    109 Toranomon Hospital; Medical Oncology Tokyo Japan 105-8470
    110 The Cancer Institute Hospital of JFCR, Respiratory Medicine Tokyo Japan 135-8550
    111 Wakayama Medical University Hospital Wakayama Japan 641-8510
    112 National Cancer Center Goyang-si Korea, Republic of 10408
    113 Chonnam National University Hwasun Hospital Jeollanam-do Korea, Republic of 58128
    114 Seoul National University Bundang Hospital Seongnam-si Korea, Republic of 13605
    115 Samsung Medical Center Seoul Korea, Republic of 06351
    116 NKI/AvL Amsterdam Netherlands 1066 CX
    117 Auckland city hospital; Auckland Regional Cancer Centre and Blood Service Auckland New Zealand 1023
    118 Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii Gdansk Poland 80-214
    119 Oddział Onkologii Klinicznej i Chemioterapii Szpitala ELBLĄSKA Warszawa Poland 01-748
    120 Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers Warszawa Poland 02-781
    121 Hospital de Santa Maria; Servico de Oncologia Medica Lisboa Portugal 1649-035
    122 Centro Hospitalar do Porto - Hospital de Santo António; Oncologia Porto Portugal 4099-001
    123 Institut Oncologic Ion Chiricuta; Departament Radioterapie Cluj-napoca Romania 400015
    124 ONCOMED - Medical Centre Timisoara Romania 300239
    125 Moscow City Oncology Hospital #62 Moscovskaya Oblast Moskovskaja Oblast Russian Federation 143423
    126 Clinic for Pulmonology, Clinical Center of Serbia Belgrade Serbia 11000
    127 University Hospital Medical Center Bezanijska kosa Belgrade Serbia 11080
    128 Institute of Oncology Ljubljana Ljubljana Slovenia 1000
    129 Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia Badalona Barcelona Spain 08916
    130 Hospital Universitario Reina Sofia; Servicio de Oncologia Córdoba Cordoba Spain 14004
    131 Hospital Son Llatzer; Servicio de Oncologia Palma de Mallorca Islas Baleares Spain 07198
    132 Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia Las Palmas de Gran Canaria LAS Palmas Spain 35016
    133 Clinica Universitaria de Navarra; Servicio de Oncologia Pamplona Navarra Spain 31008
    134 Hospital del Mar; Servicio de Oncologia Barcelona Spain 08003
    135 Hospital Univ Vall d'Hebron; Servicio de Oncologia Barcelona Spain 08035
    136 Hospital Clinic de Barcelona. Unidad de Nuevas Terapias;Oncology Department Barcelona Spain 08036
    137 Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia Barcelona Spain 08041
    138 Institut Catala d Oncologia Hospital Duran i Reynals Barcelona Spain 08908
    139 Hospital San Pedro De Alcantara; Servicio de Oncologia Caceres Spain 10003
    140 Complejo Hospitalario de Jaen Jaen Spain 23007
    141 Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología La Coruña Spain 15006
    142 Hospital Lucus Augusti; Servicio de Oncologia Lugo Spain 27003
    143 Hospital General Universitario Gregorio Marañon; Servicio de Oncologia Madrid Spain 28007
    144 Hospital Ramon y Cajal; Servicio de Oncologia Madrid Spain 28034
    145 Hospital Universitario Clínico San Carlos; Servicio de Oncologia Madrid Spain 28040
    146 Hospital Universitario 12 de Octubre; Servicio de Oncologia Madrid Spain 28041
    147 Hospital Universitario La Paz; Servicio de Oncologia Madrid Spain 28046
    148 HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia Madrid Spain 28050
    149 Hospital Regional Universitario Carlos Haya; Servicio de Oncologia Malaga Spain 29011
    150 Hospital Universitario Virgen del Rocio; Servicio de Oncologia Sevilla Spain 41013
    151 Hospital General Universitario de Valencia; Servicio de oncologia Valencia Spain 46014
    152 Hospital NisA 9 de Octubre Valencia Spain 46015
    153 CHUV; Departement d'Oncologie Lausanne Switzerland 1011
    154 Changhua Christian Hospital; Internal Medicine Changhua Taiwan 500
    155 China Medical University Hospital; Urology Taichung Taiwan 40447
    156 National Taiwan Uni Hospital; Dept of Oncology Taipei Taiwan 100
    157 Chulalongkorn Hospital; Medical Oncology Bangkok Thailand 10330
    158 Ramathibodi Hospital; Medicine/Oncology Bangkok Thailand 10400
    159 Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology Bangkok Thailand 10700
    160 Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi Edirne Turkey 22030
    161 Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology Istanbul Turkey 34300
    162 Hacettepe Uni Medical Faculty Hospital; Oncology Dept Sihhiye/Ankara Turkey 06230
    163 Municipal Institution Podilskiy Regional Center of Oncology; Department of Chemotherapy Vinnytsia Podolia Governorate Ukraine 21029
    164 Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU; Chair of Oncology and Medical Radiology Dnipropetrovsk Ukraine 49102
    165 The Clatterbridge Cancer Centre NHS Foundation Trust Liverpool United Kingdom L7 8YA
    166 Barts & London School of Med; Medical Oncology London United Kingdom EC1A 7BE
    167 Royal Free Hospital; Oncology & Haematology London United Kingdom NW3 2QG
    168 St George's Hospital; Oncology London United Kingdom SW17 0QT
    169 Royal Marsden Hospital - London London United Kingdom SW3 6JJ
    170 Charing Cross Hospital; Medical Oncology. London United Kingdom W6 8RF
    171 Christie Hospital NHS Trust Manchester United Kingdom M20 4BX
    172 Nottingham City Hospital; Oncology Nottingham United Kingdom NG5 1PB
    173 Royal Marsden Hospital - Surrey Surrey United Kingdom SM2 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:
    Jun 23, 2022
    Last Verified:
    Jun 1, 2022
    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 Jun 23, 2022