AzTrials
AzTrials

Carcinoma, Renal CellPhase 3NCT07489495

A Clinical Study of Belzutifan (MK-6482) and Zanzalintinib in People With Renal Cell Carcinoma (RCC) (LITESPARK-034/LS-034/MK-6482-034)

A Phase 3 study testing Belzutifan and Zanzalintinib in people with Carcinoma, Renal Cell, run by Merck Sharp & Dohme LLC at 106 sites in 19 countries.

Recruiting

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

Sites and contacts
Official record
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Trial summary

Researchers are looking for new ways to treat advanced renal cell carcinoma (RCC). A standard (usual) treatment for certain people with RCC is belzutifan (a study medicine), which is a targeted therapy. Targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread. 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 Zanzalintinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
758 participants
Where
106 sitesin 19 countries
Study dates
9 Apr 2026to 27 Nov 2030
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 carcinoma (RCC) with clear cell component (with or without sarcomatoid features) ie, Stage IV RCC per American Joint Committee on Cancer (8th Edition)
  • Has measurable disease per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
  • Has received no more than 3 prior systemic regimens for RCC, including only 1 prior anti-Programmed Cell Death-1/Programmed Cell Death 1 Ligand 1 therapy

Who cannot join

  • For exclusion criteria: The main exclusion criteria include but are not limited to the following:
  • Has any of the following: a pulse oximeter reading <92% at rest, requires intermittent supplemental oxygen, or required chronic supplemental oxygen
  • Has clinically significant cardiovascular disease within 12 months from first dose of study intervention
  • Has 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
Show all 12Show fewer
  • Has current pneumonitis/interstitial lung disease
  • Has a history of human immunodeficiency virus infection
  • Has Hepatitis B or Hepatitis C virus infection
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
  • Has a history of solid organ transplant
  • Has not adequately recovered from major surgery or has ongoing surgical complications

Trial locations and contacts

106 sites in 19 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

106 sites in 19 countries

United States11 sites, 11 recruiting

  • Beth Israel Deaconess Medical Center ( Site 0139)

    Boston, Massachusetts, 02215

    Study Coordinator, 617-667-7000

    Recruiting

  • Dana Farber Cancer Institute ( Site 0135)

    Boston, Massachusetts, 02215

    Study Coordinator, 617-632-3000

    Recruiting

  • UT Southwestern Medical Center ( Site 0119)

    Dallas, Texas, 75390

    Study Coordinator, 214-648-3111

    Recruiting

  • The West Clinic, P.C. ( Site 0115)

    Germantown, Tennessee, 38138

    Study Coordinator, 901-683-0055

    Recruiting

  • The Cancer and Hematology Centers ( Site 0123)

    Grand Rapids, Michigan, 49503

    Study Coordinator, 616-954-9800

    Recruiting

  • University of Louisville, James Graham Brown Cancer Center ( Site 0133)

    Louisville, Kentucky, 40202

    Study Coordinator, 502-562-4673

    Recruiting

  • Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0104)

    Louisville, Kentucky, 40207

    Study Coordinator, 502-899-3366

    Recruiting

  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0102)

    Marietta, Georgia, 30060

    Study Coordinator, 770-281-5124

    Recruiting

  • Atlantic Health System Morristown Medical Center ( Site 0109)

    Morristown, New Jersey, 07960

    Study Coordinator, 973-971-7960

    Recruiting

  • Memorial Sloan Kettering Cancer Center ( Site 0126)

    New York, New York, 10065

    Study Coordinator, 347-798-9213

    Recruiting

  • Washington University School of Medicine ( Site 0114)

    St Louis, Missouri, 63110

    Study Coordinator, 314-362-7355

    Recruiting

Other trials in United States

Italy10 sites, 10 recruiting

  • Azienda Ospedaliera Policlinico di Bari ( Site 1802)

    Bari, 70124

    Study Coordinator, 00390805593767

    Recruiting

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1803)

    Bologna, 40138

    Study Coordinator, +390512142204

    Recruiting

  • Istituto Oncologico Veneto IRCCS ( Site 1806)

    Catselfranco Veneto, Padova, 31033

    Study Coordinator, +39 0423732336

    Recruiting

  • Azienda Ospedaliera Universitaria Careggi ( Site 1807)

    Florence, Tuscany, 50134

    Study Coordinator, +390557949648

    Recruiting

  • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 1809)

    Meldola, Emilia-Romagna, 47014

    Study Coordinator, +390543739100

    Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1800)

    Milan, 20133

    Study Coordinator, 02 2390 3028

    Recruiting

  • AO Santa Maria della Misericordia ( Site 1805)

    Perugia, 06132

    Study Coordinator, +39 0755784188

    Recruiting

  • Istituto Nazionale Tumori Regina Elena ( Site 1804)

    Roma, 00144

    Study Coordinator, +39 0652666919

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1801)

    Roma, 00168

    Study Coordinator, 00390630155202

    Recruiting

  • Istituto Clinico Humanitas ( Site 1808)

    Rozzano, Milano, 20089

    Study Coordinator, 0282244061

    Recruiting

Other trials in Italy

Argentina9 sites, 9 recruiting

  • Centro Oncologico Korben ( Site 0254)

    CABA, Buenos Aires, C1426AHB

    Study Coordinator, +541159507952

    Recruiting

  • Instituto Alexander Fleming ( Site 0252)

    CABA, C1426ANZ

    Study Coordinator, +541132218900

    Recruiting

  • Hospital Italiano de Buenos Aires ( Site 0253)

    Ciudad de Buenos Aires, Buenos Aires, 1181

    Study Coordinator, +541149590200

    Recruiting

  • Centro Oncológico Riojano Integral ( Site 0256)

    La Rioja, X5004BAL

    Study Coordinator, +543804436443X108

    Recruiting

  • Instituto de Investigaciones Clinicas Mar del Plata ( Site 0250)

    Mar del Plata, Buenos Aires, B7600FZO

    Study Coordinator, +542234963224

    Recruiting

  • Centro Privado de RMI Río Cuarto S.A. II ( Site 0255)

    Río Cuarto, Córdoba Province, X5800ALB

    Study Coordinator, +543584620273

    Recruiting

  • Sanatorio Parque ( Site 0251)

    Rosario, Santa Fe Province, S2000DSV

    Study Coordinator, +5493416955611

    Recruiting

  • Instituto de Oncología de Rosario ( Site 0257)

    Rosario, Santa Fe Province, S2000KZE

    Study Coordinator, +543414484830

    Recruiting

  • COE (Centro Oncológico de Excelencia) ( Site 0259)

    San Juan, J5402BGA

    Study Coordinator, +54 2644229585

    Recruiting

Other trials in Argentina

United Kingdom8 sites, 8 recruiting

  • University Hospitals Birmingham NHS Foundation Trust ( Site 2610)

    Birmingham, B15 2GW

    Study Coordinator, +4407789651543

    Recruiting

  • Addenbrookes Hospital ( Site 2605)

    Cambridge, Cambridgeshire, CB2 0QQ

    Study Coordinator, +441223805000

    Recruiting

  • Velindre Cancer Centre ( Site 2612)

    Cardiff, CF14 2TL

    Study Coordinator, +442920615888

    Recruiting

  • Western General Hospital ( Site 2608)

    Edinburgh, Edinburgh, City of, EH4 2XU

    Study Coordinator, +441315371398

    Recruiting

  • The Beatson West of Scotland Cancer Centre ( Site 2602)

    Glasgow, Glasgow City, G12 0YN

    Study Coordinator, +441413019916

    Recruiting

  • Leicester Royal Infirmary ( Site 2604)

    Leicester, Leicestershire, LE1 5WW

    Study Coordinator, 0300 303 1573

    Recruiting

  • University Hospital of Southampton ( Site 2606)

    Southampton, SO16 6YD

    Study Coordinator, 023 8077 7222

    Recruiting

  • The Christie Hospital NHS Foundation Trust ( Site 2601)

    Withington, Manchester, M20 4BX

    Study Coordinator, 0161 918 2546

    Recruiting

Other trials in United Kingdom

France7 sites, 7 recruiting

  • CHU Angers ( Site 1204)

    Angers, Maine-et-Loire, 49933

    Study Coordinator, +33241354694

    Recruiting

  • Clinique Victor Hugo Le Mans-Oncology-Radiotherapy ( Site 1203)

    Le Mans, Pays de la Loire Region, 72000

    Study Coordinator, +33 243297908

    Recruiting

  • Hopital Europeen Marseille ( Site 1216)

    Marseille, Bouches-du-Rhone, 13003

    Study Coordinator, +33413427427

    Recruiting

  • Centre Antoine Lacassagne ( Site 1209)

    Nice, Alpes-Maritimes, 06189

    Study Coordinator, +33492031538

    Recruiting

  • CHU de Saint-Etienne ( Site 1202)

    Saint Priest En Jarez, Pays de la Loire Region, 42271

    Study Coordinator, +33477917082

    Recruiting

  • LBM ONCOPOLE CLAUDIUS REGAUD ( Site 1215)

    Toulouse, Haute-Garonne, 31059

    Study Coordinator, +33531155050

    Recruiting

  • Gustave Roussy ( Site 1214)

    Villejuif, Val-de-Marne, 94800

    Study Coordinator, +33142114211

    Recruiting

Other trials in France

Spain7 sites, 7 recruiting

  • Hospital Universitari Vall d Hebron ( Site 2303)

    Barcelona, 08035

    Study Coordinator, +34934894350

    Recruiting

  • Institut Català d'Oncologia - L'Hospitalet ( Site 2305)

    L'Hospitalet de Llobregat, Barcelona, 08908

    Study Coordinator, +34932607744

    Recruiting

  • Hospital Insular de Gran Canaria ( Site 2308)

    Las Palmas, 35016

    Study Coordinator, +34928441738

    Recruiting

  • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 2301)

    Madrid, Madrid, Comunidad de, 28007

    Study Coordinator, +34914269393

    Recruiting

  • Hospital Universitario 12 de Octubre ( Site 2300)

    Madrid, 28041

    Study Coordinator, +34913908339

    Recruiting

  • Hospital Universitario Virgen del Rocio ( Site 2306)

    Seville, Andalusia, 41013

    Study Coordinator, +34955013068

    Recruiting

  • Fundación Instituto Valenciano de Oncología ( Site 2307)

    Valencia, 46009

    Study Coordinator, +34961114229

    Recruiting

Other trials in Spain

Czechia6 sites, 6 recruiting

  • Masarykuv onkologicky ustav ( Site 0903)

    Brno, Brno-mesto, 656 53

    Study Coordinator, +420543132216

    Recruiting

  • Fakultni nemocnice Hradec Kralove ( Site 0902)

    Hradec Králové, 500 05

    Study Coordinator, +420727854666

    Recruiting

  • Fakultni nemocnice Olomouc ( Site 0901)

    Olomouc, 779 00

    Study Coordinator, +420588445923

    Recruiting

  • Fakultni nemocnice Ostrava ( Site 0904)

    Ostrava, Ostrava Mesto, 708 52

    Study Coordinator, +420597374322

    Recruiting

  • Fakulti poliklinika ( Site 0906)

    Prague, 128 08

    Study Coordinator, +420224966405

    Recruiting

  • Fakultni nemocnice v Motole ( Site 0900)

    Prague, 150 06

    Study Coordinator, +420734236410

    Recruiting

Other trials in Czechia

Poland6 sites, 6 recruiting

  • Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2106)

    Gliwice, Silesian Voivodeship, 44-102

    Study Coordinator, +48322788237

    Recruiting

  • Pratia MCM Krakow ( Site 2115)

    Krakow, Lesser Poland Voivodeship, 30-727

    Study Coordinator, +48122958160

    Recruiting

  • Mazowiecki Szpital Wojewódzki im. Sw. Jana Pawla II w Siedlcach Sp. z o.o. ( Site 2102)

    Siedlce, Masovian Voivodeship, 08-110

    Study Coordinator, +48256403300

    Recruiting

  • AIDPORT Sp. z o.o. ( Site 2118)

    Skórzewo, Greater Poland Voivodeship, 60-185

    Study Coordinator, +48570783100

    Recruiting

  • MTZ Clinical Research Powered by Pratia ( Site 2107)

    Warsaw, Masovian Voivodeship, 02-172

    Study Coordinator, +48225725959

    Recruiting

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Moczowego ( Site 2100)

    Warsaw, Masovian Voivodeship, 02-781

    Study Coordinator, +48225462331

    Recruiting

Other trials in Poland

Turkey (Türkiye)6 sites, 6 recruiting

  • Adana Medical Park Seyhan Hastanesi ( Site 2505)

    Adana, 01140

    Study Coordinator, +905372688986

    Recruiting

  • Ankara University Health Practice and Research Hospitals ( Site 2506)

    Ankara, 06620

    Study Coordinator, +90 312 595 71 12

    Recruiting

  • Trakya University Medical Faculty Hospital ( Site 2502)

    Edirne, 22030

    Study Coordinator, +9005378528123

    Recruiting

  • Koc Universitesi Hastanesi ( Site 2501)

    Istanbul, 34010

    Study Coordinator, 0090 850 250 8 250

    Recruiting

  • Ege Universitesi Hastanesi ( Site 2503)

    Izmir, 35080

    Study Coordinator, 0 232 343 43 43

    Recruiting

  • Hacettepe Universite Hastaneleri ( Site 2500)

    Sıhhiye, Ankara, 06230

    Study Coordinator, +905439340493

    Recruiting

Other trials in Turkey (Türkiye)

Brazil5 sites, 5 recruiting

  • Instituto do Câncer e Transplante de Curitiba ( Site 0300)

    Curitiba, Paraná, 80510-130

    Study Coordinator, +55 41 99205-7755

    Recruiting

  • Liga Norte Riograndense Contra o Câncer ( Site 0307)

    Natal, Rio Grande do Norte, 59062-000

    Study Coordinator, +55 84 4009-5595

    Recruiting

  • Hope - Humanizacao Em Oncologia, Pesquisa E Ensino ( Site 0306)

    Ribeirão Preto, São Paulo, 14026-610

    Study Coordinator, +55 16 3913-8181

    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, +55 17 3201-5054

    Recruiting

  • CEDOES ( Site 0303)

    Vitória, Espírito Santo, 29055-450

    Study Coordinator, +552721250202

    Recruiting

Other trials in Brazil

Chile5 sites, 5 recruiting

  • IC La Serena Research ( Site 0405)

    La Serena, Coquimbo Region, 1720430

    Study Coordinator, 56958646664

    Recruiting

  • Clínica Puerto Montt ( Site 0404)

    Port Montt, Los Lagos Region, 5500243

    Study Coordinator, +56985383586

    Recruiting

  • Fundacion Arturo Lopez Perez ( Site 0401)

    Santiago, Region M. de Santiago, 7500921

    Study Coordinator, 56224205098

    Recruiting

  • Bradfordhill ( Site 0400)

    Santiago, Region M. de Santiago, 8420383

    Study Coordinator, 56229490970

    Recruiting

  • ONCOCENTRO APYS ( Site 0403)

    Viña del Mar, Valparaiso, 2520598

    Study Coordinator, 56323320850

    Recruiting

Other trials in Chile

Australia4 sites

  • Macquarie University ( Site 2700)

    Macquarie University, New South Wales, 2109

    Suspended

  • Peter MacCallum Cancer Centre ( Site 2702)

    Melbourne, Victoria, 3000

    Suspended

  • Fiona Stanley Hospital ( Site 2704)

    Murdoch, Western Australia, 6150

    Suspended

  • Princess Alexandra Hospital ( Site 2703)

    Woolloongabba, Queensland, 4102

    Suspended

Other trials in Australia

Germany4 sites, 4 recruiting

  • Universitaetsklinikum Augsburg ( Site 1316)

    Augsburg, Bavaria, 86156

    Study Coordinator, +498214002348

    Recruiting

  • Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 1312)

    Berlin, 10117

    Study Coordinator, +4930450515288

    Recruiting

  • Universitätsklinikum Jena ( Site 1313)

    Jena, Thuringia, 07747

    Study Coordinator, +4936419329970

    Recruiting

  • klinikum rechts der isar der technischen universität münchen ( Site 1315)

    Munich, Bavaria, 81675

    Study Coordinator, 00498941402522

    Recruiting

Other trials in Germany

Israel4 sites, 4 recruiting

  • Rambam Health Care Campus ( Site 1600)

    Haifa, 3109601

    Study Coordinator, +97247772688

    Recruiting

  • Meir Medical Center. ( Site 1603)

    Kfar Saba, 4428164

    Study Coordinator, +97297472555

    Recruiting

  • Rabin Medical Center ( Site 1602)

    Petah Tikva, 4941492

    Study Coordinator, 97239378074

    Recruiting

  • Sheba Medical Center ( Site 1601)

    Ramat Gan, 5265601

    Study Coordinator, 97235303030

    Recruiting

Other trials in Israel

Netherlands4 sites, 4 recruiting

  • Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL) ( Site 1900)

    Amsterdam, North Holland, 1066 CX

    Study Coordinator, +3120 512 9111

    Recruiting

  • Maastricht UMC+ ( Site 1901)

    Maastricht, Limburg, 6229 HX

    Study Coordinator, +31433877025

    Recruiting

  • Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 1903)

    Schiedam, South Holland, 3118 JH

    Study Coordinator, +31108931441

    Recruiting

  • Haga Ziekenhuis locatie Leyweg ( Site 1906)

    The Hague, South Holland, 2545 AA

    Study Coordinator, +3170 210 2143

    Recruiting

Other trials in Netherlands

Denmark3 sites, 3 recruiting

  • Aarhus Universitetshospital, Skejby ( Site 1001)

    Aarhus, Central Jutland, 8200

    Study Coordinator, +4591167472

    Recruiting

  • Herlev Hospital ( Site 1002)

    Herlev, Capital Region, 2730

    Study Coordinator, 00 45 38689191

    Recruiting

  • Odense Universitets Hospital ( Site 1000)

    Odense, Region Syddanmark, 5000

    Study Coordinator, +4566113333

    Recruiting

Other trials in Denmark

Greece3 sites, 3 recruiting

  • Alexandra General Hospital of Athens ( Site 1400)

    Athens, Attica, 115 28

    Study Coordinator, +302132162543

    Recruiting

  • ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1401)

    Athens, Attica, 124 62

    Study Coordinator, +302105832549

    Recruiting

  • Metropolitan Hospital ( Site 1402)

    Athens, Attica, 185 47

    Study Coordinator, +302104809667

    Recruiting

Other trials in Greece

South Korea3 sites, 3 recruiting

  • Severance Hospital, Yonsei University Health System ( Site 2903)

    Seoul, 03722

    Study Coordinator, +82-2-2228-8138

    Recruiting

  • Asan Medical Center ( Site 2901)

    Seoul, 05505

    Study Coordinator, +82-2-3010-5977

    Recruiting

  • Samsung Medical Center ( Site 2902)

    Seoul, 06351

    Study Coordinator, +82-2-3410-1767

    Recruiting

Other trials in South Korea

Canada1 site, 1 recruiting

  • The Ottawa Hospital Cancer Centre ( Site 0003)

    Ottawa, Ontario, K1H 8L6

    Study Coordinator, 613-737-7700

    Recruiting

Other trials in Canada

About this study

Official title: A Phase 3, Randomized, Double-blind, Study of Belzutifan + Zanzalintinib Versus Belzutifan + Placebo in Participants With Advanced RCC Who Have Progressed on or After Both PD-1/L1 and VEGF-TKI Therapies in Sequence or in Combination (LITESPARK-034)

Researchers are looking for new ways to treat advanced renal cell carcinoma (RCC).

A standard (usual) treatment for certain people with RCC is belzutifan (a study medicine), which is a targeted therapy. Targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread. Researchers want to learn if adding another targeted therapy called zanzalintinib (another study medicine) can treat more people with advanced RCC than belzutifan alone.

The goal of this study is to learn if people who receive belzutifan and zanzalintinib live longer overall and without the cancer getting worse compared to people who receive belzutifan and placebo.

Being tested
Belzutifan, Zanzalintinib, Placebo
Medical subject headings
Carcinoma, Renal Cell

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

    Tablet for oral administration.

  • ZanzalintinibDrug

    Also called XL092

    Tablet for oral administration.

  • PlaceboDrug

    Zanzalintinib-matching placebo tablet for oral administration.

Study groups in NCT07489495
Study groupRoleWhat they receive
Belzutifan + ZanzalintinibExperimentalParticipants will receive 120 mg belzutifan orally and 60 mg zanzalintinib once daily for approximately 24 months.
Receives: Drug: Belzutifan; Drug: Zanzalintinib
Belzutifan + PlaceboActive comparatorParticipants will receive 120 mg belzutifan orally and zanzalintinib-matching placebo once daily for approximately 24 months.
Receives: Drug: Belzutifan; Drug: Placebo

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 disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR) or death due to any cause, whichever occurs first.

    Measured: Up to approximately 30 months

  2. Overall Survival (OS)

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

    Measured: Up to approximately 50 months

Secondary outcomes (12)

  1. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants who have achieved confirmed Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by BICR.

    Measured: Up to approximately 30 months

  2. Duration of Response (DOR)

    DOR is defined as the interval from the first documented evidence of a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 until Progressive Disease (PD) or death due to any cause, whichever occurs first, in participants demonstrating a best confirmed response of CR or PR. 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.

    Measured: Up to approximately 30 months

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

    An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who experience an AE will be reported.

    Measured: Up to approximately 25 months

  4. Number of Participants who Discontinue Study Treatment Due to an AE

    An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who discontinue study treatment due to an AE will be reported.

    Measured: Up to approximately 24 months

  5. Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score

    EORTC QLQ-C30 is a questionnaire to assess the overall quality of life (QoL) of cancer patients. Participant responses to questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and 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). The combined score of GHS (Item 29) and QoL (Item 30) is computed by averaging the raw scores of the 2 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. The change from baseline in GHS and QoL combined score will be presented.

    Measured: Baseline and up to approximately 25 months

  6. Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score

    EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 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. The change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score will be presented.

    Measured: Baseline and up to approximately 25 months

  7. Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score

    The EORTC QLQ-C30 is a cancer specific health-related quality of life questionnaire. The role functioning score is based on participant responses to questions scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score was computed by averaging the raw scores of Items 6 and 7 and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. Higher scores indicate better role functioning. The change from baseline in EORTC QLQ-C30 Role Functioning (Items 6 and 7) combined score will be reported.

    Measured: Baseline and up to approximately 25 months

  8. 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. 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.

    Measured: Baseline and up to approximately 25 months

  9. Time to Deterioration (TTD) in EORTC QLQ-C30 Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score

    EORTC QLQ-C30 is a questionnaire to assess QoL of cancer patients. Participant responses to questions on GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall QoL during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) was computed by averaging raw scores of the 2 items and 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. TTD was defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in GHS-QoL combined score. A longer TTD indicates a better outcome.

    Measured: Up to approximately 25 months

  10. TTD in EORTC QLQ-C30 Physical Functioning (Items 1-5) Score

    EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 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. TTD was defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in physical functioning (Items 1 to 5). A longer TTD indicates a better outcome.

    Measured: Up to approximately 25 months

  11. TTD in EORTC QLQ-C30 Role Functioning (Items 6 and 7) Score

    EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions about their role functioning (Items 6 and 7) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of Items 6 and 7 was computed by averaging the raw scores of the 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. TTD was defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in role functioning (Items 6 and 7). A longer TTD indicates a better outcome.

    Measured: Up to approximately 25 months

  12. TTD in Disease Symptoms Using the FKSI-DRS (Items 1-9) Score

    TTD is defined as time from the first dose of study treatment to the date of deterioration of FKSI-DRS score. The FKSI-DRS index consists of a 9-item questionnaire that assesses the extent of participant symptoms from kidney cancer. 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 posted24 Mar 2026
  2. Study start9 Apr 2026
  3. Primary completion27 Nov 2030 (estimated)
  4. Study completion27 Nov 2030 (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
758 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07489495
Sponsor's protocol ID
6482-034
Other IDs
U1111-1311-4692, 2024-516993-31-00, LITESPARK-034, MK-6482-034, LS-034
Status last verified
Oct 2026
First submitted
20 Mar 2026
Last updated
29 Oct 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 and Zanzalintinib in people with Carcinoma, Renal Cell, run by Merck Sharp & Dohme LLC at 106 sites in 19 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 4 inclusion and 12 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 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 106 sites in United States, Italy, Argentina, United Kingdom, France and 14 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 30 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 NCT07489495.

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 29 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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