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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04586231
Other study ID # 6482-011
Secondary ID MK-6482-011jRCT2
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date February 25, 2021
Est. completion date December 23, 2024

Study information

Verified date May 2024
Source Merck Sharp & Dohme LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will compare the efficacy and safety of belzutifan + lenvatinib versus cabozantinib in participants with advanced renal cell carcinoma (RCC) with clear cell component after prior therapy. The primary hypothesis is that belzutifan + lenvatinib is superior to cabozantinib in terms of progression-free survival or overall survival.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 708
Est. completion date December 23, 2024
Est. primary completion date December 23, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Unresectable, locally advanced or metastatic clear cell renal cell carcinoma (RCC). - Disease progression on or after an anti-programmed cell death-1/ligand 1 (PD-1/L1) therapy as either first or second-line treatment for locally advanced/metastatic RCC or as adjuvant treatment or neoadjuvant/adjuvant with progression on or within 6 months of last dose. - Measurable disease per RECIST 1.1 criteria as assessed by local study investigator. - Karnofsky performance status (KPS) score of at least 70% assessed within 10 days before randomization. - Received no more than 2 prior systemic regimens including: one anti-PD-1/L1 containing adjuvant or neoadjuvant/adjuvant regimens with progression on or within 6 months from the last dose of that regimen OR one or 2 regimens for locoregional/advanced disease - Received only 1 prior antiPD-1/L1 therapy for adjuvant, neoadjuvant/adjuvant or locally advanced/metastatic RCC. - A male participant is eligible to participate if he is abstinent from heterosexual intercourse or agrees to use contraception during the intervention period and for at least 7 days after the last dose of belzutifan or lenvatinib in the belzutifan+lenvatinib arm, whichever occurs last, and 23 days after the last dose of cabozantinib. - A female participant is eligible to participate if they are not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a woman of childbearing potential (WOCBP) or a WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 30 days after the last dose of study intervention in the belzutifan+ lenvatinib arm, or 120 days after the last dose of study intervention in the cabozantinib arm. - Adequately controlled blood pressure. - Adequate organ function. Exclusion Criteria: - A pulse oximeter reading <92% at rest, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen. - Known additional malignancy that is progressing or has required active treatment within the past 3 years except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy. - Known central nervous system (CNS) metastases and/or carcinomatous meningitis. - Clinically significant cardiac disease within 6 months of first dose of study intervention. - Prolongation of QTc interval to >480 ms. - Symptomatic pleural effusion (e.g.,cough, dyspnea, pleuritic chest pain) that is not clinically stable. - Pre-existing =Grade 3 gastrointestinal or nongastrointestinal fistula. - Moderate to severe hepatic impairment. - History of significant bleeding within 3 months before randomization. - History of solid organ transplantation. - Known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study. - Unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (e.g., gastrectomy, partial bowel obstruction, malabsorption). - Known hypersensitivity or allergy to the active pharmaceutical ingredients or any component of the study intervention formulations. - Received colony-stimulating factors [eg, granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GMCSF) or recombinant erythropoietin (EPO)] within 28 days before randomization. - Prior treatment with belzutifan or another hypoxia-inducible factor (HIF)-2a inhibitor. - Prior treatment with lenvatinib. - Prior treatment with cabozantinib. - Currently participating in a study of an investigational agent or using an investigational device. - Active infection requiring systemic therapy. - History of human immunodeficiency virus (HIV) infection. - History of hepatitis B or known active hepatitis C infection.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Belzutifan
Immediate-release 40 mg tablet
Lenvatinib
Capsule available in 4 mg and 10 mg dosages
Cabozantinib
Tablet available in 20 mg, 40 mg and 60 mg dosages

Locations

Country Name City State
Argentina Asociación de Beneficencia Hospital Sirio Libanés ( Site 0804) Buenos Aires
Argentina Centro de Urología (CDU) ( Site 0803) Caba Buenos Aires
Argentina Hospital Británico de Buenos Aires-Oncology ( Site 0801) Ciudad autónoma de Buenos Aires Buenos Aires
Argentina Instituto Alexander Fleming ( Site 0800) Ciudad Autónoma de Buenos Aires Buenos Aires
Argentina Sanatorio Británico-Clinical Oncology Department ( Site 0802) Rosario Santa Fe
Argentina Sanatorio Parque ( Site 0806) Rosario Santa Fe
Australia Lyell McEwin Hospital ( Site 4004) Elizabeth Vale South Australia
Australia Peninsula Health Frankston Hospital ( Site 4001) Frankston Victoria
Australia Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 4010) Melbourne Victoria
Australia GenesisCare North Shore ( Site 4011) St Leonards New South Wales
Austria Medizinische Universitätsklinik Graz ( Site 1051) Graz Steiermark
Austria Ordensklinikum Linz GmbH Elisabethinen-Urologie ( Site 1001) Linz Oberosterreich
Austria Klinik Ottakring-1.Medizinische Abteilung - Zentrum für Onkologie und Hämatologie ( Site 1031) Vienna Wien
Austria Krankenhaus der Barmherzigen Brüder Wien ( Site 1041) Wien
Austria Medizinische Universität Wien ( Site 1021) Wien
Belgium Institut Jules Bordet ( Site 1103) Anderlecht Bruxelles-Capitale, Region De
Belgium Cliniques Universitaires Saint Luc - Bruxelles ( Site 1105) Brussels Bruxelles-Capitale, Region De
Belgium Grand Hopital de Charleroi ( Site 1104) Charleroi Hainaut
Belgium UZ Gent ( Site 1100) Gent Oost-Vlaanderen
Belgium UZ Leuven ( Site 1101) Leuven Vlaams-Brabant
Belgium CHU de Liege ( Site 1102) Liege
Brazil Liga Norte Riograndense Contra o Cancer ( Site 0313) Natal Rio Grande Do Norte
Brazil Centro Gaucho Integrado de Oncologia ( Site 0304) Porto Alegre Rio Grande Do Sul
Brazil BP - A Beneficencia Portuguesa de São Paulo-Medical Oncology ( Site 0311) Sao Paulo
Brazil Hospital Paulistano - Amil Clinical Research ( Site 0308) Sao Paulo
Canada Tom Baker Cancer Centre ( Site 0109) Calgary Alberta
Canada Cross Cancer Institute ( Site 0111) Edmonton Alberta
Canada CISSS de la Monteregie-Centre ( Site 0103) Greenfield Park Quebec
Canada Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0114) Hamilton Ontario
Canada Kingston Health Sciences Centre ( Site 0105) Kingston Ontario
Canada The Moncton Hospital ( Site 0101) Moncton New Brunswick
Canada The Ottawa Hospital - General Campus-The Ottawa Hospital Cancer Centre ( Site 0116) Ottawa Ontario
Canada Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0 Quebec
Canada CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0102) Sherbrooke Quebec
Canada Sunnybrook Health Sciences - Odette Cancer Centre ( Site 0113) Toronto Ontario
Canada BC Cancer Vancouver-Clinical Trials Unit ( Site 0110) Vancouver British Columbia
Chile Bradfordhill-Clinical Area ( Site 0400) Santiago Region M. De Santiago
Chile James Lind Centro de Investigación del Cáncer ( Site 0402) Temuco Araucania
Colombia Instituto Nacional de Cancerología-Clinical Oncology ( Site 0500) Bogotá Cundinamarca
Colombia Fundación Colombiana de Cancerología Clínica Vida ( Site 0505) Medellin Antioquia
Colombia Fundación Cardiovascular de Colombia ( Site 0501) Piedecuesta Santander
Colombia Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 0508) Valledupar Cesar
Czechia Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 2203) Brno Brno-mesto
Czechia Nemocnice Ceské Budejovice-Onkologicke oddeleni ( Site 2204) Ceské Budejovice Jihocesky Kraj
Czechia Fakultni nemocnice Hradec Kralove-Klinika onkologie a radioterapie ( Site 2201) Hradec Kralove
Czechia Fakultni Thomayerova nemocnice-Onkologicka klinika 1. LF UK ( Site 2200) Prague Praha 4
Czechia Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 2205) Praha Praha 5
Finland HYKS ( Site 1800) Helsinki Uusimaa
Finland Tampereen yliopistollinen sairaala ( Site 1801) Tampere Pirkanmaa
Finland TYKS ( Site 1802) Turku Varsinais-Suomi
France Institut de Cancerologie de l Ouest Site Paul Papin ( Site 1200) Angers Maine-et-Loire
France CHU de Bordeaux- Hopital Saint Andre ( Site 1209) Bordeaux Gironde
France Clinique Francois Chenieux ( Site 1210) Limoges Haute-Vienne
France Centre Antoine Lacassagne ( Site 1217) Nice Alpes-Maritimes
France Hopital Tenon ( Site 1213) Paris
France Institut Jean Godinot ( Site 1216) Reims Ain
France Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 1201) Saint Herblain Loire-Atlantique
France Institut de cancérologie Strasbourg Europe (ICANS) ( Site 1218) Strasbourg Alsace
France Institut Claudius Regaud ( Site 1215) Toulouse Haute-Garonne
Germany Universitaetsklinikum Aachen AOER ( Site 1317) Aachen Nordrhein-Westfalen
Germany Charite Universitaetsmedizin Berlin ( Site 1321) Berlin
Germany HELIOS Klinikum Berlin-Buch ( Site 1311) Berlin
Germany Helios Klinikum Erfurt GmbH ( Site 1315) Erfurt Thuringen
Germany Universitaetsklinikum Frankfurt ( Site 1301) Frankfurt am Main Hessen
Germany Klinik fuer Urologie ( Site 1303) Freiburg Baden-Wurttemberg
Germany Krankenhaus Martha Maria Halle-Doelau ( Site 1314) Halle Sachsen-Anhalt
Germany NCT-Department of Medical Oncology ( Site 1320) Heidelberg Baden-Wurttemberg
Germany Universitaetsklinikum des Saarlandes ( Site 1305) Homburg/ Saar Saarland
Germany Klinikum Nuernberg Nord ( Site 1300) Nuremberg Bayern
Greece Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 3304) Athens Attiki
Greece Athens Medical Center ( Site 3303) Athens Attiki
Greece ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 3301) Chaidari Attiki
Greece UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 3302) Patras Achaia
Greece European Interbalkan Medical Center-Oncology Department ( Site 3300) Thessaloniki
Ireland Mater Private Hospital - Dublin ( Site 3202) Dublin
Ireland Tallaght University Hospital ( Site 3200) Dublin
Ireland Mater Misericordiae University Hospital ( Site 3201) Dublin 7 Dublin
Italy Medical Oncology Ospedale San Donato ( Site 1404) Arezzo
Italy Azienda Ospedaliera Policlinico di Bari ( Site 1402) Bari
Italy Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 1407) Meldola Forli-Cesena
Italy Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1400) Milano
Italy IRCCS Ospedale San Raffaele ( Site 1409) Milano
Italy Ospedale San Luigi Gonzaga ( Site 1405) Orbassano Torino
Italy Istituti Clinici Scientifici Maugeri Spa ( Site 1403) Pavia
Italy Fondazione Policlinico Universitario Agostino Gemelli-Medical Oncology ( Site 1410) Roma
Italy Istituto Clinico Humanitas Research Hospital ( Site 1406) Rozzano Milano
Italy Azienda Ospedaliera S. Maria di Terni ( Site 1401) Terni
Italy Ospedale Maggiore Borgo Trento ( Site 1408) Verona
Japan Tokyo Medical and Dental University Hospital ( Site 5009) Bunkyo-ku Tokyo
Japan Kyushu University Hospital ( Site 5005) Fukuoka
Japan Hamamatsu University School of Medicine University Hospital ( Site 5004) Hamamatsu Shizuoka
Japan Nara Medical University Hospital ( Site 5002) Kashihara Nara
Japan National Cancer Center Hospital East ( Site 5000) Kashiwa Chiba
Japan Kobe City Medical Center General Hospital ( Site 5017) Kobe Hyogo
Japan Toranomon Hospital ( Site 5001) Minato-ku Tokyo
Japan Niigata University Medical & Dental Hospital ( Site 5013) Niigata
Japan Osaka International Cancer Institute ( Site 5016) Osaka
Japan Kindai University Hospital- Osakasayama Campus-Urology ( Site 5010) Osakasayama Osaka
Japan Toho University Sakura Medical Center ( Site 5014) Sakura Chiba
Japan Sapporo Medical University Hospital ( Site 5008) Sapporo Hokkaido
Japan Osaka University Hospital ( Site 5012) Suita Osaka
Japan Keio university hospital ( Site 5011) Tokyo
Japan Nippon Medical School Hospital ( Site 5006) Tokyo
Japan Tokyo Women's Medical University Adachi Medical Center ( Site 5015) Tokyo
Japan Fujita Health University ( Site 5003) Toyoake Aichi
Japan Yokohama City University Hospital ( Site 5007) Yokohama Kanagawa
Korea, Republic of Chonnam National University Hwasun Hospital-Oncology ( Site 4203) Hwasun Jeonranamdo
Korea, Republic of Asan Medical Center ( Site 4200) Seoul
Korea, Republic of Samsung Medical Center ( Site 4201) Seoul
Netherlands Antoni van Leeuwenhoek Ziekenhuis ( Site 1901) Amsterdam Noord-Holland
Netherlands Amphia Hospital Location Molengracht ( Site 1912) Breda Noord-Brabant
Netherlands Haga Ziekenhuis locatie Leyweg-Oncology ( Site 1917) Den Haag Zuid-Holland
Netherlands Medisch Centrum Leeuwarden ( Site 1905) Leeuwarden Fryslan
Netherlands Erasmus MC ( Site 1913) Rotterdam Zuid-Holland
Netherlands Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 1909) Schiedam Zuid-Holland
Netherlands Zuyderland Medical Centre-Trialbureau Interne Geneeskunde ( Site 1904) Sittard-Geleen Limburg
Netherlands Universitair Medisch Centrum Utrecht ( Site 1910) Utrecht
Poland Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 2402) Bydgoszcz Kujawsko-pomorskie
Poland Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - O-Klinika Onkologii Klinicznej ( Site 240 Krakow Malopolskie
Poland Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 2401) Poznan Wielkopolskie
Poland Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 2400) Warszawa Mazowieckie
Romania Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 2500) Cluj Napoca Cluj
Romania Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 2501) Cluj Napoca Cluj
Romania Centrul de Oncologie "Sfântul Nectarie" ( Site 2502) Craiova Dolj
Russian Federation Ivanovo Regional Oncology Dispensary ( Site 2616) Ivanovo Ivanovskaya Oblast
Russian Federation MEDSI Clinical Hospital on Pyatnitsky Highway-Departmentof Antitumor Drug therapy ( Site 2618) Krasnogorsk Moskovskaya Oblast
Russian Federation FSBI United Hospital with Polyclinic ( Site 2613) Moscow Moskva
Russian Federation Hadassah Medical-Oncology department ( Site 2609) Moscow Moskovskaya Oblast
Russian Federation SHI of Moscow City Oncology Clinical Hospital - 62 ( Site 2614) Moscow Moskva
Russian Federation Volgograd Regional Uronephrological Center ( Site 2615) Volzhsky Volgogradskaya Oblast
Russian Federation Yaroslavl Regional Cancer Hospital-Oncology ( Site 2619) Yaroslavl Yaroslavskaya Oblast
Spain Complejo Hospitalario Universitario A Coruna ( Site 1502) A Coruna La Coruna
Spain Hospital Clinic i Provincial ( Site 1500) Barcelona
Spain Hospital Santa Creu i Sant Pau ( Site 1501) Barcelona
Spain Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1507) Barcelona
Spain Hospital Clinico San Carlos ( Site 1504) Madrid
Spain Hospital General Universitario Gregorio Maranon ( Site 1505) Madrid
Spain Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1508) Madrid Madrid, Comunidad De
Spain Hospital Virgen del Rocio ( Site 1503) Sevilla
Switzerland Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 1604) Bellinzona Ticino
Switzerland Kantonsspital Graubuenden ( Site 1600) Chur Grisons
Switzerland Hopitaux Universitaires de Geneve HUG ( Site 1602) Geneva Geneve
Switzerland Universitaetsspital Zuerich ( Site 1601) Zuerich Zurich
United Kingdom Aberdeen Royal Infirmary-Department of Oncology ( Site 3105) Aberdeen Aberdeen City
United Kingdom Royal United Hospital Bath England ( Site 3108) Bath Bath And North East Somerset
United Kingdom Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 3107) London London, City Of
United Kingdom Mount Vernon Cancer Centre ( Site 3101) Northwood London, City Of
United Kingdom Nottingham University Hospitals NHS Trust. City Hospital Campus ( Site 3106) Nottingham England
United Kingdom Southend University Hospital ( Site 3112) Southend Essex
United Kingdom Singleton Hospital ( Site 3111) Swansea Wales
United Kingdom Musgrove Park Hospital ( Site 3103) Taunton Somerset
United States Lehigh Valley Hospital- Cedar Crest-Oncology Clinical Trials ( Site 0056) Allentown Pennsylvania
United States University Cancer & Blood Center, LLC ( Site 0057) Athens Georgia
United States Emory University Hospital ( Site 0012) Atlanta Georgia
United States Lahey Hospital & Medical Center ( Site 0090) Burlington Massachusetts
United States University of Vermont Medical Center ( Site 0001) Burlington Vermont
United States Ironwood Cancer & Research Centers ( Site 0077) Chandler Arizona
United States Levine Cancer Institute ( Site 0004) Charlotte North Carolina
United States Rush University Medical Center ( Site 0040) Chicago Illinois
United States University of Texas, Southwestern Medical Center ( Site 0015) Dallas Texas
United States Duke Cancer Institute ( Site 0096) Durham North Carolina
United States Parkview Cancer Institute ( Site 0088) Fort Wayne Indiana
United States Cancer & Hematology Centers of Western Michigan ( Site 0018) Grand Rapids Michigan
United States University of Mississippi Medical Ctr ( Site 0037) Jackson Mississippi
United States R.J. Zuckerberg Cancer Center-Medical Oncology ( Site 0013) Lake Success New York
United States Cancer Partners of Nebraska ( Site 0086) Lincoln Nebraska
United States Cedars Sinai Medical Center ( Site 0027) Los Angeles California
United States UCLA Hematology/Oncology - Santa Monica ( Site 0048) Los Angeles California
United States Norton Cancer Institute - St. Matthews ( Site 0065) Louisville Kentucky
United States Rutgers Cancer Institute of New Jersey ( Site 0078) New Brunswick New Jersey
United States Tulane University School of Medicine ( Site 0098) New Orleans Louisiana
United States Memorial Sloan Kettering Cancer Center ( Site 0055) New York New York
United States St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 0095) Orange California
United States UC Irvine Health ( Site 0029) Orange California
United States AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0003) Orlando Florida
United States Orlando Health, Inc. ( Site 0035) Orlando Florida
United States Illinois Cancer Care, PC ( Site 0008) Peoria Illinois
United States Blue Ridge Cancer Care - Roanoke ( Site 0043) Roanoke Virginia
United States HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0005) Saint Louis Park Minnesota
United States Huntsman Cancer Institute-HCI Clinical Trials Office ( Site 7001) Salt Lake City Utah
United States Providence Saint John's Health Center ( Site 0083) Santa Monica California
United States Seattle Cancer Care Alliance-Renal/Melanoma/MCC ( Site 0093) Seattle Washington
United States Georgetown University Medical Center ( Site 0006) Washington District of Columbia
United States Confluence Health | Wenatchee Valley Hospital & Clinics ( Site 0061) Wenatchee Washington

Sponsors (2)

Lead Sponsor Collaborator
Merck Sharp & Dohme LLC Eisai Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Chile,  Colombia,  Czechia,  Finland,  France,  Germany,  Greece,  Ireland,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Poland,  Romania,  Russian Federation,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as =20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of =5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review will be presented. Up to approximately 34 months
Primary Overall Survival (OS) OS is defined as time from randomization to death due to any cause. Up to approximately 44 months
Secondary Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) ORR is defined as the percentage of participants who have a complete response (CR: Disappearance of all target lesions) or a partial response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience a CR or PR as assessed by blinded independent central review based on RECIST 1.1 will be presented. Up to approximately 24 months
Secondary Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) For participants who demonstrate a confirmed complete response (CR: Disappearance of all target lesions) or confirmed partial response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death. The DOR as assessed by blinded independent central review will be presented. Up to approximately 44 months
Secondary Number of Participants Who Experienced One or More Adverse Events (AEs) An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Up to approximately 44 months
Secondary Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE) An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Up to approximately 44 months
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