AzTrials
AzTrials

Renal Cell CarcinomaPhase 3LITESPARK-033NCT07227402

A Clinical Study of Belzutifan and Zanzalintinib in People With Recurrent Kidney Cancer Following Adjuvant Therapy (MK-6482-033)

A Phase 3 study testing Belzutifan, Zanzalintinib and Cabozantinib in people with Renal Cell Carcinoma, run by Merck Sharp & Dohme LLC at 127 sites in 23 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Researchers are looking for more ways to treat advanced renal cell carcinoma (RCC) that is recurrent. Researchers want to learn if recurrent advanced renal cell carcinoma (RCC) responds (gets smaller or goes away) after treatment with belzutifan (MK-6482) and zanzalintinib compared to cabozantinib. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cell Carcinoma
What is being tested?
Belzutifan, Zanzalintinib and Cabozantinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
904 participants
Where
127 sitesin 23 countries
Study dates
26 Nov 2025to 27 Feb 2032
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

  • The main inclusion criteria include but are not limited to the following:
  • Has a histologically confirmed diagnosis of unresectable, advanced renal cell cancer (RCC) with clear cell component (with or without sarcomatoid features) i.e., Stage IV renal cell cancer per American Joint Committee on Cancer (AJCC) (8th Edition)
  • Has measurable disease per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)
  • Has disease recurrence during adjuvant anti-programmed cell death 1/programmed cell death ligand 1 (PD-1/L1) therapy or recurrence ≤24 months following the last dose of adjuvant anti-PD-1/L1 therapy
  • Has received no other prior systemic therapy for their RCC except for their adjuvant anti-PD-1/L1 therapy

Who cannot join

  • The main exclusion criteria include but are not limited to the following:
  • Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, new-onset angina, pulmonary embolism, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability
  • Had deep vein thrombosis within 3 months before randomization unless stable, asymptomatic, and treated with therapeutic anticoagulation for at least 4 weeks before randomization
  • Has a left ventricular ejection fraction ≤50% or below the institutional (or local laboratory) normal range as determined by multigated acquisition or echocardiogram
  • Has had major surgery within 8 weeks before randomization or has not adequately recovered from major surgery or has ongoing surgical complications
  • Has current pneumonitis/interstitial lung disease
Show all 14Show fewer
  • Has symptomatic pleural effusion (for example cough, dyspnea, pleuritic chest pain), ascites, or pericardial fluid requiring drainage within 4 weeks prior to randomization
  • Has a gastrointestinal disorder including those associated with a high risk of perforation or fistula formation
  • Has a serious active nonhealing wound/ulcer/bone fracture
  • Has a requirement for hemodialysis or peritoneal dialysis
  • Has history of human immunodeficiency virus infection
  • Has hepatitis B or hepatitis C virus
  • Has pharmacologically uncompensated, symptomatic hypothyroidism
  • Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention

Trial locations and contacts

127 sites in 23 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

127 sites in 23 countries

Italy14 sites, 14 recruiting

  • Azienda USL 8 di Arezzo ( Site 1605)

    Arezzo, 52100

    Study Coordinator, +390575255446

    Recruiting

  • A.O.U.C. Policlinico di Bari ( Site 1602)

    Bari, 70124

    Study Coordinator, +390805592909

    Recruiting

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1604)

    Bologna, 40138

    Study Coordinator, +390512142575

    Recruiting

  • Istituto Oncologico Veneto IRCCS ( Site 1612)

    Castelfranco Veneto, Veneto, 31033

    Study Coordinator, +39 0423.732336

    Recruiting

  • Azienda Ospedaliera Universitaria Careggi ( Site 1608)

    Florence, Tuscany, 50134

    Study Coordinator, +390557949648

    Recruiting

  • Ospedale San Martino ( Site 1606)

    Genova, 16132

    Study Coordinator, 003901015553303

    Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1600)

    Milan, Milano, 20133

    Study Coordinator, 00390223903028

    Recruiting

  • Azienda Ospedaliera Di Rilievo Nazionale A. Cardarelli ( Site 1609)

    Naples, Campania, 80131

    Study Coordinator, 00390817472223

    Recruiting

  • Azienda Ospedaliera S. Luigi Gonzaga ( Site 1607)

    Orbassano, Piedmont, 10043

    Study Coordinator, 00390119026534

    Recruiting

  • Azienda Ospedaliera Universitaria di Parma ( Site 1603)

    Parma, 43126

    Study Coordinator, +39 0521702682

    Recruiting

  • Casa di Cura Dott. Pederzoli - UO Oncologia ( Site 1610)

    Peschiera del Garda, Veneto, 37019

    Study Coordinator, +390456444193

    Recruiting

  • Istituto Nazionale Tumori Regina Elena ( Site 1611)

    Rome, Lazio, 00144

    Study Coordinator, +39 0652666919

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1601)

    Rome, Roma, 00618

    Study Coordinator, 00390630155202

    Recruiting

  • Istituto Clinico Humanitas ( Site 1613)

    Rozzano, Milano, 20089

    Study Coordinator, 00390282244061

    Recruiting

Other trials in Italy

France11 sites, 11 recruiting

  • Centre Hospitalier Universitaire d'Angers-Urology ( Site 1104)

    Angers, Pays de la Loire Region, 49933

    Study Coordinator, +33665807200

    Recruiting

  • Centre Hospitalier de la Cote Basque ( Site 1113)

    Bayonne, Pyrenees-Atlantiques, 64109

    Study Coordinator, +33559443535

    Recruiting

  • CHU de Bordeaux Hop St ANDRE ( Site 1115)

    Bordeaux, Gironde, 33075

    Study Coordinator, +33556795679

    Recruiting

  • HENRI MONDOR HOSPITAL ( Site 1116)

    Créteil, Val-de-Marne, 94010

    Study Coordinator, +33145178243

    Recruiting

  • CHD Vendee ( Site 1103)

    La Roche-sur-Yon, Vendee, 85000

    Study Coordinator, +33251446173

    Recruiting

  • CHU GRENOBLE ALPES ( Site 1101)

    La Tronche, Isere, 38700

    Study Coordinator, +33476765451

    Recruiting

  • Centre de Cancérologie du Grand Montpellier ( Site 1112)

    Montpellier, Herault, 34070

    Study Coordinator, +33467926155

    Recruiting

  • Centre d'Oncologie de Gentilly ( Site 1117)

    Nancy, Lorraine, 54100

    Study Coordinator, +33355685518

    Recruiting

  • centre hospitalier lyon sud ( Site 1102)

    Pierre-Bénite, Rhone, 69310

    Study Coordinator, +33472118088

    Recruiting

  • CHU de Rouen ( Site 1108)

    Rouen, Seine-Maritime, 76031

    Study Coordinator, +33232881315

    Recruiting

  • Hôpital Foch ( Site 1118)

    Suresnes, Hauts-de-Seine, 92150

    Study Coordinator, +33146253671

    Recruiting

Other trials in France

Germany11 sites, 11 recruiting

  • Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 1203)

    Berlin, 10117

    Study Coordinator, +49 30 45050

    Recruiting

  • Universitaetsklinikum Carl Gustav Carus Dresden ( Site 1213)

    Dresden, Saxony, 01307

    Study Coordinator, +493514584425

    Recruiting

  • HELIOS Klinikum Erfurt ( Site 1208)

    Erfurt, Thuringia, 99089

    Study Coordinator, +493617810

    Recruiting

  • Universitätsmedizin Göttingen - Georg-August-Universität ( Site 1211)

    Göttingen, Lower Saxony, 37075

    Study Coordinator, +4955139 68145

    Recruiting

  • Universitaetsklinikum Hamburg-Eppendorf ( Site 1214)

    Hamburg, 20246

    Study Coordinator, +4915222823094

    Recruiting

  • Marienhospital Herne ( Site 1215)

    Herne, North Rhine-Westphalia, 44625

    Study Coordinator, +492323 4990

    Recruiting

  • Universitätsklinikum Jena ( Site 1204)

    Jena, Thuringia, 07747

    Study Coordinator, +4936419329901

    Recruiting

  • Universitaetsklinikum Muenster ( Site 1202)

    Münster, North Rhine-Westphalia, 70174

    Study Coordinator, +492518344658

    Recruiting

  • Helios Kliniken Schwerin GmbH ( Site 1206)

    Schwerin, Mecklenburg-Vorpommern, 19055

    Study Coordinator, +493855202120

    Recruiting

  • Klinikum Stuttgart - Katharinenhospital ( Site 1201)

    Stuttgart, Baden-Wurttemberg, 70174

    Study Coordinator, +49 7071 278 54564

    Recruiting

  • UniversitaetsklInikum Tuebingen ( Site 1207)

    Tübingen, Baden-Wurttemberg, 72076

    Study Coordinator, 004970712987235

    Recruiting

Other trials in Germany

Spain11 sites, 11 recruiting

  • Hospital Universitari Vall d'Hebron ( Site 1804)

    Barcelona, 08035

    Study Coordinator, +34934894350

    Recruiting

  • Hospital Clinic de Barcelona ( Site 1810)

    Barcelona, 08036

    Study Coordinator, +34932275402

    Recruiting

  • Hospital Universitario Reina Sofia ( Site 1809)

    Córdoba, 14004

    Study Coordinator, +34957011464

    Recruiting

  • Institut Català d'Oncologia (ICO) - Girona ( Site 1806)

    Girona, Gerona, 17007

    Study Coordinator, +34972225832

    Recruiting

  • Institut Català d'Oncologia - L'Hospitalet ( Site 1805)

    L'Hospitalet de Llobregat, Barcelona, 08908

    Study Coordinator, +34932607744

    Recruiting

  • Hospital Universitario Ramón y Cajal ( Site 1801)

    Madrid, Madrid, Comunidad de, 28034

    Study Coordinator, +34 913368263

    Recruiting

  • Hospital Clinico San Carlos ( Site 1802)

    Madrid, 28040

    Study Coordinator, +34 91 330 35 46

    Recruiting

  • Hospital Universitario Fundacion Jimenez Diaz ( Site 1803)

    Madrid, 28040

    Study Coordinator, +34915504800-2869

    Recruiting

  • Hospital Universitario 12 de Octubre ( Site 1800)

    Madrid, 28041

    Study Coordinator, +34 91 390 83 39

    Recruiting

  • Hospital Universitario Marqués de Valdecilla ( Site 1807)

    Santander, Cantabria, 39008

    Study Coordinator, +34 942 20 25 25

    Recruiting

  • Fundación Instituto Valenciano de Oncología ( Site 1808)

    Valencia, Valenciana, Comunitat, 46009

    Study Coordinator, +34 961114605

    Recruiting

Other trials in Spain

United States10 sites, 10 recruiting

  • Alaska Oncology and Hematology ( Site 0133)

    Anchorage, Alaska, 99508

    Study Coordinator, 907-257-9851

    Recruiting

  • Greater Baltimore Medical Center ( Site 0145)

    Baltimore, Maryland, 21204

    Study Coordinator, 443-849-8136

    Recruiting

  • Carolina Oncology Specialists, PA ( Site 9002)

    Charlotte, North Carolina, 28207

    Study Coordinator, 704-342-1900

    Recruiting

  • Providence Medical Foundation ( Site 0141)

    Fullerton, California, 92835

    Study Coordinator, 714-446-5900

    Recruiting

  • Thompson Cancer Survival Center ( Site 0125)

    Knoxville, Tennessee, 37916

    Study Coordinator, 865-331-1678

    Recruiting

  • USC Norris Comprehensive Cancer Center ( Site 0126)

    Los Angeles, California, 90033

    Study Coordinator, 800-872-2273

    Recruiting

  • Cedars-Sinai Medical Center ( Site 0112)

    Los Angeles, California, 90048

    Study Coordinator, 310-423-3227

    Recruiting

  • Oncology Hematology West P.C. dba Nebraska Cancer Specialists ( Site 0131)

    Omaha, Nebraska, 68130-2042

    Study Coordinator, 402-691-6971

    Recruiting

  • Metro-Minnesota Community Clinical Oncology ( Site 0144)

    Saint Louis Park, Minnesota, 55426

    Study Coordinator, 952-993-1555

    Recruiting

  • New England Cancer Specialists ( Site 0132)

    Westbrook, Maine, 04092

    Study Coordinator, 207-303-3300

    Recruiting

Other trials in United States

Argentina9 sites, 9 recruiting

  • Hospital Italiano de Buenos Aires. ( Site 0203)

    Caba, Buenos Aires, C1199ABB

    Study Coordinator, +541149590200

    Recruiting

  • Asociación de Beneficencia Hospital Sirio Libanés ( Site 0205)

    Caba, Buenos Aires, C1419AHN

    Study Coordinator, +541145740870

    Recruiting

  • Hospital Aleman ( Site 0204)

    CABA, Buenos Aires, C1118AAT

    Study Coordinator, +5448277000

    Recruiting

  • Instituto Alexander Fleming ( Site 0202)

    CABA, Buenos Aires, C1426ANZ

    Study Coordinator, +541132218900

    Recruiting

  • Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 0208)

    Caba., Buenos Aires F.D., C1431FWO

    Study Coordinator, +541152990000

    Recruiting

  • Hospital Privado Universitario de Córdoba ( Site 0207)

    Córdoba, X5016KEH

    Study Coordinator, +543514688200

    Recruiting

  • Hospital Universitario Austral ( Site 0212)

    Pilar, Buenos Aires, B1629AHJ

    Study Coordinator, +542304387649

    Recruiting

  • Sanatorio Parque ( Site 0201)

    Rosario, Santa Fe Province, S2000DSV

    Study Coordinator, +5493416955611

    Recruiting

  • Instituto de Oncología de Rosario ( Site 0209)

    Rosario, Santa Fe Province, S2000KZE

    Study Coordinator, +5493414218909

    Recruiting

Other trials in Argentina

Poland8 sites, 8 recruiting

  • Zakład Diagnostyki Laboratoryjnej, Centrum Onkologii ( Site 1707)

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

    Study Coordinator, +48523743883

    Recruiting

  • Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie ( Site 1701)

    Koszalin, West Pomeranian Voivodeship, 75-581

    Study Coordinator, 943488930

    Recruiting

  • Pratia MCM Krakow ( Site 1713)

    Krakow, Lesser Poland Voivodeship, 30-727

    Study Coordinator, +48122958160

    Recruiting

  • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 1703)

    Krakow, Lesser Poland Voivodeship, 31-826

    Study Coordinator, +48126468251

    Recruiting

  • Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1710)

    Przemyśl, Podkarpackie Voivodeship, 37-700

    Study Coordinator, +48166775511

    Recruiting

  • Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1702)

    Siedlce, Masovian Voivodeship, 08-110

    Study Coordinator, +48256403300

    Recruiting

  • AIDPORT Sp. z o.o. ( Site 1716)

    Skórzewo, Greater Poland Voivodeship, 60-185

    Study Coordinator, +48570783100

    Recruiting

  • MTZ Clinical Research Powered by Pratia ( Site 1705)

    Warsaw, Masovian Voivodeship, 02-172

    Study Coordinator, +48225725959

    Recruiting

Other trials in Poland

Czechia7 sites, 7 recruiting

  • Masarykuv onkologicky ustav ( Site 0903)

    Brno, Brno-mesto, 656 53

    Study Coordinator, +420543136831

    Recruiting

  • Nemocnice České Budějovice ( Site 0905)

    České Budějovice, 370 01

    Study Coordinator, +420387871111

    Recruiting

  • Fakultni nemocnice Hradec Kralove ( Site 0902)

    Hradec Králové, 500 05

    Study Coordinator, +420 607 192 913

    Recruiting

  • Fakultni nemocnice Olomouc ( Site 0901)

    Olomouc, 779 00

    Study Coordinator, +420588444295

    Recruiting

  • Fakultni nemocnice Ostrava ( Site 0904)

    Ostrava, Ostrava Mesto, 708 52

    Study Coordinator, +420597374322

    Recruiting

  • Vseobecna fakultni nemocnice v Praze ( Site 0906)

    Prague, 128 08

    Study Coordinator, +420 224 966 405

    Recruiting

  • Fakultni nemocnice v Motole ( Site 0900)

    Prague, 150 06

    Study Coordinator, +420224439427

    Recruiting

Other trials in Czechia

South Korea6 sites, 6 recruiting

  • Chonnam National University Hwasun Hospital ( Site 2505)

    Hwasun-gun, Jeonranamdo, 58128

    Study Coordinator, +82613797623

    Recruiting

  • Seoul National University Bundang Hospital ( Site 2504)

    Seongnam, Kyonggi-do, 13620

    Study Coordinator, +82317877039

    Recruiting

  • Severance Hospital, Yonsei University Health System ( Site 2503)

    Seoul, 03722

    Study Coordinator, +82222280430

    Recruiting

  • Asan Medical Center ( Site 2501)

    Seoul, 05505

    Study Coordinator, +82230105977

    Recruiting

  • Samsung Medical Center ( Site 2502)

    Seoul, 06351

    Study Coordinator, +82234101767

    Recruiting

  • Chungnam National University Hospital ( Site 2506)

    Taejŏn, Taejon-Kwangyokshi, 35015

    Study Coordinator, +82422808369

    Recruiting

Other trials in South Korea

Brazil5 sites, 5 recruiting

  • IPC - MT Instituto de Pesquisas Clínicas do Mato Grosso ( Site 0305)

    Cuiabá, Mato Grosso, 78020-500

    Study Coordinator, +5565999470522

    Recruiting

  • Liga Norte Riograndense Contra o Câncer ( Site 0307)

    Natal, Rio Grande do Norte, 59062-000

    Study Coordinator, +558440095595

    Recruiting

  • Hospital Moinhos de Vento ( Site 0309)

    Porto Alegre, Rio Grande do Sul, 90560-032

    Study Coordinator, +5551980609999

    Recruiting

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0302)

    São José do Rio Preto, São Paulo, 15090-000

    Study Coordinator, +551732015000

    Recruiting

  • Hospital Alemao Oswaldo Cruz ( Site 0311)

    São Paulo, São Paulo, 01327-001

    Study Coordinator, +551135490391

    Recruiting

Other trials in Brazil

Mexico5 sites, 5 recruiting

  • CIO - Centro de Inmuno-Oncología de Occidente ( Site 0503)

    Guadalajara, Jalisco, 44630

    Study Coordinator, 3331721132

    Recruiting

  • Higiea Oncologia ( Site 0504)

    Mexico City, 11810

    Study Coordinator, +525652731712

    Recruiting

  • I CAN ONCOLOGY CENTER S.A. DE C.V. ( Site 0507)

    Monterrey, Nuevo León, 64710

    Study Coordinator, 8125558165 Ext. 1005

    Recruiting

  • Centro de Investigacion Clinica de Oaxaca ( Site 0502)

    Oaxaca City, Oaxaca, 68020

    Study Coordinator, +529516035559

    Recruiting

  • Clinica Integral Internacional de Oncología ( Site 0506)

    Puebla City, 72530

    Study Coordinator, +522229525806

    Recruiting

Other trials in Mexico

Belgium4 sites, 4 recruiting

  • Cliniques Universitaires Saint-Luc ( Site 0703)

    Brussels, Bruxelles-Capitale, Region de, 1200

    Study Coordinator, +3227643546

    Recruiting

  • Ziekenhuis Oost-Limburg, Campus St.-Jan ( Site 0701)

    Genk, Limburg, 3600

    Study Coordinator, +32 89 80 40 40

    Recruiting

  • UZ Gent ( Site 0702)

    Ghent, Oost-Vlaanderen, 9000

    Study Coordinator, +32 (0)9 332 62 18

    Recruiting

  • UZ Leuven ( Site 0700)

    Leuven, Vlaams-Brabant, 3000

    Study Coordinator, +32 (0)16 34 69 12

    Recruiting

Other trials in Belgium

Taiwan4 sites, 4 recruiting

  • China Medical University Hospital ( Site 2603)

    Taichung, 40447

    Study Coordinator, +886422052121

    Recruiting

  • Taichung Veterans General Hospital ( Site 2602)

    Taichung, 40705

    Study Coordinator, +886423592525x5121

    Recruiting

  • Taipei Veterans General Hospital ( Site 2600)

    Taipei, 11217

    Study Coordinator, +886218712121x86334

    Recruiting

  • Chang Gung Memorial Hospital - Linkou Branch ( Site 2604)

    Taoyuan, 333

    Study Coordinator, +88633281200

    Recruiting

Other trials in Taiwan

Chile3 sites, 3 recruiting

  • Fundacion Arturo Lopez Perez ( Site 0401)

    Santiago, Region M. de Santiago, 7500921

    Study Coordinator, +56224457398

    Recruiting

  • Centro de Investigacion Clinica UC CICUC ( Site 0402)

    Santiago, Region M. de Santiago, 833000

    Study Coordinator, 56934331806

    Recruiting

  • Oncocentro Valdivia ( Site 0408)

    Valdivia, Los Ríos Region, 5112129

    Study Coordinator, +56632632200

    Recruiting

Other trials in Chile

Croatia3 sites, 3 recruiting

  • Klinički Bolnički Centar Split ( Site 0802)

    Split, Split-Dalmatia County, 21000

    Study Coordinator, +385915297299

    Recruiting

  • Klinički bolnički centar Sestre milosrdnice ( Site 0801)

    Zagreb, City of Zagreb, 10000

    Study Coordinator, +38513787421

    Recruiting

  • Klinički bolnički centar Zagreb ( Site 0800)

    Zagreb, City of Zagreb, 10000

    Study Coordinator, +38512388575

    Recruiting

Other trials in Croatia

Denmark3 sites, 3 recruiting

  • Aarhus University Hospital Skejby ( Site 1001)

    Aarhus, Central Jutland, 8200

    Study Coordinator, +45 91167192

    Recruiting

  • Herlev Hospital ( Site 1002)

    Herlev, Capital Region, 2730

    Study Coordinator, +45 38688798

    Recruiting

  • Odense Universitetshospital ( Site 1000)

    Odense, Region Syddanmark, 9000

    Study Coordinator, +45 65411516

    Recruiting

Other trials in Denmark

Greece3 sites, 3 recruiting

  • Alexandra General Hospital of Athens ( Site 1300)

    Athens, Attica, 115 28

    Study Coordinator, +302132162543

    Recruiting

  • Metropolitan Hospital ( Site 1302)

    Athens, Attica, 185 47

    Study Coordinator, +302104809667

    Recruiting

  • University General Hospital ''Attikon'' - General Hospital of West Attica "H AGIA VARVARA" ( Site 1301)

    Chaïdári, Attica, 124 62

    Study Coordinator, +302105832549

    Recruiting

Other trials in Greece

Austria2 sites, 2 recruiting

  • Ordensklinikum Linz GmbH Elisabethinen-Urologie ( Site 0600)

    Linz, Upper Austria, 4020

    Study Coordinator, +43 732 7676 4641

    Recruiting

  • Medizinische Universitat Wien ( Site 0601)

    Vienna, 1090

    Study Coordinator, +43 1 40400 60430

    Recruiting

Other trials in Austria

Hong Kong2 sites, 2 recruiting

  • Prince of Wales Hospital ( Site 2200)

    Hong Kong

    Study Coordinator, +85235051042

    Recruiting

  • Queen Mary Hospital ( Site 2201)

    Hong Kong

    Study Coordinator, +85222554361

    Recruiting

Other trials in Hong Kong

Ireland2 sites, 2 recruiting

  • Cork University Hospital ( Site 1501)

    Cork, T12 YK23

    Study Coordinator, +353214234802

    Recruiting

  • Tallaght University Hospital ( Site 1500)

    Dublin, D24 NR0A

    Study Coordinator, +35314144000

    Recruiting

Other trials in Ireland

Singapore2 sites, 2 recruiting

  • National University Hospital ( Site 2400)

    Singapore, Central Singapore, 119074

    Study Coordinator, 6908 2222

    Recruiting

  • National Cancer Centre Singapore ( Site 2401)

    Singapore, Central Singapore, 168583

    Study Coordinator, +6564368000

    Recruiting

Other trials in Singapore

Australia1 site, 1 recruiting

  • Macquarie University-MQ Health Clinical Trials Unit ( Site 2100)

    Sydney, New South Wales, 2109

    Study Coordinator, +61 2 9812 3526

    Recruiting

Other trials in Australia

United Kingdom1 site, 1 recruiting

  • Addenbrookes Hospital ( Site 2005)

    Cambridge, Cambridgeshire, CB2 0QQ

    Study Coordinator, +441223216083

    Recruiting

Other trials in United Kingdom

About this study

Official title: A Phase 3, Randomized, Open-label Study of Belzutifan + Zanzalintinib Versus Cabozantinib in Participants With Advanced RCC Who Experienced Disease Recurrence During or After Prior Adjuvant Anti-PD-1/L1 Therapy (LITESPARK-033)

Researchers are looking for more ways to treat advanced renal cell carcinoma (RCC) that is recurrent. Researchers want to learn if recurrent advanced renal cell carcinoma (RCC) responds (gets smaller or goes away) after treatment with belzutifan (MK-6482) and zanzalintinib compared to cabozantinib.

The goal of this study is to learn if:

People who take belzutifan and zanzalintinib live longer overall and without the cancer getting worse than people who take cabozantinib.

Being tested
Belzutifan, Zanzalintinib, Cabozantinib
Keywords
Carcinoma, Renal cell, Belzutifan, Zanzalintinib
Medical subject headings
Carcinoma, Renal Cell, Carcinoma

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™

    Administered orally QD

  • ZanzalintinibDrug

    Also called XL092

    Administered orally QD

  • CabozantinibDrug

    Administered orally QD

Study groups in NCT07227402
Study groupRoleWhat they receive
Belzutifan plus ZanzalintinibExperimentalParticipants will receive belzutifan orally once daily (QD) PLUS zanzalintinib orally QD until one of the reasons for discontinuation of study intervention are met.
Receives: Drug: Belzutifan; Drug: Zanzalintinib
CabozantinibActive comparatorParticipants will receive cabozantinib orally QD until one of the reasons for discontinuation of study intervention are met.
Receives: Drug: Cabozantinib

What is being measured

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

  1. Progression Free Survival (PFS)

    PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. PD will be assessed by Response Criteria in Solid Tumors Version 1.1 (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 (BICR) will be presented.

    Measured: Up to approximately 73 months

  2. Overall Survival (OS)

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

    Measured: Up to approximately 73 months

Secondary outcomes (12)

  1. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.

    Measured: Up to approximately 73 months

  2. Duration of Response (DOR)

    For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1), DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by Blinded Independent Central Review (BICR) will be presented.

    Measured: Up to approximately 73 months

  3. Number of Participants Who Experience One or More Adverse Events (AEs)

    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 73 months

  4. 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 discontinue the study treatment due to an AE will be reported.

    Measured: Up to approximately 73 months

  5. Change From Baseline in European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC QLQ-C30) Global Health/Health-Related Quality of Life (HRQoL) Items 29 and 30 Combined Score

    The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to the questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and Quality of Life (QoL; "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), then summed. Summed raw scores are standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome.

    Measured: Up to approximately 25 months

  6. Change From Baseline in EORTC QLC-C30 Physical Functioning 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 (Items 1-5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome.

    Measured: Up to approximately 25 months

  7. Change From Baseline in EORTC QLQ-C30 Role Functioning Items 6-7 Score

    The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 2 questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Summed raw scores are standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating a better level of functioning.

    Measured: Up to approximately 25 months

  8. Change From Baseline in 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.

    Measured: Up to approximately 25 months

  9. Time From Baseline to First Deterioration in EORTC-QLC-C30 Global Health/HRQoL Score

    Time to True Deterioration (TTD) is defined as the time from baseline to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in Items 29 and 30 scale scores. A longer TTD indicates a better outcome. TTD is reported based on the product-limit (Kaplan-Meier) method for censored data.

    Measured: Up to approximately 25 months

  10. Time From Baseline to First Deterioration in EORTC-QLC-C30 Physical Functioning Score

    TTD is defined as the time from baseline to the first onset of a ≥10-point deterioration (decrease) from baseline in physical functioning score (EORTC QLQ-C30 Items 1-5). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in physical functioning score will be presented. A longer TTD indicates a better outcome.

    Measured: Up to approximately 25 months

  11. Time From Baseline to First Deterioration in EORTC-QLC-C30 Role Functioning Score

    TTD is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) from baseline in role functioning (EORTC QLQ-C30 Items 6 and 7) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10 point negative change (decrease) from baseline in role functioning score, will be presented. A longer TTD indicates a better outcome.

    Measured: Up to approximately 25 months

  12. Time From Baseline to First Deterioration in FKSI-DRS Score

    TTD is defined as time from the first dose of study treatment to the date of deterioration of FKSI-DRS Score. Each item is scored on a 5-point scale (0=not at all to 4=very much). FKSI-DRS total score ranged from 0 (most severe symptoms) to 36 (no symptoms) with a higher score indicating a better outcome. Deterioration is defined as a 3-point decrease (i.e. lower score) in symptom score and the time to true deterioration is the time to first onset of 3 or more decreases from baseline with confirmation under right-censoring rule (the last observation). A longer TTD indicates a better outcome.

    Measured: Up to approximately 25 months

Timeline

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

  1. First posted12 Nov 2025
  2. Study start26 Nov 2025
  3. Primary completion27 Feb 2032 (estimated)
  4. Study completion27 Feb 2032 (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
None (open label)
Enrolment
904 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07227402
Sponsor's protocol ID
6482-033
Other IDs
U1111-1311-6892, 2024-517136-21
Acronym
LITESPARK-033
Status last verified
Jul 2026
First submitted
7 Nov 2025
Last updated
3 Aug 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Belzutifan, Zanzalintinib and Cabozantinib in people with Renal Cell Carcinoma, run by Merck Sharp & Dohme LLC at 127 sites in 23 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 5 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 127 sites in Italy, France, Germany, Spain, United States and 18 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?

Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: Up to approximately 73 months). The study lists 2 primary outcomes in all. 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 NCT07227402.

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 3 Aug 2026.

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