Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma
NCT ID: NCT02811861
Last Updated: 2026-01-08
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
PHASE3
Total Enrollment
1069 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-10-13
Study Completion Date
2026-03-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Renal Cell Carcinoma
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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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.
Group Type
EXPERIMENTAL
Lenvatinib
Intervention Type
DRUG
Everolimus
Intervention Type
DRUG
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.
Group Type
EXPERIMENTAL
Lenvatinib
Intervention Type
DRUG
Pembrolizumab
Intervention Type
DRUG
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.
Group Type
ACTIVE_COMPARATOR
Sunitinib
Intervention Type
DRUG
Interventions
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Lenvatinib
Intervention Type
DRUG
Everolimus
Intervention Type
DRUG
Pembrolizumab
Intervention Type
DRUG
Sunitinib
Intervention Type
DRUG
Eligibility Criteria
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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.
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.
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.
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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Sponsor Role
collaborator
Eisai Inc.
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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Stanford School of Medicine
Stanford, California, United States
Site Status
Boca Raton Community Hospital
Boca Raton, Florida, United States
Site Status
Florida Cancer Specialists
Fort Myers, Florida, United States
Site Status
University of Miami
Miami, Florida, United States
Site Status
Mount Sinai Medical Center
Miami Beach, Florida, United States
Site Status
Florida Hospital Cancer Institute
Orlando, Florida, United States
Site Status
Florida Cancer Specialists ( North Region)
St. Petersburg, Florida, United States
Site Status
Florida Cancer Specialists
West Palm Beach, Florida, United States
Site Status
Joliet Oncology - Hematology Associates
Joliet, Illinois, United States
Site Status
Healthcare Research Network III, LLC
Tinley Park, Illinois, United States
Site Status
Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC
Overland Park, Kansas, United States
Site Status
Cotton-Oneil Clinical Research Center
Topeka, Kansas, United States
Site Status
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Site Status
Associates in Oncology & Hematology, PC
Bethesda, Maryland, United States
Site Status
Massachusetts General Hospital- MGH
Boston, Massachusetts, United States
Site Status
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Site Status
Karmanos Cancer Center
Detroit, Michigan, United States
Site Status
GU Research Network
Omaha, Nebraska, United States
Site Status
Nebraska Cancer Specialists
Omaha, Nebraska, United States
Site Status
Hackensack Medical Center
Hackensack, New Jersey, United States
Site Status
Rosewell Park Cancer Institute
Buffalo, New York, United States
Site Status
Broome Oncology
Johnson City, New York, United States
Site Status
Weill Cornell Medical College New York Presbyterian Hospital
New York, New York, United States
Site Status
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Site Status
Montefiore Medical Center
The Bronx, New York, United States
Site Status
Mission Hospital_ Cancer Care of Western North Carolina
Asheville, North Carolina, United States
Site Status
Oncology Hematology Care
Cincinnati, Ohio, United States
Site Status
Medical University of South Carolina
Charleston, South Carolina, United States
Site Status
SCRI - Tennessee Oncology
Nashville, Tennessee, United States
Site Status
Texas Oncology, P.A.
Dallas, Texas, United States
Site Status
Texas Oncology PA
Fort Worth, Texas, United States
Site Status
Texas Oncology PA - McAllen
McAllen, Texas, United States
Site Status
Texas Oncology PA - Paris
Paris, Texas, United States
Site Status
USOR Texas Oncology
The Woodlands, Texas, United States
Site Status
Texas Oncology PA - Tyler
Tyler, Texas, United States
Site Status
Box Hill Hospital
Box Hill, Victoria, Australia
Site Status
Austin Health
Heidelberg, Victoria, Australia
Site Status
Royal Hobart Hospital
Hobart, , Australia
Site Status
Macquarie University Hospital
Macquarie Park, , Australia
Site Status
ICON Cancer Foundation
South Brisbane, , Australia
Site Status
Sunshine Hospital
St Albans, , Australia
Site Status
Medizinische Universitat Innsbruck
Innsbruck, , Austria
Site Status
Krankenhaus der barmherzigen Schwestern Linz
Linz, , Austria
Site Status
AKH - Medizinische Universität Wien
Vienna, , Austria
Site Status
O.L.V Ziekenhuis
Aalst, , Belgium
Site Status
ZNA Middelheim
Antwerp, , Belgium
Site Status
Imeldaziekenhuis
Bonheiden, , Belgium
Site Status
Institut Jules Bordet
Brussels, , Belgium
Site Status
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt, , Belgium
Site Status
Domaine Universitaire
Liège, , Belgium
Site Status
GZA Ziekenhuizen - Campus Sint-Augustinus
Wilrijk, , Belgium
Site Status
Cross Cancer Institute
Edmonton, Alberta, Canada
Site Status
BC Cancer Agency Vancouver Centre
Vancouver, British Columbia, Canada
Site Status
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Site Status
London Institute of Health Sciences
London, Ontario, Canada
Site Status
Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Site Status
Sunnybrook Research Institute - University of Toronto
Toronto, Ontario, Canada
Site Status
Centre de santé et de services sociaux Champlain-Charles-Le Moyne
Greenfield Park, Quebec, Canada
Site Status
Fakultni nemocnice u sv. Anny v Brne
Brno, , Czechia
Site Status
Masarykuv onkologicky ustav
Brno, , Czechia
Site Status
Fakultni nemocnice Olomouc, Neurologicka klinika
Olomouc, , Czechia
Site Status
Fakultni nemocnice v Motole
Prague, , Czechia
Site Status
Nemocnice Na Bulovce
Prague, , Czechia
Site Status
Thomayerova nemocnice
Prague, , Czechia
Site Status
ICO - Site Paul Papin
Angers, Maine Et Loire, France
Site Status
Centre Georges François Leclerc
Dijon, , France
Site Status
Clinique Victor Hugo - Centre Jean Bernard
Le Mans, , France
Site Status
Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes
Lyon, , France
Site Status
Institut Regional du Cancer de Montpellier
Montpellier, , France
Site Status
Hopital la Petie Salpetriere
Paris, , France
Site Status
Hopital Europeen Georges Pompidou
Paris, , France
Site Status
Boulevard du Professeur Jacques Monod
Saint-Herblain, , France
Site Status
CHU Strasbourg - Nouvel Hopital Civil
Strasbourg, , France
Site Status
EISAI Trial site 4
Stuttgart, Baden-Wurttemberg, Germany
Site Status
EISAI Trial site 1
Tübingen, Baden-Wurttemberg, Germany
Site Status
EISAI Trial site 7
München, Bavaria, Germany
Site Status
EISAI Trial site 6
Frankfurt am Main, Hesse, Germany
Site Status
EISAI Trial site 8
Hanover, Lower Saxony, Germany
Site Status
EISAI Trial site 14
Greifswald, Mecklenburg-Vorpommern, Germany
Site Status
EISAI Trial site 13
Münster, North Rhine-Westphalia, Germany
Site Status
EISAI Trial site 2
Homburg/Saar, Saarland, Germany
Site Status
EISAI Trial site 5
Berlin, , Germany
Site Status
General Hospital of Athens "Alexandra"
Athens, , Greece
Site Status
University of Patras Medical School
Pátrai, , Greece
Site Status
General Hospital Papageorgiou
Thessaloniki, , Greece
Site Status
Interbalkan Hospital of Thessaloniki
Thessaloniki, , Greece
Site Status
Cork University Hospital,Wilton
Cork, , Ireland
Site Status
Adelaide and Meath Hospital Incorp The National Children's Hospital
Dublin, , Ireland
Site Status
Beaumont Hospital
Dublin, , Ireland
Site Status
University Hospital Galway
Galway, , Ireland
Site Status
Assaf Harofeh Medical Center
Be’er Ya‘aqov, , Israel
Site Status
Rambam MC
Haifa, , Israel
Site Status
Sapir Medical Center, Meir Hospital
Kfar Saba, , Israel
Site Status
Rabin Medical Center-Beilinson Campus
Petah Tikva, , Israel
Site Status
Chaim Sheba Medical Center
Ramat Gan, , Israel
Site Status
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Site Status
Azienda Unità Sanitaria Locale- Ravenna
Faenza, Ravenna, Italy
Site Status
Ospedale San Donato
Arezzo, , Italy
Site Status
Azienda Ospedaliera Universitaria Policlinico SantOrsola Malpighi
Bologna, , Italy
Site Status
Istituto Nazionale per la Ricerca sul Cancro di Genova
Genova, , Italy
Site Status
Presidio Ospedaliero Vito Fazzi
Lecce, , Italy
Site Status
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST
Meldola, , Italy
Site Status
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
Site Status
A.O.U. Policlinico di Modena
Modena, , Italy
Site Status
Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli
Napoli, , Italy
Site Status
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli, , Italy
Site Status
Fondazione IRCCS Policlinico San Matteo
Pavia, , Italy
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I.R.C.S.S Fondazione Maugeri
Pavia, , Italy
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Azienda Ospedaliera Santa Maria Degli Angeli
Pordenone, , Italy
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Azienda Ospedaliera San Camillo Forlanini
Roma, , Italy
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Universita Campus Bio-Medico di Roma
Rome, , Italy
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Facility #1
Aichi, , Japan
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Facility #1
Akita, , Japan
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Facility #1
Aomori, , Japan
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Facility #2
Chiba, , Japan
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Facility #1
Fukuoka, , Japan
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Facility #1
Hiroshima, , Japan
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Facility #1
Hokkaido, , Japan
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Facility #2
Hokkaido, , Japan
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Facility #1
Hyōgo, , Japan
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Facility #1
Kagawa, , Japan
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Facility #2
Kanagawa, , Japan
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Facility #3
Kanagawa, , Japan
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Facility #1
Nagasaki, , Japan
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Facility #1
Nara, , Japan
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Facility #1
Niigata, , Japan
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Facility #1
Okayama, , Japan
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Facility #1
Osaka, , Japan
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Facility #2
Osaka, , Japan
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Facility #1
Saitama, , Japan
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Facility #1
Tokushima, , Japan
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Facility #1
Tokyo, , Japan
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Facility #2
Tokyo, , Japan
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Facility #3
Tokyo, , Japan
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Facility #4
Tokyo, , Japan
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Facility #5
Tokyo, , Japan
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Facility #6
Tokyo, , Japan
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Antoni van Leeuwenhoek
Amsterdam, , Netherlands
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VU Medisch Centrum
Amsterdam, , Netherlands
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UMC Utrecht
Utrecht, , Netherlands
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Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
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Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Lublin, , Poland
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SPWSZ w Szczecinie im. Marii Sklodowskiej-Curie
Szczecin, , Poland
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FSBSI Russian Oncological Scientific Center n.a. N.N. Blokhin - Department of Oncology
Moscow, , Russia
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FSBI "Moscow scientific research oncology institute n.a. P.A. Gertsen" of MoH of RF
Moscow, , Russia
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FSBSI Russian Oncological Scientific Center n.a. N.N. Blokhin - Department of Urology
Moscow, , Russia
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FBHI Privolzhskiy District Medical Centre FMBA of Russia
Nizhny Novgorod, , Russia
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SBHI of Novosibirsk region "Novosibirsk Regional Oncological Dispensary"
Novosibirsk, , Russia
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FSBI "National Medical Research Radiological Center" of the MoH of the RF
Obninsk, , Russia
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BHI of Omsk region "Clinical Oncology Dispensary"
Omsk, , Russia
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Kyungpook National University Chilgok Hospital
Daegu, , South Korea
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National Cancer Center
Goyang-si, , South Korea
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Asan Medical Center: Medical Oncology Department
Seoul, , South Korea
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Asan Medical Center: Urology Department
Seoul, , South Korea
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Department of Internal Medicine Division of Hematology/Oncology Cancer center 11F
Seoul, , South Korea
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Samsung Medical Center
Seoul, , South Korea
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Seoul National University Hospital
Seoul, , South Korea
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Severance Hospital, Yonsei University Health System
Seoul, , South Korea
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The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
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Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
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Hospital Clinic i Provincial de Barcelona
Barcelona, , Spain
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ICO l'Hospitalet - Hospital Duran I Reynals
Barcelona, , Spain
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Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
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Hospital Universitari Vall d'Hebron
Barcelona, , Spain
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Hospital San Pedro de Alcantara
Cáceres, , Spain
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Hospital Universitario Reina Sofia
Córdoba, , Spain
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Hospital Universitario Ramon y Cajal
Madrid, , Spain
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Hospital General Universitario Gregorio Maranon
Madrid, , Spain
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Hospital Universitario Clinico San Carlos
Madrid, , Spain
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Hospital Universitario HM Madrid Sanchinarro
Madrid, , Spain
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MD Anderson Cancer Centre
Madrid, , Spain
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Hospital Universitario Central de Asturias
Oviedo, , Spain
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Hospital Universitario Virgen del Rocio
Seville, , Spain
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Oncologia
Valencia, , Spain
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Inselspital - Universitaetsspital Bern
Bern, , Switzerland
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Royal Bournemouth General Hospital
Bournemouth, , United Kingdom
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Velindre Cancer Centre
Cardiff, , United Kingdom
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Western General Hospital
Edinburgh, , United Kingdom
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Beatson West Of Scotland Cancer Centre
Glasgow, , United Kingdom
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St. James's University Hospital
Leeds, , United Kingdom
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Guy's Hospital
London, , United Kingdom
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Royal Free Hospital
London, , United Kingdom
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Christie Hospital NHS Foundation Trust
Manchester, , United Kingdom
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
Australia
Austria
Belgium
Canada
Czechia
France
Germany
Greece
Ireland
Israel
Italy
Japan
Netherlands
Poland
Russia
South Korea
Spain
Switzerland
United Kingdom
References
Explore related publications, articles, or registry entries linked to this study.
Fawsitt CG, Pan J, Orishaba P, Jackson CH, Thom H. Unanchored simulated treatment comparison on survival outcomes using parametric and Royston-Parmar models with application to lenvatinib plus pembrolizumab in renal cell carcinoma. BMC Med Res Methodol. 2025 Jan 30;25(1):26. doi: 10.1186/s12874-025-02480-x.
Reference Type
DERIVED
Zheng H, Zhou J, Tong Y, Zhang J. Cost-Effectiveness Analysis of Lenvatinib plus Pembrolizumab or Everolimus as First-Line Treatment for Advanced Renal Cell Carcinoma. Clin Genitourin Cancer. 2025 Feb;23(1):102264. doi: 10.1016/j.clgc.2024.102264. Epub 2024 Nov 15.
Reference Type
DERIVED
Motzer RJ, Choueiri TK, Hutson T, Young Rha S, Puente J, Lalani AA, Winquist E, Eto M, Basappa NS, Tannir NM, Vaishampayan U, Bjarnason GA, Oudard S, Grunwald V, Burgents J, Xie R, McKenzie J, Powles T. Characterization of Responses to Lenvatinib plus Pembrolizumab in Patients with Advanced Renal Cell Carcinoma at the Final Prespecified Survival Analysis of the Phase 3 CLEAR Study. Eur Urol. 2024 Jul;86(1):4-9. doi: 10.1016/j.eururo.2024.03.015. Epub 2024 Apr 6.
Reference Type
DERIVED
Motzer RJ, Porta C, Eto M, Powles T, Grunwald V, Hutson TE, Alekseev B, Rha SY, Merchan J, Goh JC, Lalani AA, De Giorgi U, Melichar B, Hong SH, Gurney H, Mendez-Vidal MJ, Kopyltsov E, Tjulandin S, Gordoa TA, Kozlov V, Alyasova A, Winquist E, Maroto P, Kim M, Peer A, Procopio G, Takagi T, Wong S, Bedke J, Schmidinger M, Rodriguez-Lopez K, Burgents J, He C, Okpara CE, McKenzie J, Choueiri TK; CLEAR Trial Investigators. Lenvatinib Plus Pembrolizumab Versus Sunitinib in First-Line Treatment of Advanced Renal Cell Carcinoma: Final Prespecified Overall Survival Analysis of CLEAR, a Phase III Study. J Clin Oncol. 2024 Apr 10;42(11):1222-1228. doi: 10.1200/JCO.23.01569. Epub 2024 Jan 16.
Reference Type
DERIVED
Grunwald V, Powles T, Eto M, Kopyltsov E, Rha SY, Porta C, Motzer R, Hutson TE, Mendez-Vidal MJ, Hong SH, Winquist E, Goh JC, Maroto P, Buchler T, Takagi T, Burgents JE, Perini R, He C, Okpara CE, McKenzie J, Choueiri TK. Phase 3 CLEAR study in patients with advanced renal cell carcinoma: outcomes in subgroups for the lenvatinib-plus-pembrolizumab and sunitinib arms. Front Oncol. 2023 Aug 16;13:1223282. doi: 10.3389/fonc.2023.1223282. eCollection 2023. Erratum In: Front Oncol. 2024 Mar 01;13:1343027. doi: 10.3389/fonc.2023.1343027.
Reference Type
DERIVED
Rha SY, Choueiri TK, Matveev VB, Alyasova A, Hong SH, Gordoa TA, Gurney H, Bjarnason GA, Buchler T, Pedrazzoli P, Takagi T, Park SH, Lee JL, Perini RF, He CS, McKenzie JA, Eto M. Efficacy and safety of lenvatinib plus pembrolizumab vs sunitinib in the East Asian subset of patients with advanced renal cell carcinoma from the CLEAR trial. Int J Cancer. 2023 Sep 15;153(6):1241-1250. doi: 10.1002/ijc.34608. Epub 2023 Jun 9.
Reference Type
DERIVED
Aldin A, Besiroglu B, Adams A, Monsef I, Piechotta V, Tomlinson E, Hornbach C, Dressen N, Goldkuhle M, Maisch P, Dahm P, Heidenreich A, Skoetz N. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 May 4;5(5):CD013798. doi: 10.1002/14651858.CD013798.pub2.
Reference Type
DERIVED
Motzer R, George S, Merchan JR, Hutson TE, Song X, Perini RF, Xie R, Bapat U, Puente J. Characterization and Management of Adverse Reactions From the CLEAR Study in Advanced Renal Cell Carcinoma Treated With Lenvatinib Plus Pembrolizumab. Oncologist. 2023 Jun 2;28(6):501-509. doi: 10.1093/oncolo/oyac269.
Reference Type
DERIVED
Choueiri TK, Eto M, Motzer R, De Giorgi U, Buchler T, Basappa NS, Mendez-Vidal MJ, Tjulandin S, Hoon Park S, Melichar B, Hutson T, Alemany C, McGregor B, Powles T, Grunwald V, Alekseev B, Rha SY, Kopyltsov E, Kapoor A, Alonso Gordoa T, Goh JC, Staehler M, Merchan JR, Xie R, Perini RF, Mody K, McKenzie J, Porta CG. Lenvatinib plus pembrolizumab versus sunitinib as first-line treatment of patients with advanced renal cell carcinoma (CLEAR): extended follow-up from the phase 3, randomised, open-label study. Lancet Oncol. 2023 Mar;24(3):228-238. doi: 10.1016/S1470-2045(23)00049-9.
Reference Type
DERIVED
Motzer R, Porta C, Alekseev B, Rha SY, Choueiri TK, Mendez-Vidal MJ, Hong SH, Kapoor A, Goh JC, Eto M, Bennett L, Wang J, Pan JJ, Saretsky TL, Perini RF, He CS, Mody K, Cella D. Health-related quality-of-life outcomes in patients with advanced renal cell carcinoma treated with lenvatinib plus pembrolizumab or everolimus versus sunitinib (CLEAR): a randomised, phase 3 study. Lancet Oncol. 2022 Jun;23(6):768-780. doi: 10.1016/S1470-2045(22)00212-1. Epub 2022 Apr 27.
Reference Type
DERIVED
Motzer R, Alekseev B, Rha SY, Porta C, Eto M, Powles T, Grunwald V, Hutson TE, Kopyltsov E, Mendez-Vidal MJ, Kozlov V, Alyasova A, Hong SH, Kapoor A, Alonso Gordoa T, Merchan JR, Winquist E, Maroto P, Goh JC, Kim M, Gurney H, Patel V, Peer A, Procopio G, Takagi T, Melichar B, Rolland F, De Giorgi U, Wong S, Bedke J, Schmidinger M, Dutcus CE, Smith AD, Dutta L, Mody K, Perini RF, Xing D, Choueiri TK; CLEAR Trial Investigators. Lenvatinib plus Pembrolizumab or Everolimus for Advanced Renal Cell Carcinoma. N Engl J Med. 2021 Apr 8;384(14):1289-1300. doi: 10.1056/NEJMoa2035716. Epub 2021 Feb 13.
Reference Type
DERIVED
Hofmann F, Hwang EC, Lam TB, Bex A, Yuan Y, Marconi LS, Ljungberg B. Targeted therapy for metastatic renal cell carcinoma. Cochrane Database Syst Rev. 2020 Oct 14;10(10):CD012796. doi: 10.1002/14651858.CD012796.pub2.
Reference Type
DERIVED
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KEYNOTE-581
Identifier Type: OTHER
Identifier Source: secondary_id
2016-000916-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
E7080-G000-307
Identifier Type: -
Identifier Source: org_study_id
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