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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03434379




Registration number
NCT03434379
Ethics application status
Date submitted
31/01/2018
Date registered
15/02/2018

Titles & IDs
Public title
A Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma
Scientific title
A Phase III, Open-Label, Randomized Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma
Secondary ID [1] 0 0
2017-003691-31
Secondary ID [2] 0 0
YO40245
Universal Trial Number (UTN)
Trial acronym
IMbrave150
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Hepatocellular 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Atezolizumab
Treatment: Drugs - Bevacizumab
Treatment: Drugs - Sorafenib

Experimental: Atezolizumab + Bevacizumab - Participants will receive Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator

Active comparator: Sorafenib - Participants will receive Sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator


Treatment: Drugs: Atezolizumab
Atezolizumab will be administered by IV, 1200 mg on day 1 of each 21 day cycle

Treatment: Drugs: Bevacizumab
Bevacizumab will be administered by IV, 15 mg/kg on day 1 of each 21 day cycle

Treatment: Drugs: Sorafenib
Sorafenib will be administered by mouth, 400 mg twice per day, on days 1-21 of each 21-day cycle
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) in the Global Population
Timepoint [1] 0 0
From randomization to death from any cause up to the clinical cut off date (CCOD) of 29Aug2019 (up to approximately 18 months) and 31Aug2020 (up to approximately 30 months)
Primary outcome [2] 0 0
Progression Free Survival by Independent Review Facility-Assessment (PFS-IRF) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in the Global Population
Timepoint [2] 0 0
Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
Primary outcome [3] 0 0
Overall Survival (OS) in the China Population
Timepoint [3] 0 0
From randomization to death from any cause up to the clinical cut off date (CCOD) of 29Aug2019 (up to approximately 18 months) and 31Aug2020 (up to approximately 30 months)
Primary outcome [4] 0 0
PFS-IRF Per RECIST v1.1 in the China Population
Timepoint [4] 0 0
Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
Secondary outcome [1] 0 0
Objective Response Rate by IRF-Assessment (ORR-IRF) Per RECIST v1.1 in the Global Population
Timepoint [1] 0 0
Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
Secondary outcome [2] 0 0
Objective Response Rate by IRF-Assessment (ORR-IRF) Per Hepatocellular Carcinoma (HCC) Modified RECIST (mRECIST) in the Global Population
Timepoint [2] 0 0
Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
Secondary outcome [3] 0 0
ORR by Investigator-Assessment (ORR-INV) Per RECIST v1.1 in the Global Population
Timepoint [3] 0 0
Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
Secondary outcome [4] 0 0
Duration of Response by IRF-Assessment (DOR-IRF) Per RECIST v1.1 in the Global Population
Timepoint [4] 0 0
Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
Secondary outcome [5] 0 0
Duration of Response by IRF Assessment (DOR-IRF) Per HCC mRECIST in the Global Population
Timepoint [5] 0 0
Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
Secondary outcome [6] 0 0
Duration of Response by Investigator Assessment (DOR-INV) Per RECIST v1.1 in the Global Population
Timepoint [6] 0 0
Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
Secondary outcome [7] 0 0
PFS-IRF Per HCC mRECIST in the Global Population
Timepoint [7] 0 0
Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
Secondary outcome [8] 0 0
PFS by Investigator Assessment (PFS-INV) Per RECIST v1.1 in the Global Population
Timepoint [8] 0 0
Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
Secondary outcome [9] 0 0
Time to Progression (TTP) by IRF Assessment (TTP-IRF) Per RECIST v1.1 in the Global Population
Timepoint [9] 0 0
Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
Secondary outcome [10] 0 0
TTP-IRF Per HCC mRECIST in the Global Population
Timepoint [10] 0 0
Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
Secondary outcome [11] 0 0
TTP by Investigator Assessment (TTP-INV) Per RECIST v1.1 in the Global Population
Timepoint [11] 0 0
Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
Secondary outcome [12] 0 0
Overall Survival by Baseline AFP in the Global Population
Timepoint [12] 0 0
From randomization to death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
Secondary outcome [13] 0 0
PFS-IRF Per RECIST v1.1 by Baseline AFP in the Global Population
Timepoint [13] 0 0
Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
Secondary outcome [14] 0 0
PFS-INV Per RECIST v1.1 by Baseline AFP in the Global Population
Timepoint [14] 0 0
Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
Secondary outcome [15] 0 0
Time to Deterioration (TTD) in the Global Population
Timepoint [15] 0 0
Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
Secondary outcome [16] 0 0
Number of Participants With Adverse Events (AEs) in the Global Population
Timepoint [16] 0 0
Up to end of study (up to approximately 56 months)
Secondary outcome [17] 0 0
Maximum Serum Concentration (Cmax) of Atezolizumab at Cycle 1 in the Global Population
Timepoint [17] 0 0
Post-dose on Day 1 of Cycle 1 (cycle length = 21 days)
Secondary outcome [18] 0 0
Trough Serum Concentration (Cmin) of Atezolizumab in the Global Population
Timepoint [18] 0 0
Pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 (cycle length = 21 days)
Secondary outcome [19] 0 0
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab in the Global Population
Timepoint [19] 0 0
Baseline and post-baseline on Day 1 (pre-dose) of Cycles 2, 3, 4, 8, 12, 16 (cycle length = 21 days) and treatment discontinuation visit (up to approximately 30 months)
Secondary outcome [20] 0 0
Objective Response Rate by IRF-Assessment (ORR-IRF) Per RECIST v1.1 in the China Population
Timepoint [20] 0 0
Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
Secondary outcome [21] 0 0
Objective Response Rate by IRF-Assessment (ORR-IRF) Per Hepatocellular Carcinoma (HCC) Modified RECIST (mRECIST) in the China Population
Timepoint [21] 0 0
Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
Secondary outcome [22] 0 0
ORR by Investigator-Assessment (ORR-INV) Per RECIST v1.1 in the China Population
Timepoint [22] 0 0
Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
Secondary outcome [23] 0 0
Duration of Response by IRF-Assessment (DOR-IRF) Per RECIST v1.1 in the China Population
Timepoint [23] 0 0
Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
Secondary outcome [24] 0 0
Duration of Response by IRF Assessment (DOR-IRF) Per HCC mRECIST in the China Population
Timepoint [24] 0 0
Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
Secondary outcome [25] 0 0
Duration of Response by Investigator Assessment (DOR-INV) Per RECIST v1.1 in the China Population
Timepoint [25] 0 0
Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
Secondary outcome [26] 0 0
PFS-IRF Per HCC mRECIST in the China Population
Timepoint [26] 0 0
Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
Secondary outcome [27] 0 0
PFS by Investigator Assessment (PFS-INV) Per RECIST v1.1 in the China Population
Timepoint [27] 0 0
Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
Secondary outcome [28] 0 0
Time to Progression (TTP) by IRF Assessment (TTP-IRF) Per RECIST v1.1 in the China Population
Timepoint [28] 0 0
Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
Secondary outcome [29] 0 0
TTP-IRF Per HCC mRECIST in the China Population
Timepoint [29] 0 0
Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
Secondary outcome [30] 0 0
TTP by Investigator Assessment (TTP-INV) Per RECIST v1.1 in the China Population
Timepoint [30] 0 0
Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
Secondary outcome [31] 0 0
Time to Deterioration (TTD) in the China Population
Timepoint [31] 0 0
Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
Secondary outcome [32] 0 0
Number of Participants With Adverse Events (AEs) in the China Population
Timepoint [32] 0 0
Up to end of study (up to approximately 56 months)
Secondary outcome [33] 0 0
Maximum Serum Concentration (Cmax) of Atezolizumab in the China Population
Timepoint [33] 0 0
Post-dose on Day 1 of Cycle 1 (cycle length = 21 days)
Secondary outcome [34] 0 0
Trough Serum Concentration (Cmin) of Atezolizumab in the China Population
Timepoint [34] 0 0
Pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 (cycle length = 21 days)
Secondary outcome [35] 0 0
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab in the China Population
Timepoint [35] 0 0
Baseline and post-baseline on Day 1 (pre-dose) of Cycles 2, 3, 4, 8, 12, 16 (cycle length = 21 days) and treatment discontinuation visit (up to approximately 18 months)

Eligibility
Key inclusion criteria
* Locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC)
* No prior systemic therapy for HCC. Previous use of herbal therapies/traditional Chinese medicines with anti-cancer activity included in the label is allowed, provided that these medications are discontinued prior to randomization.
* At least one measurable untreated lesion
* ECOG Performance Status of 0 or 1
* Adequate hematologic and end-organ function
* For women of childbearing potential: agreement to remain abstinent
* For men: agreement to remain abstinent
* Child-Pugh class A
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of leptomeningeal disease
* Active or history of autoimmune disease or immune deficiency
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan
* Known active tuberculosis
* History of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
* Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within at least 5 months after the last dose of atezolizumab, 6 months after the last dose of bevacizumab, or 1 month after the last dose of sorafenib
* Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
* Untreated or incompletely treated esophageal and/or gastric varices with bleeding or high-risk for bleeding
* A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment.
* Moderate or severe ascites
* History of hepatic encephalopathy
* Co-infection of HBV and HCV
* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
* Uncontrolled tumor-related pain
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
* Uncontrolled or symptomatic hypercalcemia
* Treatment with systemic immunostimulatory agents
* Inadequately controlled arterial hypertension
* Prior history of hypertensive crisis or hypertensive encephalopathy
* Evidence of bleeding diathesis or significant coagulopathy
* History of intestinal obstruction and/or clinical signs or symptoms of GI obstruction including sub-occlusive disease related to the underlying disease or requirement for routine parenteral hydration
* Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture
* Metastatic disease that involves major airways or blood vessels, or centrally located mediastinal tumor masses
* Local therapy to liver within 28 days prior to initiation of study treatment or non-recovery from side effects of any such procedure
* Chronic daily treatment with a non-steroidal anti-inflammatory drug (NSAID)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/03/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/11/2022
Sample size
Target
Accrual to date
Final
558
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [2] 0 0
St George Hospital - Kogarah
Recruitment hospital [3] 0 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [4] 0 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 0 0
2200 - Bankstown
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
5011 - Woodville
Recruitment postcode(s) [4] 0 0
3021 - St Albans
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New Mexico
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Washington
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Canada
State/province [15] 0 0
Quebec
Country [16] 0 0
China
State/province [16] 0 0
Beijing City
Country [17] 0 0
China
State/province [17] 0 0
Beijing
Country [18] 0 0
China
State/province [18] 0 0
Changchun
Country [19] 0 0
China
State/province [19] 0 0
Changsha CITY
Country [20] 0 0
China
State/province [20] 0 0
Foshan
Country [21] 0 0
China
State/province [21] 0 0
Fuzhou
Country [22] 0 0
China
State/province [22] 0 0
Guangzhou City
Country [23] 0 0
China
State/province [23] 0 0
Guangzhou
Country [24] 0 0
China
State/province [24] 0 0
Hangzhou City
Country [25] 0 0
China
State/province [25] 0 0
Hangzhou
Country [26] 0 0
China
State/province [26] 0 0
Harbin
Country [27] 0 0
China
State/province [27] 0 0
Hefei City
Country [28] 0 0
China
State/province [28] 0 0
Hefei
Country [29] 0 0
China
State/province [29] 0 0
Jinan
Country [30] 0 0
China
State/province [30] 0 0
Nanjing City
Country [31] 0 0
China
State/province [31] 0 0
Shanghai City
Country [32] 0 0
China
State/province [32] 0 0
Shanghai
Country [33] 0 0
China
State/province [33] 0 0
Wuhan
Country [34] 0 0
Czechia
State/province [34] 0 0
Brno
Country [35] 0 0
Czechia
State/province [35] 0 0
Olomouc
Country [36] 0 0
France
State/province [36] 0 0
Lille
Country [37] 0 0
France
State/province [37] 0 0
Lyon
Country [38] 0 0
France
State/province [38] 0 0
Marseille
Country [39] 0 0
France
State/province [39] 0 0
Montpellier
Country [40] 0 0
France
State/province [40] 0 0
Nantes
Country [41] 0 0
France
State/province [41] 0 0
Nice Cedex
Country [42] 0 0
France
State/province [42] 0 0
Rouen
Country [43] 0 0
France
State/province [43] 0 0
Strasbourg
Country [44] 0 0
France
State/province [44] 0 0
Vandoeuvre-les-nancy
Country [45] 0 0
France
State/province [45] 0 0
Villejuif
Country [46] 0 0
Germany
State/province [46] 0 0
Berlin
Country [47] 0 0
Germany
State/province [47] 0 0
Frankfurt
Country [48] 0 0
Germany
State/province [48] 0 0
Hamburg
Country [49] 0 0
Germany
State/province [49] 0 0
Hannover
Country [50] 0 0
Germany
State/province [50] 0 0
Leipzig
Country [51] 0 0
Germany
State/province [51] 0 0
Mainz
Country [52] 0 0
Germany
State/province [52] 0 0
Regensburg
Country [53] 0 0
Hong Kong
State/province [53] 0 0
Hong Kong
Country [54] 0 0
Hong Kong
State/province [54] 0 0
Shatin
Country [55] 0 0
Italy
State/province [55] 0 0
Campania
Country [56] 0 0
Italy
State/province [56] 0 0
Emilia-Romagna
Country [57] 0 0
Italy
State/province [57] 0 0
Piemonte
Country [58] 0 0
Italy
State/province [58] 0 0
Sardegna
Country [59] 0 0
Italy
State/province [59] 0 0
Toscana
Country [60] 0 0
Italy
State/province [60] 0 0
Veneto
Country [61] 0 0
Japan
State/province [61] 0 0
Chiba
Country [62] 0 0
Japan
State/province [62] 0 0
Fukuoka
Country [63] 0 0
Japan
State/province [63] 0 0
Hokkaido
Country [64] 0 0
Japan
State/province [64] 0 0
Ishikawa
Country [65] 0 0
Japan
State/province [65] 0 0
Kanagawa
Country [66] 0 0
Japan
State/province [66] 0 0
Kumamoto
Country [67] 0 0
Japan
State/province [67] 0 0
Osaka
Country [68] 0 0
Japan
State/province [68] 0 0
Saga
Country [69] 0 0
Japan
State/province [69] 0 0
Shizuoka
Country [70] 0 0
Japan
State/province [70] 0 0
Tokyo
Country [71] 0 0
Korea, Republic of
State/province [71] 0 0
Jeollanam-do
Country [72] 0 0
Korea, Republic of
State/province [72] 0 0
Seoul
Country [73] 0 0
Korea, Republic of
State/province [73] 0 0
Ulsan
Country [74] 0 0
Poland
State/province [74] 0 0
Gdansk
Country [75] 0 0
Poland
State/province [75] 0 0
Myslowice
Country [76] 0 0
Poland
State/province [76] 0 0
Olsztyn
Country [77] 0 0
Poland
State/province [77] 0 0
Warszawa
Country [78] 0 0
Poland
State/province [78] 0 0
Wroc?aw
Country [79] 0 0
Russian Federation
State/province [79] 0 0
Moskovskaja Oblast
Country [80] 0 0
Russian Federation
State/province [80] 0 0
Sankt Petersburg
Country [81] 0 0
Singapore
State/province [81] 0 0
Singapore
Country [82] 0 0
Spain
State/province [82] 0 0
Barcelona
Country [83] 0 0
Spain
State/province [83] 0 0
Madrid
Country [84] 0 0
Spain
State/province [84] 0 0
Zaragoza
Country [85] 0 0
Taiwan
State/province [85] 0 0
Tainan
Country [86] 0 0
Taiwan
State/province [86] 0 0
Taipei
Country [87] 0 0
Taiwan
State/province [87] 0 0
Taoyuan County
Country [88] 0 0
United Kingdom
State/province [88] 0 0
Glasgow
Country [89] 0 0
United Kingdom
State/province [89] 0 0
London
Country [90] 0 0
United Kingdom
State/province [90] 0 0
Manchester

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03434379