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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02369874




Registration number
NCT02369874
Ethics application status
Date submitted
18/02/2015
Date registered
24/02/2015
Date last updated
10/02/2021

Titles & IDs
Public title
Study of MEDI4736 Monotherapy and in Combination With Tremelimumab Versus Standard of Care Therapy in Patients With Head and Neck Cancer
Scientific title
A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 Monotherapy and MEDI4736 in Combination With Tremelimumab Versus Standard of Care Therapy in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Secondary ID [1] 0 0
D4193C00002
Universal Trial Number (UTN)
Trial acronym
EAGLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrent or Metastatic PD-L1-positive or -Negative Squamous Cell Carcinoma of the Head and Neck SCCHN 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
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MEDI4736
Treatment: Drugs - MEDI4736 + Tremelimumab
Treatment: Drugs - Standard of Care

Experimental: MEDI4736 - MEDI4736 monotherapy

Experimental: MEDI4736 + Tremelimumab - MEDI4736 + tremelimumab combination therapy

Active Comparator: Standard of Care - Standard of Care


Treatment: Drugs: MEDI4736
MEDI4736 Monotherapy

Treatment: Drugs: MEDI4736 + Tremelimumab
MEDI4736 + Tremelimumab combination therapy

Treatment: Drugs: Standard of Care
Standard of Care

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) - OS is defined as the time from the date of randomization until death due to any cause. OS was analyzed for the full analysis set, regardless of programmed death-ligand 1 (PD-L1) status.
Timepoint [1] 0 0
September 2015 to September 2018 (36 months)
Secondary outcome [1] 0 0
Overall Survival (OS) in PD-L1 Negative Participants - OS is defined as the time from the date of randomization until death due to any cause. PD-L1 negative was defined as <25% of tumor cells with membrane staining for PD-L1 at any intensity.
Timepoint [1] 0 0
September 2015 to September 2018 (36 months)
Secondary outcome [2] 0 0
Overall Survival (OS) in PD-L1 Positive Participants - OS is defined as the time from the date of randomization until death due to any cause. PD-L1 positive was defined as =25% of tumor cells with membrane staining for PD-L1 at any intensity.
Timepoint [2] 0 0
September 2015 to September 2018 (36 months)
Secondary outcome [3] 0 0
Progression Free Survival (PFS) - PFS was defined as the time from the date of randomization until the date of objective disease progression or death based on investigator assessments, according to response evaluation criteria in solid tumors 1.1 (RECIST1.1). Objective disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Timepoint [3] 0 0
September 2015 to September 2018 (36 months)
Secondary outcome [4] 0 0
Objective Response Rate (ORR) - The percentage of participants who experienced an objective response (complete response [CR] or partial response [PR]), based on investigator assessments according to response evaluation criteria in solid tumors 1.1 (RECIST1.1). A CR was defined as the disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm. A PR was defined as at least a 30% decrease in the sum of the diameters of TLs, taking as reference the baseline sum of diameters.
Timepoint [4] 0 0
Assessed at randomization and every 8 weeks thereafter
Secondary outcome [5] 0 0
Duration of Response (DoR) - Median DoR, in months, based on investigator assessments, according to response evaluation criteria in solid tumors 1.1 (RECIST1.1). A complete response was defined as the disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm. A partial response was defined as at least a 30% decrease in the sum of the diameters of TLs, taking as reference the baseline sum of diameters.
Timepoint [5] 0 0
September 2015 to September 2018 (36 months)
Secondary outcome [6] 0 0
Disease Control Rate (DCR) - 6 Months: The percentage of participants who had a best objective response of complete response (CR) or partial response (PR) in the first 6 months or had demonstrated stable disease (SD) for a minimum interval of 24 weeks following randomization.
12 Months: The percentage of participants who had a best objective response of CR or PR within 12 months or had demonstrated SD for a minimum interval of 48 weeks following randomization.
Objective response was based on investigator assessments, according to response evaluation criteria in solid tumors 1.1 (RECIST1.1). A CR was defined as the disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm. A PR was defined as at least a 30% decrease in the sum of the diameters of TLs, taking as reference the baseline sum of diameters.
Timepoint [6] 0 0
Baseline up to 6 months; baseline up to 12 months
Secondary outcome [7] 0 0
Percentage of Participants Alive and Progression Free (APF) - APF is defined as the percentage of participants who are alive and progression free at 6 months and 12 months after randomization. Estimates of progression free survival were based on investigator assessments according to response evaluation criteria in solid tumors 1.1 (RECIST1.1). Objective disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Timepoint [7] 0 0
Baseline up to 6 months; baseline up to 12 months
Secondary outcome [8] 0 0
Percentage of Participants Alive - Percentage of participants alive at 12, 18 and 24 months using a Kaplan Meier estimate.
Timepoint [8] 0 0
12, 18 and 24 months
Secondary outcome [9] 0 0
Progression Free Survival (PFS) in PD-L1 Negative Participants - Number of participants with confirmed objective disease progression (PD) at the time of the participant's last evaluable response evaluation criteria in solid tumors 1.1 (RECIST1.1) assessment. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. PD-L1 negative was defined as <25% of tumor cells with membrane staining for PD-L1 at any intensity.
Timepoint [9] 0 0
September 2015 to September 2018 (36 months)
Secondary outcome [10] 0 0
Objective Response Rate (ORR) in PD-L1 Negative Participants - The percentage of PD-L1 negative participants who experienced an objective response (complete response [CR] or partial response [PR]), based on investigator assessments according to response evaluation criteria in solid tumors 1.1 (RECIST1.1). A CR was defined as the disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm. A PR was defined as at least a 30% decrease in the sum of the diameters of TLs, taking as reference the baseline sum of diameters. PD-L1 negative was defined as <25% of tumor cells with membrane staining for PD-L1 at any intensity.
Timepoint [10] 0 0
September 2015 to September 2018 (36 months)
Secondary outcome [11] 0 0
Time to Deterioration in European Organisation for Research and Treatment of Cancer 30-item Core Quality of Life Questionnaire, Version 3 (EORTC QLQ-C30) - The EORTC QLQ-C30 consists of 30 questions that can be combined to produce functional scales (e.g. physical), symptom scales (e.g. fatigue), and a global measure of health status. Each of the scales are measured from 0 to 100. Deterioration was defined as a 10-point decrease from baseline in a functioning or global health status/ quality of life score or a 10-point increase from baseline in a symptom score.
Timepoint [11] 0 0
September 2015 to September 2018 (36 months)
Secondary outcome [12] 0 0
Time to Deterioration for European Organisation for Research and Treatment of Cancer 35-item Head and Neck Quality of Life Questionnaire (EORTC QLQ-H&N35) - The EORTC QLQ-H&N35 comprises of 35 questions to assess head and neck cancer symptoms (e.g. pain, swallowing). Deterioration was defined as a 10-point increase from baseline in the symptom score.
Timepoint [12] 0 0
September 2015 to September 2018 (36 months)
Secondary outcome [13] 0 0
Number of Participants Reporting One or More Adverse Events (AE) - An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Inclusive of AEs and serious AEs.
Timepoint [13] 0 0
First dose to last dose + 90 days or data cut off (up to 36 months)

Eligibility
Key inclusion criteria
- Age =18 years; - Written informed consent obtained from the
patient/legal representative; - Histologically or cytologically confirmed recurrent or
metastatic SCCHN; - Tumor progression or recurrence during or after only one palliative
systemic treatment regimen for recurrent or metastatic disease that must have contained a
platinum agent OR progression within 6 months of the last dose of platinum given as part of
multimodality therapy with curative intent; - Confirmed PD-L1-positive or -negative SCCHN
by the Ventana PD-L1 SP263 IHC assay; - WHO/Eastern Cooperative Oncology Group (ECOG)
performance status of 0 or 1; At least 1 measurable lesion, - Not previously irradiated; -
No prior exposure to immune-mediated therapy; - Adequate organ and marrow function;
Evidence of post-menopausal status or negative urinary or serum pregnancy test for female
pre-menopausal patients.
Minimum age
18 Years
Maximum age
96 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Histologically or cytologically confirmed
squamous cell carcinoma of any other primary anatomic location in the head and neck; -
Received more than 1 palliative systemic regimen for recurrent or metastatic disease; -Any
concurrent chemotherapy, Investigational Product, biologic, or hormonal therapy for cancer
treatment; - Receipt of any investigational anticancer therapy within 28 days or 5
half-lives; - Receipt of last dose of an approved (marketed) anticancer therapy
(chemotherapy, targeted therapy, biologic therapy, mAbs, etc) within 21 days prior to the
first dose of study treatment; - Major surgical procedure within 28 days prior to the first
dose of Investigational Product; - Any unresolved toxicity NCI CTCAE Grade =2 from previous
anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values
defined in the inclusion criterion; - Current or prior use of immunosuppressive medication
within 14 days before the first dose of their assigned Investigational Product; - History
of allogeneic organ transplantation; - Active or prior documented autoimmune or
inflammatory disorders; - Uncontrolled intercurrent illness; - Patients with a history of
brain metastases, spinal cord compression, or leptomeningeal carcinomatosis; - Mean QT
interval corrected for heart rate (QTc) =470 ms calculated from 3 electrocardiograms (ECGs)
using Fridericia's Correction; - History of active primary immunodeficiency; - Active
tuberculosis; - Active infection including hepatitis B, hepatitis C or human
immunodeficiency virus (HIV); - Receipt of live, attenuated vaccine within 30 days prior to
the first dose of Investigational Product; - Pregnant or breast-feeding female patients; -
Known allergy or hypersensitivity to Investigational Product

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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Adelaide
Recruitment hospital [2] 0 0
Research Site - Heidelberg
Recruitment hospital [3] 0 0
Research Site - Melbourne
Recruitment hospital [4] 0 0
Research Site - St Leonards
Recruitment hospital [5] 0 0
Research Site - Woolloongabba
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
2065 - St Leonards
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
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
Delaware
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
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United States of America
State/province [6] 0 0
Georgia
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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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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
New York
Country [11] 0 0
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North Carolina
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Pennsylvania
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United States of America
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Tennessee
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
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United States of America
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Virginia
Country [16] 0 0
Argentina
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Caba
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Argentina
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San Miguel de Tucuman
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Belgium
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Brussels
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Belgium
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Bruxelles
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Charleroi
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Kortrijk
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Leuven
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Belgium
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Namur
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Barretos
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Curitiba
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Porto Alegre
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Rio de Janeiro
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Santo Andre
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São José do Rio Preto
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São Paulo
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Bulgaria
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Shumen
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Bulgaria
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Sofia
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Bulgaria
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Varna
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Chile
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Temuco
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Croatia
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Osijek
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Croatia
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Zagreb
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Czechia
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Olomouc
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Czechia
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Zlin
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Angers
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Montpellier Cedex 5
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Paris Cedex 5
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Plerin SUR MER
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Rouen
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St Grégoire
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Villejuif Cedex
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Lorient Cedex
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Berlin
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Essen
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Halle
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Hannover
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Heidelberg
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Leipzig
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München
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Potsdam
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Hungary
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Budapest
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Hungary
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Gyor
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Hungary
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Kecskemét
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Israel
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Haifa
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Israel
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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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Tel Hashomer
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Italy
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Aosta
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Italy
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Bologna
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Italy
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Gallarate
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Italy
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Legnago
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Italy
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Milano
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Italy
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Napoli
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Italy
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Pavia
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Italy
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Roma
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Italy
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Siena
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Japan
State/province [77] 0 0
Chuo-ku
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Japan
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Fukuoka-shi
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Japan
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Hirakata-shi
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Japan
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Isehara-shi
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Japan
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Kashiwa
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Japan
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Kitaadachi-gun
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Japan
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Kobe-shi
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Japan
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Koto-ku
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Japan
State/province [85] 0 0
Matsuyama-shi
Country [86] 0 0
Japan
State/province [86] 0 0
Nagoya
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Japan
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Natori-shi
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Japan
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Okayama
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Japan
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Osakasayama
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Osaka
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Sapporo
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Shimotsuke-shi
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Japan
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Sunto-gun
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Japan
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Takatsuki-shi
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Japan
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Yokohama-shi
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Japan
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Yokohama
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Korea, Republic of
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Daegu
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Korea, Republic of
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Goyang-si
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Korea, Republic of
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Seoul
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Korea, Republic of
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Suwon
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Poland
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Kraków
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Poland
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Poznan
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Poland
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Lódz
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Romania
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Baia Mare
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Brasov
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Romania
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Cluj-Napoca
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Romania
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Cluj
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Romania
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Craiova
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Russian Federation
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Arkhangelsk
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Russian Federation
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Chelyabinsk
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Russian Federation
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Kursk
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Russian Federation
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Moscow
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Russian Federation
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Nizhniy Novgorod
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Russian Federation
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Omsk
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Russian Federation
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Pyatigorsk
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Russian Federation
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Saint Petersburg
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Sankt-Peterburg
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Russian Federation
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Sochi
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Russian Federation
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Ufa
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Russian Federation
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Vladimir
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Serbia
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Belgrade
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Serbia
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Belgrad
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Serbia
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Kragujevac
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Serbia
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Nis
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Serbia
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Sremska Kamenica
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Spain
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Barcelona
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Spain
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L'Hospitalet de Llobregat
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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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Marbella
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Spain
State/province [132] 0 0
Pamplona
Country [133] 0 0
Spain
State/province [133] 0 0
Valencia
Country [134] 0 0
Spain
State/province [134] 0 0
Zaragoza
Country [135] 0 0
Taiwan
State/province [135] 0 0
Kaohsiung
Country [136] 0 0
Taiwan
State/province [136] 0 0
Taipei
Country [137] 0 0
Taiwan
State/province [137] 0 0
Taoynan
Country [138] 0 0
Ukraine
State/province [138] 0 0
Dnipro
Country [139] 0 0
Ukraine
State/province [139] 0 0
Kyiv
Country [140] 0 0
Ukraine
State/province [140] 0 0
Sumy
Country [141] 0 0
Ukraine
State/province [141] 0 0
Uzhhorod
Country [142] 0 0
Ukraine
State/province [142] 0 0
Zaporizhzhia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a randomized, open-label, multi-center, global, Phase III study to determine the
efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy
versus SoC therapy in the target patient population.
Trial website
https://clinicaltrials.gov/show/NCT02369874
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Nassim Morsli, MD
Address 0 0
Medical Director AstraZeneca
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

Summary results
Other publications