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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03768063




Registration number
NCT03768063
Ethics application status
Date submitted
30/11/2018
Date registered
7/12/2018
Date last updated
24/10/2024

Titles & IDs
Public title
A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study
Scientific 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)
Secondary ID [1] 0 0
2023-506184-34-00
Secondary ID [2] 0 0
BO40729
Universal Trial Number (UTN)
Trial acronym
IMbrella B
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Atezolizumab
Treatment: Drugs - Bevacizumab
Treatment: Drugs - Alectinib
Treatment: Drugs - Cobimetinib
Treatment: Drugs - Vemurafenib
Treatment: Drugs - FAP IL2V
Treatment: Drugs - Venetoclax
Treatment: Drugs - Enzalutamide
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Sunitinib
Treatment: Drugs - Niraparib
Treatment: Drugs - Cabozantinib
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Emactuzumab
Treatment: Drugs - Rucaparib

Experimental: Atezolizumab Monotherapy - Participants will receive atezolizumab by intravenous infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

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.

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.


Treatment: Drugs: 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).

Treatment: Drugs: Bevacizumab
Bevacizumab will be administered as directed per the parent study.

Treatment: Drugs: Alectinib
Alectinib will be administered as directed per the parent study.

Treatment: Drugs: Cobimetinib
Cobimetinib will be administered as directed per the parent study.

Treatment: Drugs: Vemurafenib
Vemurafenib will be administered as directed per the parent study.

Treatment: Drugs: FAP IL2V
FAP IL2V will be administered as directed per the parent study.

Treatment: Drugs: Venetoclax
Venetoclax will be administered as directed per the parent study.

Treatment: Drugs: Enzalutamide
Enzalutamide will be administered as directed per the parent study.

Treatment: Drugs: Pembrolizumab
Pembrolizumab will be administered as directed per the parent study.

Treatment: Drugs: Sunitinib
Sunitinib will be administered as directed per the parent study.

Treatment: Drugs: Niraparib
Niraparib will be administered as directed per the parent study.

Treatment: Drugs: Cabozantinib
Cabozantinib will be administered as directed per the parent study.

Treatment: Drugs: Pemetrexed
Pemetrexed will be administered as directed per the parent study.

Treatment: Drugs: Paclitaxel
Paclitaxel will be administered as directed per the parent study.

Treatment: Drugs: Emactuzumab
Emactuzumab will be administered as directed per the parent study.

Treatment: Drugs: Rucaparib
Rucaparib will be administered as directed per the parent study.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Continued Access to Atezolizumab-Based Therapy and/or Comparator Agent(s)
Timepoint [1] 0 0
Day 1 up to maximum 10 years
Secondary outcome [1] 0 0
Percentage of Participants With Serious Adverse Events (SAEs) According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Timepoint [1] 0 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)
Secondary outcome [2] 0 0
Percentage of Participants With Adverse Events of Special Interest Determined According to NCI CTCAE Version 5.0
Timepoint [2] 0 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)
Secondary outcome [3] 0 0
Treatment Duration
Timepoint [3] 0 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)
Secondary outcome [4] 0 0
Total Dose Received
Timepoint [4] 0 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)
Secondary outcome [5] 0 0
Number of Treatment Cycles
Timepoint [5] 0 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)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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). Exception: Participants who permanently discontinued atezolizumab from parent studies that permit participants to continue treatment with the combination agent(s) alone after permanently discontinuing atezolizumab are eligible to enroll in this study.
* 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/02/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
5/07/2028
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
St Vincent'S Hospital - Darlinghurst
Recruitment hospital [3] 0 0
The Prince Charles Hospital; Oncology Dept. - Chermside
Recruitment hospital [4] 0 0
The Townsville Hospital - Douglas
Recruitment hospital [5] 0 0
Townsville Hospital - Townsville
Recruitment hospital [6] 0 0
Cabrini Hospital Malvern - Malvern
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
4032 - Chermside
Recruitment postcode(s) [4] 0 0
4814 - Douglas
Recruitment postcode(s) [5] 0 0
4810 - Townsville
Recruitment postcode(s) [6] 0 0
3144 - Malvern
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
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Connecticut
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Maine
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United States of America
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Maryland
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United States of America
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Massachusetts
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United States of America
State/province [14] 0 0
Michigan
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
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Ohio
Country [19] 0 0
United States of America
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Pennsylvania
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Washington
Country [23] 0 0
Belgium
State/province [23] 0 0
Brussel
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Belgium
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Bruxelles
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Belgium
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Gent
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Belgium
State/province [26] 0 0
Leuven
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Brazil
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GO
Country [28] 0 0
Brazil
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RJ
Country [29] 0 0
Brazil
State/province [29] 0 0
RS
Country [30] 0 0
Brazil
State/province [30] 0 0
SP
Country [31] 0 0
Bulgaria
State/province [31] 0 0
Plovdiv
Country [32] 0 0
Bulgaria
State/province [32] 0 0
Sofia
Country [33] 0 0
Canada
State/province [33] 0 0
British Columbia
Country [34] 0 0
Canada
State/province [34] 0 0
Ontario
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Chile
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Santiago
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Czechia
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Brno
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Czechia
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Olomouc
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Denmark
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København Ø
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France
State/province [39] 0 0
Angers
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France
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Bordeaux
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France
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Clermont Ferrand
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France
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Lille
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France
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Lyon
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France
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Marseille
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France
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Montpellier
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France
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Nice
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France
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Paris
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France
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Saint-Mande
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France
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Toulon
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France
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Toulouse
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France
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Villejuif
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Germany
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Essen
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Germany
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Frankfurt am Main
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Germany
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Freiburg
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Germany
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Gauting
Country [56] 0 0
Germany
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Gera
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Germany
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Hamburg
Country [58] 0 0
Germany
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Heidelberg
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Germany
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Heilbronn
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Germany
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Immenhausen
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Germany
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Leipzig
Country [62] 0 0
Germany
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Muenster
Country [63] 0 0
Germany
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München
Country [64] 0 0
Germany
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Regensburg
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Germany
State/province [65] 0 0
Tübingen
Country [66] 0 0
Greece
State/province [66] 0 0
Athens
Country [67] 0 0
Greece
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Larissa
Country [68] 0 0
Guatemala
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Guatemala City
Country [69] 0 0
Hong Kong
State/province [69] 0 0
Hong Kong
Country [70] 0 0
Hungary
State/province [70] 0 0
Budapest
Country [71] 0 0
Hungary
State/province [71] 0 0
Gyor
Country [72] 0 0
Hungary
State/province [72] 0 0
Pecs
Country [73] 0 0
Hungary
State/province [73] 0 0
Szeged
Country [74] 0 0
Hungary
State/province [74] 0 0
Szekesfehervar
Country [75] 0 0
Italy
State/province [75] 0 0
Lombardia
Country [76] 0 0
Japan
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Aichi
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Japan
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Ehime
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Japan
State/province [78] 0 0
Fukuoka
Country [79] 0 0
Japan
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Hokkaido
Country [80] 0 0
Japan
State/province [80] 0 0
Ibaraki
Country [81] 0 0
Japan
State/province [81] 0 0
Ishikawa
Country [82] 0 0
Japan
State/province [82] 0 0
Iwate
Country [83] 0 0
Japan
State/province [83] 0 0
Kanagawa
Country [84] 0 0
Japan
State/province [84] 0 0
Miyagi
Country [85] 0 0
Japan
State/province [85] 0 0
Niigata
Country [86] 0 0
Japan
State/province [86] 0 0
Okayama
Country [87] 0 0
Japan
State/province [87] 0 0
Osaka
Country [88] 0 0
Japan
State/province [88] 0 0
Saitama
Country [89] 0 0
Japan
State/province [89] 0 0
Sakai-shi
Country [90] 0 0
Korea, Republic of
State/province [90] 0 0
Gyeonggi-do
Country [91] 0 0
Korea, Republic of
State/province [91] 0 0
Seongnam-si
Country [92] 0 0
Korea, Republic of
State/province [92] 0 0
Seoul
Country [93] 0 0
Korea, Republic of
State/province [93] 0 0
Yangsan
Country [94] 0 0
Latvia
State/province [94] 0 0
Riga
Country [95] 0 0
Mexico
State/province [95] 0 0
Nuevo LEON
Country [96] 0 0
Mexico
State/province [96] 0 0
Mexico City
Country [97] 0 0
Mexico
State/province [97] 0 0
Toluca de Lerdo
Country [98] 0 0
Norway
State/province [98] 0 0
Førde
Country [99] 0 0
Poland
State/province [99] 0 0
Brzozów
Country [100] 0 0
Poland
State/province [100] 0 0
Bytom
Country [101] 0 0
Poland
State/province [101] 0 0
Gdansk
Country [102] 0 0
Poland
State/province [102] 0 0
Konin
Country [103] 0 0
Poland
State/province [103] 0 0
Kraków
Country [104] 0 0
Poland
State/province [104] 0 0
Olsztyn
Country [105] 0 0
Poland
State/province [105] 0 0
Otwock
Country [106] 0 0
Poland
State/province [106] 0 0
Pozna?
Country [107] 0 0
Poland
State/province [107] 0 0
Poznan
Country [108] 0 0
Poland
State/province [108] 0 0
Warszawa
Country [109] 0 0
Portugal
State/province [109] 0 0
Porto
Country [110] 0 0
Romania
State/province [110] 0 0
Cluj Napoca
Country [111] 0 0
Romania
State/province [111] 0 0
Craiova
Country [112] 0 0
Romania
State/province [112] 0 0
Iasi
Country [113] 0 0
Romania
State/province [113] 0 0
Timisoara
Country [114] 0 0
Russian Federation
State/province [114] 0 0
Arhangelsk
Country [115] 0 0
Russian Federation
State/province [115] 0 0
Moskovskaja Oblast
Country [116] 0 0
Russian Federation
State/province [116] 0 0
Sankt Petersburg
Country [117] 0 0
Russian Federation
State/province [117] 0 0
Ivanovo
Country [118] 0 0
Singapore
State/province [118] 0 0
Singapore
Country [119] 0 0
Slovakia
State/province [119] 0 0
Bratislava
Country [120] 0 0
Spain
State/province [120] 0 0
Barcelona
Country [121] 0 0
Spain
State/province [121] 0 0
Islas Baleares
Country [122] 0 0
Spain
State/province [122] 0 0
Navarra
Country [123] 0 0
Spain
State/province [123] 0 0
Lugo
Country [124] 0 0
Spain
State/province [124] 0 0
Madrid
Country [125] 0 0
Spain
State/province [125] 0 0
Malaga
Country [126] 0 0
Spain
State/province [126] 0 0
Valencia
Country [127] 0 0
Switzerland
State/province [127] 0 0
Fribourg
Country [128] 0 0
Taiwan
State/province [128] 0 0
Putzu
Country [129] 0 0
Taiwan
State/province [129] 0 0
Taichung
Country [130] 0 0
Taiwan
State/province [130] 0 0
Taipei City
Country [131] 0 0
Thailand
State/province [131] 0 0
Bangkok
Country [132] 0 0
Ukraine
State/province [132] 0 0
Kharkiv Governorate
Country [133] 0 0
Ukraine
State/province [133] 0 0
KIEV Governorate
Country [134] 0 0
Ukraine
State/province [134] 0 0
Podolia Governorate
Country [135] 0 0
Ukraine
State/province [135] 0 0
Volhynian Governorate
Country [136] 0 0
Ukraine
State/province [136] 0 0
Kiev
Country [137] 0 0
Ukraine
State/province [137] 0 0
Kryvyi Rih
Country [138] 0 0
Ukraine
State/province [138] 0 0
Lutsk
Country [139] 0 0
Ukraine
State/province [139] 0 0
Sumy
Country [140] 0 0
United Kingdom
State/province [140] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
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 combination/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.
Trial website
https://clinicaltrials.gov/study/NCT03768063
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: BO40729 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. and Canada)
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03768063