A Study of Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab for Resected High-Risk Melanoma in Participants With High-Risk Stage II-IV Melanoma (MK-7684A-010/KEYVIBE-010)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,594

Participants

Timeline

Start Date

January 19, 2023

Primary Completion Date

March 6, 2024

Study Completion Date

September 26, 2025

Conditions
Melanoma
Interventions
BIOLOGICAL

Pembrolizumab/Vibostolimab

Co-formulation of pembrolizumab 200 mg/20 mL vial and vibostolimab 200 mg administered as IV infusion for up to 17 administrations

BIOLOGICAL

Pembrolizumab

Pembrolizumab 25 mg/mL administered as IV infusion for up to 17 administrations

Trial Locations (205)

1011

CHUV (centre hospitalier universitaire vaudois) ( Site 1304), Lausanne

1090

Medizinische Universität Wien-Department of Dermatology ( Site 0600), Vienna

1200

Cliniques universitaires Saint-Luc ( Site 0652), Brussels

1211

Hôpitaux Universitaires de Genève (HUG)-Oncology ( Site 1307), Geneva

1951

Hôpital de Sion ( Site 1305), Sion

2065

Melanoma Institute Australia-Clinical Trials Unit ( Site 1450), Wollstonecraft

2148

Blacktown Hospital-Blacktown Cancer and Haematology Centre - Medical Oncology ( Site 1464), Blacktown

2196

Medical Oncology Centre of Rosebank ( Site 1160), Johannesburg

Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 1151), Sandton

2298

Calvary Mater Newcastle-Medical Oncology ( Site 1462), Waratah

2610

GZA Ziekenhuizen campus Sint-Augustinus ( Site 0655), Wilrijk

3000

Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 1455), Melbourne

UZ Leuven-General Medical Oncology ( Site 0650), Leuven

3010

Inselspital Bern ( Site 1301), Bern

3100

Universitätsklinikum St. Pölten-Department of Dermatology ( Site 0606), Sankt Pölten

3112

Tauranga Hospital-Bay of Plenty Clinical Trials Unit ( Site 1501), Tauranga

3500

Jessa Ziekenhuis ( Site 0656), Hasselt

3900

Abraham Oncology ( Site 1150), Richards Bay

4020

Ordensklinikum Linz GmbH Elisabethinen-Dermatologie ( Site 0602), Linz

4029

Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si, Brisbane

4056

University Hospital Basel ( Site 1303), Basel

4091

The Oncology Centre ( Site 1157), Durban

4120

Gallipoli Medical Research Ltd-GMRF CTU ( Site 1451), Greenslopes

4215

Tasman Oncology Research ( Site 1456), Southport

4414

P3 Research - Palmerston North ( Site 1510), Palmerston North

4870

Cairns Hospital-Clinical Research Unit ( Site 1458), Cairns

5000

Royal Adelaide Hospital-RAH Cancer Centre ( Site 1457), Adelaide

5020

Uniklinikum Salzburg-Department of Dermatology and Allergology ( Site 0604), Salzburg

5530

Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 0653), Yvoir

6009

One Clinical Research ( Site 1460), Nedlands

6020

Medizinische Universitaet Innsbruck-Univ Klinik für Dermatologie, Venerologie und Allergologie ( Sit, Innsbruck

6055

CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 1161), Port Elizabeth

6500

Ospedale Regionale Bellinzona e Valli ( Site 1308), Bellinzona

7000

Icon Cancer Centre Hobart ( Site 1465), Hobart

7570

Cape Town Oncology Trials ( Site 1155), Cape Town

7700

Cancercare Rondebosch Oncology-Clinical trials ( Site 1159), Rondebosch

8011

New Zealand Clinical Research (Christchurch) ( Site 1509), Christchurch

8036

Medizinische Universität Graz-Innere Medizin Klin. Abt. Onkologie ( Site 0601), Graz

8058

UniversitätsSpital Zürich-Dermatology ( Site 1300), Zürich Flughafen

9007

Cantonal Hospital St.Gallen-Oncology & Hematology ( Site 1306), Sankt Gallen

9016

Dunedin Hospital ( Site 1511), Dunedin

10016

Laura and Isaac Perlmutter Cancer Center-Hematology and Oncology ( Site 0113), New York

10029

Icahn School of Medicine at Mount Sinai ( Site 0118), New York

10065

Weill Cornell Medical College ( Site 0115), New York

10117

Charité Universitaetsmedizin Berlin - Campus Mitte-Hauttumorcentrum Charité (HTCC) ( Site 0756), Berlin

11042

R.J. Zuckerberg Cancer Center-Medical Oncology ( Site 0132), Lake Success

11501

Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0146), Mineola

13005

Assistance Publique Hôpitaux de Marseille - Hôpital de la Ti-Service de Dermatologie et Cancérologi, Marseille

15224

Children's Hospital of Pittsburgh ( Site 0141), Pittsburgh

15232

UPMC Hillman Cancer Center ( Site 0135), Pittsburgh

20007

Georgetown University Medical Center ( Site 0144), Washington D.C.

20014

Onkologikoa - Instituto Oncologico de San Sebastian ( Site 1203), Doniostia - San Sebastian

20133

Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1000), Milan

20141

Istituto Europeo di Oncologia IRCCS ( Site 1008), Milan

20246

Universitaetsklinikum Hamburg-Eppendorf ( Site 0752), Hamburg

21614

Elbe Kliniken Stade-Buxtehude, Klinikum Buxtehude-Dermatologisches Zentrum ( Site 0754), Buxtehude

22031

Inova Schar Cancer Institute ( Site 0103), Fairfax

24105

Universitaetsklinikum Schleswig-Holstein Campus Kiel-Hautklinik ( Site 0767), Kiel

26953

Centre Hospitalier de Valence-Service de Dermatologie ( Site 0702), Valence

28034

Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1204), Madrid

28204

Levine Cancer Institute ( Site 0138), Charlotte

29011

H.R.U Málaga - Hospital General-Oncology ( Site 1201), Málaga

30625

Medizinische Hochschule Hannover ( Site 0758), Hanover

32429

Johannes Wesling Klinikum Minden-Skin Cancer Center Minden ( Site 0759), Minden

33136

University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0110), Miami

33240

Mersin Sehir Eğitim ve Araştırma Hastanesi-Oncology ( Site 1361), Mersin

33612

Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center ( Site 0124), Tampa

34722

TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1358), Istanbul

37232

Vanderbilt University Medical Center ( Site 0139), Nashville

38105

St. Jude Children's Research Hospital ( Site 0106), Memphis

38138

The West Clinic, PLLC dba West Cancer Center ( Site 0119), Germantown

41009

Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1205), Seville

41125

Azienda Ospedaliero Universitaria ( Site 1002), Modena

44093

Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu-Onco-Dermatology ( Site 0707), Nantes

44805

Institut de Cancérologie de l'Ouest-Oncologie Médicale ( Site 0706), Saint-Herblain

45147

Universitaetsklinikum Essen-Klinik für Dermatologie, Venerologie und Allergologie ( Site 0761), Essen

46014

Hospital General Universitario de Valencia ( Site 1200), Valencia

47014

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 1004), Meldola

48202

Henry Ford Hospital ( Site 0133), Detroit

52242

University of Iowa-Holden Comprehensive Cancer Center ( Site 0107), Iowa City

53100

Azienda Ospedaliero Universitaria Senese ( Site 1005), Siena

53792

University of Wisconsin Hospital and Clinics ( Site 0108), Madison

55139

Ondokuz Mayıs Universitesi-Oncology department ( Site 1359), Samsun

57104

Sanford Cancer Center ( Site 0125), Sioux Falls

58102

Sanford Fargo Medical Center ( Site 0127), Fargo

59037

Hopital Claude Huriez - CHU de Lille-Clinique de Dermatologie ( Site 0700), Lille

60068

Advocate Medical Group-Oncology ( Site 0102), Park Ridge

60611

Northwestern Memorial Hospital ( Site 0109), Chicago

64000

Centre Hospitalier de Pau ( Site 0708), Pau

68167

Universitätsmedizin Mannheim ( Site 0751), Mannheim

69120

Universitaetsklinikum Heidelberg ( Site 0765), Heidelberg

69310

centre hospitalier lyon sud-Service de dermatologie ( Site 0714), Pierre-Bénite

70124

Instituto Tumori Giovanni Paolo II ( Site 1003), Bari

75014

Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0711), Paris

77030

University of Texas MD Anderson Cancer Center ( Site 0145), Houston

80113

The Melanoma & Skin Cancer Institute ( Site 0120), Englewood

80131

Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1001), Napoli

80337

Klinik und Poliklinik für Dermatologie und Allergologie-Dermato-oncology ( Site 0757), München

89169

Comprehensive Cancer Centers of Nevada ( Site 0142), Las Vegas

90025

The Angeles Clinic and Research Institute - West Los Angeles Office ( Site 0123), Los Angeles

90095

UCLA Hematology/Oncology - Westwood (Building 100) ( Site 0131), Los Angeles

90129

A.O.U. Policlinico Paolo Giaccone-Depatment of Discipline Chirurgiche, Oncologiche e Stomatologiche, Palermo

91054

Universitaetsklinikum Erlangen-Hautklinik ( Site 0750), Erlangen

94115

California Pacific Medical Center - Pacific Campus ( Site 0111), San Francisco

94158

UCSF Medical Center at Mission Bay ( Site 0130), San Francisco

94800

Gustave Roussy-Dermatologie ( Site 0713), Villejuif

100035

Beijing Ji Shui Tan Hospital ( Site 1657), Beijing

100142

Beijing Cancer hospital-Renal carcinoma and melanoma ( Site 1650), Beijing

110029

All India Institute of Medical Sciences-Medical oncology ( Site 1552), New Delhi

111321

Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0358), Bogotá

122001

Artemis hospital ( Site 1551), Gurugram

130021

The First Hospital of Jilin University-Oncology ( Site 1665), Changchun

200032

Fudan University Shanghai Cancer Center ( Site 1658), Shanghai

210000

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology (, Nanjing

210029

Jiangsu Province Hospital-Oncology Department ( Site 1663), Nanjing

310022

Zhejiang Cancer Hospital-Oncology ( Site 1661), Hangzhou

330006

The First Affiliated Hospital of Nanchang University ( Site 1652), Nanchang

350014

Fujian Provincial Cancer Hospital ( Site 1659), Fuzhou

400012

Tata Memorial Hospital-Medical Oncology ( Site 1550), Mumbai

400030

Chongqing University Cancer Hospital ( Site 1651), Chongqing

410011

The Second Xiangya Hospital of Central South University-Oncology ( Site 1673), Changsha

430022

Wuhan Union Hospital Cancer Center-Cancer Center ( Site 1664), Wuhan

450001

The Third Hospital of Zhengzhou-Oncology ( Site 1653), Zhengzhou

510060

Sun Yat-sen University Cancer Center-melanoma ( Site 1655), Guangzhou

530021

Guangxi Medical University Affiliated Tumor Hospital ( Site 1668), Nanning

610041

West China Hospital, Sichuan University-Head and Neck Oncology ( Site 1667), Chengdu

650106

Yunnan Province Cancer Hospital-Biotherapy Center ( Site 1666), Kunming

730006

Mediservis del Tolima IPS S.A.S ( Site 0357), Ibagué

760032

Fundación Valle del Lili ( Site 0352), Santiago de Cali

830000

Xinjiang Medical University Cancer Hospital - Urumqi-Bone and Soft Tissue Department ( Site 1674), Ürümqi

1240000

Bradford Hill Norte ( Site 0308), Antofagasta

1834111

Emek Medical Center-oncology ( Site 0952), Afula

2520598

ONCOCENTRO APYS-ACEREY ( Site 0300), Viña del Mar

3109601

Rambam Health Care Campus-Oncology Division ( Site 0955), Haifa

4941492

Rabin Medical Center-Oncology ( Site 0954), Petah Tikva

5112129

Oncocentro Valdivia ( Site 0307), Valdivia

5265601

Sheba Medical Center-ONCOLOGY ( Site 0950), Ramat Gan

7500921

FALP-UIDO ( Site 0303), Santiago

7510032

Oncovida ( Site 0304), Santiago

7620002

Clínica UC San Carlos de Apoquindo ( Site 0305), Santiago

8410101

Soroka Medical Center ( Site 0953), Beersheba

8420383

Bradfordhill-Clinical Area ( Site 0302), Santiago

9112001

Hadassah Medical Center ( Site 0951), Jerusalem

30130090

Centro Avançado de Tratamento Oncológico- CENANTRON ( Site 0256), Belo Horizonte

88501001

ANIMI - Unidade de Tratamento Oncologico ( Site 0255), Lages

92093-0698

Moores Cancer Center ( Site 0116), La Jolla

C1027AAP

Centro de Investigaciones Metabólicas (CINME)-Oncology ( Site 0204), Ciudad Autónoma de Buenos Aires

C1426ANZ

Instituto Alexander Fleming-Alexander Fleming ( Site 0209), Ciudad Autónoma de Buenos Aires

C1431FWO

Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0200), Buenos Aires

S2000KZE

Instituto de Oncología de Rosario ( Site 0206), Rosario

C1187AAN

Sanatorio Finochietto ( Site 0212), Buenos Aires

C1430EGF

Clinica Adventista Belgrano-Oncology ( Site 0211), CABA

B-9100

VITAZ-Medical Oncology ( Site 0654), Sint-Niklaas

86015-520

Hospital de Cancer de Londrina-Clinical Research Unit ( Site 0252), Londrina

99010-080

Associação Hospitalar Beneficente São Vicente de Paulo-Instituto do Câncer ( Site 0259), Passo Fundo

09060-870

CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia ( Site 0262), Santo André

01509-010

A. C. Camargo Cancer Center ( Site 0258), São Paulo

K1H 8L6

The Ottawa Hospital - General Campus-The Ottawa Hospital Cancer Centre ( Site 0004), Ottawa

M4N 3M5

Sunnybrook Research Institute ( Site 0003), Toronto

M5G 2M9

Princess Margaret Cancer Centre ( Site 0006), Toronto

050035

Fourth Hospital of Hebei Medical University ( Site 1669), Shijiazhuang

030032

Shanxi Bethune Hospital ( Site 1660), Taiyuan

Unknown

Tianjin Medical University Cancer Institute & Hospital-Biotherapy ( Site 1671), Tianjin

050025

Instituto de Cancerología ( Site 0356), Medellín

050030

Fundación Colombiana de Cancerología Clínica Vida ( Site 0355), Medellín

01307

Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Dermatologie ( Site 0766), Dresden

04103

Universitätsklinikum Leipzig ( Site 0762), Leipzig

D08 E9P6

St. James's Hospital-Cancer clinical trials office ( Site 0900), Dublin

Dublin 9

Beaumont Hospital, Dublin-Cancer Clinical Trials & Research Unit ( Site 0902), Dublin

06129

AO Santa Maria della Misericordia ( Site 1006), Perugia

466-8560

Nagoya University Hospital ( Site 1753), Nagoya

060-8543

Sapporo Medical University Hospital ( Site 1755), Sapporo

951-8566

Niigata Cancer Center Hospital ( Site 1751), Niigata

411-8777

Shizuoka Cancer Center ( Site 1752), Nagaizumi-cho,Sunto-gun

104-0045

National Cancer Center Hospital ( Site 1750), Chuo-ku

541-8567

Osaka International Cancer Institute ( Site 1754), Osaka

0627

Harbour Cancer & Wellness ( Site 1508), Auckland

60-780

Szpital Kliniczny im. H. Swiecickiego nr 2-Oddział Kliniczny Onkologii Klinicznej i Doświadczalnej (, Poznan

85-796

Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1061), Bydgoszcz

30-727

Pratia MCM Krakow ( Site 1053), Krakow

08-110

Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1058), Siedlce

02-781

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (, Warsaw

15-027

Bialostockie Centrum Onkologii ( Site 1065), Bialystok

80-214

Uniwersyteckie Centrum Kliniczne-Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólnej ( Site, Gdansk

76-200

Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Słupsku-Oncologii, Chemioterapii ( Site 1064), Słupsk

44-101

Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1056), Gliwice

71-730

Zachodniopomorskie Centrum Onkologii ( Site 1063), Szczecin

25-734

Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 1054), Kielce

0040

Wilgers Oncology Centre ( Site 1154), Pretoria

0084

Curo Oncology ( Site 1158), Pretoria

0181

LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 1152), Pretoria

03080

Seoul National University Hospital-Oncology ( Site 1600), Seoul

03722

Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1601), Seoul

06351

Samsung Medical Center-Division of Hematology/Oncology ( Site 1602), Seoul

08908

Institut Català d'Oncologia - L'Hospitalet ( Site 1202), L'Hospitalet de Llobregat

553 05

Länssjukhuset Ryhov-Onkologkliniken ( Site 1253), Jönköping

171 64

Karolinska Universitetssjukhuset Solna ( Site 1252), Stockholm

06800

Ankara City Hospital-Medical Oncology ( Site 1357), Çankaya

009035575

I.E.U. Medical Point Hastanesi-Oncology ( Site 1360), Izmir, Karsiyaka

06230

Hacettepe Universite Hastaneleri ( Site 1363), Ankara

06680

Liv Hospital Ankara-Oncology ( Site 1353), Ankara

07059

Akdeniz Universitesi Hastanesi-Medical Oncology ( Site 1355), Antalya

CB2 2QQ

Addenbrooke's Hospital ( Site 1400), Cambridge

NW1 2PG

University College London Hospital ( Site 1405), London

SE1 9RT

Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 1401), London

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY