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)


Condition: Renal Cell Carcinoma

Intervention:

  • Drug: lenvatinib
  • Drug: everolimus
  • Drug: pembrolizumab
  • Drug: Sunitinib

Purpose: This is a multicenter, randomized, open-label, Phase 3 study to compare the efficacy and safety of lenvatinib in combination with everolimus (Arm A) or pembrolizumab (Arm B) versus sunitinib (Arm C) as first-line treatment in participants with advanced renal cell carcinoma.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02811861

Sponsor: Eisai Inc.

Primary Outcome Measures:

  • Measure: Progression-free survival (PFS) by independent review
  • Time Frame: up to 43 months approximately
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Objective response rate (ORR)
  • Time Frame: up to approximately 53 months
  • Safety Issue:
  • Measure: Overall survival (OS)
  • Time Frame: up to approximately 53 months
  • Safety Issue:
  • Measure: Number of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
  • Time Frame: up to approximately 53 months
  • Safety Issue:
  • Measure: Number of participants who discontinued treatment due to toxicity
  • Time Frame: up to approximately 53 months
  • Safety Issue:
  • Measure: Time to treatment failure due to toxicity
  • Time Frame: up to approximately 53 months
  • Safety Issue:
  • Measure: Health-Related Quality of Life (HRQoL) scores
  • Time Frame: up to approximately 53 months
  • Safety Issue:
  • Measure: PFS on next-line of therapy (PFS2)
  • Time Frame: up to approximately 53 months
  • Safety Issue:
  • Measure: PFS by investigator assessment
  • Time Frame: up to 53 Months approximately
  • Safety Issue:
  • Measure: Model-predicted clearance for lenvatinib and everolimus
  • Time Frame: 0.5-4 hours (h) and 6-10 h postdose on Cycle 1 Day 1; predose and 2-12 h postdose on Cycle 1 Day 15; predose and 0.5-4 h and 6-10 h postdose on Cycle 2 Day 1; predose on Day 1 of Cycles 3, 4, 5, and 6
  • Safety Issue:
  • Measure: AUC for lenvatinib and everolimus
  • Time Frame: 0.5-4 h and 6-10 h postdose on Cycle 1 Day 1; predose and 2-12 h postdose on Cycle 1 Day 15; predose and 0.5-4 h and 6-10 h postdose on Cycle 2 Day 1; predose on Day 1 of Cycles 3, 4, 5, and 6
  • Safety Issue:

Estimated Enrollment: 1050

Study Start Date: October 13, 2016

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Histological or cytological confirmation of renal cell carcinoma (RCC) with a clear-cell component
  • At least 1 measurable target lesion according to Response Evaluation in Solid Tumors (RECIST) 1.1
  • Karnofsky Performance Status (KPS) of ≥70
  • Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150/90 mmHg at Screening and no change in antihypertensive medications within 1 week prior to Cycle 1/Day 1 (C1/D1)
  • Adequate organ function per blood work

Exclusion Criteria:

  • Participants who have received any systemic anticancer therapy for RCC, including anti-vascular endothelial growth factor (VEGF) therapy, or any systemic investigational anticancer agent
  • Participants with central nervous system (CNS) metastases are not eligible, unless they have completed local therapy (eg, 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 (eg, radiologic) or symptoms of CNS metastases must be stable for at least 4 weeks before starting study treatment
  • 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
  • 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
  • Received a live vaccine within 30 days of planned start of study treatment
  • Participants with urine protein ≥1 gram/24 hour
  • 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
  • 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
  • Prolongation of corrected QT (QTc) interval to >480 milliseconds (ms)
  • 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
  • Clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study drug
  • 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 below the institutional normal range as determined by multiple-gated acquisition scan or echocardiogram
  • Active infection (any infection requiring systemic treatment)
  • Participants known to be positive for Human Immunodeficiency Virus (HIV).
  • Known active Hepatitis B (eg, Hepatitis B surface antigen (HBsAg) reactive) or Hepatitis C (eg, hepatitis C virus ribonucleic acid (HCV RNA) [qualitative] is detected)
  • Known history of, or any evidence of, interstitial lung disease
  • Has a history of (non-infectious) pneumonitis that required steroids, or current pneumonitis
  • 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
  • Active autoimmune disease (with the exception of psoriasis) that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
  • Known intolerance to any of the study drugs (or any of the excipients)
  • Participant has had an allogenic tissue/solid organ transplant.

Contact:

  • Eisai Medical Information
  • 1-888-274-2378

Locations:

  • Stanford University Medical Center
  • Palo Alto California 94305 United States
  • Stanford School of Medicine
  • Stanford California 94305-5826 United States
  • Yale University
  • New Haven Connecticut 06520 United States
  • Boca Raton Community Hospital
  • Boca Raton Florida 33486 United States
  • Florida Cancer Specialists
  • Fort Myers Florida 33901 United States
  • Mount Sinai Medical Center
  • Miami Beach Florida 33136 United States
  • Mount Sinai Medical Center
  • Miami Beach Florida 33140 United States
  • University of Miami
  • Miami Florida 33136-1002 United States
  • University of Miami
  • Miami Florida 33136 United States
  • Florida Hospital Cancer Institute
  • Orlando Florida 32804 United States
  • Florida Cancer Specialists ( North Region)
  • Saint Petersburg Florida 33705 United States
  • Florida Cancer Specialists
  • West Palm Beach Florida 33401 United States
  • Columbus Regional Research Institute
  • Columbus Georgia 31904 United States
  • Cancer Center of Middle Georgia
  • Dublin Georgia 31021 United States
  • Joliet Oncology - Hematology Associates
  • Joliet Illinois 60435 United States
  • Joliet Oncology-Hematology Associates, LTD
  • Joliet Illinois 60435 United States
  • Illinois Cancer Specialists
  • Niles Illinois 60714 United States
  • Healthcare Research Network III, LLC
  • Tinley Park Illinois 60487 United States
  • Healthcare Research Network LLC
  • Tinley Park Illinois 60487 United States
  • Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC
  • Overland Park Kansas 66209 United States
  • SCRI - Tennessee Oncology
  • Overland Park Kansas 66209 United States
  • Cotton-O'Neil Clinical Research Center, Hematology and Oncology
  • Topeka Kansas 66604 United States
  • Cotton-Oneil Clinical Research Center
  • Topeka Kansas 66604 United States
  • Ochsner Clinic Foundation
  • New Orleans Louisiana 70121 United States
  • Associates in Oncology & Hematology, PC
  • Bethesda Maryland 20817 United States
  • Associates in Oncology & Hematology
  • Rockville Maryland 20817 United States
  • Dana Farber Cancer Institute
  • Boston Massachusetts 02114 United States
  • Massachusetts General Hospital- MGH
  • Boston Massachusetts 02214 United States
  • Dana Farber Cancer Institute
  • Boston Massachusetts 02215 United States
  • Karmanos Cancer Center
  • Detroit Michigan 48201 United States
  • Minnesote Oncology Hematology, P.A
  • Minneapolis Minnesota 55404 United States
  • GU Research Network
  • Omaha Nebraska 68130 United States
  • Nebraska Cancer Specialists
  • Omaha Nebraska 68130 United States
  • Cooper Research Institute
  • Camden New Jersey 08103 United States
  • Hackensack Medical Center
  • Hackensack New Jersey 07601 United States
  • Hackensack University Medical Center PARTNER
  • Hackensack New Jersey 07601 United States
  • Montefiore Medical Center PRIME
  • Bronx New York 10461 United States
  • Montefiore Medical Center
  • Bronx New York 10461 United States
  • Roswell Park Cancer Institute
  • Buffalo New York 14263-0001 United States
  • Rosewell Park Cancer Institute
  • Buffalo New York 14263 United States
  • Broome Oncology, LLC
  • Johnson City New York 13790 United States
  • Broome Oncology
  • Johnson City New York 13790 United States
  • Weill Cornell Medical College New York Presbyterian Hospital
  • New York New York 10021 United States
  • MSKCC
  • New York New York 10065-6007 United States
  • Memorial Sloan Kettering Cancer Center
  • New York New York 10065 United States
  • Mission Hospital_ Cancer Care of Western North Carolina
  • Asheville North Carolina 28801 United States
  • Oncology Hematology Care
  • Cincinnati Ohio 45242 United States
  • Mid Ohio Oncology Hematology, Inc
  • Columbus Ohio 43219 United States
  • Providence Cancer Center
  • Portland Oregon 97213 United States
  • Providence Portland Medical Center
  • Portland Oregon 97213 United States
  • Medical University of South Carolina
  • Charleston South Carolina 29412 United States
  • Medical University of South Carolina (MUSC)
  • Charleston South Carolina 29425 United States
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  • Nashville Tennessee 37203 United States
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  • Dallas Texas 75231 United States
  • Texas Oncology PA
  • Fort Worth Texas 76104 United States
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  • Houston Texas 75231 United States
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  • McAllen Texas 78503-1298 United States
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  • McAllen Texas 78503 United States
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  • Paris Texas 75460 United States
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  • Paris Texas 75460 United States
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  • Tyler Texas 75702 United States
  • Texas Oncology, P.A. - Tyler
  • Tyler Texas 75702 United States
  • Wenatchee Valley Hospital & Clinics
  • Wenatchee Washington 98801 United States
  • 3 Technology Place
  • North Ryde New South Wales 2109 Australia
  • 48 Liverpool Street
  • Hobart Tasmania 7000 Australia
  • Level 2, 5 Arnold Street, Eastern Clinical Research Unit
  • Box Hill Victoria 3128 Australia
  • 145 Studley Road, Heidelberg, Victoria, 3084
  • Heidelberg Victoria 3084 Australia
  • 176 Furlong Road
  • St Albans Victoria 3021 Australia
  • Box Hill Hospital
  • Box Hill Australia
  • 956 Gympie Road, Chermside Medical Complex, Level 1
  • Chermside Australia
  • Austin Health
  • Heidelberg Australia
  • Royal Hobart Hospital
  • Hobart Australia
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  • South Brisbane Australia
  • Sunshine Hospital
  • St Albans Australia
  • Anichstraße 35
  • Innsbruck 6020 Austria
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  • Lyon France
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  • Institut Regional du Cancer de Montpellier
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  • Paris France
  • Boulevard du Professeur Jacques Monod
  • Saint Herblain 4805 France
  • 1 Place de l Hopital
  • Strasbourg 67091 France
  • CHU Strasbourg - Nouvel Hopital Civil
  • Strasbourg France
  • 1 Avenue Irène Joliot-Curie
  • Toulouse 31059 France
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  • Berlin 12200 Germany
  • Medizinische Klinik III, , Fetscherstrasse 74
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  • Frankfurt 60590 Germany
  • Carl-Neuberg-Strasse 1
  • Hannover 30625 Germany
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  • Homburg/saar 66424 Germany
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  • Luebeck 23538 Germany
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  • Muenchen 81377 Germany
  • Kriegsbergstrasse 60
  • Stuttgart 70174 Germany
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  • Tuebingen 72076 Germany
  • Wilton
  • Cork Ireland
  • P O Box 1297, Dublin, 9
  • Dublin 1297 Ireland
  • Cookstown Way, Dublin, 24
  • Dublin 24 Ireland
  • Adelaide and Meath Hospital Incorp The National Children's Hospital
  • Dublin Ireland
  • Beaumont Hospital
  • Dublin Ireland
  • Newcastle Road
  • Galway 0000 Ireland
  • University Hospital Galway
  • Galway Ireland
  • Zerifin
  • Be'er Ya'aqov 70300 Israel
  • 8 Haaliyya St., Bat Galim
  • Haifa 3109601 Israel
  • Rambam MC
  • Haifa Israel
  • Kiryat Hadassah
  • Jerusalem, 9112001 Israel
  • Hadassah University Hospital - Ein Kerem
  • Jerusalem Israel
  • 59 Tshernichovski St
  • Kfar-Saba 4428164 Israel
  • Sapir Medical Center, Meir Hospital
  • Kfar-Saba Israel
  • Rabin Medical Center
  • Petah Tikva 49100 Israel
  • Rabin MC
  • Petah Tikva Israel
  • Tel Hashomer
  • Ramat Gan 5265601 Israel
  • Chaim Sheba Medical Center
  • Ramat-Gan Israel
  • Assaf Harofeh
  • Rishon Lezion Israel
  • 6 Weizmann St
  • Tel Aviv 64239 Israel
  • Tel Aviv Sourasky Medical Center
  • Tel Aviv Israel
  • Via Pietro Nenni, 1
  • Arezzo 52100 Italy
  • Ospedale San Donato- ASL 8 Arezzo
  • Arezzo Italy
  • Viale Ercolani 4/2
  • Bologna 40138 Italy
  • Azienda Ospedaliera Universitaria Policlinico SantOrsola Malpighi
  • Bologna Italy
  • Viale Stradone, 9
  • Faenza 48018 Italy
  • Largo Rosanna Benzi 10
  • Genova 16132 Italy
  • Piazza F. Muratore
  • Lecce 73100 Italy
  • Via P. Maroncelli, 40
  • Meldola 47014 Italy
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST
  • Meldola Italy
  • Via Olgettina, 60
  • Milano 20132 Italy
  • Via del Pozzo
  • Modena 71 Italy
  • Via A. Cardarell. 9
  • Napoli , 80131 Italy
  • Via Mariano Semmola 3
  • Napoli 80131 Italy
  • Istituto Nazionale Tumori Fondazione G. Pascale
  • Napoli Italy
  • UOC Farmacia,Via Gattamelata, 64
  • Padova 35128 Italy
  • Viale Camillo Golgi 19
  • Pavia 27100 Italy
  • Fondazione IRCCS Policlinico San Matteo
  • Pavia Italy
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  • Pordenone 33170 Italy
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  • Ravenna Italy
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  • Roma 00128 Italy
  • Circonvallazione Gianicolense, 87
  • Roma 00152 Italy
  • Azienda Ospedaliera San Camillo Forlanini
  • Roma Italy
  • Universita Campus Bio-Medico di Roma
  • Rome Italy
  • Facility #1
  • Aichi Japan
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  • Aichi Japan
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  • Akita Japan
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  • Tokyo Japan
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  • Tokyo Japan
  • 323, Ilsan-ro
  • Goyang-si Ilsandong-gu 0408 Korea, Republic of
  • National Cancer Center
  • Goyang-si Korea, Republic of
  • 82 Gumi-ro 173beon-gil Bundang-gu
  • Seongnam-si 13620 Korea, Republic of
  • Seoul National University Bundang Hospital
  • Seongnam-si Korea, Republic of
  • 101 Daehak-ro, Jongno-gu
  • Seoul 03080 Korea, Republic of
  • 50-1, Yonsei-ro, Seodaemun-gu,
  • Seoul 03722 Korea, Republic of
  • 88, Olympic-ro 43-gil
  • Seoul 05505 Korea, Republic of
  • 81, Irwon-ro, Gangnam-gu
  • Seoul 06351 Korea, Republic of
  • 81, Irwon-ro
  • Seoul 06351 Korea, Republic of
  • 222 Banpo-Daero, Seocho-gu,
  • Seoul 06591 Korea, Republic of
  • Asan Medical Center: Medical Oncology Department
  • Seoul Korea, Republic of
  • Asan Medical Center: Urology Department
  • Seoul Korea, Republic of
  • Samsung Medical Center: Medical Oncology Department
  • Seoul Korea, Republic of
  • Samsung Medical Center: Urology Department
  • Seoul Korea, Republic of
  • Seoul National University Hospital
  • Seoul Korea, Republic of
  • Severance Hospital, Yonsei University Health System
  • Seoul Korea, Republic of
  • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Seoul Korea, Republic of
  • Uniwersyteckie Centrum Kliniczne
  • Gdansk Poland
  • Uniwersyteckie Centrum Kliniczne
  • Gdańsk 80-952 Poland
  • Instytut MSF Sp. o.o
  • Lodz Poland
  • ul Jaczewskiego 8
  • Lublin 20-954 Poland
  • Dr n med. Slawomir Mandziuk Specjalistyczna Praktyka Lekarska
  • Lublin Poland
  • Szamarzewskiego 82/84
  • Poznan 60-569 Poland
  • Samodzielny Publiczny Szpital Kliniczny Nr 2 Pum W Szczecinie
  • Szczecin 71-455 Poland
  • SPWSZ w Szczecinie im. Marii Sklodowskiej-Curie
  • Szczecin Poland
  • Centrum Onkologii Instytut Im. Marii Sklodowskiej-Curie
  • Warszawa 02-781 Poland
  • ul. Szaserow 128,
  • Warszawa 04-141 Poland
  • ul. Pabianicka 62, Lodz, 93-513
  • Łódź Poland
  • 24, Kashirskoe shosse
  • Moscow 115478 Russian Federation
  • 2, Plakhotnogo str.
  • Moscow 11919 Russian Federation
  • 3, 2nd Botkinsky proezd
  • Moscow 125284 Russian Federation
  • FSBI Moscow scientific research oncology institute n.a. P.A. Gertsen of MoH of RF
  • Moscow Russian Federation
  • FSBSI Russian Oncological Scientific Center n.a. N.N. Blokhin
  • Moscow Russian Federation
  • Reshetnikovskaya street, 2
  • Nizhniy Novgorod 603006 Russian Federation
  • FBHI Privolzhskiy District Medical Centre FMBA of Russia
  • Nizhniy Novgorod Russian Federation
  • Koroleva str., 4
  • Obninsk 249036 Russian Federation
  • 9/1, Zavertyaeva str.
  • Omsk Russian Federation
  • 32, Barnaulskaya str., Tyumen, 625041
  • Tyumen 625041 Russian Federation
  • Medicinskiy gorod
  • Tyumen Russian Federation
  • Passeig Vall d'Hebron, 119-129, Vall d'Hebron University Hospital
  • Barcelona 08035 Spain
  • Hospital Clinic I Provincial
  • Barcelona 08036 Spain
  • Medical Oncology Department
  • Barcelona 08041 Spain
  • Hospital Clinic i Provincial de Barcelona
  • Barcelona Spain
  • Hospital de la Santa Creu i Sant Pau
  • Barcelona Spain
  • Hospital Universitari Vall d'Hebron
  • Barcelona Spain
  • Avda Pablo Naranjo s/n
  • Caceres 10003 Spain
  • Hospital San Pedro de Alcantara
  • Caceres Spain
  • Hospital Universitario Reina Sofia
  • Cordoba Spain
  • Hospital Universitario Reina Sofia
  • Córdoba 14004 Spain
  • Avinguda Gran Via de l'Hospitalet, 199-203
  • L'Hospitalet de Llobregat, 08908 Spain
  • ICO l'Hospitalet - Hospital Duran I Reynals
  • L'Hospitalet de Llobregat Spain
  • Dr Esquerdo 46
  • Madrid 28007 Spain
  • Oña, 10
  • Madrid 28034 Spain
  • Servicio Oncologia Médica - planta -2 derecha- Oficina ensayos clínicos
  • Madrid 28034 Spain
  • Calle del Profesor Martin Lagos s/n
  • Madrid 28040 Spain
  • Hospital General Universitario Gregorio Maranon
  • Madrid Spain
  • Hospital Universitario Clinico San Carlos
  • Madrid Spain
  • Hospital Universitario HM Madrid Sanchinarro
  • Madrid Spain
  • Hospital Universitario Ramon y Cajal
  • Madrid Spain
  • MD Anderson Cancer Centre
  • Madrid Spain
  • Avenida de Roma, s/n
  • Oviedo 33011 Spain
  • Hospital Universitario Central de Asturias
  • Oviedo Spain
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  • Pamplona Spain
  • Clinica Universidad de Navarra
  • Pamplona Spain
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  • Sevilla 41013 Spain
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  • Seville Spain
  • Prof. Beltran Baguena
  • Valencia 46009 Spain
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  • Valencia Spain
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  • Bern Switzerland
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  • Winterthur, 8401 Switzerland
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  • Winterthur Switzerland
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  • Bebington Ch63 4JY United Kingdom
  • Castle Lane East
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  • Edinburgh EH4 2XU United Kingdom
  • Western General Hospital
  • Edinburgh United Kingdom
  • Beatson West Of Scotland Cancer Centre
  • Glasgow G12 0YN United Kingdom
  • Beatson West of Scotland Cancer Centre
  • Glasgow United Kingdom
  • St. James's University Hospital
  • Leeds LS9 7TF United Kingdom
  • 7th Floor, Gloucester House
  • London EC1A 7BE United Kingdom
  • 5 St Thomas Street
  • London SE1 9RT United Kingdom
  • Fulham Road
  • London SW3 6IJ United Kingdom
  • Guy's Hospital
  • London United Kingdom
  • Royal Free Hospital
  • London United Kingdom
  • Christie Hospital NHS Foundation Trust
  • Manchester M20 4BX United Kingdom

View trial on ClinicalTrials.gov


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