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Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma
Sponsor: Eisai Inc.
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).
Official 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1069
Start Date
2016-10-13
Completion Date
2027-03-31
Last Updated
2026-02-23
Healthy Volunteers
No
Conditions
Interventions
Lenvatinib
Everolimus
Pembrolizumab
Sunitinib
Locations (183)
Stanford School of Medicine
Stanford, California, United States
Boca Raton Community Hospital
Boca Raton, Florida, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
University of Miami
Miami, Florida, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
Florida Hospital Cancer Institute
Orlando, Florida, United States
Florida Cancer Specialists ( North Region)
St. Petersburg, Florida, United States
Florida Cancer Specialists
West Palm Beach, Florida, United States
Joliet Oncology - Hematology Associates
Joliet, Illinois, United States
Healthcare Research Network III, LLC
Tinley Park, Illinois, United States
Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC
Overland Park, Kansas, United States
Cotton-Oneil Clinical Research Center
Topeka, Kansas, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Associates in Oncology & Hematology, PC
Bethesda, Maryland, United States
Massachusetts General Hospital- MGH
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Karmanos Cancer Center
Detroit, Michigan, United States
GU Research Network
Omaha, Nebraska, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
Hackensack Medical Center
Hackensack, New Jersey, United States
Rosewell Park Cancer Institute
Buffalo, New York, United States
Broome Oncology
Johnson City, New York, United States
Weill Cornell Medical College New York Presbyterian Hospital
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Mission Hospital_ Cancer Care of Western North Carolina
Asheville, North Carolina, United States
Oncology Hematology Care
Cincinnati, Ohio, United States
Medical University of South Carolina
Charleston, South Carolina, United States
SCRI - Tennessee Oncology
Nashville, Tennessee, United States
Texas Oncology, P.A.
Dallas, Texas, United States
Texas Oncology PA
Fort Worth, Texas, United States
Texas Oncology PA - McAllen
McAllen, Texas, United States
Texas Oncology PA - Paris
Paris, Texas, United States
USOR Texas Oncology
The Woodlands, Texas, United States
Texas Oncology PA - Tyler
Tyler, Texas, United States
Box Hill Hospital
Box Hill, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Royal Hobart Hospital
Hobart, Australia
Macquarie University Hospital
Macquarie Park, Australia
ICON Cancer Foundation
South Brisbane, Australia
Sunshine Hospital
St Albans, Australia
Medizinische Universitat Innsbruck
Innsbruck, Austria
Krankenhaus der barmherzigen Schwestern Linz
Linz, Austria
AKH - Medizinische Universität Wien
Vienna, Austria
O.L.V Ziekenhuis
Aalst, Belgium
ZNA Middelheim
Antwerp, Belgium
Imeldaziekenhuis
Bonheiden, Belgium
Institut Jules Bordet
Brussels, Belgium
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt, Belgium
Domaine Universitaire
Liège, Belgium
GZA Ziekenhuizen - Campus Sint-Augustinus
Wilrijk, Belgium
Cross Cancer Institute
Edmonton, Alberta, Canada
BC Cancer Agency Vancouver Centre
Vancouver, British Columbia, Canada
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
London Institute of Health Sciences
London, Ontario, Canada
Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Sunnybrook Research Institute - University of Toronto
Toronto, Ontario, Canada
Centre de santé et de services sociaux Champlain-Charles-Le Moyne
Greenfield Park, Quebec, Canada
Fakultni nemocnice u sv. Anny v Brne
Brno, Czechia
Masarykuv onkologicky ustav
Brno, Czechia
Fakultni nemocnice Olomouc, Neurologicka klinika
Olomouc, Czechia
Fakultni nemocnice v Motole
Prague, Czechia
Nemocnice Na Bulovce
Prague, Czechia
Thomayerova nemocnice
Prague, Czechia
ICO - Site Paul Papin
Angers, Maine Et Loire, France
Centre Georges François Leclerc
Dijon, France
Clinique Victor Hugo - Centre Jean Bernard
Le Mans, France
Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes
Lyon, France
Institut Regional du Cancer de Montpellier
Montpellier, France
Hopital la Petie Salpetriere
Paris, France
Hopital Europeen Georges Pompidou
Paris, France
Boulevard du Professeur Jacques Monod
Saint-Herblain, France
CHU Strasbourg - Nouvel Hopital Civil
Strasbourg, France
EISAI Trial site 4
Stuttgart, Baden-Wurttemberg, Germany
EISAI Trial site 1
Tübingen, Baden-Wurttemberg, Germany
EISAI Trial site 7
München, Bavaria, Germany
EISAI Trial site 6
Frankfurt am Main, Hesse, Germany
EISAI Trial site 8
Hanover, Lower Saxony, Germany
EISAI Trial site 14
Greifswald, Mecklenburg-Vorpommern, Germany
EISAI Trial site 13
Münster, North Rhine-Westphalia, Germany
EISAI Trial site 2
Homburg/Saar, Saarland, Germany
EISAI Trial site 5
Berlin, Germany
General Hospital of Athens "Alexandra"
Athens, Greece
University of Patras Medical School
Pátrai, Greece
General Hospital Papageorgiou
Thessaloniki, Greece
Interbalkan Hospital of Thessaloniki
Thessaloniki, Greece
Cork University Hospital,Wilton
Cork, Ireland
Adelaide and Meath Hospital Incorp The National Children's Hospital
Dublin, Ireland
Beaumont Hospital
Dublin, Ireland
University Hospital Galway
Galway, Ireland
Assaf Harofeh Medical Center
Be’er Ya‘aqov, Israel
Rambam MC
Haifa, Israel
Sapir Medical Center, Meir Hospital
Kfar Saba, Israel
Rabin Medical Center-Beilinson Campus
Petah Tikva, Israel
Chaim Sheba Medical Center
Ramat Gan, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Azienda Unità Sanitaria Locale- Ravenna
Faenza, Ravenna, Italy
Ospedale San Donato
Arezzo, Italy
Azienda Ospedaliera Universitaria Policlinico SantOrsola Malpighi
Bologna, Italy
Istituto Nazionale per la Ricerca sul Cancro di Genova
Genova, Italy
Presidio Ospedaliero Vito Fazzi
Lecce, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST
Meldola, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
A.O.U. Policlinico di Modena
Modena, Italy
Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli
Naples, Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Naples, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
I.R.C.S.S Fondazione Maugeri
Pavia, Italy
Azienda Ospedaliera Santa Maria Degli Angeli
Pordenone, Italy
Azienda Ospedaliera San Camillo Forlanini
Roma, Italy
Universita Campus Bio-Medico di Roma
Rome, Italy
Facility #1
Aichi, Japan
Facility #1
Akita, Japan
Facility #1
Aomori, Japan
Facility #2
Chiba, Japan
Facility #1
Fukuoka, Japan
Facility #1
Hiroshima, Japan
Facility #1
Hokkaido, Japan
Facility #2
Hokkaido, Japan
Facility #1
Hyōgo, Japan
Facility #1
Kagawa, Japan
Facility #2
Kanagawa, Japan
Facility #3
Kanagawa, Japan
Facility #1
Nagasaki, Japan
Facility #1
Nara, Japan
Facility #1
Niigata, Japan
Facility #1
Okayama, Japan
Facility #1
Osaka, Japan
Facility #2
Osaka, Japan
Facility #1
Saitama, Japan
Facility #1
Tokushima, Japan
Facility #1
Tokyo, Japan
Facility #2
Tokyo, Japan
Facility #3
Tokyo, Japan
Facility #4
Tokyo, Japan
Facility #5
Tokyo, Japan
Facility #6
Tokyo, Japan
Antoni van Leeuwenhoek
Amsterdam, Netherlands
VU Medisch Centrum
Amsterdam, Netherlands
UMC Utrecht
Utrecht, Netherlands
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Lublin, Poland
SPWSZ w Szczecinie im. Marii Sklodowskiej-Curie
Szczecin, Poland
FSBSI Russian Oncological Scientific Center n.a. N.N. Blokhin - Department of Oncology
Moscow, Russia
FSBI "Moscow scientific research oncology institute n.a. P.A. Gertsen" of MoH of RF
Moscow, Russia
FSBSI Russian Oncological Scientific Center n.a. N.N. Blokhin - Department of Urology
Moscow, Russia
FBHI Privolzhskiy District Medical Centre FMBA of Russia
Nizhny Novgorod, Russia
SBHI of Novosibirsk region "Novosibirsk Regional Oncological Dispensary"
Novosibirsk, Russia
FSBI "National Medical Research Radiological Center" of the MoH of the RF
Obninsk, Russia
BHI of Omsk region "Clinical Oncology Dispensary"
Omsk, Russia
Kyungpook National University Chilgok Hospital
Daegu, South Korea
National Cancer Center
Goyang-si, South Korea
Asan Medical Center: Medical Oncology Department
Seoul, South Korea
Asan Medical Center: Urology Department
Seoul, South Korea
Department of Internal Medicine Division of Hematology/Oncology Cancer center 11F
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain
ICO l'Hospitalet - Hospital Duran I Reynals
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital San Pedro de Alcantara
Cáceres, Spain
Hospital Universitario Reina Sofia
Córdoba, Spain
Hospital Universitario Ramon y Cajal
Madrid, Spain
Hospital General Universitario Gregorio Maranon
Madrid, Spain
Hospital Universitario Clinico San Carlos
Madrid, Spain
Hospital Universitario HM Madrid Sanchinarro
Madrid, Spain
MD Anderson Cancer Centre
Madrid, Spain
Hospital Universitario Central de Asturias
Oviedo, Spain
Hospital Universitario Virgen del Rocio
Seville, Spain
Oncologia
Valencia, Spain
Inselspital - Universitaetsspital Bern
Bern, Switzerland
Royal Bournemouth General Hospital
Bournemouth, United Kingdom
Velindre Cancer Centre
Cardiff, United Kingdom
Western General Hospital
Edinburgh, United Kingdom
Beatson West Of Scotland Cancer Centre
Glasgow, United Kingdom
St. James's University Hospital
Leeds, United Kingdom
Guy's Hospital
London, United Kingdom
Royal Free Hospital
London, United Kingdom
Christie Hospital NHS Foundation Trust
Manchester, United Kingdom