AzTrials
AzTrials

Carcinoma, Renal CellPhase 3NCT05239728

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)

A Phase 3 study testing Belzutifan and Pembrolizumab in people with Carcinoma, Renal Cell, run by Merck Sharp & Dohme LLC at 285 sites in 32 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Renal Cell
What is being tested?
Belzutifan and Pembrolizumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,800 participants
Where
285 sitesin 32 countries
Study dates
15 Mar 2022to 28 Sep 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

285 sites in 32 countries.

285 sites in 32 countries

United States37 sites

  • University of Colorado Anschutz Medical Campus ( Site 3514)

    Aurora, Colorado, 80045

  • MidLantic urology ( Site 3501)

    Bala-Cynwyd, Pennsylvania, 19004

  • Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center- GU Oncology ( Site 3549)

    Baltimore, Maryland, 21231

  • St. Vincent Frontier Cancer Center-Research ( Site 3506)

    Billings, Montana, 59102

  • Massachusetts General Hospital ( Site 3571)

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center-Cancer Clinical Trials Office ( Site 3572)

    Boston, Massachusetts, 02215

  • Dana-Farber Cancer Institute-GU ( Site 3505)

    Boston, Massachusetts, 02215

  • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 3507)

    Columbus, Ohio, 43210

  • UT Southwestern Medical Center ( Site 3529)

    Dallas, Texas, 75390

  • City of Hope Comprehensive Cancer Center ( Site 3567)

    Duarte, California, 91010

  • Englewood Hospital and Medical Center ( Site 3557)

    Englewood, New Jersey, 07631

  • Inova Schar Cancer Institute ( Site 3525)

    Fairfax, Virginia, 22031

  • Parkview Research Center at Parkview Regional Medical Center ( Site 3526)

    Fort Wayne, Indiana, 46845

  • The West Clinic, PLLC dba West Cancer Center ( Site 3522)

    Germantown, Tennessee, 38138

  • Intermountain Health St. Mary's Regional Hospital ( Site 3562)

    Grand Junction, Colorado, 81501

  • Cancer and Hematology Centers of Western Michigan ( Site 3502)

    Grand Rapids, Michigan, 49503

  • University of Texas MD Anderson Cancer Center-Urology ( Site 3569)

    Houston, Texas, 77030

  • Moores Cancer Center-Clinical Trials Office- Genitourinary ( Site 3516)

    La Jolla, California, 92093

  • Monter Cancer Center ( Site 3560)

    Lake Success, New York, 11042

  • UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro ( Site 3520)

    Los Angeles, California, 90095

  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 3515)

    Marietta, Georgia, 30060

  • University of Miami Hospital and Clinics, Sylvester Cancer Center-Cancer Research Services ( Site 3517)

    Miami, Florida, 33136

  • Urology Associates ( Site 3512)

    Nashville, Tennessee, 37209

  • Rutgers Cancer Institute of New Jersey ( Site 3541)

    New Brunswick, New Jersey, 08903

  • Icahn School of Medicine at Mount Sinai ( Site 3539)

    New York, New York, 10029

  • Memorial Sloan Kettering Cancer Center ( Site 3568)

    New York, New York, 10065

  • Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 3550)

    Omaha, Nebraska, 68130

  • University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 3518)

    Orange, California, 92868

  • Stanford Cancer Center ( Site 3523)

    Palo Alto, California, 94304

  • Fox Chase Cancer Center-GU Oncology ( Site 3535)

    Philadelphia, Pennsylvania, 19111

  • Mayo Clinic in Arizona - Phoenix ( Site 3554)

    Phoenix, Arizona, 85054

  • University of Rochester Medical Center ( Site 3528)

    Rochester, New York, 14642

  • Seattle Cancer Care Alliance-Renal/Melanoma/MCC ( Site 3524)

    Seattle, Washington, 98109

  • Sanford Cancer Center ( Site 3551)

    Sioux Falls, South Dakota, 57104

  • Washington University-Internal Medicine/Oncology ( Site 3531)

    St Louis, Missouri, 63110

  • Moffitt Cancer Center ( Site 3540)

    Tampa, Florida, 33612

  • Georgetown University Medical Center ( Site 3534)

    Washington D.C., District of Columbia, 20007

Other trials in United States

China30 sites

  • Cancer Hospital Chinese Academy of Medical Sciences ( Site 0435)

    Beijing, Beijing Municipality, 100021

  • Beijing Cancer hospital-Urinary Surgery ( Site 0406)

    Beijing, Beijing Municipality, 100142

  • First Medical Center of Chinese PLA General Hospital ( Site 0415)

    Beijing, Beijing Municipality, 100853

  • Peking University First Hospital-Urology ( Site 0407)

    Beijing, Beijing Municipality, 102627

  • The First Affiliated Hospital of Bengbu Medical University- Urology Surgery ( Site 0438)

    Bengbu, Anhui, 233004

  • Hunan Cancer Hospital ( Site 0421)

    Changsha, Hunan, 410006

  • West China Hospital of Sichuan University-Urology Surgery ( Site 0410)

    Chengdu, Sichuan, 610041

  • Chongqing University Cancer Hospital ( Site 0414)

    Chongqing, Chongqing Municipality, 400030

  • Army Medical Center of People's Liberation Army ( Site 0439)

    Chongqing, Chongqing Municipality, 400042

  • The First Affiliated Hospital of Fujian Medical University ( Site 0445)

    Fuzhou, Fujian, 350005

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 0402)

    Guangzhou, Guangdong, 510000

  • Sun Yat-Sen University Cancer Center ( Site 0417)

    Guangzhou, Guangdong, 510060

  • The First Affiliated Hospital of Guangzhou Medical University ( Site 0403)

    Guangzhou, Guangdong, 510120

  • The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 0428)

    Hangzhou, Zhejiang, 310003

  • Zhejiang Provincial People's Hospital ( Site 0426)

    Hangzhou, Zhejiang, 310014

  • The Second Hospital Of Anhui Medical University ( Site 0416)

    Hefei, Anhui, 230000

  • The Second Affiliated Hospital of Nanchang University ( Site 0443)

    Nanchang, Jiangxi, 330006

  • The First Affiliated Hospital of Nanchang University ( Site 0432)

    Nanchang, Jiangxi, 330209

  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 0424)

    Nanjing, Jiangsu, 210008

  • The First Affiliated Hospital of Ningbo University ( Site 0433)

    Ningbo, Zhejiang, 315010

  • Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 0418)

    Shanghai, Shanghai Municipality, 200001

  • Huadong Hospital ( Site 0405)

    Shanghai, Shanghai Municipality, 200040

  • Fudan University Shanghai Cancer Center ( Site 0401)

    Shanghai, Shanghai Municipality, 200120

  • Tianjin Medical University Cancer Institute and Hospital ( Site 0422)

    Tianjin, Tianjin Municipality, 300000

  • The First Affiliated Hospital of Wenzhou Medical University ( Site 0425)

    Wenzhou, Zhejiang, 325000

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0430)

    Wuhan, Hubei, 430022

  • Tongji Hospital Tongji Medical College of HUST ( Site 0423)

    Wuhan, Hubei, 430030

  • Hubei Cancer Hospital-Urinary surgery ( Site 0419)

    Wuhan, Hubei, 430079

  • The First Affiliated Hospital of Xi'an Jiaotong University ( Site 0431)

    Xi'an, Shaanxi, 710061

  • Henan Cancer Hospital-Urology ( Site 0441)

    Zhengzhou, Henan, 450008

Other trials in China

Japan21 sites

  • Kyushu University Hospital ( Site 1715)

    Fukuoka, 812-8582

  • Hamamatsu University Hospital ( Site 1708)

    Hamamatsu, Shizuoka, 431-3192

  • Kagoshima University Hospital ( Site 1719)

    Kagoshima, 890-8520

  • Nara Medical University Hospital ( Site 1712)

    Kashihara, Nara, 634-0813

  • National Cancer Center Hospital East ( Site 1704)

    Kashiwa, Chiba, 277-8577

  • Kumamoto University Hospital ( Site 1716)

    Kumamoto, 860-8556

  • Toranomon Hospital ( Site 1706)

    Minato-ku, Tokyo, 105-8470

  • Okayama University Hospital ( Site 1720)

    Okayama, 700-8558

  • Bell Land General Hospital ( Site 1710)

    Sakai, Osaka, 599-8247

  • Toho University Sakura Medical Center ( Site 1718)

    Sakura, Chiba, 285-8741

  • Sapporo Medical University Hospital ( Site 1702)

    Sapporo, Hokkaido, 060-8543

  • Hokkaido University Hospital ( Site 1701)

    Sapporo, Hokkaido, 060-8648

  • The University of Osaka Hospital ( Site 1711)

    Suita, Osaka, 565-0871

  • Nippon Medical School Hospital ( Site 1705)

    Tokyo, 113-8603

  • Tokyo Women's Medical University Adachi Medical Center ( Site 1717)

    Tokyo, 123-8558

  • Keio University Hospital ( Site 1707)

    Tokyo, 160-8582

  • Ehime University Hospital ( Site 1714)

    Tōon, Ehime, 791-0295

  • Fujita Health University Hospital ( Site 1709)

    Toyoake, Aichi-ken, 470-1192

  • Toyama University Hospital ( Site 1713)

    Toyoma, Toyama, 930-0194

  • Wakayama Medical University Hospital ( Site 1721)

    Wakayama, 641-8510

  • Kanagawa Cancer Center ( Site 1703)

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

Germany16 sites

  • Universitätsklinikum Aachen ( Site 1024)

    Aachen, North Rhine-Westphalia, 52074

  • Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 1022)

    Berlin, 10117

  • Helios Klinikum Berlin-Buch ( Site 1011)

    Berlin, 13125

  • Universitätsklinikum Bonn ( Site 1006)

    Bonn, North Rhine-Westphalia, 53127

  • Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Urologie ( Site 1021)

    Dresden, Saxony, 01307

  • Universitaetsklinikum Duesseldorf ( Site 1017)

    Düsseldorf, North Rhine-Westphalia, 40225

  • Universitaetsklinikum Essen ( Site 1004)

    Essen, North Rhine-Westphalia, 45147

  • SRH Wald-Klinikum Gera ( Site 1015)

    Gera, Thuringia, 07548

  • Krankenhaus Martha-Maria Halle-Dölau-Klinik für Urologie, Kinderurologie und urologische Onkologie ( Site 1008)

    Halle, Saxony-Anhalt, 06120

  • Universitaetsklinikum Hamburg-Eppendorf-Onkologisches Zentrum ( Site 1001)

    Hamburg, 20246

  • Universitaetsklinikum des Saarlandes-Klinik fuer Urologie und Kinderurologies ( Site 1020)

    Homburg, Saarland, 66421

  • Universitätsklinikum Jena ( Site 1007)

    Jena, Thuringia, 07747

  • klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Site 1003)

    Munich, Bavaria, 81675

  • Universitätsklinikum Münster - Albert Schweitzer Campus ( Site 1005)

    Münster, North Rhine-Westphalia, 48149

  • Hegau-Bodensee-Klinikum Singen ( Site 1016)

    Singen, Baden-Wurttemberg, 78224

  • Universitaetsklinikum Tuebingen ( Site 1002)

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

Netherlands15 sites

  • Amsterdam UMC, locatie AMC ( Site 3105)

    Amsterdam, North Holland, 1105 AZ

  • Ziekenhuis Rijnstate-Rijnstate Centrum Oncologisch Onderzoek ( Site 3113)

    Arnhem, Gelderland, 6815 AD

  • Amphia Ziekenhuis, locatie Breda Molengracht ( Site 3103)

    Breda, North Brabant, 4818 CK

  • Maxima Medisch Centrum, locatie Eindhoven ( Site 3116)

    Eindhoven, North Brabant, 5600 PD

  • University Medical Center Groningen ( Site 3121)

    Groningen, 9713 GZ

  • Tergooiziekenhuizen, locatie Hilversum ( Site 3102)

    Hilversum, North Holland, 1213 XZ

  • Spaarne Gasthuis - Hoofddorp-Oncology ( Site 3107)

    Hoofddorp, North Holland, 2134 TM

  • Haaglanden MC - locatie Antoniushove ( Site 3117)

    Leidschendam, South Holland, 2501 ck

  • Maastricht UMC+ ( Site 3104)

    Maastricht, Limburg, 6229 HX

  • Radboudumc ( Site 3120)

    Nijmegen, Gelderland, 6525 GA

  • Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 3101)

    Schiedam, South Holland, 3118 JH

  • Haga Ziekenhuis locatie Leyweg-Oncology ( Site 3108)

    The Hague, South Holland, 2545 AA

  • St. Antonius Ziekenhuis, locatie Utrecht-Interne geneeskunde ( Site 3112)

    Utrecht, 3543 AZ

  • Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 3106)

    Utrecht, 3584 CX

  • Isala, locatie Zwolle-Oncology ( Site 3111)

    Zwolle, Overijssel, 8025 AB

Other trials in Netherlands

Mexico12 sites

  • Centro de Oncología Personalizada ( Site 1911)

    Culiacán, Sinaloa, 80040

  • Terapias Integrales del Riñon SA de CV ( Site 1910)

    Guadalajara, Jalisco, 44260

  • Hospital Civil Fray Antonio Alcalde-Oncology ( Site 1906)

    Guadalajara, Jalisco, 44280

  • BRCR Global Mexico - Guadalajara-Research ( Site 1908)

    Guadalajara, Jalisco

  • INSTITUTO NACIONAL DE CANCEROLOGIA ( Site 1902)

    Mexico City, Mexico City, 14080

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran-Oncologia y Hematologia ( Site 1912)

    Mexico City, Mexico City, 14080

  • Filios Alta Medicina ( Site 1903)

    Monterrey, Nuevo León, 64460

  • iCan Oncology Center Centro Medico AVE ( Site 1901)

    Monterrey, Nuevo León, 64710

  • Centro de Investigacion Clinica de Oaxaca ( Site 1904)

    Oaxaca City, 68020

  • Oncocenter ( Site 1909)

    Puebla City, 72530

  • Hospital H+ Queretaro-Cuidados Oncológicos ( Site 1905)

    Querétaro City, Querétaro, 76000

  • BRCR Global Mexico - Queretaro-SMIQ ( Site 1907)

    Querétaro City, Querétaro, 76070

Other trials in Mexico

Poland12 sites

  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2307)

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

  • Przychodnia Lekarska KOMED ( Site 2304)

    Konin, Greater Poland Voivodeship, 62-500

  • Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 2302)

    Koszalin, West Pomeranian Voivodeship, 75-581

  • Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 2312)

    Poznan, Greater Poland Voivodeship, 60-569

  • Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 2306)

    Przemyśl, Podkarpackie Voivodeship, 37-700

  • Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2313)

    Siedlce, Masovian Voivodeship, 08-110

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne ( Site 2315)

    Szczecin, West Pomeranian Voivodeship, 71-434

  • Szpital Wojewódzki im. Świętego Lukasza SP ZOZ w Tarnowie ( Site 2311)

    Tarnów, Lesser Poland Voivodeship, 33-100

  • MICS Centrum Medyczne Torun ( Site 2305)

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100

  • Luxmed Onkologia sp. z o. o. ( Site 2303)

    Warsaw, Masovian Voivodeship, 01-748

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 2301)

    Warsaw, Masovian Voivodeship, 02-781

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu ( Site 2309)

    Wrocław, Silesian Voivodeship, 50556

Other trials in Poland

Italy10 sites

  • Azienda USL 8 di Arezzo-Medical Oncology ( Site 1610)

    Arezzo, 52100

  • A.O.U.C. Policlinico di Bari ( Site 1607)

    Bari, Apulia, 70124

  • IRCCS - AOU di Bologna-Oncologia Medica Ardizzoni ( Site 1605)

    Bologna, 40138

  • Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 1601)

    Florence, Tuscany, 50134

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-Oncologia Medica ( Site 1603)

    Meldola, Emilia-Romagna, 47014

  • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1608)

    Milan, Lombardy, 20133

  • Ospedale San Raffaele-Oncologia Medica ( Site 1606)

    Milan, 20132

  • Azienda Sanitaria Ospedaliera S Luigi Gonzaga-SCDU Oncologia Medica ( Site 1602)

    Orbassano, Piedmont, 10043

  • Fondazione Policlinico Universitario Agostino Gemelli-Medical Oncology ( Site 1604)

    Rome, Lazio, 00168

  • Azienda Ospedaliera Santa Maria Terni-SC Oncologia ( Site 1609)

    Terni, 05100

Other trials in Italy

France9 sites

  • Centre Hospitalier Universitaire d'Angers-Urology ( Site 0901)

    Angers, Maine-et-Loire, 49933

  • CHU Besançon-Medical oncology ( Site 0904)

    Besançon, Doubs, 25000

  • ROC37 ( Site 0910)

    Chambray-lès-Tours, Centre-Val de Loire, 37170

  • CENTRE LEON BERARD-Medical oncology ( Site 0902)

    Lyon, Auvergne-Rhône-Alpes, 69373 Cedex 08

  • Hôpital Saint-Louis ( Site 0905)

    Paris, 75010

  • Hôpital Européen Georges Pompidou-Service d'Oncologie Médicale ( Site 0906)

    Paris, 75015

  • Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou ( Site 0908)

    Rennes, Brittany Region, 35000

  • Hopitaux Universitaires de Strasbourg ( Site 0903)

    Strasbourg, Bas-Rhin, 67200

  • Gustave Roussy ( Site 0907)

    Villejuif, Île-de-France Region, 94805

Other trials in France

Canada8 sites

  • Arthur J.E. Child Comprehensive Cancer Centre ( Site 3706)

    Calgary, Alberta, T2N 5G2

  • Hamilton Health Sciences-Juravinski Cancer Centre ( Site 3710)

    Hamilton, Ontario, L8V 5C2

  • London Health Sciences Centre ( Site 3705)

    London, Ontario, N6A 5W9

  • CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 3708)

    Montreal, Quebec, H1T 2M4

  • McGill University Health Centre ( Site 3709)

    Montreal, Quebec, H4A 3J1

  • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 3701)

    Québec, Quebec, G1J 1Z4

  • Princess Margaret Cancer Centre ( Site 3703)

    Toronto, Ontario, M5G 2M9

  • BC Cancer Vancouver-Clinical Trials Unit ( Site 3707)

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Chile8 sites

  • Bradford Hill Norte ( Site 0303)

    Antofagasta, 1240000

  • Clínica Puerto Montt ( Site 0309)

    Port Montt, Los Lagos Region, 5500243

  • FALP-UIDO ( Site 0302)

    Santiago, Region M. de Santiago, 7500921

  • Oncovida ( Site 0306)

    Santiago, Region M. de Santiago, 7500994

  • Bradfordhill ( Site 0305)

    Santiago, Region M. de Santiago, 8420383

  • James Lind Centro de Investigacion del Cancer ( Site 0307)

    Temuco, Araucania, 4800827

  • Oncocentro Valdivia ( Site 0312)

    Valdivia, Los Ríos Region, 5112129

  • ONCOCENTRO APYS-ACEREY ( Site 0301)

    Viña del Mar, Valparaiso, 2520598

Other trials in Chile

Spain8 sites

  • Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2702)

    Barcelona, 08035

  • Institut Català d'Oncologia (ICO) - Girona ( Site 2707)

    Girona, Gerona, 17007

  • Hospital Lucus Augusti-Oncology ( Site 2706)

    Lugo, 27003

  • Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2710)

    Madrid, Madrid, Comunidad de, 28034

  • Hospital Universitario 12 de Octubre-Medical Oncology ( Site 2708)

    Madrid, Madrid, Comunidad de, 28041

  • Hospital Clinico San Carlos-Oncology Department ( Site 2703)

    Madrid, 28040

  • Hospital Universitario Virgen de la Victoria-Phase II-III-IV Trials ( Site 2709)

    Málaga, 29010

  • Fundación Instituto Valenciano de Oncología ( Site 2705)

    Valencia, Valenciana, Comunitat, 46009

Other trials in Spain

Taiwan8 sites

  • Kaohsiung Veterans General Hospital ( Site 2901)

    Kaohsiung City, 81362

  • Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 2905)

    Kaohsiung Niao Sung Dist, Kaohsiung, 83301

  • China Medical University Hospital-Department of Urology ( Site 2907)

    Taichung, 40447

  • Taichung Veterans General Hospital ( Site 2902)

    Taichung, 407

  • National Taiwan University Hospital ( Site 2904)

    Taipei, 10002

  • Taipei Veterans General Hospital ( Site 2903)

    Taipei, 112

  • Tri-Service General Hospital ( Site 2908)

    Taipei City, Taipei, 11490

  • Chang Gung Medical Foundation-Linkou Branch-Urology ( Site 2906)

    Taoyuan, 333

Other trials in Taiwan

Turkey (Türkiye)8 sites

  • Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 3208)

    Adana, 01250

  • Ankara Gülhane Eitim ve Aratrma Hastanesi-Oncology ( Site 3207)

    Ankara, 06010

  • Ankara University Hospital Cebeci ( Site 3209)

    Ankara, 06100

  • Hacettepe Universitesi-oncology hospital ( Site 3203)

    Ankara, 06230

  • Ankara Bilkent Şehir Hastanesi-oncology ( Site 3206)

    Ankara, 6800

  • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 3201)

    Istanbul, 34722

  • Istanbul Universitesi Cerrahpasa-Internal Diseases ( Site 3204)

    Istanbul- Fatih, Istanbul, 34098

  • Ege University Medicine of Faculty-Medical Oncology ( Site 3202)

    Izmir, 35100

Other trials in Turkey (Türkiye)

Australia7 sites

  • Blacktown Hospital ( Site 0002)

    Blacktown, New South Wales, 2148

  • Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 0001)

    Brisbane, Queensland, 4029

  • Lyell McEwin Hospital-Oncology Clinical Trials Unit ( Site 0008)

    Elizabeth Vale, South Australia, 5112

  • Austin Health-Cancer Clinical Trials Centre ( Site 0005)

    Heidelberg, Victoria, 3084

  • Macquarie University-MQ Health Clinical Trials Unit ( Site 0003)

    Macquarie University, New South Wales, 2109

  • Fiona Stanley Hospital-Medical Oncology ( Site 0004)

    Murdoch, Western Australia, 6150

  • Tamworth Hospital-North West Cancer Centre ( Site 0006)

    North Tamworth, New South Wales, 2340

Other trials in Australia

Brazil7 sites

  • Centro Avançado de Tratamento Oncológico- CENANTRON-Clinical Research ( Site 0105)

    Belo Horizonte, Minas Gerais, 30130090

  • Instituto do Câncer e Transplante de Curitiba ( Site 0102)

    Curitiba, Paraná, 80510-130

  • Hospital São Carlos-Oncocentro Ce ( Site 0104)

    Fortaleza, Ceará, 60135-237

  • Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0103)

    Natal, Rio Grande do Norte, 59075-740

  • Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0101)

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Hospital de Clínicas de Ribeirão Preto ( Site 0112)

    Ribeirão Preto, São Paulo, 14048900

  • BP - A Beneficencia Portuguesa de São Paulo ( Site 0111)

    São Paulo, 01321-001

Other trials in Brazil

Czechia7 sites

  • Fakultni Nemocnice u sv. Anny v Brne-Onkologicko-chirurgicke oddeleni ( Site 0603)

    Brno, Brno-mesto, 602 00

  • Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0605)

    Brno, Brno-mesto, 656 53

  • Fakultni nemocnice Hradec Kralove-Klinika onkologie a radioterapie ( Site 0604)

    Hradec Králové, 500 05

  • Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0601)

    Olomouc, Olomouc Region, 779 00

  • Fakultni nemocnice Ostrava-Klinika onkologicka ( Site 0606)

    Ostrava, Moravian-Silesian Region, 708 52

  • Fakultni Thomayerova nemocnice-Onkologicka klinika 1. LF UK ( Site 0602)

    Prague, Praha 4, 140 59

  • Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 0607)

    Prague, Praha 5, 150 06

Other trials in Czechia

United Kingdom7 sites

  • Beatson West of Scotland Cancer Centre-Clinical Trials Unit ( Site 3305)

    Glasgow, Glasgow City, G12 0YN

  • Royal Free Hospital ( Site 3304)

    London, England, NW3 2QG

  • Charing Cross Hospital ( Site 3302)

    London, Hammersmith and Fulham, W6 8RF

  • St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 3307)

    London, London, City of, EC1A 7BE

  • The Christie NHS Foundation Trust ( Site 3301)

    Manchester, M20 4BX

  • City Hospital, Nottingham University Hospitals ( Site 3303)

    Nottingham, England, NG5 1PF

  • Singleton Hospital ( Site 3306)

    Swansea, SA2 8QA

Other trials in United Kingdom

Israel6 sites

  • Soroka Medical Center ( Site 1505)

    Beersheba, 8410101

  • Rambam Health Care Campus-Oncology ( Site 1502)

    Haifa, 3109601

  • Hadassah Medical Center-Oncology ( Site 1506)

    Jerusalem, 9112001

  • Rabin Medical Center-Oncology ( Site 1503)

    Petah Tikva, 4941492

  • Sheba Medical Center-ONCOLOGY ( Site 1504)

    Ramat Gan, 5265601

  • Sourasky Medical Center-Oncology ( Site 1501)

    Tel Aviv, 6423906

Other trials in Israel

Romania6 sites

  • MEMORIAL HEALTHCARE INTERNATIONAL S.R.L ( Site 2407)

    Bucharest, 013812

  • Cardiomed SRL Cluj-Napoca ( Site 2406)

    Cluj-Napoca, Cluj, 400015

  • Centrul de Oncologie Sfantul Nectarie-Medical ( Site 2401)

    Craiova, Dolj, 200746

  • Amethyst Radiotherapy Center-Oncologie Medicala ( Site 2405)

    Florești, Cluj, 407280

  • Radiology Therapeutic Center-Oncology ( Site 2404)

    Otopeni, Ilfov, 075100

  • Cabinet Medical Oncomed ( Site 2403)

    Timișoara, Timiș County, 300239

Other trials in Romania

Finland5 sites

  • Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 0803)

    Helsinki, Uusimaa, 00290

  • Kuopion Yliopistollinen Sairaala-Syöpäkeskus ( Site 0804)

    Kuopio, Northern Savonia, 70210

  • Oulun yliopistollinen sairaala ( Site 0802)

    Oulu, North Ostrobothnia, 90220

  • Tampereen yliopistollinen sairaala ( Site 0805)

    Tampere, Pirkanmaa, 33520

  • Turku University Hospital ( Site 0801)

    Turku, Southwest Finland, 20520

Other trials in Finland

Greece5 sites

  • Alexandra Hospital-ONCOLOGY DEPT. ( Site 1102)

    Athens, Attica, 115 28

  • Metropolitan Hospital-2nd Oncology Dept ( Site 1104)

    Athens, Attica, 185 47

  • ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1101)

    Chaïdári, Attica, 124 62

  • Euromedica General Clinic Thessaloniki-Oncology Unit ( Site 1103)

    Thessaloniki, 546 45

  • European Interbalkan Medical Center-Oncology Department ( Site 1105)

    Thessaloniki, 570 01

Other trials in Greece

Hungary5 sites

  • Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 1316)

    Budapest, Pest County, 1122

  • Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 1310)

    Debrecen, 4032

  • Petz Aladar Egyetemi Oktato Korhaz-Onkológiai Osztály ( Site 1321)

    Győr, Győr-Moson-Sopron, 9024

  • Somogy Megyei Kaposi Mór Oktató Kórház-Oncology center ( Site 1311)

    Kaposvár, Somogy County, 7400

  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ ( Site 1319)

    Szeged, Csongrád megye, 6725

Other trials in Hungary

Colombia4 sites

  • Clinica de la Costa S.A.S. ( Site 0506)

    Barranquilla, Atlántico, 080020

  • Administradora Country S.A. - Clinica del Country ( Site 0504)

    Bogotá, Bogota D.C., 110221

  • IMAT S.A.S ( Site 0501)

    Montería, Departamento de Córdoba, 230002

  • Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 0505)

    Valledupar, Cesar Department, 200001

Other trials in Colombia

Ireland4 sites

  • Cork University Hospital ( Site 1404)

    Cork, T12 E8YV

  • St. Vincent's University Hospital ( Site 1401)

    Dublin, Dublin, D04 T6F4

  • Tallaght University Hospital ( Site 1402)

    Dublin, Dublin, D24 NR0A

  • Beaumont Hospital, Dublin-Cancer Clinical Trials & Research Unit ( Site 1403)

    Dublin, Dublin 9

Other trials in Ireland

South Korea4 sites

  • National Cancer Center-Center for Urologic Cancer ( Site 2604)

    Goyang-si, Kyonggi-do, 10408

  • Seoul National University Bundang Hospital-Urology ( Site 2602)

    Seongnam, Kyonggi-do, 13620

  • Samsung Medical Center ( Site 2603)

    Seoul, 06351

  • Asan Medical Center-Oncology ( Site 2601)

    Songpagu, Seoul, 05505

Other trials in South Korea

Thailand4 sites

  • Chulalongkorn University ( Site 3005)

    Bangkok, Bangkok, 10330

  • Ramathibodi Hospital ( Site 3001)

    Bangkok, Bangkok, 10400

  • Faculty of Medicine Siriraj Hospital ( Site 3002)

    Bangkok, Bangkok, 10700

  • Songklanagarind hospital ( Site 3004)

    Hat Yai, Changwat Songkhla, 90110

Other trials in Thailand

Bulgaria3 sites

  • MBAL Uni Hospital-Department of Medical Oncology ( Site 0204)

    Panagyurishte, Pazardzhik, 4500

  • Complex Cancer Center Plovdiv-First Medical Oncology Department ( Site 0205)

    Plovdiv, 4004

  • MHAT Serdika-Second Department of Medical Oncology ( Site 0203)

    Sofia, Sofia (stolitsa), 1301

Other trials in Bulgaria

Malaysia3 sites

  • Hospital Pulau Pinang ( Site 1806)

    George Town, Pulau Pinang, 10450

  • Sarawak General Hospital-Radiotherapy Unit ( Site 1805)

    Kuching, Sarawak, 93586

  • University Malaya Medical Centre ( Site 1804)

    Lembah Pantai, Kuala Lumpur, 59100

Other trials in Malaysia

Sweden3 sites

  • Sahlgrenska Universitetssjukhuset ( Site 2801)

    Gothenburg, Västra Götaland County, 413 45

  • Karolinska Universitetssjukhuset Solna ( Site 2802)

    Stockholm, Stockholm County, 171 76

  • Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 2803)

    Uppsala, Uppsala County, 751 85

Other trials in Sweden

Singapore2 sites

  • National Cancer Centre Singapore ( Site 3601)

    Singapore, Central Singapore, 168583

  • National University Hospital ( Site 3602)

    Singapore, South West, 119074

Other trials in Singapore

New Zealand1 site

  • Auckland City Hospital ( Site 2003)

    Auckland, 1023

Other trials in New Zealand

About this study

Official title: A Multicenter, Double-blind, Randomized Phase 3 Study to Compare the Efficacy and Safety of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in the Adjuvant Treatment of Clear Cell Renal Cell Carcinoma (ccRCC) Post Nephrectomy (MK-6482-022)

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).

Being tested
Belzutifan, Pembrolizumab, Placebo
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1(PDL1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2), Hypoxia inducible factor 2 alpha (HIF-2 alpha), Hypoxia inducible factor 2α (HIF-2α)
Medical subject headings
Carcinoma, Renal Cell, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BelzutifanDrug

    Also called MK-6482, PT2977, WELIREG™

    Three 40 mg tablets given as a single oral 120 mg dose.

  • PembrolizumabBiological

    Also called MK-3475, Keytruda®

    400 mg via IV infusion

  • PlaceboDrug

    Oral tablet

Study groups in NCT05239728
Study groupRoleWhat they receive
Belzutifan + PembrolizumabExperimentalParticipants 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).
Receives: Drug: Belzutifan; Biological: Pembrolizumab
Placebo + PembrolizumabExperimentalParticipants 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).
Receives: Biological: Pembrolizumab; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-Free Survival (DFS)

    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.

    Measured: Up to approximately 54 months

Secondary outcomes (9)

  1. Overall Survival (OS)

    OS is defined as the time from randomization to death due to any cause.

    Measured: Up to approximately 89 months

  2. Number of Participants Who Experience at Least One Adverse Event (AE)

    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.

    Measured: Up to approximately 66 weeks

  3. Number of Participants Who Discontinue Study Treatment Due to an AE

    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.

    Measured: Up to approximately 54 weeks

  4. Disease Recurrence-Specific Survival 1 (DRSS1)

    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.

    Measured: Up to approximately 54 months

  5. Disease Recurrence-Specific Survival 2 (DRSS2)

    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.

    Measured: Up to approximately 54 months

  6. 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

    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 scores will be presented.

    Measured: Baseline (Day 1) and up to approximately 36 months

  7. Change From Baseline in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score

    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.

    Measured: Baseline (Day 1) and up to approximately 36 months

  8. Change From Baseline in Role Functioning Using the EORTC QLQ-C30 Items 6 and 7 Score

    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 score indicate a worse level of function. Change from baseline in the score of EORTC QLQ-C30 Items 6-7 will be presented.

    Measured: Baseline (Day 1) and up to approximately 36 months

  9. 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

    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.

    Measured: Baseline (Day 1) and up to approximately 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2022
  2. Study start15 Mar 2022
  3. Primary completion28 Oct 2026 (estimated)
  4. Study completion28 Sep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
1,800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05239728
Sponsor's protocol ID
6482-022
Other IDs
MK-6482-022, LITESPARK-022, jRCT2051220030, 2023-505023-31-00, U1111-1290-7346, 2021-003436-92, 2023
Status last verified
May 2026
First submitted
4 Feb 2022
Last updated
15 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • Choueiri TK, Motzer RJ, Karam JA, Yip W, Suarez C, Ye D, He Z, Caglevic C, Ferguson T, Chang YH, Rojas C, Iacovelli R, Urun Y, Verzoni E, Vazquez Limon JC, Porta C, Uzzo RG, Lee JL, Venugopal B, McKay RR, Hammers H, Miyake H, Chahoud J, Liu H, Burgents JE, Sharma M, Powles TB; LITESPARK-022 Investigators. Adjuvant Pembrolizumab plus Belzutifan for Renal-Cell Carcinoma. N Engl J Med. 2026 Jul 2;395(1):32-43. doi: 10.1056/NEJMoa2518245.

    PubMed 42384869

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Belzutifan and Pembrolizumab in people with Carcinoma, Renal Cell, run by Merck Sharp & Dohme LLC at 285 sites in 32 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 285 sites in United States, China, Japan, Germany, Netherlands and 27 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-Free Survival (DFS) (time frame: Up to approximately 54 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05239728, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.

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