Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02420821




Registration number
NCT02420821
Ethics application status
Date submitted
15/04/2015
Date registered
20/04/2015
Date last updated
30/01/2023

Titles & IDs
Public title
A Study of Atezolizumab in Combination With Bevacizumab Versus Sunitinib in Participants With Untreated Advanced Renal Cell Carcinoma (RCC)
Scientific title
A Phase III, Open-Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Bevacizumab Versus Sunitinib in Patients With Untreated Advanced Renal Cell Carcinoma
Secondary ID [1] 0 0
2014-004684-20
Secondary ID [2] 0 0
WO29637
Universal Trial Number (UTN)
Trial acronym
IMmotion151
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Treatment: Drugs - Bevacizumab
Treatment: Drugs - Sunitinib

Experimental: Atezolizumab + Bevacizumab - Participants will receive both atezolizumab and bevacizumab until loss of clinical benefit, unacceptable toxicity or symptomatic deterioration attributed to disease progression, withdrawal of consent, or death, whichever occurs first.

Active comparator: Sunitinib - Participants will receive sunitinib until loss of clinical benefit, unacceptable toxicity or symptomatic deterioration attributed to disease progression, withdrawal of consent, or death, whichever occurs first.


Treatment: Drugs: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg) via intravenous (IV) infusion on Days 1 and 22 of each 42-day cycle.

Treatment: Drugs: Bevacizumab
Bevacizumab will be administered at a dose of 15 milligrams per kilogram (mg/kg) via IV infusion on Days 1 and 22 of each 42-day cycle.

Treatment: Drugs: Sunitinib
Sunitinib will be administered at a dose of 50 mg once daily, orally via capsule, on Day 1 through Day 28 of each 42-day cycle.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Disease Progression as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Death From Any Cause in Programmed Death-Ligand 1 (PD-L1)-Selected Population
Timepoint [1] 0 0
Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)
Primary outcome [2] 0 0
Progression-Free Survival (PFS) as Determined by the Investigator According to RECIST v1.1 in PD-L1-Selected Population
Timepoint [2] 0 0
Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)
Primary outcome [3] 0 0
Percentage of Participants Who Died of Any Cause in ITT Population
Timepoint [3] 0 0
Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months)
Primary outcome [4] 0 0
Overall Survival (OS) in ITT Population
Timepoint [4] 0 0
Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months)
Secondary outcome [1] 0 0
Percentage of Participants Who Died of Any Cause in PD-L1-Selected Population
Timepoint [1] 0 0
Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months)
Secondary outcome [2] 0 0
OS in PD-L1-Selected Population
Timepoint [2] 0 0
Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months)
Secondary outcome [3] 0 0
Percentage of Participants With PD as Determined by an Independent Review Committee (IRC) According to RECIST v1.1 or Death From Any Cause in ITT Population
Timepoint [3] 0 0
Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)
Secondary outcome [4] 0 0
PFS as Determined by an IRC According to RECIST v1.1 in ITT Population
Timepoint [4] 0 0
Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)
Secondary outcome [5] 0 0
Percentage of Participants With PD as Determined by an IRC According to RECIST v1.1 or Death From Any Cause in PD-L1-Selected Population
Timepoint [5] 0 0
Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)
Secondary outcome [6] 0 0
PFS as Determined by an IRC According to RECIST v1.1 in PD-L1-Selected Population
Timepoint [6] 0 0
Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)
Secondary outcome [7] 0 0
Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) as Determined by the Investigator According to RECIST v1.1 in Objective Response Rate (ORR)-Evaluable Population
Timepoint [7] 0 0
Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)
Secondary outcome [8] 0 0
Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1 in DOR-Evaluable Population
Timepoint [8] 0 0
Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)
Secondary outcome [9] 0 0
Percentage of Participants With an Objective Response of CR or PR as Determined by an IRC According to RECIST v1.1 in ORR-Evaluable Population
Timepoint [9] 0 0
Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)
Secondary outcome [10] 0 0
DOR as Determined by an IRC According to RECIST v1.1 in DOR-Evaluable Population
Timepoint [10] 0 0
Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)
Secondary outcome [11] 0 0
Percentage of Participants With PD as Determined by the Investigator According to Immune-Modified RECIST or Death From Any Cause in ITT Population
Timepoint [11] 0 0
Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)
Secondary outcome [12] 0 0
PFS as Determined by the Investigator According to Immune-Modified RECIST in ITT Population
Timepoint [12] 0 0
Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)
Secondary outcome [13] 0 0
Percentage of Participants With an Objective Response of CR or PR as Determined by the Investigator According to Immune-Modified RECIST in ORR-Evaluable Population
Timepoint [13] 0 0
Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)
Secondary outcome [14] 0 0
DOR as Determined by the Investigator According to Immune-Modified RECIST in DOR-Evaluable Population
Timepoint [14] 0 0
Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)
Secondary outcome [15] 0 0
Percentage of Participants With PD as Determined by the Investigator According to RECIST v1.1 or Death From Any Cause in ITT Population
Timepoint [15] 0 0
Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)
Secondary outcome [16] 0 0
PFS as Determined by the Investigator According to RECIST v1.1 in ITT Population
Timepoint [16] 0 0
Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)
Secondary outcome [17] 0 0
Percentage of Participants With PD as Determined by the Investigator According to RECIST v1.1 or Death From Any Cause in Participants With Sarcomatoid Histology
Timepoint [17] 0 0
Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)
Secondary outcome [18] 0 0
PFS as Determined by the Investigator According to RECIST v1.1 in Participants With Sarcomatoid Histology
Timepoint [18] 0 0
Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)
Secondary outcome [19] 0 0
Percentage of Participants Who Died of Any Cause in Participants With Sarcomatoid Histology
Timepoint [19] 0 0
Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months)
Secondary outcome [20] 0 0
OS in Participants With Sarcomatoid Histology
Timepoint [20] 0 0
Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months)
Secondary outcome [21] 0 0
Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score
Timepoint [21] 0 0
Baseline (Day 1 Cycle 1); Day 22 Cycle 1; Day 1 and 22 of every cycle from Cycle 2 up to Cycle 19; Cycle length = 42 days
Secondary outcome [22] 0 0
Change From Baseline in Symptom Severity as Determined by MDASI Part I Score
Timepoint [22] 0 0
Baseline; End of Treatment (EoT) visit (up to approximately 27 months)
Secondary outcome [23] 0 0
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Timepoint [23] 0 0
Baseline (Day 1 Cycle 1); every week for first 12 weeks, Days 1 and 22 of each cycle (Cycle 3 up to 19), within 30 days of PD (up to 27 months), at EoT (up to 27 months) and at 6, 12, 24, and 36 weeks after EoT (overall up to 27 months); 1 cycle=42 days
Secondary outcome [24] 0 0
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Timepoint [24] 0 0
Baseline (Day 1 Cycle 1); every week for first 12 weeks, Days 1 and 22 of each cycle (Cycle 3 up to 19), within 30 days of PD (up to 27 months), at EoT (up to 27 months) and at 6, 12, 24, and 36 weeks after EoT (overall up to 27 months); 1 cycle=42 days
Secondary outcome [25] 0 0
Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score
Timepoint [25] 0 0
Day 1 and 22 of every cycle (Baseline = Day 1 Cycle 1) up to Cycle 19; Cycle length = 42 days
Secondary outcome [26] 0 0
Number of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab
Timepoint [26] 0 0
Baseline (Predose [Hour 0] at Day 1 Cycle 1); Post-Baseline (Predose at Cycles 2, 4, and 8, and every eight cycles thereafter up to EoT [up to approximately 27 months] and 120 days after EoT [up to approximately 27 months]) (Cycle length=42 days)
Secondary outcome [27] 0 0
Number of Participants With ATAs Against Bevacizumab
Timepoint [27] 0 0
Baseline (Predose [Hour 0] at Day 1 Cycle 1); Post-Baseline (Predose at Cycle 3, at EoT [up to approximately 27 months] and at 120 days after EoT [up to approximately 27 months]) (Cycle length=42 days)
Secondary outcome [28] 0 0
Maximum Observed Serum Concentration (Cmax) for Atezolizumab
Timepoint [28] 0 0
30 minutes after the end of bevacizumab infusion (atezolizumab infusion duration: 30-60 min; bevacizumab infusion duration: 30-90 minutes) on Day 1 of Cycle 1 (Cycle length = 42 days)
Secondary outcome [29] 0 0
Minimum Observed Serum Concentration (Cmin) for Atezolizumab
Timepoint [29] 0 0
Predose (Hour 0) on Day 22 of Cycle 1; predose (Hour 0) on Day 1 of Cycles 2; Cycle length = 42 days
Secondary outcome [30] 0 0
Cmax for Bevacizumab
Timepoint [30] 0 0
30 minutes after the end of bevacizumab infusion (atezolizumab infusion duration: 30-60 min; bevacizumab infusion duration: 30-90 minutes) on Day 1 of Cycle 1 (Cycle length = 42 days)
Secondary outcome [31] 0 0
Cmin for Bevacizumab
Timepoint [31] 0 0
Pre-dose (Hour 0) on Day 1 of Cycle 3 (Cycle length = 42 days)

Eligibility
Key inclusion criteria
* Definitive diagnosis of unresectable locally advanced or metastatic RCC with clear-cell histology and/or a component of sarcomatoid carcinoma, with no prior treatment in the metastatic setting
* Evaluable Memorial Sloan Kettering Cancer Center risk score
* Measurable disease, as defined by RECIST v1.1
* Karnofsky performance status greater than or equal to 70%
* Adequate hematologic and end-organ function prior to randomization
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Disease-Specific Exclusions:

* Radiotherapy for RCC within 14 days prior to treatment
* Active central nervous system disease
* Uncontrolled pleural effusion, pericardial effusion, or ascites
* Uncontrolled hypercalcemia
* Any other malignancies within 5 years except for low-risk prostate cancer or those with negligible risk of metastasis or death

General Medical Exclusions:

* Life expectancy less than 12 weeks
* Participation in another experimental drug study within 4 weeks prior to treatment
* Pregnant or lactating women
* Known hypersensitivity to any component of atezolizumab or other study medication
* History of autoimmune disease except controlled, treated hypothyroidism or type I diabetes mellitus
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis
* Positive human immunodeficiency virus test
* Active or chronic hepatitis B or C
* Severe infections within 4 weeks prior to treatment
* Exposure to oral or IV antibiotics within 2 weeks prior to treatment
* Live attenuated vaccines within 4 weeks prior to treatment (for influenza vaccination participants must agree not to receive live, attenuated influenza vaccine within 4 weeks prior to treatment, during treatment or within 5 months following the last dose)
* Significant cardiovascular disease
* Prior allogeneic stem cell or solid organ transplantation

Exclusion Criteria Related to Medications:

* Prior treatment with cluster of differentiation 137 agonists, anti-cytotoxic T-lymphocyte associated protein-4, anti-programmed death (PD)-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents
* Treatment with immunostimulatory agents for non-malignant conditions within 6 weeks or immunosuppressive agents within 2 weeks prior to treatment

Bevacizumab- and Sunitinib-Specific Exclusions:

* History of hypertensive crisis or hypertensive encephalopathy
* Baseline electrocardiogram showing corrected QT interval greater than 460 milliseconds

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
20/05/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/12/2021
Sample size
Target
Accrual to date
Final
915
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Macquarie University Hospital - Macquarie Park
Recruitment hospital [3] 0 0
Calvary Mater Newcastle; Medical Oncology - Waratah
Recruitment hospital [4] 0 0
Icon Cancer Foundation - South Brisbane
Recruitment hospital [5] 0 0
Ashford Cancer Center Research - Kurralta Park
Recruitment hospital [6] 0 0
Austin Hospital; Medical Oncology - Heidelberg
Recruitment hospital [7] 0 0
St John of God Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2109 - Macquarie Park
Recruitment postcode(s) [3] 0 0
2298 - Waratah
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment postcode(s) [7] 0 0
6150 - Murdoch
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
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Nevada
Country [11] 0 0
United States of America
State/province [11] 0 0
New Jersey
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oregon
Country [15] 0 0
United States of America
State/province [15] 0 0
Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Virginia
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
Bosnia and Herzegovina
State/province [19] 0 0
Banja Luka
Country [20] 0 0
Brazil
State/province [20] 0 0
RS
Country [21] 0 0
Brazil
State/province [21] 0 0
SP
Country [22] 0 0
Canada
State/province [22] 0 0
Nova Scotia
Country [23] 0 0
Canada
State/province [23] 0 0
Ontario
Country [24] 0 0
Canada
State/province [24] 0 0
Quebec
Country [25] 0 0
Czechia
State/province [25] 0 0
Brno
Country [26] 0 0
Czechia
State/province [26] 0 0
Olomouc
Country [27] 0 0
Czechia
State/province [27] 0 0
Praha 2
Country [28] 0 0
Czechia
State/province [28] 0 0
Praha 4 - Krc
Country [29] 0 0
Denmark
State/province [29] 0 0
Aarhus N
Country [30] 0 0
Denmark
State/province [30] 0 0
Herlev
Country [31] 0 0
Denmark
State/province [31] 0 0
Odense C
Country [32] 0 0
France
State/province [32] 0 0
Angers
Country [33] 0 0
France
State/province [33] 0 0
Bordeaux
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France
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Caen
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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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Nancy
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France
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Paris
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France
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Saint Herblain
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France
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Villejuif
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Germany
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Dresden
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Germany
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Essen
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Germany
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Heidelberg
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Germany
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München
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Germany
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Tübingen
Country [47] 0 0
Italy
State/province [47] 0 0
Campania
Country [48] 0 0
Italy
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Emilia-Romagna
Country [49] 0 0
Italy
State/province [49] 0 0
Lazio
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Italy
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Lombardia
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Italy
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Toscana
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Japan
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Aichi
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Japan
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Chiba
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Japan
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Fukuoka
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Japan
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Gunma
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Japan
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Hokkaido
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Japan
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Ibaraki
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Japan
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Iwate
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Kanagawa
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Japan
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Kumamoto
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Niigata
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Okayama
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Osaka
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Tokushima
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Tokyo
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Korea, Republic of
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Daejeon
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Korea, Republic of
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Goyang-si
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Korea, Republic of
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Seongnam-si
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Korea, Republic of
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Seoul
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Mexico
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Queretaro
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Mexico
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Toluca
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Poland
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Lublin
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Poznan
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Poland
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Warsaw
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Russian Federation
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Altaj
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Russian Federation
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Niznij Novgorod
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Russian Federation
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Moscow
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Singapore
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Singapore
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Barcelona
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Cordoba
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Spain
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Madrid
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Spain
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Sevilla
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Taiwan
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Taichung
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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Thailand
State/province [86] 0 0
Bangkok
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Thailand
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Chiangmai
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Thailand
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Songkhla
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Turkey
State/province [89] 0 0
Ankara
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Turkey
State/province [90] 0 0
Edirne
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Turkey
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Istanbul
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United Kingdom
State/province [92] 0 0
Bebington
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United Kingdom
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Birmingham
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United Kingdom
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Blackburn
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United Kingdom
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Cambridge
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Oxford
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United Kingdom
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Southampton
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United Kingdom
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Sutton
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United Kingdom
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Swansea

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

No information has been provided regarding IPD availability


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/NCT02420821