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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02538666




Registration number
NCT02538666
Ethics application status
Date submitted
26/08/2015
Date registered
2/09/2015
Date last updated
5/01/2023

Titles & IDs
Public title
An Investigational Immuno-therapy Study of Nivolumab, or Nivolumab in Combination With Ipilimumab, or Placebo in Patients With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based Chemotherapy
Scientific title
A Randomized, Multicenter, Double-Blind, Phase 3 Study of Nivolumab, Nivolumab in Combination With Ipilimumab, or Placebo as Maintenance Therapy in Subjects With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based First Line Chemotherapy (CheckMate 451: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 451)
Secondary ID [1] 0 0
2015-002441-61
Secondary ID [2] 0 0
CA209-451
Universal Trial Number (UTN)
Trial acronym
CheckMate 451
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Experimental: Nivolumab monotherapy - Nivolumab intravenous fusion

Experimental: Nivolumab and ipilimumab combination therapy - Nivolumab and ipilimumab intravenous fusion

Placebo comparator: Placebo - Placebo
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) of Nivolumab + Ipilimumab Versus Placebo In The Global Population
Timepoint [1] 0 0
From randomization to 400 deaths across the two treatment groups (Nivo+Ipi vs Placebo) (up to approximately 37 months)
Secondary outcome [1] 0 0
Overall Survival (OS) of Nivolumab Versus Placebo
Timepoint [1] 0 0
From randomization to the date of death or last known alive date (up to approximately 73 months)
Secondary outcome [2] 0 0
Overall Survival (OS) of Nivolumab + Ipilimumab Versus Nivolumab
Timepoint [2] 0 0
From randomization to the date of death or last known alive date (up to approximately 73 months)
Secondary outcome [3] 0 0
Progression Free Survival (PFS) Per BICR
Timepoint [3] 0 0
From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 73 months)
Secondary outcome [4] 0 0
Overall Survival (OS) in Tumor Mutational Burden (TMB) High and Low Subgroups by TMB Cutoff In The Global Population
Timepoint [4] 0 0
From randomization to the date of death or last known alive date (up to approximately 73 months)
Secondary outcome [5] 0 0
Progression Free Survival (PFS) Per BICR in Tumor Mutational Burden (TMB) High and Low Subgroups by TMB Cutoff In The Global Population
Timepoint [5] 0 0
From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 73 months)

Eligibility
Key inclusion criteria
* Subjects with histologically or cytologically confirmed extensive stage disease SCLC
* Ongoing response of stable disease or better following 4 cycles of platinum-based first line chemotherapy
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects with symptomatic Central Nervous System (CNS) metastases
* Subjects receiving consolidative chest radiation
* Subjects with active, known, or suspected autoimmune disease are excluded
* All side effects attributed to prior anti-cancer therapy must have resolved to Grade 1 or baseline

Other protocol-defined inclusion/exclusion criteria apply

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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
13/10/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/11/2021
Sample size
Target
Accrual to date
Final
907
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - Kogarah
Recruitment hospital [2] 0 0
Local Institution - Wollongong
Recruitment hospital [3] 0 0
Local Institution - Birtinya
Recruitment hospital [4] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [5] 0 0
Local Institution - 0137 - Adelaide
Recruitment hospital [6] 0 0
Local Institution - 0035 - East Melbourne
Recruitment postcode(s) [1] 0 0
- Kogarah
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment postcode(s) [3] 0 0
4575 - Birtinya
Recruitment postcode(s) [4] 0 0
4102 - Brisbane
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
3165 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
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California
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Connecticut
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Florida
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Georgia
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Indiana
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Kansas
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Kentucky
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Maryland
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Massachusetts
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Missouri
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New York
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North Carolina
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North Dakota
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Ohio
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Oregon
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Pennsylvania
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South Carolina
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South Dakota
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Utah
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Virginia
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Argentina
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Buenos Aires
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Cordoba
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Tucuman
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Innsbruck
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Salzburg
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Brussels
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Charleroi
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Roeselare
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Ceara
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Salvador
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Alberta
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New Brunswick
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Canada
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Ontario
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China
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Anhui
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China
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Beijing
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China
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Heilongjiang
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China
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Hubei
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China
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Jiangsu
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China
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Jilin
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Liaoning
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Avignon Cedes 9
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Lyon Cedex 08
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Marseille Cedex 20
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France
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Paris Cedex 20
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France
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Pierre Benite
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France
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Rennes Cedex 9
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France
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Saint Herblain
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Toulouse
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Augsburg
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Bad Berka
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Berlin
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Germany
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Bochum
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Germany
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Gauting
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Germany
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Grosshansdorf
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Germany
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Immenhausen
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Tübingen
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Greece
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N.Kifissia
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Greece
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Cork
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Limerick
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Jerusalem
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Israel
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Petach Tikva
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Israel
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Tel Aviv
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Israel
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Zerifin
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Italy
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Lombardia
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Italy
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Avellino
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Italy
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Bologna
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Italy
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Messina
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Italy
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Chiba
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Fukuoka
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Hyogo
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Ishikawa
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Miyagi
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Okayama
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Osaka
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Saitama
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Tokyo
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Wakayama
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Korea, Republic of
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Gyeonggi-do
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Kyonggi-do
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Korea, Republic of
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Gangnam-gu
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Korea, Republic of
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Seoul
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Mexico
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Netherlands
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's-Hertogenbosch
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Eindhoven
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Netherlands
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Rotterdam
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Peru
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Lima
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Poland
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Gdansk
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Gdynia
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Olsztyn
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Poland
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Warszawa
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Romania
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Bucharest
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Romania
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Craiova
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Romania
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Lasi
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Romania
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Romania
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Romania
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Timisoara, Timis
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Russian Federation
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Moscow
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Russian Federation
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St Petersburg
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Russian Federation
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St. Petersburg
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Singapore
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Singapore
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South Africa
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Gauteng
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South Africa
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Western Cape
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South Africa
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Western CAPE
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Sevilla
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Sweden
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Lund
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Sweden
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Uppsala
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Switzerland
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Aarau
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Switzerland
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Geneve
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Switzerland
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St. Gallen
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Taiwan
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TNN
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Taiwan
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Taoyuan
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United Kingdom
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Cornwall
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United Kingdom
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Greater London
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United Kingdom
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Lancashire
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United Kingdom
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Oxfordshire
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United Kingdom
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Surrey
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United Kingdom
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Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Ono Pharmaceutical Co. Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol Myers Squibb
Address 0 0
Bristol-Myers Squibb
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/NCT02538666