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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03829332




Registration number
NCT03829332
Ethics application status
Date submitted
1/02/2019
Date registered
4/02/2019

Titles & IDs
Public title
Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) in Adults With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Treatment-naïve Nonsmall Cell Lung Cancer (NSCLC) (MK-7902-007/E7080-G000-314/LEAP-007)
Scientific title
A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) in Participants With Treatment-naïve, Metastatic Nonsmall Cell Lung Cancer (NSCLC) Whose Tumors Have a Tumor Proportion Score (TPS) Greater Than or Equal to 1% (LEAP-007)
Secondary ID [1] 0 0
MK-7902-007
Secondary ID [2] 0 0
7902-007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small Cell 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
Description of intervention(s) / exposure
Treatment: Other - Pembrolizumab
Treatment: Drugs - Lenvatinib
Treatment: Drugs - Placebo for lenvatinib

Experimental: Pembrolizumab + Lenvatinib - Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity.

Active comparator: Pembrolizumab + Placebo - Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity.


Treatment: Other: Pembrolizumab
IV infusion

Treatment: Drugs: Lenvatinib
oral capsule

Treatment: Drugs: Placebo for lenvatinib
oral capsule
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Timepoint [1] 0 0
Up to approximately 25 months
Primary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Up to approximately 25 months
Secondary outcome [1] 0 0
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Timepoint [1] 0 0
Up to approximately 25 months
Secondary outcome [2] 0 0
Number of Participants Who Experience an Adverse Event (AE)
Timepoint [2] 0 0
Through 90 days post last dose of study treatment (Up to approximately 27 months)
Secondary outcome [3] 0 0
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Timepoint [3] 0 0
Through last dose of study treatment (Up to approximately 24 months)
Secondary outcome [4] 0 0
Change From Baseline in Global Health Status (GHS) (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 [EORTC QLQ-C30] Item 29) Score
Timepoint [4] 0 0
Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)
Secondary outcome [5] 0 0
Change From Baseline in Quality of Life (QoL) (EORTC QLQ-C30 Item 30) Score
Timepoint [5] 0 0
Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)
Secondary outcome [6] 0 0
Change From Baseline in Cough (EORTC Quality of Life Questionnaire-Lung Cancer Module 13 [QLQ-LC13] Item 31) Score
Timepoint [6] 0 0
Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)
Secondary outcome [7] 0 0
Change From Baseline in Chest Pain (EORTC QLQ-LC13 Item 40) Score
Timepoint [7] 0 0
Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)
Secondary outcome [8] 0 0
Change From Baseline in Dyspnea (EORTC QLQ-C30 Item 8) Score
Timepoint [8] 0 0
Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)
Secondary outcome [9] 0 0
Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Score
Timepoint [9] 0 0
Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)
Secondary outcome [10] 0 0
Time to True Deterioration (TTD) Based on Change From Baseline in Global Health Status (GHS) (EORTC QLQ-C30 Item 29) Score
Timepoint [10] 0 0
Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)
Secondary outcome [11] 0 0
Time to True Deterioration (TTD) Based on Change From Baseline in Quality of Life (QoL) (EORTC QLQ-C30 Item 30) Score
Timepoint [11] 0 0
Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)
Secondary outcome [12] 0 0
Time to True Deterioration (TTD) Based on Change From Baseline in the Composite Endpoint of Cough (EORTC QLQ-LC13 Item 31), Chest Pain (EORTC QLQ-LC13 Item 40), or Dyspnea (EORTC QLQ-C30 Item 8)
Timepoint [12] 0 0
Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)
Secondary outcome [13] 0 0
Time to True Deterioration (TTD) Based on Change From Baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Score
Timepoint [13] 0 0
Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)

Eligibility
Key inclusion criteria
* Has a histologically or cytologically confirmed diagnosis of NSCLC.
* Has Stage IV NSCLC (American Joint Committee on Cancer [AJCC 8th edition]).
* Has measurable disease based on RECIST 1.1.
* Has tumor tissue that demonstrates programmed cell death-ligand 1 (PD-L1) expression in =1% of tumor cells (Tumor Proportion Score [TPS] =1%) as assessed by immunohistochemistry (IHC) 22C3 pharmDx assay (Dako North America, Inc.) at a central laboratory.
* Has a life expectancy of =3 months.
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study treatment but before randomization.
* Male participants must agree to the following during the treatment period and for =7 days after the last dose of lenvatinib/matching placebo: 1) Be abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent, OR 2) Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause).
* Female participants are eligible to participate if not pregnant or breastfeeding, and =1 of the following applies: 1) Is not a woman of child-bearing potential (WOCBP), OR 2) Is a WOCBP and is using a highly effective contraceptive method that has a low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle during the treatment period and for =120 days post pembrolizumab or =30 days post lenvatinib/matching placebo, whichever occurs last.
* Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP =150/90 mm Hg and no change in antihypertensive medications within 1 week before randomization.
* Has adequate organ function.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has known untreated central nervous system metastases and/or carcinomatous meningitis.
* Has active hemoptysis (at least 0.5 teaspoon of bright red blood) within 2 weeks prior to the first dose of study intervention.
* Has radiographic evidence of intratumoral cavitations, encasement, or invasion of a major blood vessel.
* Has a known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for =3 years since initiation of that therapy. (Note: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers.)
* Has an active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
* Has had an allogeneic tissue/solid organ transplant.
* Has a known history of human immunodeficiency virus (HIV) infection.
* Has a history of (noninfectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease.
* Has a known history of hepatitis B or known active hepatitis C virus infection.
* Has a history of a gastrointestinal condition or procedure that in the opinion of the investigator may affect oral study drug absorption.
* Has significant cardiovascular impairment within 12 months of the first dose of study treatment, such as a history of congestive heart failure greater than New York Heart Association Class II, unstable angina, myocardial infarction, cerebrovascular accident/stroke, or cardiac arrhythmia associated with hemodynamic instability.
* Has not recovered adequately from any toxicity and/or complications from major surgery before starting study treatment.
* Has a known history of active tuberculosis (TB).
* Has an active infection requiring systemic therapy.
* Has previously had a severe hypersensitivity reaction to treatment with a monoclonal antibody or has a known sensitivity or intolerance to any component of lenvatinib or pembrolizumab.
* Has received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLC.
* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], Tumor necrosis factor receptor superfamily, member 4 [OX 40], tumor necrosis factor receptor superfamily member 9 [CD137]) or has received lenvatinib as monotherapy or in combination with anti- programmed cell death protein (anti-PD-1) agents.
* Has received radiotherapy within 14 days before the first dose of study treatment or received lung radiation therapy of >30 Gray (Gy) within 6 months before the first dose of study treatment. (Note: Participants must have recovered from all radiation-related toxicities to =Grade 1, not require corticosteroids, and not have had radiation pneumonitis.)
* Has a diagnosis of immunodeficiency or is receiving any form of immunosuppressive therapy within 7 days before the first dose of study treatment.
* Is receiving systemic steroid therapy (doses >10 mg daily of prednisone equivalent) within 7 days before the first dose of study treatment.
* Has received a live or attenuated vaccine within 30 days before the first dose of study treatment.
* Has had major surgery within 3 weeks prior to first dose of study treatment
* Has pre-existing =Grade 3 gastrointestinal or nongastrointestinal fistula.

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 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
13/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/04/2024
Sample size
Target
Accrual to date
Final
623
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Orange Health Services ( Site 0002) - Orange
Recruitment hospital [2] 0 0
Wollongong Private Hospital ( Site 0005) - Wollongong
Recruitment hospital [3] 0 0
The Prince Charles Hospital ( Site 0011) - Chermside
Recruitment hospital [4] 0 0
Ballarat Oncology and Haematology Services ( Site 0008) - Wendouree
Recruitment hospital [5] 0 0
St John of God Murdoch Medical Clinic ( Site 0001) - Perth
Recruitment postcode(s) [1] 0 0
2800 - Orange
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment postcode(s) [3] 0 0
4032 - Chermside
Recruitment postcode(s) [4] 0 0
3355 - Wendouree
Recruitment postcode(s) [5] 0 0
6150 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alaska
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
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
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
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Missouri
Country [13] 0 0
United States of America
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Montana
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
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Ohio
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United States of America
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Oregon
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
Canada
State/province [18] 0 0
Alberta
Country [19] 0 0
Canada
State/province [19] 0 0
British Columbia
Country [20] 0 0
Canada
State/province [20] 0 0
Ontario
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec
Country [22] 0 0
China
State/province [22] 0 0
Anhui
Country [23] 0 0
China
State/province [23] 0 0
Beijing
Country [24] 0 0
China
State/province [24] 0 0
Hunan
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China
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Jiangsu
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China
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Jilin
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China
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Shanghai
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China
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Shanxi
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China
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Sichuan
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China
State/province [30] 0 0
Zhejiang
Country [31] 0 0
Colombia
State/province [31] 0 0
Antioquia
Country [32] 0 0
Colombia
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Atlantico
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Colombia
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Cesar
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Colombia
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Cordoba
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Colombia
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Valle Del Cauca
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Estonia
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Harjumaa
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Estonia
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Tartumaa
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France
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Doubs
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France
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Hauts-de-Seine
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France
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Herault
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France
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Isere
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Loire-Atlantique
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France
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Pyrenees-Atlantiques
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Seine-Maritime
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France
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Somme
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France
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Var
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France
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Paris
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Hungary
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Bekes
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Hungary
State/province [49] 0 0
Borsod-Abauj-Zemplen
Country [50] 0 0
Hungary
State/province [50] 0 0
Gyor-Moson-Sopron
Country [51] 0 0
Hungary
State/province [51] 0 0
Jasz-Nagykun-Szolnok
Country [52] 0 0
Hungary
State/province [52] 0 0
Pest
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Hungary
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Budapest
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Hungary
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Kaposvar
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Israel
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Heifa
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Israel
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Tel Aviv
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Israel
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Beer Sheva
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Israel
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Haifa
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Israel
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Kfar-Saba
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Israel
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Petah Tikva
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Israel
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?eifa
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Italy
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Lazio
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Italy
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Messina
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Italy
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Pordenone
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Italy
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Avellino
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Italy
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Catanzaro
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Italy
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Firenze
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Italy
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Ravenna
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Italy
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Roma
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Japan
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Aichi
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Japan
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Fukuoka
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Japan
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Hyogo
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Japan
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Kanagawa
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Japan
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Miyagi
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Japan
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Osaka
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Japan
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Okayama
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Japan
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Tokyo
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Korea, Republic of
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Chungbuk
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Korea, Republic of
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Kyonggi-do
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Korea, Republic of
State/province [80] 0 0
Ulsan-Kwangyokshi
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Korea, Republic of
State/province [81] 0 0
Seoul
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Malaysia
State/province [82] 0 0
Pahang
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Malaysia
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Pulau Pinang
Country [84] 0 0
Malaysia
State/province [84] 0 0
Sarawak
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Malaysia
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Selangor
Country [86] 0 0
Malaysia
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Wilayah Persekutuan Putrajaya
Country [87] 0 0
Malaysia
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Kuala Lumpur
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Mexico
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Distrito Federal
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Mexico
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Jalisco
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Mexico
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Tamaulipas
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Mexico
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Mexico City
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Mexico
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Oaxaca
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Poland
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Lodzkie
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Poland
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Lubuskie
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Malopolskie
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Mazowieckie
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Poland
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Podkarpackie
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Poland
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Wielkopolskie
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Russian Federation
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Baskortostan, Respublika
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Russian Federation
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Krasnoyarskiy Kray
Country [101] 0 0
Russian Federation
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Samarskaya Oblast
Country [102] 0 0
Russian Federation
State/province [102] 0 0
Sankt-Peterburg
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Russian Federation
State/province [103] 0 0
Tatarstan, Respublika
Country [104] 0 0
Taiwan
State/province [104] 0 0
Hsinchu
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Taiwan
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New Taipei
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Taiwan
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Tainan
Country [107] 0 0
Taiwan
State/province [107] 0 0
Taipei
Country [108] 0 0
Turkey
State/province [108] 0 0
Adana
Country [109] 0 0
Turkey
State/province [109] 0 0
Ankara
Country [110] 0 0
Turkey
State/province [110] 0 0
Antalya
Country [111] 0 0
Turkey
State/province [111] 0 0
Izmir
Country [112] 0 0
Turkey
State/province [112] 0 0
Sakarya
Country [113] 0 0
Turkey
State/province [113] 0 0
Samsun
Country [114] 0 0
Ukraine
State/province [114] 0 0
Cherkaska Oblast
Country [115] 0 0
Ukraine
State/province [115] 0 0
Dnipropetrovska Oblast
Country [116] 0 0
Ukraine
State/province [116] 0 0
Ivano-Frankivska Oblast
Country [117] 0 0
Ukraine
State/province [117] 0 0
Kharkivska Oblast
Country [118] 0 0
Ukraine
State/province [118] 0 0
Kirovohradska Oblast
Country [119] 0 0
Ukraine
State/province [119] 0 0
Kyivska Oblast
Country [120] 0 0
Ukraine
State/province [120] 0 0
Lvivska Oblast
Country [121] 0 0
Ukraine
State/province [121] 0 0
Odeska Oblast
Country [122] 0 0
Ukraine
State/province [122] 0 0
Vinnytska Oblast

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Eisai Inc.
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
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
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?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


What supporting documents are/will be available?




Results publications and other study-related documents

TypeCitations or Other Details
Journal Yang JC, Han B, De La Mora Jimenez E, Lee JS, Kora... [More Details]


Results not provided in https://clinicaltrials.gov/study/NCT03829332