A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Belzutifan + Lenvatinib Belzutifan 120 mg and lenvatinib 20 mg orally once a day |
Drug: Belzutifan
Immediate-release 40 mg tablet
Other Names:
Drug: Lenvatinib
Capsule available in 4 mg and 10 mg dosages
Other Names:
|
| Active Comparator: Cabozantinib Cabozantinib 60 mg orally once a day |
Drug: Cabozantinib
Tablet available in 20 mg, 40 mg and 60 mg dosages
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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) [Up to approximately 34 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 blinded independent central review will be presented.
- Overall Survival (OS) [Up to approximately 44 months]
OS is defined as time from randomization to death due to any cause.
Secondary Outcome Measures
- 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) [Up to approximately 24 months]
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.
- 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) [Up to approximately 44 months]
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.
- Number of Participants Who Experienced One or More Adverse Events (AEs) [Up to approximately 44 months]
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.
- Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE) [Up to approximately 44 months]
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.
Eligibility Criteria
Criteria
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 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.
-
Received only 1 prior antiPD-1/L1 therapy for 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 she is 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.
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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.
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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.
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Prior treatment with belzutifan or another hypoxia-inducible factor (HIF)-2α inhibitor.
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Prior treatment with lenvatinib.
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Prior treatment with cabozantinib.
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Currently participating in a study of an investigational agent or using an investigational device.
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Active infection requiring systemic therapy.
-
History of human immunodeficiency virus (HIV) infection.
-
History of hepatitis B or known active hepatitis C infection.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ironwood Cancer & Research Centers ( Site 0077) | Chandler | Arizona | United States | 85224 |
| 2 | Cedars Sinai Medical Center ( Site 0027) | Los Angeles | California | United States | 90048 |
| 3 | UCLA Hematology/Oncology - Santa Monica ( Site 0048) | Los Angeles | California | United States | 90404 |
| 4 | St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 0095) | Orange | California | United States | 92868 |
| 5 | UC Irvine Health ( Site 0029) | Orange | California | United States | 92868 |
| 6 | Providence Saint John's Health Center ( Site 0083) | Santa Monica | California | United States | 90404 |
| 7 | Georgetown University Medical Center ( Site 0006) | Washington | District of Columbia | United States | 20007 |
| 8 | AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0003) | Orlando | Florida | United States | 32804 |
| 9 | Orlando Health, Inc. ( Site 0035) | Orlando | Florida | United States | 32806 |
| 10 | University Cancer & Blood Center, LLC ( Site 0057) | Athens | Georgia | United States | 30607 |
| 11 | Emory University Hospital ( Site 0012) | Atlanta | Georgia | United States | 30322 |
| 12 | Rush University Medical Center ( Site 0040) | Chicago | Illinois | United States | 60612 |
| 13 | Illinois Cancer Care, PC ( Site 0008) | Peoria | Illinois | United States | 61615 |
| 14 | Parkview Cancer Institute ( Site 0088) | Fort Wayne | Indiana | United States | 46845 |
| 15 | Norton Cancer Institute - St. Matthews ( Site 0065) | Louisville | Kentucky | United States | 40207 |
| 16 | Tulane University School of Medicine ( Site 0098) | New Orleans | Louisiana | United States | 70112 |
| 17 | Lahey Hospital & Medical Center ( Site 0090) | Burlington | Massachusetts | United States | 01805 |
| 18 | Cancer & Hematology Centers of Western Michigan ( Site 0018) | Grand Rapids | Michigan | United States | 49503 |
| 19 | HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0005) | Saint Louis Park | Minnesota | United States | 55426 |
| 20 | University of Mississippi Medical Ctr ( Site 0037) | Jackson | Mississippi | United States | 39213 |
| 21 | Cancer Partners of Nebraska ( Site 0086) | Lincoln | Nebraska | United States | 68510 |
| 22 | Rutgers Cancer Institute of New Jersey ( Site 0078) | New Brunswick | New Jersey | United States | 08903 |
| 23 | Northwell Health- Monter Cancer Center ( Site 0013) | Lake Success | New York | United States | 11042 |
| 24 | Memorial Sloan Kettering Cancer Center ( Site 0055) | New York | New York | United States | 10065 |
| 25 | Levine Cancer Institute ( Site 0004) | Charlotte | North Carolina | United States | 28204 |
| 26 | Lehigh Valley Hospital- Cedar Crest-Oncology Clinical Trials ( Site 0056) | Allentown | Pennsylvania | United States | 18103 |
| 27 | University of Texas, Southwestern Medical Center ( Site 0015) | Dallas | Texas | United States | 75390 |
| 28 | University of Vermont Medical Center ( Site 0001) | Burlington | Vermont | United States | 05401 |
| 29 | Blue Ridge Cancer Care - Roanoke ( Site 0043) | Roanoke | Virginia | United States | 24014 |
| 30 | Seattle Cancer Care Alliance-Renal/Melanoma/MCC ( Site 0093) | Seattle | Washington | United States | 98109 |
| 31 | Confluence Health | Wenatchee Valley Hospital & Clinics ( Site 0061) | Wenatchee | Washington | United States | 98801 |
| 32 | GenesisCare North Shore ( Site 4011) | St Leonards | New South Wales | Australia | 2065 |
| 33 | Lyell McEwin Hospital ( Site 4004) | Elizabeth Vale | South Australia | Australia | 5112 |
| 34 | Peninsula Health Frankston Hospital ( Site 4001) | Frankston | Victoria | Australia | 3199 |
| 35 | Peter MacCallum Cancer Centre ( Site 4010) | Melbourne | Victoria | Australia | 3000 |
| 36 | Ordensklinikum Linz GmbH Elisabethinen-Urologie ( Site 1001) | Linz | Oberosterreich | Austria | 4020 |
| 37 | Medizinische Universitätsklinik Graz ( Site 1051) | Graz | Steiermark | Austria | 8036 |
| 38 | Klinik Ottakring-1.Medizinische Abteilung - Zentrum für Onkologie und Hämatologie ( Site 1031) | Vienna | Wien | Austria | 1160 |
| 39 | Krankenhaus der Barmherzigen Brüder Wien ( Site 1041) | Wien | Austria | 1020 | |
| 40 | Medizinische Universität Wien ( Site 1021) | Wien | Austria | 1090 | |
| 41 | Institut Jules Bordet ( Site 1103) | Anderlecht | Bruxelles-Capitale, Region De | Belgium | 1070 |
| 42 | Grand Hopital de Charleroi ( Site 1104) | Charleroi | Hainaut | Belgium | 6000 |
| 43 | UZ Gent ( Site 1100) | Gent | Oost-Vlaanderen | Belgium | 9000 |
| 44 | UZ Leuven ( Site 1101) | Leuven | Vlaams-Brabant | Belgium | 3000 |
| 45 | CHU de Liege ( Site 1102) | Liege | Belgium | 4000 | |
| 46 | Liga Norte Riograndense Contra o Cancer ( Site 0313) | Natal | Rio Grande Do Norte | Brazil | 59151600 |
| 47 | Centro Gaucho Integrado de Oncologia ( Site 0304) | Porto Alegre | Rio Grande Do Sul | Brazil | 90110-270 |
| 48 | Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0311) | Sao Paulo | Brazil | 01323-900 | |
| 49 | CISSS de la Monteregie-Centre ( Site 0103) | Greenfield Park | Quebec | Canada | J4V 2H1 |
| 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 | CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0102) | Sherbrooke | Quebec | Canada | J1H 5N4 |
| 52 | Bradfordhill-Clinical Area ( Site 0400) | Santiago | Region M. De Santiago | Chile | 8420383 |
| 53 | Clínica Vida Fundación - Sede Poblado ( Site 0505) | Medellin | Antioquia | Colombia | 050030 |
| 54 | Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 0508) | Valledupar | Cesar | Colombia | 200001 |
| 55 | Instituto Nacional de Cancerología-Clinical Oncology ( Site 0500) | Bogotá | Cundinamarca | Colombia | 111511 |
| 56 | Fundación Cardiovascular de Colombia ( Site 0501) | Piedecuesta | Santander | Colombia | 681017 |
| 57 | Tampereen yliopistollinen sairaala ( Site 1801) | Tampere | Pirkanmaa | Finland | 33520 |
| 58 | HYKS ( Site 1800) | Helsinki | Uusimaa | Finland | 00290 |
| 59 | TYKS ( Site 1802) | Turku | Varsinais-Suomi | Finland | 20520 |
| 60 | Institut Jean Godinot ( Site 1216) | Reims | Ain | France | 51726 |
| 61 | Centre Antoine Lacassagne ( Site 1217) | Nice | Alpes-Maritimes | France | 06189 |
| 62 | CHU de Bordeaux- Hopital Saint Andre ( Site 1209) | Bordeaux | Gironde | France | 33075 |
| 63 | Institut Claudius Regaud ( Site 1215) | Toulouse | Haute-Garonne | France | 31059 |
| 64 | Clinique Francois Chenieux ( Site 1210) | Limoges | Haute-Vienne | France | 87039 |
| 65 | Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 1201) | Saint Herblain | Loire-Atlantique | France | 44805 |
| 66 | Institut de Cancerologie de l Ouest Site Paul Papin ( Site 1200) | Angers | Maine-et-Loire | France | 49055 |
| 67 | Hopital Tenon ( Site 1213) | Paris | France | 75020 | |
| 68 | Klinik fuer Urologie ( Site 1303) | Freiburg | Baden-Wurttemberg | Germany | 79106 |
| 69 | NCT-Department of Medical Oncology ( Site 1320) | Heidelberg | Baden-Wurttemberg | Germany | 69120 |
| 70 | Klinikum Nuernberg Nord ( Site 1300) | Nuremberg | Bayern | Germany | 90419 |
| 71 | Universitaetsklinikum Frankfurt ( Site 1301) | Frankfurt am Main | Hessen | Germany | 60590 |
| 72 | Universitaetsklinikum Aachen AOER ( Site 1317) | Aachen | Nordrhein-Westfalen | Germany | 52074 |
| 73 | Krankenhaus Martha Maria Halle-Doelau ( Site 1314) | Halle | Sachsen-Anhalt | Germany | 06120 |
| 74 | Helios Klinikum Erfurt GmbH ( Site 1315) | Erfurt | Thuringen | Germany | 99089 |
| 75 | Charite Universitaetsmedizin Berlin ( Site 1321) | Berlin | Germany | 10117 | |
| 76 | HELIOS Klinikum Berlin-Buch ( Site 1311) | Berlin | Germany | 13125 | |
| 77 | Mater Misericordiae University Hospital ( Site 3201) | Dublin 7 | Dublin | Ireland | D07 A8NN |
| 78 | Mater Private Hospital - Dublin ( Site 3202) | Dublin | Ireland | D07 R2WY | |
| 79 | Tallaght University Hospital ( Site 3200) | Dublin | Ireland | Dublin24 | |
| 80 | Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 1407) | Meldola | Forli-Cesena | Italy | 47014 |
| 81 | Istituto Clinico Humanitas Research Hospital ( Site 1406) | Rozzano | Milano | Italy | 20089 |
| 82 | Ospedale San Luigi Gonzaga ( Site 1405) | Orbassano | Torino | Italy | 10043 |
| 83 | Medical Oncology Ospedale San Donato ( Site 1404) | Arezzo | Italy | 52100 | |
| 84 | Azienda Ospedaliera Policlinico di Bari ( Site 1402) | Bari | Italy | 70124 | |
| 85 | IRCCS Ospedale San Raffaele ( Site 1409) | Milano | Italy | 20132 | |
| 86 | Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1400) | Milano | Italy | 20133 | |
| 87 | Istituti Clinici Scientifici Maugeri Spa ( Site 1403) | Pavia | Italy | 27100 | |
| 88 | Fondazione Policlinico Universitario Agostino Gemelli-Medical Oncology ( Site 1410) | Roma | Italy | 00168 | |
| 89 | Azienda Ospedaliera S. Maria di Terni ( Site 1401) | Terni | Italy | 05100 | |
| 90 | Ospedale Maggiore Borgo Trento ( Site 1408) | Verona | Italy | 37126 | |
| 91 | Fujita Health University ( Site 5003) | Toyoake | Aichi | Japan | 470-1192 |
| 92 | National Cancer Center Hospital East ( Site 5000) | Kashiwa | Chiba | Japan | 2778577 |
| 93 | Sapporo Medical University Hospital ( Site 5008) | Sapporo | Hokkaido | Japan | 060-8543 |
| 94 | Yokohama City University Hospital ( Site 5007) | Yokohama | Kanagawa | Japan | 236-0004 |
| 95 | Nara Medical University Hospital ( Site 5002) | Kashihara | Nara | Japan | 634-8522 |
| 96 | Kindai University Hospital- Osakasayama Campus-Urology ( Site 5010) | Osakasayama | Osaka | Japan | 589-8511 |
| 97 | Osaka University Hospital ( Site 5012) | Suita | Osaka | Japan | 565-0871 |
| 98 | Hamamatsu University School of Medicine University Hospital ( Site 5004) | Hamamatsu | Shizuoka | Japan | 431-3192 |
| 99 | Tokyo Medical And Dental University Medical Hospital ( Site 5009) | Bunkyo-ku | Tokyo | Japan | 113-8510 |
| 100 | Toranomon Hospital ( Site 5001) | Minato-ku | Tokyo | Japan | 105-8470 |
| 101 | Kyushu University Hospital ( Site 5005) | Fukuoka | Japan | 812-8582 | |
| 102 | Nippon Medical School Hospital ( Site 5006) | Tokyo | Japan | 113-8603 | |
| 103 | Keio university hospital ( Site 5011) | Tokyo | Japan | 160-8582 | |
| 104 | Chonnam National University Hwasun Hospital-Oncology ( Site 4203) | Hwasun | Jeonranamdo | Korea, Republic of | 58128 |
| 105 | Samsung Medical Center ( Site 4201) | Seoul | Korea, Republic of | 06351 | |
| 106 | Medisch Centrum Leeuwarden ( Site 1905) | Leeuwarden | Fryslan | Netherlands | 8934 AD |
| 107 | Zuyderland Medical Centre-Trialbureau Interne Geneeskunde ( Site 1904) | Sittard-Geleen | Limburg | Netherlands | 6162 BG |
| 108 | Amphia Hospital Location Molengracht ( Site 1912) | Breda | Noord-Brabant | Netherlands | 4818 CK |
| 109 | Antoni van Leeuwenhoek Ziekenhuis ( Site 1901) | Amsterdam | Noord-Holland | Netherlands | 1066 CX |
| 110 | Erasmus MC ( Site 1913) | Rotterdam | Zuid-Holland | Netherlands | 3015 GD |
| 111 | Universitair Medisch Centrum Utrecht ( Site 1910) | Utrecht | Netherlands | 3584 CX | |
| 112 | Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 2402) | Bydgoszcz | Kujawsko-pomorskie | Poland | 85-796 |
| 113 | Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - O-Klinika Onkologii Klinicznej ( Site 240 | Krakow | Malopolskie | Poland | 31-115 |
| 114 | Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 2400) | Warszawa | Mazowieckie | Poland | 02-781 |
| 115 | Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego ( Site 2401) | Poznan | Wielkopolskie | Poland | 60-569 |
| 116 | Ivanovo Regional Oncology Dispensary ( Site 2616) | Ivanovo | Ivanovskaya Oblast | Russian Federation | 153040 |
| 117 | MEDSI Clinical Hospital on Pyatnitsky Highway-Departmentof Antitumor Drug therapy ( Site 2618) | Krasnogorsk | Moskovskaya Oblast | Russian Federation | 143442 |
| 118 | Hadassah Medical-Oncology department ( Site 2609) | Moscow | Moskovskaya Oblast | Russian Federation | 121205 |
| 119 | FSBI United Hospital with Polyclinic ( Site 2613) | Moscow | Moskva | Russian Federation | 119285 |
| 120 | SHI of Moscow City Oncology Clinical Hospital - 62 ( Site 2614) | Moscow | Moskva | Russian Federation | 125130 |
| 121 | Volgograd Regional Uronephrological Center ( Site 2615) | Volzhsky | Volgogradskaya Oblast | Russian Federation | 404120 |
| 122 | Yaroslavl Regional Cancer Hospital-Oncology ( Site 2619) | Yaroslavl | Yaroslavskaya Oblast | Russian Federation | 150054 |
| 123 | Complejo Hospitalario Universitario A Coruna ( Site 1502) | A Coruna | La Coruna | Spain | 15006 |
| 124 | Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1508) | Madrid | Madrid, Comunidad De | Spain | 28041 |
| 125 | Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1507) | Barcelona | Spain | 08035 | |
| 126 | Hospital Clinic i Provincial ( Site 1500) | Barcelona | Spain | 08036 | |
| 127 | Hospital Santa Creu i Sant Pau ( Site 1501) | Barcelona | Spain | 08041 | |
| 128 | Hospital General Universitario Gregorio Maranon ( Site 1505) | Madrid | Spain | 28009 | |
| 129 | Hospital Clinico San Carlos ( Site 1504) | Madrid | Spain | 28040 | |
| 130 | Hospital Virgen del Rocio ( Site 1503) | Sevilla | Spain | 41013 | |
| 131 | Hopitaux Universitaires de Geneve HUG ( Site 1602) | Geneva | Geneve | Switzerland | 1211 |
| 132 | Kantonsspital Graubuenden ( Site 1600) | Chur | Grisons | Switzerland | 7000 |
| 133 | Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 1604) | Bellinzona | Ticino | Switzerland | 6500 |
| 134 | Universitaetsspital Zuerich ( Site 1601) | Zuerich | Zurich | Switzerland | 8091 |
| 135 | Aberdeen Royal Infirmary-Department of Oncology ( Site 3105) | Aberdeen | Aberdeen City | United Kingdom | AB25 2ZN |
| 136 | Nottingham University Hospitals NHS Trust. City Hospital Campus ( Site 3106) | Nottingham | England | United Kingdom | ng5 1pb |
| 137 | Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 3107) | London | London, City Of | United Kingdom | W6 8RF |
| 138 | Mount Vernon Cancer Centre ( Site 3101) | Northwood | London, City Of | United Kingdom | HA6 2RN |
| 139 | Singleton Hospital ( Site 3111) | Swansea | Wales | United Kingdom | SA2 8QA |
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.- 6482-011
- MK-6482-011
- jRCT2031210311
- 2020-002075-35