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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02811861




Registration number
NCT02811861
Ethics application status
Date submitted
21/06/2016
Date registered
23/06/2016
Date last updated
10/07/2023

Titles & IDs
Public title
Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma
Scientific title
A Multicenter, Open-label, Randomized, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination With Everolimus or Pembrolizumab Versus Sunitinib Alone in First-Line Treatment of Subjects With Advanced Renal Cell Carcinoma (CLEAR)
Secondary ID [1] 0 0
KEYNOTE-581
Secondary ID [2] 0 0
E7080-G000-307
Universal Trial Number (UTN)
Trial acronym
CLEAR
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 - Lenvatinib
Treatment: Drugs - Everolimus
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Sunitinib

Experimental: Lenvatinib 18 mg plus Everolimus 5 mg - Lenvatinib 18 milligrams (mg) administered orally, once daily, plus everolimus 5 mg administered orally, once daily in each 21-day cycle.

Experimental: Lenvatinib 20 mg plus Pembrolizumab 200 mg - Lenvatinib 20 mg administered orally, once daily, in each 21-day cycle plus pembrolizumab 200 mg administered intravenously (IV), every 3 weeks on Day 1 of each 21-day cycle.

Active Comparator: Sunitinib 50 mg - Sunitinib 50 mg administered orally, once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment in each 21-day cycle.


Treatment: Drugs: Lenvatinib


Treatment: Drugs: Everolimus


Treatment: Drugs: Pembrolizumab


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

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS) by Independent Imaging Review (IIR)
Timepoint [1] 0 0
From the date of randomization to the date of the first documentation of PD or date of death, whichever occurred first or up to data cutoff date 28 Aug 2020 (up to approximately 46 months)
Secondary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
Up to approximately 69 months
Secondary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Up to approximately 69 months
Secondary outcome [3] 0 0
Number of Participants With At Least One Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Timepoint [3] 0 0
Up to approximately 69 months
Secondary outcome [4] 0 0
Number of Participants Who Discontinued Treatment Due to Toxicity
Timepoint [4] 0 0
Up to approximately 69 months
Secondary outcome [5] 0 0
Time to Treatment Failure Due to Toxicity
Timepoint [5] 0 0
Up to approximately 69 months
Secondary outcome [6] 0 0
Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores
Timepoint [6] 0 0
Up to approximately 69 months
Secondary outcome [7] 0 0
HRQoL Assessed by European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) Score
Timepoint [7] 0 0
Up to approximately 69 months
Secondary outcome [8] 0 0
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Score
Timepoint [8] 0 0
Up to approximately 69 months
Secondary outcome [9] 0 0
PFS on Next-line of Therapy (PFS2)
Timepoint [9] 0 0
Up to approximately 69 months
Secondary outcome [10] 0 0
PFS by Investigator Assessment
Timepoint [10] 0 0
Up to approximately 69 months
Secondary outcome [11] 0 0
Model-predicted Clearance for Lenvatinib and Everolimus
Timepoint [11] 0 0
Cycles 1 and 2 Day 1; 0.5-4 hours and 6-10 hours postdose; Cycle 1 Day 15: predose and 2-12 hours postdose; Cycles 3, 4, 5 and 6 Day 1: predose (Cycle length=21 days)
Secondary outcome [12] 0 0
Area Under the Plasma Drug Concentration-time Curve (AUC) for Lenvatinib and Everolimus
Timepoint [12] 0 0
Cycles 1 and 2 Day 1; 0.5-4 hours and 6-10 hours postdose; Cycle 1 Day 15: predose and 2-12 hours postdose; Cycles 3, 4, 5 and 6 Day 1: predose (Cycle length = 21 days

Eligibility
Key inclusion criteria
1. Histological or cytological confirmation of RCC with a clear-cell component (original
tissue diagnosis of RCC is acceptable).

2. Documented evidence of advanced RCC.

3. At least 1 measurable target lesion according to RECIST 1.1 meeting the following
criteria:

- Lymph node (LN) lesion that measures at least 1 dimension as greater than or
equal to (>=) 1.5 cm in the short axis

- Lymph node (LN) lesion that measures at least 1 dimension as greater than or
equal to (>=) 1.5 centimeter (cm) in the short axis

- Non-nodal lesion that measures greater than or equal to (>=) 1.0 cm in the
longest diameter

- The lesion is suitable for repeat measurement using computerized
tomography/magnetic resonance imaging (CT/MRI). Lesions that have had external
beam radiotherapy (EBRT) or locoregional therapy must show radiographic evidence
of disease progression based on RECIST 1.1 to be deemed a target lesion.

3.Karnofsky Performance Status (KPS) of >=70 4.Adequately controlled blood pressure (BP)
with or without antihypertensive medications, defined as BP less than or equal (<=) 150/90
millimeter of mercury (mmHg) at Screening and no change in antihypertensive medications
within 1 week prior to Cycle 1/Day 1 (C1/D1) 5.Adequate renal function defined as
creatinine <=1.5*upper limit of normal (ULN); or for participants with creatinine greater
than (>) 1.5*ULN, the calculated creatinine clearance >=30 milliliters per minute (mL/min)
(per the Cockcroft-Gault formula) is acceptable.

6.Adequate bone marrow function defined by:

- Absolute neutrophil count (ANC) >=1500/cubic millimeter (mm^3)

- Platelets >=100,000/mm^3

- Hemoglobin >=9 grams per deciliter (g/dL) NOTE: Criteria must be met without
erythropoietin dependency and without packed red blood cell (pRBC) transfusion within
the previous 2 weeks.

7.Adequate blood coagulation function defined by International Normalized ratio (INR)
<=1.5 unless participant is receiving anticoagulant therapy, as long as INR is within
therapeutic range of intended use of anticoagulants.

8.Adequate liver function defined by:

- Total bilirubin <=1.5*ULN except for unconjugated hyperbilirubinemia of Gilbert's
syndrome.

- Alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate
aminotransferase (AST) <=3*ULN (in the case of liver metastases <=5*ULN), unless there
are bone metastases. Participants with ALP values >3*ULN and known to have bone
metastases can be included.

9.Provide written informed consent. 10.Willing and able to comply with all aspects of
the protocol.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participants who have received any systemic anticancer therapy for RCC, including
anti-vascular endothelial growth factor (VEGF) therapy, or any systemic
investigational anticancer agent. Prior adjuvant treatment with an investigational
anticancer agent is not allowed unless the investigator can provide evidence of
participant's randomization to placebo arm.

2. Participants with central nervous system (CNS) metastases are not eligible, unless
they have completed local therapy (example, whole brain radiation therapy (WBRT),
surgery or radiosurgery) and have discontinued the use of corticosteroids for this
indication for at least 4 weeks before starting treatment in this study. Any signs
(example, radiologic) or symptoms of CNS metastases must be stable for at least 4
weeks before starting study treatment

3. Active malignancy (except for RCC, definitively treated basal or squamous cell
carcinoma of the skin, and carcinoma in-situ of the cervix or bladder) within the past
24 months. Participants with history of localized & low risk prostate cancer are
allowed in the study if they were treated with curative intent and there is no
prostate specific antigen (PSA) recurrence within the past 5 years

4. Prior radiation therapy within 21 days prior to start of study treatment with the
exception of palliative radiotherapy to bone lesions, which is allowed if completed 2
weeks prior to study treatment start

5. Participants who are using other investigational agents or who had received
investigational drugs <=4 weeks prior to study treatment start.

6. Received a live vaccine within 30 days of planned start of study treatment (Cycle
1/Day 1). Examples of live vaccines include, but are not limited to, measles, mumps,
rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus
Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection
are generally killed virus vaccines and are allowed; however, intranasal influenza
vaccines (example, FluMist®) are live attenuated vaccines and are not allowed.

7. Participants with proteinuria >1+ on urine dipstick testing will undergo 24-h urine
collection for quantitative assessment of proteinuria. Participants with urine protein
>=1 g/24 h will be ineligible

8. Fasting total cholesterol >300 milligram per deciliter (mg/dL) (or ?7.75 millimole per
liter (mmol/L)) and/or fasting triglycerides level ?2.5 x upper limit of normal (ULN).
Note: these participants can be included after initiation or adjustment of
lipid-lowering medication

9. Uncontrolled diabetes as defined by fasting glucose >1.5 times the ULN. Note: these
participants can be included after initiation or adjustment of glucose-lowering
medication

10. Prolongation of corrected QT (QTc) interval to >480 milliseconds (ms)

11. Participants who have not recovered adequately from any toxicity and/or complications
from major surgery prior to starting therapy.

12. Gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition
that might affect the absorption of lenvatinib, everolimus, and/or sunitinib.

13. Bleeding or thrombotic disorders or participants at risk for severe hemorrhage. The
degree of tumor invasion/infiltration of major blood vessels should be considered
because of the potential risk of severe hemorrhage associated with tumor
shrinkage/necrosis following lenvatinib therapy

14. Clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first
dose of study drug

15. Significant cardiovascular impairment within 12 months of the first dose of study
drug: history of congestive heart failure greater than New York Heart Association
Class II, unstable angina, myocardial infarction, cerebrovascular accident, or cardiac
arrhythmia associated with hemodynamic instability. The following is also excluded:
left ventricular ejection fraction (LVEF) below the institutional normal range as
determined by multiple-gated acquisition MUGA scan or echocardiogram

16. Active infection (any infection requiring systemic treatment)

17. Participants known to be positive for Human Immunodeficiency Virus (HIV).

18. Known active Hepatitis B (example, Hepatitis B surface antigen (HBsAg) reactive) or
Hepatitis C (example, hepatitis C virus ribonucleic acid (HCV RNA) [qualitative] is
detected)

19. Known history of, or any evidence of, interstitial lung disease

20. Has a history of (non-infectious) pneumonitis that required steroids, or current
pneumonitis

21. Participants with a diagnosis of immunodeficiency or who are receiving chronic
systemic steroid therapy (doses exceeding 10 mg/day of prednisone equivalent) or any
other form of immunosuppressive therapy within 7 days prior to the first dose of study
treatment. Physiologic doses of corticosteroids (up to 10 mg/day of prednisone or
equivalent) may be used during the study

22. Active autoimmune disease (with the exception of psoriasis) that has required systemic
treatment in the past 2 years (that is, with use of disease modifying agents,
corticosteroids or immunosuppressive drugs). Replacement therapy (example, thyroxine,
insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary
insufficiency) is not considered a form of systemic treatment.

23. Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a
positive beta-human chorionic gonadotropin [ß-hCG] (or human chorionic gonadotropin
[hCG]) test with a minimum sensitivity of 25 IU/L or equivalent units of ß-hCG [or
hCG]). A separate baseline assessment is required if a negative screening pregnancy
test was obtained more than 72 hours before the first dose of study drug.

24. Females of childbearing potential who:

- Do not agree to use a highly effective method of contraception for the entire
study period and for 120 days after study discontinuation, that is:

- total abstinence (if it is their preferred and usual lifestyle)

- an intrauterine device (IUD) or hormone-releasing system (IUS)

- a contraceptive implant

- an oral contraceptive (with additional barrier method) OR

- Do not have a vasectomized partner with confirmed azoospermia. For sites outside
of the EU, it is permissible that if a highly effective method of contraception
is not appropriate or acceptable to the participant, then the participant must
agree to use a medically acceptable method of contraception, that is, double
barrier methods of contraception such as condom plus diaphragm or cervical/vault
cap with spermicide.

25. Males who have not had a successful vasectomy (confirmed azoospermia) and do not agree
to use condom + spermicide OR have a female partner who does not meet the criteria
above (that is, is of childbearing potential and not practicing highly effective
contraception throughout the study period), starting with the first dose of study
therapy through 120 days after the last dose of study therapy, unless sexually
abstinent. Note: Abstinence is acceptable if this is the usual lifestyle and preferred
contraception for the participant.

26. Known intolerance to any of the study drugs (or any of the excipients)

27. Participant has had an allogenic tissue/solid organ transplant.

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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/10/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/07/2024
Actual
Sample size
Target
Accrual to date
Final
1069
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Eastern Clinical Research Unit - Box Hill
Recruitment hospital [2] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [3] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [4] 0 0
Macquarie University Hospital - Macquarie park
Recruitment hospital [5] 0 0
ICON Cancer Foundation - South Brisbane
Recruitment hospital [6] 0 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment postcode(s) [3] 0 0
- Hobart
Recruitment postcode(s) [4] 0 0
- Macquarie park
Recruitment postcode(s) [5] 0 0
- South Brisbane
Recruitment postcode(s) [6] 0 0
- St Albans
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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Florida
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United States of America
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Illinois
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Kansas
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Louisiana
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Maryland
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United States of America
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Massachusetts
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Michigan
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United States of America
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Nebraska
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New Jersey
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New York
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North Carolina
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Ohio
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United States of America
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
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Austria
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Innsbruck
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Austria
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Linz
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Austria
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Vienna
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Belgium
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Aalst
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Belgium
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Antwerpen
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Belgium
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Bonheiden
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Belgium
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Bruxelles
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Belgium
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Hasselt
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Belgium
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Liege
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Belgium
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Wilrijk
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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Czechia
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Brno
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Czechia
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Olomouc
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Czechia
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Praha 4
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Czechia
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Praha 5
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Czechia
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Praha 8
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France
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Maine Et Loire
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France
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Dijon cedex
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France
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Le Mans Cedex
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France
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Lyon
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France
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Montpellier
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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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Strasbourg
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Germany
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Baden Wuerttemberg
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Germany
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Bayern
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Germany
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Hessen
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Germany
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Mecklenburg-Vorpommern
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Germany
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Niedersachsen
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Germany
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Nordrhein Westfalen
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Germany
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Saarland
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Germany
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Berlin
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Greece
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Athens
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Greece
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Patras
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Greece
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Thessaloníki
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Ireland
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Cork
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Dublin
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Ireland
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Galway
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Israel
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Be'er Ya'aqov
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Israel
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Haifa
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Israel
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Kfar-Saba
Country [61] 0 0
Israel
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Petah Tikva
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Israel
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Ramat-Gan
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Israel
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Tel Aviv
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Italy
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Ravenna
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Italy
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Arezzo
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Italy
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Bologna
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Italy
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Genova
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Italy
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Lecce
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Italy
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Meldola
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Italy
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Milano
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Italy
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Modena
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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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Pordenone
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Italy
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Roma
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Italy
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Rome
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Japan
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Aichi
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Japan
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Akita
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Japan
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Aomori
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Japan
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Chiba
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Japan
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Fukuoka
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Hiroshima
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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Kagawa
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Japan
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Kanagawa
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Japan
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Nagasaki
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Japan
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Nara
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Japan
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Niigata
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Japan
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Okayama
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Japan
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Osaka
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Japan
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Saitama
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Japan
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Tokushima
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Japan
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Tokyo
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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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Netherlands
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Amsterdam
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Netherlands
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Utrecht
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Poland
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Gdansk
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Poland
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Lublin
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Poland
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Szczecin
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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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Novosibirsk
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Russian Federation
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Obninsk
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Russian Federation
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Omsk
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Spain
State/province [108] 0 0
Cantabria
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Spain
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Barcelona
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Spain
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Caceres
Country [111] 0 0
Spain
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Cordoba
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Spain
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Madrid
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Spain
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Oviedo
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Spain
State/province [114] 0 0
Seville
Country [115] 0 0
Spain
State/province [115] 0 0
Valencia
Country [116] 0 0
Switzerland
State/province [116] 0 0
Bern
Country [117] 0 0
United Kingdom
State/province [117] 0 0
Bournemouth
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Cardiff
Country [119] 0 0
United Kingdom
State/province [119] 0 0
Edinburgh
Country [120] 0 0
United Kingdom
State/province [120] 0 0
Glasgow
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United Kingdom
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Leeds
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United Kingdom
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London
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United Kingdom
State/province [123] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eisai Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The primary purpose of the study is to demonstrate that lenvatinib in combination with
everolimus (Arm A) or pembrolizumab (Arm B) is superior compared to sunitinib alone (Arm C)
in improving progression-free survival (PFS) (by independent imaging review [IIR] using
Response Evaluation Criteria in Solid Tumors [RECIST 1.1]) as first-line treatment in
participants with advanced renal cell carcinoma (RCC).
Trial website
https://clinicaltrials.gov/ct2/show/NCT02811861
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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