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ACTIVE NOT RECRUITING
NCT02811861
PHASE3

Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma

Sponsor: Eisai Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

Lenvatinib

DRUG

Everolimus

DRUG

Pembrolizumab

DRUG

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