A Study of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Clear Cell Renal Cell Carcinoma Post Nephrectomy (MK-6482-022)
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the efficacy and safety of oral belzutifan (MK-6482) plus intravenous (IV) pembrolizumab (MK-3475) compared to placebo plus pembrolizumab, in the adjuvant treatment of Clear Cell Renal Cell Carcinoma (ccRCC) post nephrectomy.
The primary study hypothesis is that belzutifan plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Belzutifan + Pembrolizumab Participants receive belzutifan 120 mg orally once daily (QD) for up to approximately 54 weeks PLUS pembrolizumab 400 mg via intravenous (IV) infusion once every 6 weeks (Q6W) for up to 9 administrations (up to approximately 54 weeks). |
Drug: Belzutifan
Three 40 mg tablets given as a single oral 120 mg dose.
Other Names:
Biological: Pembrolizumab
400 mg via IV infusion
Other Names:
|
| Experimental: Placebo + Pembrolizumab Participants receive placebo orally QD for up to approximately 54 weeks PLUS pembrolizumab 400 mg via IV infusion once Q6W for up to 9 administrations (up to approximately 54 weeks). |
Biological: Pembrolizumab
400 mg via IV infusion
Other Names:
Drug: Placebo
Oral tablet
|
Outcome Measures
Primary Outcome Measures
- Disease-Free Survival (DFS) [Up to approximately 66 months]
DFS is defined as the time from randomization to the first documented local recurrence, or occurrence of distant kidney cancer metastasis(es) as assessed by investigator, or death due to any cause, whichever occurs first. The DFS for all participants will be presented.
Secondary Outcome Measures
- Overall Survival (OS) [Up to approximately 94 months]
OS is defined as the time from randomization to death due to any cause.
- Number of Participants Who Experience At Least One Adverse event (AE) [Up to approximately 66 weeks]
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. 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. The number of participants who experienced an AE will be reported.
- Number of Participants Who Discontinue Study Treatment Due to an AE [Up to approximately 54 weeks]
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. 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. The number of participants who discontinued the study due to an AE will be reported.
- Disease Recurrence-Specific Survival 1 (DRSS1) [Up to approximately 66 months]
DRSS1 is defined as the time from randomization to the first documented local recurrence of RCC as assessed by the investigator. For DRSS1, only local recurrence is counted as an event.
- Disease Recurrence-Specific Survival 2 (DRSS2) [Up to approximately 66 months]
DRSS2 is defined as the time from randomization to the first documented local recurrence with visceral lesion or occurrence of distant kidney cancer metastasis(es) with visceral lesion, whichever occurs first, as assessed by investigator.
- Change From Baseline in Health-Related Quality-of-Life (HRQoL) Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 29 and 30 Score [Baseline (Day 1) and Up to approximately 66 months]
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of participants with cancer. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be presented.
- Change From Baseline in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score [Baseline (Day 1) and Up to approximately 66 months]
The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. Change from baseline in the score of EORTC QLQ-C30 Items 1-5 will be presented.
- Change From Baseline in Role Functioning Using the EORTC QLQ-C30 Items 6 and 7 Score [Baseline (Day 1) and Up to approximately 66 months]
The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. Change from baseline in the score of EORTC QLQ-C30 Items 6-7 will be presented.
- Change From Baseline in Disease Symptoms Using the Functional Assessment of Cancer Therapy-Kidney Symptom Index-Disease-related Symptoms (FKSI-DRS) Items 1-9 Score [Baseline (Day 1) and Up to approximately 66 months]
The FKSI-DRS index consists of a 9-item questionnaire that assesses the extent of participant symptoms from kidney cancer. Responses are scored on a 5-point scale (0=Not at all to 4=Very much) and summed to generate an index symptom score. These scores can range from 0 to 36, with a higher score indicating more favorable kidney cancer symptom status. Change from baseline in the score of FKSI-DRS Items 1-9 will be presented.
Eligibility Criteria
Criteria
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
-
Has a histologically or cytologically confirmed diagnosis of RCC with clear cell component per American Joint Committee on Cancer (AJCC) (8th Edition), with or without sarcomatoid features
-
Has intermediate-high risk, high risk, or M1 no evidence of disease (NED) RCC as defined by the following pathological tumor-node metastasis and tumor grading:
-
Intermediate-high risk RCC: pT2, Grade 4 or sarcomatoid, N0, M0; pT3, any grade, N0, M0
-
High risk RCC: pT4, any Grade N0, M0; pT any stage, any Grade, N+, M0
-
M1 NED RCC participants who present not only with the primary kidney tumor but also solid, isolated, soft tissue metastases that can be completely resected at one of the following: the time of nephrectomy (synchronous) or, ≤2 years from nephrectomy (metachronous)
-
Has undergone complete resection of the primary tumor (partial or radical nephrectomy) and complete resection of solid, isolated, soft tissue metastatic lesion(s) in M1 NED participants
-
Must have undergone a nephrectomy and/or metastasectomy ≤12 weeks prior to randomization
-
Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 10 days before randomization.
-
Male participants must agree to continue contraception at least 7 days after the last dose of belzutifan/placebo
-
Female participants of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of pembrolizumab or at least 30 days after last dose of belzutifan/placebo, whichever occurs last
-
Has adequate organ function
Exclusion Criteria:
-
Has had a major surgery, other than nephrectomy plus resection of preexisting metastases for M1 NED participants, within 4 weeks prior to randomization
-
Has a pulse oximeter reading <92% at rest, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen
-
Has clinically significant cardiovascular disease within 6 months from first dose of study intervention
-
Has other clinically significant disorders such as: serious active nonhealing wound/ulcer/bone fracture; requirement for hemodialysis or peritoneal dialysis
-
Has preexisting brain or bone metastatic lesions
-
Has received prior systemic therapy for RCC
-
Has received prior radiotherapy for RCC
-
Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention; administration of killed vaccines are allowed
-
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
-
Has a known additional malignancy (other than RCC treated with nephrectomy and/or metastasectomy) that is progressing or has required active treatment within the past 3 years
-
Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs); replacement therapy is allowed
-
Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
-
Has an active infection, requiring systemic therapy
-
Has a known history of human immunodeficiency virus (HIV) infection, a known history of Hepatitis B or known active Hepatitis C virus infection
-
Has had an allogenic tissue/solid organ transplant
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | City of Hope Comprehensive Cancer Center ( Site 3567) | Duarte | California | United States | 91010 |
| 2 | Stanford Cancer Center ( Site 3523) | Palo Alto | California | United States | 94304 |
| 3 | University of Colorado Anschutz Medical Campus ( Site 3514) | Aurora | Colorado | United States | 80045 |
| 4 | St. Mary's Hospital and Regional Medical Center-SCL Health Cancer Centers of Colorado-St. Mary's ( S | Grand Junction | Colorado | United States | 81501 |
| 5 | University of Miami Hospital and Clinics, Sylvester Cancer Center-Cancer Research Services ( Site 35 | Miami | Florida | United States | 33136 |
| 6 | Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 3515) | Marietta | Georgia | United States | 30060 |
| 7 | Parkview Research Center at Parkview Regional Medical Center ( Site 3526) | Fort Wayne | Indiana | United States | 46845 |
| 8 | Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center- GU Oncology ( Site 3549) | Baltimore | Maryland | United States | 21231 |
| 9 | Cancer and Hematology Centers of Western Michigan ( Site 3502) | Grand Rapids | Michigan | United States | 49503 |
| 10 | St. Vincent Frontier Cancer Center-Research ( Site 3506) | Billings | Montana | United States | 59102 |
| 11 | Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 3550) | Omaha | Nebraska | United States | 68130 |
| 12 | Englewood Hospital and Medical Center ( Site 3557) | Englewood | New Jersey | United States | 07631 |
| 13 | Rutgers Cancer Institute of New Jersey ( Site 3541) | New Brunswick | New Jersey | United States | 08903 |
| 14 | Monter Cancer Center ( Site 3560) | Lake Success | New York | United States | 11042 |
| 15 | Icahn School of Medicine at Mount Sinai ( Site 3539) | New York | New York | United States | 10029 |
| 16 | Memorial Sloan Kettering Cancer Center ( Site 3568) | New York | New York | United States | 10065 |
| 17 | MidLantic urology ( Site 3501) | Bala-Cynwyd | Pennsylvania | United States | 19004 |
| 18 | Fox Chase Cancer Center-GU Oncology ( Site 3535) | Philadelphia | Pennsylvania | United States | 19111 |
| 19 | Sanford Cancer Center ( Site 3551) | Sioux Falls | South Dakota | United States | 57104 |
| 20 | The West Clinic, PLLC dba West Cancer Center ( Site 3522) | Germantown | Tennessee | United States | 38138 |
| 21 | Urology Associates ( Site 3512) | Nashville | Tennessee | United States | 37209 |
| 22 | UT Southwestern Medical Center ( Site 3529) | Dallas | Texas | United States | 75390 |
| 23 | Inova Schar Cancer Institute ( Site 3525) | Fairfax | Virginia | United States | 22031 |
| 24 | Seattle Cancer Care Alliance-Renal/Melanoma/MCC ( Site 3524) | Seattle | Washington | United States | 98109 |
| 25 | Blacktown Hospital-Blacktown Cancer and Haematology Centre - Medical Oncology ( Site 0002) | Blacktown | New South Wales | Australia | 2148 |
| 26 | Macquarie University-MQ Health Clinical Trials Unit ( Site 0003) | Macquarie University | New South Wales | Australia | 2109 |
| 27 | Tamworth Hospital-North West Cancer Centre ( Site 0006) | North Tamworth | New South Wales | Australia | 2340 |
| 28 | Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si | Brisbane | Queensland | Australia | 4029 |
| 29 | Lyell McEwin Hospital-Oncology Clinical Trials Unit ( Site 0008) | Elizabeth Vale | South Australia | Australia | 5112 |
| 30 | Austin Health-Cancer Clinical Trials Centre ( Site 0005) | Heidelberg | Victoria | Australia | 3084 |
| 31 | Fiona Stanley Hospital-Medical Oncology ( Site 0004) | Murdoch | Western Australia | Australia | 6150 |
| 32 | Hospital de Clínicas de Ribeirão Preto ( Site 0112) | Ribeirão Preto | Sao Paulo | Brazil | 14048900 |
| 33 | James Lind Centro de Investigación del Cáncer ( Site 0307) | Temuco | Araucania | Chile | 4780000 |
| 34 | Clínica Puerto Montt ( Site 0309) | Puerto Montt | Los Lagos | Chile | 5500243 |
| 35 | FALP-UIDO ( Site 0302) | Santiago | Region M. De Santiago | Chile | 6900941 |
| 36 | Oncovida ( Site 0306) | Santiago | Region M. De Santiago | Chile | 7510032 |
| 37 | Bradfordhill ( Site 0305) | Santiago | Region M. De Santiago | Chile | 8420383 |
| 38 | ONCOCENTRO APYS-ACEREY ( Site 0301) | Viña del Mar | Valparaiso | Chile | 2520598 |
| 39 | Centro de Investigación Oncológica del Norte ( Site 0303) | Antofagasta | Chile | 1240000 | |
| 40 | Beijing Cancer hospital-Urinary Surgery ( Site 0406) | Beijing | Beijing | China | 100142 |
| 41 | Chongqing University Cancer Hospital ( Site 0414) | Chongqing | Chongqing | China | 400030 |
| 42 | SUN YAT-SEN UNIVERSITY CANCER CENTRE-Urology Surgery ( Site 0417) | Guangzhou | Guangdong | China | 510060 |
| 43 | Wuhan Union Hospital ( Site 0430) | Wuhan | Hubei | China | 430022 |
| 44 | Hubei Cancer Hospital-Urinary surgery ( Site 0419) | Wuhan | Hubei | China | 430079 |
| 45 | Fudan University Shanghai Cancer Center-Urology department ( Site 0401) | Shanghai | Shanghai | China | 200032 |
| 46 | Tianjin Medical University Cancer Institute and Hospital ( Site 0422) | Tianjin | Tianjin | China | 300060 |
| 47 | Zhejiang Provincial People's Hospital-Urology ( Site 0426) | Hangzhou | Zhejiang | China | 310014 |
| 48 | Clinica de la Costa LTDA ( Site 0506) | Barranquilla | Atlantico | Colombia | 080020 |
| 49 | Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 0505) | Valledupar | Cesar | Colombia | 200001 |
| 50 | Oncomedica S.A. ( Site 0501) | Monteria | Cordoba | Colombia | 230001 |
| 51 | Administradora Country S.A. - Clinica del Country ( Site 0504) | Bogotá | Distrito Capital De Bogota | Colombia | 110221 |
| 52 | Fakultni Nemocnice u sv. Anny v Brne-Onkologicko-chirurgicke oddeleni ( Site 0603) | Brno | Brno-mesto | Czechia | 656 91 |
| 53 | Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0605) | Brno | Brno-mesto | Czechia | 65653 |
| 54 | Fakultni nemocnice Ostrava-Klinika onkologicka ( Site 0606) | Ostrava | Moravskoslezsky Kraj | Czechia | 708 52 |
| 55 | Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0601) | Olomouc | Olomoucky Kraj | Czechia | 779 00 |
| 56 | Fakultni Thomayerova nemocnice-Onkologicka klinika 1. LF UK ( Site 0602) | Prague | Praha 4 | Czechia | 14059 |
| 57 | Fakultni nemocnice Hradec Kralove-Klinika onkologie a radioterapie ( Site 0604) | Hradec Kralove | Czechia | 500 05 | |
| 58 | Tampereen yliopistollinen sairaala ( Site 0805) | Tampere | Pirkanmaa | Finland | 33520 |
| 59 | Oulun yliopistollinen sairaala ( Site 0802) | Oulu | Pohjois-Pohjanmaa | Finland | 90220 |
| 60 | Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 0803) | Helsinki | Uusimaa | Finland | 00029 |
| 61 | Institut de cancérologie Strasbourg Europe (ICANS) ( Site 0903) | Strasbourg | Alsace | France | 67033 |
| 62 | Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou ( Site 0908) | Rennes | Bretagne | France | 35033 |
| 63 | CHU Besançon-Medical oncology ( Site 0904) | Besançon | Doubs | France | 25000 |
| 64 | Centre Hospitalier Universitaire d'Angers-Urology ( Site 0901) | Angers | Maine-et-Loire | France | 49100 |
| 65 | CENTRE LEON BERARD-Medical oncology ( Site 0902) | Lyon | Rhone-Alpes | France | 69008 |
| 66 | Hôpital Saint-Louis ( Site 0905) | Paris | France | 75010 | |
| 67 | Hôpital Européen Georges Pompidou-Service d'Oncologie Médicale ( Site 0906) | Paris | France | 75015 | |
| 68 | Universitaetsklinikum Tuebingen ( Site 1002) | Tübingen | Baden-Wurttemberg | Germany | 72076 |
| 69 | klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Sit | Munich | Bayern | Germany | 81675 |
| 70 | Universitaetsklinikum Duesseldorf ( Site 1017) | Düsseldorf | Nordrhein-Westfalen | Germany | 40225 |
| 71 | Universitätsklinikum Münster - Albert Schweitzer Campus ( Site 1005) | Münster | Nordrhein-Westfalen | Germany | 48149 |
| 72 | Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Urologie ( Site 1021) | Dresden | Sachsen | Germany | 01307 |
| 73 | SRH Wald-Klinikum Gera ( Site 1015) | Gera | Thuringen | Germany | 07548 |
| 74 | Helios Klinikum Berlin-Buch ( Site 1011) | Berlin | Germany | 13125 | |
| 75 | Universitaetsklinikum Hamburg-Eppendorf-Onkologisches Zentrum ( Site 1001) | Hamburg | Germany | 20246 | |
| 76 | Alexandra Hospital-ONCOLOGY DEPT. ( Site 1102) | Athens | Attiki | Greece | 115 28 |
| 77 | Metropolitan Hospital-2nd Oncology Dept ( Site 1104) | Athens | Attiki | Greece | 185 47 |
| 78 | Euromedica General Clinic Thessaloniki-Oncology Unit ( Site 1103) | Thessaloniki | Greece | 546 45 | |
| 79 | Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ ( Site 1319) | Szeged | Csongrad | Hungary | 6725 |
| 80 | Petz Aladar Egyetemi Oktato Korhaz-Onkológiai Osztály ( Site 1321) | Gyor | Gyor-Moson-Sopron | Hungary | 9024 |
| 81 | Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 1316) | Budapest | Pest | Hungary | 1122 |
| 82 | Somogy Megyei Kaposi Mór Oktató Kórház-Oncology center ( Site 1311) | Kaposvár | Somogy | Hungary | 7400 |
| 83 | Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 1310) | Debrecen | Hungary | 4032 | |
| 84 | St. Vincent's University Hospital ( Site 1401) | Dublin 4 | Dublin | Ireland | Dublin 4 |
| 85 | Beaumont Hospital, Dublin-Cancer Clinical Trials & Research Unit ( Site 1403) | Dublin | Ireland | D9 | |
| 86 | Rambam Health Care Campus-Oncology ( Site 1502) | Haifa | Israel | 3109601 | |
| 87 | Rabin Medical Center-Oncology ( Site 1503) | Petah-Tikva | Israel | 4941492 | |
| 88 | Sheba Medical Center-ONCOLOGY ( Site 1504) | Ramat Gan | Israel | 5265601 | |
| 89 | Sourasky Medical Center-Oncology ( Site 1501) | Tel Aviv | Israel | 6423906 | |
| 90 | Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-Oncologia Medica ( Site 1603) | Meldola | Emilia-Romagna | Italy | 47014 |
| 91 | Fondazione Policlinico Universitario Agostino Gemelli-Medical Oncology ( Site 1604) | Roma | Lazio | Italy | 00168 |
| 92 | Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1608) | Milan | Lombardia | Italy | 20133 |
| 93 | Azienda Sanitaria Ospedaliera S Luigi Gonzaga-SCDU Oncologia Medica ( Site 1602) | Orbassano | Piemonte | Italy | 10043 |
| 94 | A.O.U.C. Policlinico di Bari ( Site 1607) | Bari | Puglia | Italy | 70124 |
| 95 | IRCCS - AOU di Bologna-Oncologia Medica Ardizzoni ( Site 1605) | Bologna | Italy | 40138 | |
| 96 | Ospedale San Raffaele-Oncologia Medica ( Site 1606) | Milano | Italy | 20132 | |
| 97 | Azienda Ospedaliera Santa Maria Terni-SC Oncologia ( Site 1609) | Terni | Italy | 05100 | |
| 98 | Fujita Health University ( Site 1709) | Toyoake | Aichi | Japan | 470-1192 |
| 99 | Toho University Sakura Medical Center ( Site 1718) | Sakura | Chiba | Japan | 285-0841 |
| 100 | Hokkaido University Hospital ( Site 1701) | Sapporo | Hokkaido | Japan | 060-8648 |
| 101 | Nara Medical University Hospital ( Site 1712) | Kashihara | Nara | Japan | 634-8522 |
| 102 | Bell Land General Hospital ( Site 1710) | Sakai | Osaka | Japan | 599-8247 |
| 103 | Osaka University Hospital ( Site 1711) | Suita | Osaka | Japan | 565-0871 |
| 104 | Hamamatsu University Hospital ( Site 1708) | Hamamatsu | Shizuoka | Japan | 431-3192 |
| 105 | Toyama University Hospital ( Site 1713) | Toyoma | Toyama | Japan | 930-0194 |
| 106 | Kyushu University Hospital ( Site 1715) | Fukuoka | Japan | 812-8582 | |
| 107 | Kumamoto University ( Site 1716) | Kumamoto | Japan | 860-8556 | |
| 108 | Okayama University Hospital ( Site 1720) | Okayama | Japan | 700-8558 | |
| 109 | Nippon Medical School Hospital ( Site 1705) | Tokyo | Japan | 113-8603 | |
| 110 | Keio university hospital ( Site 1707) | Tokyo | Japan | 160-8582 | |
| 111 | National Cancer Center-Center for Urologic Cancer ( Site 2604) | Goyang-si | Kyonggi-do | Korea, Republic of | 10408 |
| 112 | Seoul National University Bundang Hospital-Urology ( Site 2602) | Seongnam | Kyonggi-do | Korea, Republic of | 13620 |
| 113 | Asan Medical Center-Oncology ( Site 2601) | Songpagu | Seoul | Korea, Republic of | 05505 |
| 114 | Samsung Medical Center ( Site 2603) | Seoul | Korea, Republic of | 06351 | |
| 115 | Hospital Civil Fray Antonio Alcalde-Oncology ( Site 1906) | Guadalajara | Jalisco | Mexico | 44280 |
| 116 | Christus Muguerza Clinica Vidriera ( Site 1903) | Monterrey | Nuevo Leon | Mexico | 64570 |
| 117 | Centro de Oncología Personalizada ( Site 1911) | Culiacán | Sinaloa | Mexico | 80040 |
| 118 | Centro de Investigacion Clinica de Oaxaca ( Site 1904) | Oaxaca | Mexico | 68020 | |
| 119 | Oncocenter ( Site 1909) | Puebla | Mexico | 72530 | |
| 120 | Ziekenhuis Rijnstate-Rijnstate Centrum Oncologisch Onderzoek ( Site 3113) | Arnhem | Gelderland | Netherlands | 6921SC |
| 121 | Maastricht UMC+ ( Site 3104) | Maastricht | Limburg | Netherlands | 6229 HX |
| 122 | Amphia Ziekenhuis, locatie Breda Molengracht ( Site 3103) | Breda | Noord-Brabant | Netherlands | 4818 CK |
| 123 | Maxima Medisch Centrum, locatie Eindhoven ( Site 3116) | Eindhoven | Noord-Brabant | Netherlands | 5600 PD |
| 124 | Tergooiziekenhuizen, locatie Hilversum ( Site 3102) | Hilversum | Noord-Holland | Netherlands | 1213 XZ |
| 125 | Haga Ziekenhuis locatie Leyweg-Oncology ( Site 3108) | Den Haag | Zuid-Holland | Netherlands | 2545 AA |
| 126 | Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 3101) | Schiedam | Zuid-Holland | Netherlands | 3118 JH |
| 127 | St. Antonius Ziekenhuis, locatie Utrecht-Interne geneeskunde ( Site 3112) | Utrecht | Netherlands | 3543 AZ | |
| 128 | Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 3106) | Utrecht | Netherlands | 3584 CX | |
| 129 | Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2307) | Bydgoszcz | Kujawsko-pomorskie | Poland | 85-796 |
| 130 | Szpital Wojewódzki im. Świętego Lukasza SP ZOZ w Tarnowie ( Site 2311) | Tarnow | Malopolskie | Poland | 33-100 |
| 131 | Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2313) | Siedlce | Mazowieckie | Poland | 08-110 |
| 132 | Luxmed Onkologia sp. z o. o. ( Site 2303) | Warszawa | Mazowieckie | Poland | 01-748 |
| 133 | Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( | Warszawa | Mazowieckie | Poland | 02-781 |
| 134 | Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 2306) | Przemysl | Podkarpackie | Poland | 37-700 |
| 135 | Przychodnia Lekarska KOMED ( Site 2304) | Konin | Wielkopolskie | Poland | 62-500 |
| 136 | Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 2302) | Koszalin | Zachodniopomorskie | Poland | 75-581 |
| 137 | Twoja Przychodnia - Szczecinskie Centrum Medyczne ( Site 2315) | Szczecin | Zachodniopomorskie | Poland | 71-434 |
| 138 | Hospital Universitari de Girona Doctor Josep Trueta ( Site 2707) | Girona | Gerona | Spain | 17007 |
| 139 | Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2710) | Madrid | Madrid, Comunidad De | Spain | 28034 |
| 140 | Hospital Universitario 12 de Octubre-Medical Oncology ( Site 2708) | Madrid | Madrid, Comunidad De | Spain | 28041 |
| 141 | Fundación Instituto Valenciano de Oncología ( Site 2705) | Valencia | Valenciana, Comunitat | Spain | 46009 |
| 142 | Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2702) | Barcelona | Spain | 08035 | |
| 143 | Hospital Lucus Augusti-Oncology ( Site 2706) | Lugo | Spain | 27003 | |
| 144 | Hospital Clinico San Carlos-Oncology Department ( Site 2703) | Madrid | Spain | 28040 | |
| 145 | Hospital Universitario Virgen de la Victoria-Phase II-III-IV Trials ( Site 2709) | Malaga | Spain | 29010 | |
| 146 | Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 2905) | Kaohsiung Niao Sung Dist | Kaohsiung | Taiwan | 83301 |
| 147 | Kaohsiung Veterans General Hospital ( Site 2901) | Kaohsiung | Taiwan | 81346 | |
| 148 | Taichung Veterans General Hospital ( Site 2902) | Taichung | Taiwan | 407 | |
| 149 | National Taiwan University Hospital ( Site 2904) | Taipei | Taiwan | 10002 | |
| 150 | Taipei Veterans General Hospital ( Site 2903) | Taipei | Taiwan | 11217 | |
| 151 | Istanbul Universitesi Cerrahpasa-Internal Diseases ( Site 3204) | Istanbul- Fatih | Istanbul | Turkey | 34098 |
| 152 | Ankara Gülhane Eitim ve Aratrma Hastanesi-Oncology ( Site 3207) | Ankara | Turkey | 06010 | |
| 153 | Ankara University Hospital Cebeci ( Site 3209) | Ankara | Turkey | 06100 | |
| 154 | Hacettepe Universitesi-oncology hospital ( Site 3203) | Ankara | Turkey | 06230 | |
| 155 | Ankara City Hospital-Medical Oncology ( Site 3206) | Ankara | Turkey | 06800 | |
| 156 | TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 3201) | Istanbul | Turkey | 34722 | |
| 157 | Ege University Medicine of Faculty-Medical Oncology ( Site 3202) | Izmir | Turkey | 35100 | |
| 158 | The Christie NHS Foundation Trust ( Site 3301) | Manchester | England | United Kingdom | M20 4BX |
| 159 | Singleton Hospital ( Site 3306) | Swansea | United Kingdom | SA2 8QA |
Sponsors and Collaborators
- Merck Sharp & Dohme LLC
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 6482-022
- MK-6482-022
- LITESPARK-022
- jRCT2051220030
- 2021-003436-92