Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07227402

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

Led by Merck Sharp & Dohme LLC · Updated on 2026-05-12

904

Participants Needed

108

Research Sites

326 weeks

Total Duration

On this page

Sponsors

M

Merck Sharp & Dohme LLC

Lead Sponsor

E

Exelixis

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed unresectable, advanced renal cell cancer with clear cell component
  • Measurable disease per RECIST 1.1 criteria
  • Disease recurrence during or within 24 months after adjuvant anti-PD-1/L1 therapy
  • No prior systemic therapy for RCC except adjuvant anti-PD-1/L1 therapy
Not Eligible

You will not qualify if you...

  • Clinically significant cardiovascular disease within 12 months before study
  • Deep vein thrombosis within 3 months before randomization unless stable and treated
  • Left ventricular ejection fraction 50% or below normal range
  • Major surgery within 8 weeks before randomization or incomplete recovery from surgery
  • Current pneumonitis or interstitial lung disease
  • Symptomatic pleural effusion, ascites, or pericardial fluid requiring recent drainage
  • Gastrointestinal disorders with high risk of perforation or fistula
  • Serious active nonhealing wound, ulcer, or bone fracture
  • Requirement for hemodialysis or peritoneal dialysis
  • History of HIV infection
  • Hepatitis B or C infection
  • Received live or live-attenuated vaccine within 30 days before first study dose

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 108 locations

1

Hospital Aleman ( Site 0204)

CABA, Buenos Aires, Argentina, C1118AAT

Actively Recruiting

2

Hospital Italiano de Buenos Aires. ( Site 0203)

Caba, Buenos Aires, Argentina, C1199ABB

Actively Recruiting

3

Asociación de Beneficencia Hospital Sirio Libanés ( Site 0205)

Caba, Buenos Aires, Argentina, C1419AHN

Actively Recruiting

4

Instituto Alexander Fleming ( Site 0202)

CABA, Buenos Aires, Argentina, C1426ANZ

Actively Recruiting

5

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

Caba., Buenos Aires F.D., Argentina, C1431FWO

Actively Recruiting

6

Sanatorio Parque ( Site 0201)

Rosario, Santa Fe Province, Argentina, S2000DSV

Actively Recruiting

7

Instituto de Oncología de Rosario ( Site 0209)

Rosario, Santa Fe Province, Argentina, S2000KZE

Actively Recruiting

8

Hospital Privado Universitario de Córdoba ( Site 0207)

Córdoba, Argentina, X5016KEH

Actively Recruiting

9

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

Sydney, New South Wales, Australia, 2109

Actively Recruiting

10

Ordensklinikum Linz GmbH Elisabethinen-Urologie ( Site 0600)

Linz, Upper Austria, Austria, 4020

Actively Recruiting

11

Medizinische Universitat Wien ( Site 0601)

Vienna, Austria, 1090

Actively Recruiting

12

Cliniques Universitaires Saint-Luc ( Site 0703)

Brussels, Bruxelles-Capitale, Region de, Belgium, 1200

Actively Recruiting

13

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

Genk, Limburg, Belgium, 3600

Actively Recruiting

14

UZ Gent ( Site 0702)

Ghent, Oost-Vlaanderen, Belgium, 9000

Actively Recruiting

15

UZ Leuven ( Site 0700)

Leuven, Vlaams-Brabant, Belgium, 3000

Actively Recruiting

16

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

Cuiabá, Mato Grosso, Brazil, 78020-500

Actively Recruiting

17

Liga Norte Riograndense Contra o Câncer ( Site 0307)

Natal, Rio Grande do Norte, Brazil, 59062-000

Actively Recruiting

18

Hospital Moinhos de Vento ( Site 0309)

Porto Alegre, Rio Grande do Sul, Brazil, 90560-032

Actively Recruiting

19

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

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

Actively Recruiting

20

Hospital Alemao Oswaldo Cruz ( Site 0311)

São Paulo, São Paulo, Brazil, 01327-001

Actively Recruiting

21

Klinički Bolnički Centar Split ( Site 0802)

Split, Split-Dalmatia County, Croatia, 21000

Actively Recruiting

22

Masarykuv onkologicky ustav ( Site 0903)

Brno, Brno-mesto, Czechia, 656 53

Actively Recruiting

23

Fakultni nemocnice Ostrava ( Site 0904)

Ostrava, Ostrava Mesto, Czechia, 708 52

Actively Recruiting

24

Nemocnice České Budějovice ( Site 0905)

České Budějovice, Czechia, 370 01

Actively Recruiting

25

Fakultni nemocnice Hradec Kralove ( Site 0902)

Hradec Králové, Czechia, 500 05

Actively Recruiting

26

Fakultni nemocnice Olomouc ( Site 0901)

Olomouc, Czechia, 779 00

Actively Recruiting

27

Vseobecna fakultni nemocnice v Praze ( Site 0906)

Prague, Czechia, 128 08

Actively Recruiting

28

Fakultni nemocnice v Motole ( Site 0900)

Prague, Czechia, 150 06

Actively Recruiting

29

Herlev Hospital ( Site 1002)

Herlev, Capital Region, Denmark, 2730

Actively Recruiting

30

Aarhus University Hospital Skejby ( Site 1001)

Aarhus, Central Jutland, Denmark, 8200

Actively Recruiting

31

Odense Universitetshospital ( Site 1000)

Odense, Region Syddanmark, Denmark, 9000

Actively Recruiting

32

CHU de Bordeaux Hop St ANDRE ( Site 1115)

Bordeaux, Gironde, France, 33075

Actively Recruiting

33

Hôpital Foch ( Site 1118)

Suresnes, Hauts-de-Seine, France, 92150

Actively Recruiting

34

Centre de Cancérologie du Grand Montpellier ( Site 1112)

Montpellier, Herault, France, 34070

Actively Recruiting

35

CHU GRENOBLE ALPES ( Site 1101)

La Tronche, Isere, France, 38700

Actively Recruiting

36

Centre d'Oncologie de Gentilly ( Site 1117)

Nancy, Lorraine, France, 54100

Actively Recruiting

37

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

Angers, Pays de la Loire Region, France, 49933

Actively Recruiting

38

Centre Hospitalier de la Côte Basque ( Site 1113)

Bayonne, Pyrenees-Atlantiques, France, 64109

Actively Recruiting

39

centre hospitalier lyon sud ( Site 1102)

Pierre-Bénite, Rhone, France, 69310

Actively Recruiting

40

CHU de Rouen ( Site 1108)

Rouen, Seine-Maritime, France, 76031

Actively Recruiting

41

HENRI MONDOR HOSPITAL ( Site 1116)

Créteil, Val-de-Marne, France, 94010

Actively Recruiting

42

CHD Vendee ( Site 1103)

La Roche-sur-Yon, Vendee, France, 85000

Actively Recruiting

43

Klinikum Stuttgart - Katharinenhospital ( Site 1201)

Stuttgart, Baden-Wurttemberg, Germany, 70174

Actively Recruiting

44

UniversitaetsklInikum Tuebingen ( Site 1207)

Tübingen, Baden-Wurttemberg, Germany, 72076

Actively Recruiting

45

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

Göttingen, Lower Saxony, Germany, 37075

Actively Recruiting

46

Helios Kliniken Schwerin GmbH ( Site 1206)

Schwerin, Mecklenburg-Vorpommern, Germany, 19055

Actively Recruiting

47

Marienhospital Herne ( Site 1215)

Herne, North Rhine-Westphalia, Germany, 44625

Actively Recruiting

48

Universitaetsklinikum Muenster ( Site 1202)

Münster, North Rhine-Westphalia, Germany, 70174

Actively Recruiting

49

Universitaetsklinikum Carl Gustav Carus Dresden ( Site 1213)

Dresden, Saxony, Germany, 01307

Actively Recruiting

50

HELIOS Klinikum Erfurt ( Site 1208)

Erfurt, Thuringia, Germany, 99089

Actively Recruiting

51

Universitätsklinikum Jena ( Site 1204)

Jena, Thuringia, Germany, 07747

Actively Recruiting

52

Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 1203)

Berlin, Germany, 10117

Actively Recruiting

53

Universitaetsklinikum Hamburg-Eppendorf ( Site 1214)

Hamburg, Germany, 20246

Actively Recruiting

54

Alexandra General Hospital of Athens ( Site 1300)

Athens, Attica, Greece, 115 28

Actively Recruiting

55

Metropolitan Hospital ( Site 1302)

Athens, Attica, Greece, 185 47

Actively Recruiting

56

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

Chaïdári, Attica, Greece, 124 62

Actively Recruiting

57

Prince of Wales Hospital ( Site 2200)

Hong Kong, Hong Kong

Actively Recruiting

58

Queen Mary Hospital ( Site 2201)

Hong Kong, Hong Kong

Actively Recruiting

59

Cork University Hospital ( Site 1501)

Cork, Ireland, T12 YK23

Actively Recruiting

60

Tallaght University Hospital ( Site 1500)

Dublin, Ireland, D24 NR0A

Actively Recruiting

61

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

Naples, Campania, Italy, 80131

Actively Recruiting

62

Istituto Nazionale Tumori Regina Elena ( Site 1611)

Rome, Lazio, Italy, 00144

Actively Recruiting

63

Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1600)

Milan, Milano, Italy, 20133

Actively Recruiting

64

Istituto Clinico Humanitas ( Site 1613)

Rozzano, Milano, Italy, 20089

Actively Recruiting

65

Azienda Ospedaliera S. Luigi Gonzaga ( Site 1607)

Orbassano, Piedmont, Italy, 10043

Actively Recruiting

66

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

Rome, Roma, Italy, 00618

Actively Recruiting

67

Azienda Ospedaliera Universitaria Careggi ( Site 1608)

Florence, Tuscany, Italy, 50134

Actively Recruiting

68

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

Peschiera del Garda, Veneto, Italy, 37019

Actively Recruiting

69

Azienda USL 8 di Arezzo ( Site 1605)

Arezzo, Italy, 52100

Actively Recruiting

70

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

Bari, Italy, 70124

Actively Recruiting

71

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

Bologna, Italy, 40138

Actively Recruiting

72

Ospedale San Martino ( Site 1606)

Genova, Italy, 16132

Actively Recruiting

73

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

Guadalajara, Jalisco, Mexico, 44630

Actively Recruiting

74

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

Monterrey, Nuevo León, Mexico, 64710

Actively Recruiting

75

Centro de Investigacion Clinica de Oaxaca ( Site 0502)

Oaxaca City, Oaxaca, Mexico, 68020

Actively Recruiting

76

Higiea Oncologia ( Site 0504)

Mexico City, Mexico, 11810

Actively Recruiting

77

Clinica Integral Internacional de Oncología ( Site 0506)

Puebla City, Mexico, 72530

Actively Recruiting

78

AIDPORT Sp. z o.o. ( Site 1716)

Skórzewo, Greater Poland Voivodeship, Poland, 60-185

Actively Recruiting

79

Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1707)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-796

Actively Recruiting

80

Pratia MCM Krakow ( Site 1713)

Krakow, Lesser Poland Voivodeship, Poland, 30-727

Actively Recruiting

81

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

Krakow, Lesser Poland Voivodeship, Poland, 31-826

Actively Recruiting

82

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

Siedlce, Masovian Voivodeship, Poland, 08-110

Actively Recruiting

83

MTZ Clinical Research Powered by Pratia ( Site 1705)

Warsaw, Masovian Voivodeship, Poland, 02-172

Actively Recruiting

84

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

Przemyśl, Podkarpackie Voivodeship, Poland, 37-700

Actively Recruiting

85

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

Koszalin, West Pomeranian Voivodeship, Poland, 75-581

Actively Recruiting

86

National University Hospital ( Site 2400)

Singapore, Central Singapore, Singapore, 119074

Actively Recruiting

87

National Cancer Centre Singapore ( Site 2401)

Singapore, Central Singapore, Singapore, 168583

Actively Recruiting

88

Chonnam National University Hwasun Hospital ( Site 2505)

Hwasun-gun, Jeonranamdo, South Korea, 58128

Actively Recruiting

89

Seoul National University Bundang Hospital ( Site 2504)

Seongnam, Kyonggi-do, South Korea, 13620

Actively Recruiting

90

Chungnam National University Hospital ( Site 2506)

Taejŏn, Taejon-Kwangyokshi, South Korea, 35015

Actively Recruiting

91

Severance Hospital, Yonsei University Health System ( Site 2503)

Seoul, South Korea, 03722

Actively Recruiting

92

Asan Medical Center ( Site 2501)

Seoul, South Korea, 05505

Actively Recruiting

93

Samsung Medical Center ( Site 2502)

Seoul, South Korea, 06351

Actively Recruiting

94

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

L'Hospitalet de Llobregat, Barcelona, Spain, 08908

Actively Recruiting

95

Hospital Universitario Marqués de Valdecilla ( Site 1807)

Santander, Cantabria, Spain, 39008

Actively Recruiting

96

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

Girona, Gerona, Spain, 17007

Actively Recruiting

97

Hospital Universitario Ramón y Cajal ( Site 1801)

Madrid, Madrid, Comunidad de, Spain, 28034

Actively Recruiting

98

Fundación Instituto Valenciano de Oncología ( Site 1808)

Valencia, Valenciana, Comunitat, Spain, 46009

Actively Recruiting

99

Hospital Universitari Vall d'Hebron ( Site 1804)

Barcelona, Spain, 08035

Actively Recruiting

100

Hospital Clinic de Barcelona ( Site 1810)

Barcelona, Spain, 08036

Actively Recruiting

101

Hospital Universitario Reina Sofia ( Site 1809)

Córdoba, Spain, 14004

Actively Recruiting

102

Hospital Clinico San Carlos ( Site 1802)

Madrid, Spain, 28040

Actively Recruiting

103

Hospital Universitario Fundacion Jimenez Diaz ( Site 1803)

Madrid, Spain, 28040

Actively Recruiting

104

Hospital Universitario 12 de Octubre ( Site 1800)

Madrid, Spain, 28041

Actively Recruiting

105

China Medical University Hospital ( Site 2603)

Taichung, Taiwan, 40447

Actively Recruiting

106

Taichung Veterans General Hospital ( Site 2602)

Taichung, Taiwan, 40705

Actively Recruiting

107

Taipei Veterans General Hospital ( Site 2600)

Taipei, Taiwan, 11217

Actively Recruiting

108

Chang Gung Memorial Hospital - Linkou Branch ( Site 2604)

Taoyuan, Taiwan, 333

Actively Recruiting

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Research Team

T

Toll Free Number

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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