A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)
Study Details
Study Description
Brief Summary
The goal of this study is to evaluate the efficacy and safety of pembrolizumab plus belzutifan plus lenvatinib or pembrolizumab/quavonlimab plus lenvatinib versus pembrolizumab plus lenvatinib as first-line treatment in participants with advanced clear cell renal cell carcinoma (ccRCC).
The primary hypotheses are (1) pembrolizumab plus belzutifan plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to progression-free survival (PFS) and overall survival (OS), in advanced ccRCC participants and (2) pembrolizumab/quavonlimab plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to PFS and OS, in advanced ccRCC participants.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Pembrolizumab + Belzutifan + Lenvatinib Participants will receive pembrolizumab 400 mg PLUS belzutifan 120 mg PLUS lenvatinib 20 mg. Pembrolizumab will be administered intravenously (IV) once every 6 weeks (Q6W) for up to 18 administrations (up to ~2 years). Belzutifan and lenvatinib will be administered orally once daily (QD) until progressive disease or discontinuation. |
Biological: Pembrolizumab
Pembrolizumab 400 mg administered Q6W via IV infusion
Other Names:
Drug: Belzutifan
Belzutifan 120 mg administered QD via oral tablet
Other Names:
Drug: Lenvatinib
Lenvatinib 20 mg administered QD via oral capsule
Other Names:
|
| Experimental: Pembrolizumab/Quavonlimab + Lenvatinib Participants will receive pembrolizumab/quavonlimab (co-formulation of pembrolizumab 400 mg and quavonlimab 25 mg) PLUS lenvatinib 20 mg. Pembrolizumab/quavonlimab will be administered IV Q6W for up to 18 administrations (up to ~2 years). Lenvatinib will be administered orally QD until progressive disease or discontinuation. |
Biological: Pembrolizumab/Quavonlimab
Pembrolizumab/quavonlimab is a co-formulated product composed of pembrolizumab 400 mg in combination with quavonlimab 25 mg, administered Q6W via IV infusion
Other Names:
Drug: Lenvatinib
Lenvatinib 20 mg administered QD via oral capsule
Other Names:
|
| Active Comparator: Pembrolizumab + Lenvatinib Participants will receive pembrolizumab 400 mg PLUS lenvatinib 20 mg. Pembrolizumab will be administered IV Q6W for up to 18 administrations (up to ~2 years). Lenvatinib will be administered orally QD until progressive disease or discontinuation. |
Biological: Pembrolizumab
Pembrolizumab 400 mg administered Q6W via IV infusion
Other Names:
Drug: Lenvatinib
Lenvatinib 20 mg administered QD via oral capsule
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) [Up to approximately 46 months]
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 BICR based on RECIST 1.1 will be presented.
- Overall Survival (OS) [Up to approximately 66 months]
OS is defined as the time from randomization to death due to any cause.
Secondary Outcome Measures
- Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR [Up to approximately 46 months]
ORR is defined as the percentage of participants who have a complete response (CR: disappearance of all target lesions) or 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 BICR based on RECIST 1.1 will be presented.
- Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR [Up to approximately 66 months]
For participants who demonstrate a confirmed CR (disappearance of all target lesions) or confirmed 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 PD or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 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. The DOR as assessed by BICR based on RECIST 1.1 will be presented.
- Number of Participants Who Experienced At least One Adverse Event (AE) [Up to approximately 66 months]
An 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. The number of participants who experience at least one AE will be presented.
- Number of Participants Who Discontinue Study Treatment Due to an AE [Up to approximately 66 months]
An 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. The number of participants who discontinue study treatment due to an AE will be presented.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Has histologically confirmed diagnosis of RCC with clear cell component
-
Has received no prior systemic therapy for advanced ccRCC
-
Male participants are abstinent from heterosexual intercourse or agree to use contraception during and for at least 7 days after last dose of study intervention with belzutifan and lenvatinib
-
Female participants are not pregnant or breastfeeding and are either not a woman of child-bearing potential (WOCBP) or use a contraceptive method that is highly effective or are abstinent from heterosexual intercourse during the intervention period and for at least 120 days after pembrolizumab or pembrolizumab/quavonlimab or for at least 30 days after last dose of lenvatinib or belzutifan, whichever occurs last
-
Has adequately controlled blood pressure with or without antihypertensive medications
-
Has adequate organ function
-
Participants receiving bone resorptive therapy must have therapy initiated at least 2 weeks prior to randomization/allocation
Exclusion Criteria:
-
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
-
Has had major surgery, other than nephrectomy within 4 weeks prior to randomization
-
Has known central nervous system (CNS) metastases and/or carcinomatous meningitis
-
Has received prior radiotherapy within 2 weeks prior to first dose of study intervention
-
Has hypoxia or requires intermittent supplemental oxygen or requires chronic supplemental oxygen
-
Has clinically significant cardiac disease within 12 months from first dose of study intervention
-
Has a history of interstitial lung disease
-
Has symptomatic pleural effusion; a participant who is clinically stable following treatment of this condition is eligible
-
Has preexisting gastrointestinal or non-gastrointestinal fistula
-
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
-
Has a known psychiatric or substance abuse disorder that would interfere with requirements of the study
-
Has received a live or live-attenuated vaccine within 30 days before the first dose of study drug; killed vaccines are allowed
-
Has an active autoimmune disease that has required systemic treatment in the past 2 years
-
Has a history of noninfectious pneumonitis that required steroids or has current pneumonitis
-
Has an active infection requiring systemic therapy
-
Has a known history of human immunodeficiency virus (HIV) infection
-
Has a known history of Hepatitis B
-
Has radiographic evidence of intratumoral cavitation, encasement or invasion of a major blood vessel
-
Has clinically significant history of bleeding within 3 months prior to randomization
-
Has had an allogenic tissue/solid organ transplant
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The University of Alabama at Birmingham ( Site 0010) | Birmingham | Alabama | United States | 35294-3300 |
| 2 | UC San Diego ( Site 0050) | La Jolla | California | United States | 92037 |
| 3 | Cedars Sinai Medical Center ( Site 0027) | Los Angeles | California | United States | 90048 |
| 4 | University of California Irvine ( Site 0029) | Orange | California | United States | 92868 |
| 5 | UCLA Hematology Oncology Santa Monica ( Site 0048) | Santa Monica | California | United States | 90404 |
| 6 | Hartford Hospital ( Site 0024) | Hartford | Connecticut | United States | 06102 |
| 7 | Advent Health Hematology & Oncology ( Site 0003) | Orlando | Florida | United States | 32804 |
| 8 | University Cancer & Blood Center, LLC ( Site 0057) | Athens | Georgia | United States | 30607 |
| 9 | Emory University Winship Cancer Institute ( Site 0012) | Atlanta | Georgia | United States | 30322 |
| 10 | Rush University Medical Center ( Site 0040) | Chicago | Illinois | United States | 60612 |
| 11 | Parkview Cancer Institute ( Site 0088) | Fort Wayne | Indiana | United States | 46845 |
| 12 | Norton Cancer Institute - St. Matthews ( Site 0065) | Louisville | Kentucky | United States | 40207 |
| 13 | Ochsner Medical Center ( Site 0049) | New Orleans | Louisiana | United States | 70121 |
| 14 | New England Cancer Specialists ( Site 0082) | Scarborough | Maine | United States | 04074 |
| 15 | Massachusetts General Hospital ( Site 0094) | Boston | Massachusetts | United States | 02114 |
| 16 | Beth Israel Deaconess Medical Center ( Site 0089) | Boston | Massachusetts | United States | 02215 |
| 17 | Dana Farber Cancer Institute ( Site 0093) | Boston | Massachusetts | United States | 02215 |
| 18 | Lahey Hospital & Medical Center ( Site 0090) | Burlington | Massachusetts | United States | 01805 |
| 19 | Henry Ford Hospital ( Site 0038) | Detroit | Michigan | United States | 48202 |
| 20 | Cancer & Hematology Centers of Western Michigan ( Site 0018) | Grand Rapids | Michigan | United States | 49503 |
| 21 | HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0005) | Saint Louis Park | Minnesota | United States | 55426 |
| 22 | Regions Hospital ( Site 0095) | Saint Paul | Minnesota | United States | 55101 |
| 23 | Dartmouth Hitchcock Medical Center ( Site 0075) | Lebanon | New Hampshire | United States | 03756 |
| 24 | Roswell Park Cancer Institute ( Site 0032) | Buffalo | New York | United States | 14263 |
| 25 | Northwell Health- Monter Cancer Center ( Site 0013) | Lake Success | New York | United States | 11042 |
| 26 | Sidney Kimmel Center for Prostate and Urologic Cancers ( Site 0055) | New York | New York | United States | 10065 |
| 27 | Oregon Health & Science University ( Site 0071) | Portland | Oregon | United States | 97239 |
| 28 | Ralph H. Johnson VA Center ( Site 0073) | Charleston | South Carolina | United States | 29401 |
| 29 | University of Tennessee Medical Center Knoxville ( Site 0019) | Knoxville | Tennessee | United States | 37920 |
| 30 | Vanderbilt University Medical Center ( Site 0069) | Nashville | Tennessee | United States | 37232 |
| 31 | UTSW Medical Center ( Site 0015) | Dallas | Texas | United States | 75390 |
| 32 | Confluence Health | Wenatchee Valley Hospital & Clinics ( Site 0061) | Wenatchee | Washington | United States | 98801 |
| 33 | Liverpool Hospital ( Site 4006) | Liverpool | New South Wales | Australia | 2170 |
| 34 | Macquarie University ( Site 4007) | Macquarie Park | New South Wales | Australia | 2109 |
| 35 | Lyell McEwin Hospital ( Site 4004) | Elizabeth Vale | South Australia | Australia | 5112 |
| 36 | Monash Health ( Site 4008) | Clayton | Victoria | Australia | 3168 |
| 37 | Fiona Stanley Hospital ( Site 4009) | Murdoch | Western Australia | Australia | 6150 |
| 38 | Oncocentro Ceara ( Site 0309) | Fortaleza | Ceara | Brazil | 60135-237 |
| 39 | Centro de Pesquisas Clinicas em Oncologia ( Site 0306) | Cachoeiro de Itapemirim | Espirito Santo | Brazil | 29308-014 |
| 40 | Centro Avançado de Tratamento Oncológico- CENATRON-Clinical Research ( Site 0303) | Belo Horizonte | Minas Gerais | Brazil | 30130090 |
| 41 | Liga Norte Riograndense Contra o Cancer ( Site 0308) | Natal | Rio Grande Do Norte | Brazil | 59075-740 |
| 42 | Hospital de Clinicas de Porto Alegre ( Site 0310) | Porto Alegre | Rio Grande Do Sul | Brazil | 90035-903 |
| 43 | Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0302) | Sao Paulo | Brazil | 01246-000 | |
| 44 | A.C. Camargo Cancer Center ( Site 0301) | Sao Paulo | Brazil | 01525-001 | |
| 45 | Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0300) | Sao Paulo | Brazil | 03123-900 | |
| 46 | Tom Baker Cancer Centre ( Site 0119) | Calgary | Alberta | Canada | T4N 4N2 |
| 47 | BC Cancer - Vancouver Center ( Site 0120) | Vancouver | British Columbia | Canada | V5Z 4E6 |
| 48 | Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0117) | Hamilton | Ontario | Canada | L8V 5C2 |
| 49 | Sunnybrook Research Institute ( Site 0116) | Toronto | Ontario | Canada | M4N 3M5 |
| 50 | Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0 | Quebec City | Quebec | Canada | G1J 1Z4 |
| 51 | Centro Investigacion Cancer James Lind ( Site 0402) | Temuco | Araucania | Chile | 4780000 |
| 52 | IC La Serena Research ( Site 0403) | La Serena | Coquimbo | Chile | 1700000 |
| 53 | Servicios Medicos Urumed ( Site 0405) | Rancagua | Lbtdr Gen Bernardo O Higgins | Chile | 2852424 |
| 54 | Fundacion Arturo Lopez Perez ( Site 0400) | Santiago | Region M. De Santiago | Chile | 7500921 |
| 55 | Bradfordhill-Clinical Area ( Site 0401) | Santiago | Region M. De Santiago | Chile | 8420383 |
| 56 | Beijing Cancer hospital-Renal carcinoma and melanoma ( Site 6000) | Beijing | Beijing | China | 100142 |
| 57 | Chongqing University Cancer Hospital ( Site 6009) | Chongqing | Chongqing | China | 400030 |
| 58 | Guangzhou First People's Hospital ( Site 6007) | Guangzhou | Guangdong | China | 510180 |
| 59 | Henan Cancer Hospital-Urology ( Site 6006) | Zhengzhou | Henan | China | 450008 |
| 60 | Wuhan Union Hospital ( Site 6002) | Wuhan | Hubei | China | 430022 |
| 61 | Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( S | Nanjing | Jiangsu | China | 210000 |
| 62 | The First Affiliated Hospital of Nanchang University ( Site 6019) | Nanchang | Jiangxi | China | 330006 |
| 63 | The First Affiliated Hospital of Xi'an Jiaotong University ( Site 6014) | Xi'an | Shaanxi | China | 710061 |
| 64 | The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 6021) | Wenzhou | Zhejiang | China | 325000 |
| 65 | Instituto de Cancerología S.A Clínica de las Americas (ICCLA) ( Site 0500) | Medellin | Antioquia | Colombia | 050024 |
| 66 | Clinica de la Costa Ltda. ( Site 0502) | Barranquilla | Atlantico | Colombia | 080020 |
| 67 | Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0505) | Valledupar | Cesar | Colombia | 200001 |
| 68 | Administradora Country SA - Clinica del Country ( Site 0504) | Bogota | Distrito Capital De Bogota | Colombia | 110221 |
| 69 | Instituto Nacional de Cancerología E.S.E. ( Site 0503) | Bogotá | Distrito Capital De Bogota | Colombia | 111511 |
| 70 | Oncólogos del Occidente S.A ( Site 0501) | Pereira | Risaralda | Colombia | 660001 |
| 71 | Fundacion Cardiovascular de Colombia ( Site 0506) | Piedecuesta | Santander | Colombia | 681017 |
| 72 | Klinicki Bolnicki Centar Zagreb ( Site 3200) | Zagreb | Grad Zagreb | Croatia | 10000 |
| 73 | Klinički Bolnički Centar Split ( Site 3202) | Split | Splitsko-dalmatinska Zupanija | Croatia | 21000 |
| 74 | Klinicki bolnicki centar "Sestre milosrdnice" ( Site 3201) | Zagreb | Zagrebacka Zupanija | Croatia | 10000 |
| 75 | Masarykuv onkologicky ustav ( Site 2203) | Brno | Brno-mesto | Czechia | 65653 |
| 76 | Fakultni nemocnice u sv. Anny v Brne ( Site 2205) | Brno | Jihomoravsky Kraj | Czechia | 656 91 |
| 77 | Nemocnice AGEL Novy Jicin a.s. ( Site 2202) | Novy Jicin | Moravskoslezsky Kraj | Czechia | 741 01 |
| 78 | Fakultni nemocnice Ostrava ( Site 2208) | Ostrava | Moravskoslezsky Kraj | Czechia | 708 52 |
| 79 | Fakultni nemocnice Olomouc ( Site 2200) | Olomouc | Czechia | 775 20 | |
| 80 | Fakultni Thomayerova nemocnice ( Site 2201) | Praha 4 | Czechia | 140 59 | |
| 81 | 2 LF UK a FN Motol ( Site 2207) | Praha 5 | Czechia | 150 06 | |
| 82 | Herlev Hospital ( Site 1700) | Herlev | Hovedstaden | Denmark | 2730 |
| 83 | Odense University Hospital ( Site 1701) | Odense | Syddanmark | Denmark | 5000 |
| 84 | TAYS ( Site 1801) | Tampere | Pirkanmaa | Finland | 33520 |
| 85 | Kuopion Yliopistollinen Sairaala ( Site 1803) | Kuopio | Pohjois-Savo | Finland | 70210 |
| 86 | HYKS ( Site 1800) | Helsinki | Uusimaa | Finland | 00290 |
| 87 | TYKS ( Site 1802) | Turku | Varsinais-Suomi | Finland | 20520 |
| 88 | Institut Paoli Calmettes ( Site 1206) | Marseille | Bouches-du-Rhone | France | 13009 |
| 89 | CHU Jean Minjoz ( Site 1205) | Besancon | Doubs | France | 25000 |
| 90 | Institut Claudius Regaud ( Site 1214) | Toulouse | Haute-Garonne | France | 31059 |
| 91 | Clinique Francois Chenieux ( Site 1209) | Limoges | Haute-Vienne | France | 87039 |
| 92 | CHU Angers ( Site 1200) | Angers | Maine-et-Loire | France | 49933 |
| 93 | Clinique Ambroise Pare Beuvry ( Site 1213) | Beuvry | Nord-Pas-de-Calais | France | 62660 |
| 94 | CH Lyon Sud Hospices Civils de Lyon ( Site 1203) | Pierre Benite | Rhone | France | 69310 |
| 95 | Gustave Roussy ( Site 1207) | Villejuif | Val-de-Marne | France | 94800 |
| 96 | Hopital Tenon ( Site 1212) | Paris | France | 75020 | |
| 97 | Universitaetsklinik fuer Urologie ( Site 1300) | Tuebingen | Baden-Wurttemberg | Germany | 72076 |
| 98 | Helios Kliniken Schwerin GmbH ( Site 1302) | Schwerin | Mecklenburg-Vorpommern | Germany | 19049 |
| 99 | Charite Universitaetsmedizin Berlin ( Site 1301) | Berlin | Germany | 10117 | |
| 100 | Centro Medico Integral de Cancerologia CEMIC ( Site 0701) | Salcaja | Quetzaltenango | Guatemala | 09002 |
| 101 | Oncomedica ( Site 0700) | Guatemala | Guatemala | 01010 | |
| 102 | Grupo Angeles SA ( Site 0705) | Guatemala | Guatemala | 01015 | |
| 103 | Sanatorio Nuestra Senora del Pilar ( Site 0702) | Guatemala | Guatemala | 01015 | |
| 104 | Medi-K Cayala ( Site 0703) | Guatemala | Guatemala | 01016 | |
| 105 | Centro Regional de Sub Especialidades Medicas SA ( Site 0704) | Quetzaltenango | Guatemala | 09001 | |
| 106 | Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2308) | Kecskemét | Bacs-Kiskun | Hungary | 6000 |
| 107 | Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 2309) | Gyula | Bekes | Hungary | 5700 |
| 108 | Jasz - Nagykun Szolnok megyei Hetenyi Geza Korhaz - Rendelointezet ( Site 2300) | Szolnok | Jasz-Nagykun-Szolnok | Hungary | 5004 |
| 109 | Markusovszky Egyetemi Oktatokorhaz ( Site 2303) | Szombathely | Vas | Hungary | 9700 |
| 110 | Orszagos Onkologiai Intezet ( Site 2304) | Budapest | Hungary | 1122 | |
| 111 | Debreceni Egyetem Klinikai Kozpont ( Site 2301) | Debrecen | Hungary | 4032 | |
| 112 | Azienda Ospedaliero - Universitaria Policlinico di Modena ( Site 1404) | Modena | Emilia-Romagna | Italy | |
| 113 | Fondazione Policlinico Universitario A. Gemelli ( Site 1414) | Rome | Roma | Italy | 00168 |
| 114 | Azienda Ospedaliera Policlinico di Bari ( Site 1411) | Bari | Italy | 70124 | |
| 115 | Ospedale San Raffaele-Oncologia Medica ( Site 1417) | Milano | Italy | 20132 | |
| 116 | Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1409) | Milano | Italy | 20133 | |
| 117 | Istituto Nazionale Tumori Fondazione Pascale ( Site 1412) | Napoli | Italy | 80131 | |
| 118 | Azienda Ospedaliera S. Maria di Terni ( Site 1410) | Terni | Italy | 05100 | |
| 119 | Fujita Health University ( Site 5003) | Toyoake | Aichi | Japan | 470-1192 |
| 120 | Chiba cancer center ( Site 5021) | Chiba-shi | Chiba | Japan | 260-8717 |
| 121 | National Cancer Center Hospital East ( Site 5000) | Kashiwa | Chiba | Japan | 277-8577 |
| 122 | Ehime University Hospital ( Site 5020) | Toon | Ehime | Japan | 791-0295 |
| 123 | Sapporo Medical University Hospital ( Site 5008) | Sapporo | Hokkaido | Japan | 060-8543 |
| 124 | Hokkaido University Hospital ( Site 5013) | Sapporo | Hokkaido | Japan | 060-8648 |
| 125 | Kanagawa cancer center ( Site 5016) | Yokohama | Kanagawa | Japan | 241-8515 |
| 126 | Nara Medical University Hospital ( Site 5002) | Kashihara | Nara | Japan | 634-8522 |
| 127 | Kindai University Hospital- Osakasayama Campus-Urology ( Site 5010) | Osakasayama | Osaka | Japan | 589-8511 |
| 128 | Osaka University Hospital ( Site 5012) | Suita | Osaka | Japan | 565-0871 |
| 129 | Saitama Medical University International Medical Center ( Site 5015) | Hidaka-city | Saitama | Japan | 350-1298 |
| 130 | Hamamatsu University School of Medicine University Hospital ( Site 5004) | Hamamatsu | Shizuoka | Japan | 431-3192 |
| 131 | Tokyo Medical And Dental University Medical Hospital-Urology ( Site 5009) | Bunkyō | Tokyo | Japan | 113-8519 |
| 132 | Toranomon Hospital ( Site 5001) | Minato-ku | Tokyo | Japan | 105-8470 |
| 133 | Toyama University Hospital ( Site 5014) | Toyoma | Toyama | Japan | 930-0194 |
| 134 | Kyushu University Hospital ( Site 5005) | Fukuoka | Japan | 812-8582 | |
| 135 | Kumamoto University ( Site 5022) | Kumamoto | Japan | 860-8556 | |
| 136 | Okayama University Hospital ( Site 5017) | Okayama | Japan | 700-8558 | |
| 137 | Tokushima University Hospital-Department of Urology ( Site 5019) | Tokushima | Japan | 770-8503 | |
| 138 | Nippon Medical School Hospital ( Site 5006) | Tokyo | Japan | 113-8603 | |
| 139 | Tokyo Women's Medical University Adachi Medical Center ( Site 5023) | Tokyo | Japan | 123-8558 | |
| 140 | Keio university hospital ( Site 5011) | Tokyo | Japan | 160-8582 | |
| 141 | National Cancer Center ( Site 4202) | Goyang-si | Kyonggi-do | Korea, Republic of | 10408 |
| 142 | Chungnam National University Hospital ( Site 4205) | Daejeon | Taejon-Kwangyokshi | Korea, Republic of | 35015 |
| 143 | Korea University Anam Hospital ( Site 4206) | Seoul | Korea, Republic of | 02841 | |
| 144 | Seoul National University Hospital ( Site 4201) | Seoul | Korea, Republic of | 03080 | |
| 145 | Severance Hospital Yonsei University Health System ( Site 4204) | Seoul | Korea, Republic of | 03722 | |
| 146 | Asan Medical Center ( Site 4203) | Seoul | Korea, Republic of | 05505 | |
| 147 | Samsung Medical Center ( Site 4200) | Seoul | Korea, Republic of | 06351 | |
| 148 | Hospital Sultan Ismail ( Site 4303) | Johor Bahru | Johor | Malaysia | 81100 |
| 149 | Institut Kanser Negara - National Cancer Institute ( Site 4302) | Putrajaya | Wilayah Persekutuan Putrajaya | Malaysia | 62250 |
| 150 | Hospital Kuala Lumpur ( Site 4301) | Kuala Lumpur | Malaysia | 50586 | |
| 151 | Universiti Malaya Medical Centre ( Site 4300) | Kuala Lumpur | Malaysia | 59100 | |
| 152 | Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0610) | Guadalajara | Jalisco | Mexico | 44280 |
| 153 | I CAN Oncology SA de SV ( Site 0601) | Monterrey | Nuevo Leon | Mexico | 64710 |
| 154 | Cuidados Oncologicos ( Site 0608) | Santiago De Quetaro | Queretaro | Mexico | 76000 |
| 155 | Instituto Nacional de Cancerologia ( Site 0602) | Cdmx | Mexico | 14080 | |
| 156 | Centro de Investigacion Clinica de Oaxaca ( Site 0605) | Oaxaca | Mexico | 68020 | |
| 157 | Akershus universitetssykehus ( Site 2000) | Lorenskog | Akershus | Norway | 1478 |
| 158 | Soerlandet sykehus HF Kristiansand ( Site 2007) | Kristiansand | Aust-Agder | Norway | 4615 |
| 159 | Helse Bergen HF - Haukeland Universitetssykehus ( Site 2002) | Bergen | Hordaland | Norway | 5021 |
| 160 | Sykehuset Østfold HF Kalnes ( Site 2003) | Gralum | Ostfold | Norway | 1714 |
| 161 | St. Olavs Hospital HF ( Site 2005) | Trondheim | Sor-Trondelag | Norway | 7030 |
| 162 | Oslo Universitetssykehus Radiumhospitalet ( Site 2001) | Oslo | Norway | 0379 | |
| 163 | Manila Doctors Hospital ( Site 4601) | Manila | National Capital Region | Philippines | 1000 |
| 164 | The Medical City ( Site 4602) | Pasig City | National Capital Region | Philippines | 1605 |
| 165 | Cardinal Santos Medical Center ( Site 4603) | San Juan | National Capital Region | Philippines | 1502 |
| 166 | Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2420) | Bydgoszcz | Kujawsko-pomorskie | Poland | 85-796 |
| 167 | Radomskie Centrum Onkologii ( Site 2418) | Radom | Mazowieckie | Poland | 26-600 |
| 168 | Luxmed Onkologia sp. z o. o. ( Site 2412) | Warszawa | Mazowieckie | Poland | 01-748 |
| 169 | Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 2405) | Warszawa | Mazowieckie | Poland | 02-781 |
| 170 | Przychodnia Lekarska KOMED ( Site 2419) | Konin | Wielkopolskie | Poland | 62-500 |
| 171 | Szpital Kliniczny Przemienienia Panskiego UM im. K. Marcinkowskiego ( Site 2406) | Poznan | Wielkopolskie | Poland | 60-569 |
| 172 | Szpital Wojewodzki im. Mikolaja Kopernika ( Site 2407) | Koszalin | Zachodniopomorskie | Poland | 75-581 |
| 173 | Altay Regional Oncology Dispensary ( Site 2610) | Barnaul | Altayskiy Kray | Russian Federation | 656045 |
| 174 | Ivanovo Regional Oncology Dispensary ( Site 2615) | Ivanovo | Ivanovskaya Oblast | Russian Federation | 153040 |
| 175 | Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 2609) | Krasnoyarsk | Krasnoyarskiy Kray | Russian Federation | 660133 |
| 176 | The Loginov Moscow Clinical Scientific Center ( Site 2604) | Moscow | Moskva | Russian Federation | 111123 |
| 177 | Moscow Oncological Clinical Dispensary #1 ( Site 2619) | Moscow | Moskva | Russian Federation | 129090 |
| 178 | Nizhniy Novgorod Region Oncology Dispensary ( Site 2621) | Nizhniy Novgorod | Nizhegorodskaya Oblast | Russian Federation | 603081 |
| 179 | FBHI Privolzhsky District Medical Center of the FMBA ( Site 2611) | Nizhny Novgorod | Nizhegorodskaya Oblast | Russian Federation | 603074 |
| 180 | Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 2617) | Saint Petersburg | Sankt-Peterburg | Russian Federation | 197758 |
| 181 | City clinical oncological dispensary ( Site 2605) | Sankt-Petersburg | Sankt-Peterburg | Russian Federation | 198255 |
| 182 | Klinicki centar Srbije. ( Site 3333) | Belgrade | Beograd | Serbia | 112106 |
| 183 | Klinicki centar Nis ( Site 3322) | Nis | Nisavski Okrug | Serbia | 18000 |
| 184 | Cancer Care Langenhoven Drive Oncology Centre ( Site 3009) | Port Elizabeth | Eastern Cape | South Africa | 6045 |
| 185 | Wits Clinical Research ( Site 3012) | Johannesburg | Gauteng | South Africa | 2193 |
| 186 | Sandton Oncology Medical Group PTY LTD ( Site 3000) | Johannesburg | Gauteng | South Africa | 2196 |
| 187 | Univ. Pretoria and Steve Biko Academic Hospitals ( Site 3002) | Pretoria | Gauteng | South Africa | 0002 |
| 188 | Life Wilgers Hospital ( Site 3004) | Pretoria | Gauteng | South Africa | 0040 |
| 189 | Mary Potter Oncology Centre, Little Company of Mary Hospital ( Site 3001) | Pretoria | Gauteng | South Africa | 0181 |
| 190 | Vaal Triangle Oncology Centre ( Site 3010) | Vereeniging | Gauteng | South Africa | 1939 |
| 191 | Groote Schuur Hospital ( Site 3011) | Cape Town | Western Cape | South Africa | 7925 |
| 192 | Cape Town Oncology Trials Pty Ltd ( Site 3006) | Kraaifontein | Western Cape | South Africa | 7570 |
| 193 | Cancercare Rondebosch Oncology ( Site 3005) | Rondebosch | Western Cape | South Africa | 7700 |
| 194 | Instituto Catalan de Oncologia - ICO ( Site 1502) | L Hospitalet De Llobregat | Barcelona | Spain | 08908 |
| 195 | Hospital Universitario Marques de Valdecilla ( Site 1501) | Santander | Cantabria | Spain | 39008 |
| 196 | Hospital Universitario de Girona Doctor Josep Trueta ( Site 1500) | Girona | Gerona | Spain | 17007 |
| 197 | Hospital Clinico San Carlos ( Site 1503) | Madrid | Spain | 28040 | |
| 198 | Hospital Universitario 12 de Octubre ( Site 1505) | Madrid | Spain | 28041 | |
| 199 | Hospital Universitario Virgen de la Victoria ( Site 1504) | Malaga | Spain | 29016 | |
| 200 | Lanssjukhuset Ryhov ( Site 2103) | Jonkoping | Jonkopings Lan | Sweden | 551 85 |
| 201 | Karolinska Universitetssjukhuset Solna ( Site 2100) | Stockholm | Stockholms Lan | Sweden | 171 76 |
| 202 | Akademiska Sjukhuset ( Site 2105) | Uppsala | Uppsala Lan | Sweden | 751 85 |
| 203 | Norrlands Universitetssjukhus ( Site 2106) | Umea | Vasterbottens Lan | Sweden | 901 85 |
| 204 | Sahlgrenska Universitetssjukhuset ( Site 2102) | Goteborg | Vastra Gotalands Lan | Sweden | 413 45 |
| 205 | Chang Gung Medical Foundation. Kaohsiung Branch ( Site 4405) | Kaohsiung | Taiwan | 833 | |
| 206 | Taichung Veterans General Hospital ( Site 4403) | Taichung | Taiwan | 40705 | |
| 207 | National Cheng Kung University Hospital ( Site 4404) | Tainan | Taiwan | 704 | |
| 208 | National Taiwan University Hospital ( Site 4401) | Taipei | Taiwan | 100 | |
| 209 | Taipei Veterans General Hospital ( Site 4402) | Taipei | Taiwan | 11217 | |
| 210 | Ramathibodi Hospital. ( Site 4500) | Bangkok | Krung Thep Maha Nakhon | Thailand | 10400 |
| 211 | Siriraj Hospital ( Site 4501) | Bangkok | Krung Thep Maha Nakhon | Thailand | 10700 |
| 212 | Ankara Universitesi Tip Fakultesi ( Site 2902) | Ankara | Turkey | 06100 | |
| 213 | Hacettepe Universitesi Tıp Fakultesi ( Site 2903) | Ankara | Turkey | 06100 | |
| 214 | Trakya University Medical Faculty Balkan Oncology Hospital ( Site 2906) | Edirne | Turkey | 22030 | |
| 215 | Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2900) | Istanbul | Turkey | 34098 | |
| 216 | TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2901) | Istanbul | Turkey | 34722 | |
| 217 | Ege Universitesi Tip Fakultesi Hastanesi ( Site 2904) | Izmir | Turkey | 35040 | |
| 218 | Dokuz Eylul Universitesi Tip Fakultesi Hastanesi ( Site 2905) | Izmir | Turkey | 35340 | |
| 219 | Cherkasy Regional Oncology Dispensary ( Site 2704) | Cherkasy | Cherkaska Oblast | Ukraine | 18009 |
| 220 | Chernihiv Medical Center of Modern Oncology ( Site 2709) | Chernihiv | Chernihivska Oblast | Ukraine | 14029 |
| 221 | MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov ( Site 2710) | Dnipropetrovsk | Dnipropetrovska Oblast | Ukraine | 49005 |
| 222 | Clinical oncology dispensary of Dnipro ( Site 2700) | Dnipro | Dnipropetrovska Oblast | Ukraine | 49055 |
| 223 | Ivano-Frankivsk Regional Hospital-Urology department ( Site 2707) | Ivano-Frankivsk | Ivano-Frankivska Oblast | Ukraine | 76008 |
| 224 | Ivano-Frankivsk Regional Oncology Clinical Dispensary ( Site 2711) | Ivano-Frankivsk | Ivano-Frankivska Oblast | Ukraine | 76018 |
| 225 | Regional Oncology Center of Kharkiv ( Site 2708) | Kharkiv | Kharkivska Oblast | Ukraine | 61000 |
| 226 | Reg. Clinical Center of Urology and Nephrology n.a. V. I. Shapoval ( Site 2715) | Kharkiv | Kharkivska Oblast | Ukraine | 61037 |
| 227 | Kyiv City Clinical Oncology Center ( Site 2706) | Kyiv | Kyivska Oblast | Ukraine | 03115 |
| 228 | Lviv State Regional Oncological Center ( Site 2712) | Lviv | Lvivska Oblast | Ukraine | 79031 |
| 229 | Barts Health NHS Trust - St Bartholomew s Hospital ( Site 3116) | London | England | United Kingdom | EC1A 7BE |
| 230 | Mount Vernon Cancer Centre ( Site 3101) | Northwood | London, City Of | United Kingdom | HA6 2RN |
Sponsors and Collaborators
- Merck Sharp & Dohme LLC
- Eisai Inc.
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 6482-012
- MK-6482-012
- jRCT2031210435
- PHRR210911-003887
- 2020-002216-52