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)

April 4, 2024 updated by: Merck Sharp & Dohme LLC

A Phase 3, Randomized, Double-blind, Active-Comparator-Controlled Clinical Study of Adjuvant MK-7684A (Vibostolimab With Pembrolizumab) Versus Adjuvant Pembrolizumab in Participants With High-risk Stage II-IV Melanoma (KEYVIBE-010)

The primary purpose of this study is to compare pembrolizumab/vibostolimab to pembrolizumab with respect to recurrence-free survival (RFS). The primary hypothesis is that pembrolizumab/vibostolimab is superior to pembrolizumab with respect to RFS as assessed by the investigator in participants with high-risk resected Stage IIB, IIC, III and IV melanoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1560

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1187AAN
        • Recruiting
        • Sanatorio Finochietto ( Site 0212)
        • Contact:
          • Study Coordinator
          • Phone Number: 5491158216233
      • Caba, Argentina, C1430EGF
        • Recruiting
        • Clinica Adventista Belgrano-Oncology ( Site 0211)
        • Contact:
          • Study Coordinator
          • Phone Number: 5491132682903
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426ANZ
        • Recruiting
        • Instituto Alexander Fleming-Alexander Fleming ( Site 0209)
        • Contact:
          • Study Coordinator
          • Phone Number: 54111531493950
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1027AAP
        • Recruiting
        • Centro de Investigaciones Metabólicas (CINME)-Oncology ( Site 0204)
        • Contact:
          • Study Coordinator
          • Phone Number: 5491156455799
    • Caba
      • Buenos Aires, Caba, Argentina, C1431FWO
        • Recruiting
        • Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0200)
        • Contact:
          • Study Coordinator
          • Phone Number: 5411529901002543
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000KZE
        • Recruiting
        • Instituto de Oncología de Rosario ( Site 0206)
        • Contact:
          • Study Coordinator
          • Phone Number: 54 9 341 5778394
  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Recruiting
        • Blacktown Hospital-Blacktown Cancer and Haematology Centre - Medical Oncology ( Site 1464)
        • Contact:
          • Study Coordinator
          • Phone Number: 61298455200
      • Waratah, New South Wales, Australia, 2298
        • Recruiting
        • Calvary Mater Newcastle-Medical Oncology ( Site 1462)
        • Contact:
          • Study Coordinator
          • Phone Number: 61249211561
      • Wollstonecraft, New South Wales, Australia, 2065
        • Recruiting
        • Melanoma Institute Australia-Clinical Trials Unit ( Site 1450)
        • Contact:
          • Study Coordinator
          • Phone Number: 61299117336
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Recruiting
        • Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si
        • Contact:
          • Study Coordinator
          • Phone Number: 61736464311
      • Cairns, Queensland, Australia, 4870
        • Recruiting
        • Cairns Hospital-Clinical Research Unit ( Site 1458)
        • Contact:
          • Study Coordinator
          • Phone Number: 61499200998
      • Greenslopes, Queensland, Australia, 4120
        • Recruiting
        • Gallipoli Medical Research Ltd-GMRF CTU ( Site 1451)
        • Contact:
          • Study Coordinator
          • Phone Number: +61448632604
      • Southport, Queensland, Australia, 4215
        • Recruiting
        • Tasman Oncology Research ( Site 1456)
        • Contact:
          • Study Coordinator
          • Phone Number: +61 7 5613 2480
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Royal Adelaide Hospital-RAH Cancer Centre ( Site 1457)
        • Contact:
          • Study Coordinator
          • Phone Number: 61870745559
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Recruiting
        • Icon Cancer Centre Hobart ( Site 1465)
        • Contact:
          • Study Coordinator
          • Phone Number: 61361668308
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Recruiting
        • Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 1455)
        • Contact:
          • Study Coordinator
          • Phone Number: +6138559500
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Recruiting
        • One Clinical Research ( Site 1460)
        • Contact:
          • Study Coordinator
          • Phone Number: 0410565868
  • Austria
      • Salzburg, Austria, 5020
        • Recruiting
        • Uniklinikum Salzburg-Department of Dermatology and Allergology ( Site 0604)
        • Contact:
          • Study Coordinator
          • Phone Number: +435725557842
    • Niederosterreich
      • St. Polten, Niederosterreich, Austria, 3100
        • Recruiting
        • Universitätsklinikum St. Pölten-Department of Dermatology ( Site 0606)
        • Contact:
          • Study Coordinator
          • Phone Number: +43 2742 9004 11091
    • Oberosterreich
      • Linz, Oberosterreich, Austria, 4020
        • Recruiting
        • Ordensklinikum Linz GmbH Elisabethinen-Dermatologie ( Site 0602)
        • Contact:
          • Study Coordinator
          • Phone Number: +4373276764508
    • Steiermark
      • Graz, Steiermark, Austria, 8036
        • Recruiting
        • Medizinische Universität Graz-Innere Medizin Klin. Abt. Onkologie ( Site 0601)
        • Contact:
          • Study Coordinator
          • Phone Number: +4331638581320
    • Tirol
      • Innsbruck, Tirol, Austria, 6020
        • Recruiting
        • Medizinische Universitaet Innsbruck-Univ Klinik für Dermatologie, Venerologie und Allergologie ( Sit
        • Contact:
          • Study Coordinator
          • Phone Number: +4351250481473
    • Wien
      • Vienna, Wien, Austria, 1090
        • Recruiting
        • Medizinische Universität Wien-Department of Dermatology ( Site 0600)
        • Contact:
          • Study Coordinator
          • Phone Number: +4314040077310
  • Belgium
    • Antwerpen
      • Wilrijk, Antwerpen, Belgium, 2610
        • Recruiting
        • GZA Ziekenhuizen campus Sint-Augustinus ( Site 0655)
        • Contact:
          • Study Coordinator
          • Phone Number: +3234433737
    • Bruxelles-Capitale, Region De
      • Brussels, Bruxelles-Capitale, Region De, Belgium, 1200
        • Recruiting
        • Cliniques universitaires Saint-Luc ( Site 0652)
        • Contact:
          • Study Coordinator
          • Phone Number: 3227645471
    • Limburg
      • Hasselt, Limburg, Belgium, 3500
        • Recruiting
        • Jessa Ziekenhuis ( Site 0656)
        • Contact:
          • Study Coordinator
          • Phone Number: 0473 497 669
    • Namur
      • Yvoir, Namur, Belgium, 5530
        • Recruiting
        • Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 0653)
        • Contact:
          • Study Coordinator
          • Phone Number: 3281423858
    • Oost-Vlaanderen
      • Sint-Niklaas, Oost-Vlaanderen, Belgium, B-9100
        • Recruiting
        • VITAZ-Medical Oncology ( Site 0654)
        • Contact:
          • Study Coordinator
          • Phone Number: 3293326056
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Recruiting
        • UZ Leuven-General Medical Oncology ( Site 0650)
        • Contact:
          • Study Coordinator
          • Phone Number: 3216346900
  • Brazil
      • Sao Paulo, Brazil, 01509-010
        • Recruiting
        • A. C. Camargo Cancer Center ( Site 0258)
        • Contact:
          • Study Coordinator
          • Phone Number: +55 11 994270884
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30130090
        • Recruiting
        • Centro Avançado de Tratamento Oncológico- CENANTRON ( Site 0256)
        • Contact:
          • Study Coordinator
          • Phone Number: 5531999785050
    • Parana
      • Londrina, Parana, Brazil, 86015-520
        • Recruiting
        • Hospital de Cancer de Londrina-Clinical Research Unit ( Site 0252)
        • Contact:
          • Study Coordinator
          • Phone Number: +5543999087733
    • Rio Grande Do Sul
      • Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080
        • Recruiting
        • Associação Hospitalar Beneficente São Vicente de Paulo-Instituto do Câncer ( Site 0259)
        • Contact:
          • Study Coordinator
          • Phone Number: 555421033490
    • Santa Catarina
      • Lages, Santa Catarina, Brazil, 88501001
        • Recruiting
        • ANIMI - Unidade de Tratamento Oncologico ( Site 0255)
        • Contact:
          • Study Coordinator
          • Phone Number: 4933805200
    • Sao Paulo
      • Santo André, Sao Paulo, Brazil, 09060-870
        • Recruiting
        • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia ( Site 0262)
        • Contact:
          • Study Coordinator
          • Phone Number: 5511974029832
  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • The Ottawa Hospital - General Campus-The Ottawa Hospital Cancer Centre ( Site 0004)
        • Contact:
          • Study Coordinator
          • Phone Number: 6137377700 ext 70208
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre ( Site 0006)
        • Contact:
          • Study Coordinator
          • Phone Number: 4169464628
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Research Institute ( Site 0003)
        • Contact:
          • Study Coordinator
          • Phone Number: (416) 480-4270
  • Chile
      • Antofagasta, Chile, 1240000
        • Recruiting
        • Bradford Hill Norte ( Site 0308)
        • Contact:
          • Study Coordinator
          • Phone Number: 56994198125
    • Los Rios
      • Valdivia, Los Rios, Chile, 5112129
        • Recruiting
        • Oncocentro Valdivia ( Site 0307)
        • Contact:
          • Study Coordinator
          • Phone Number: +56992195434
    • Region M. De Santiago
      • Santiago, Region M. De Santiago, Chile, 7620002
        • Recruiting
        • Clínica UC San Carlos de Apoquindo ( Site 0305)
        • Contact:
          • Study Coordinator
          • Phone Number: 56223546919
      • Santiago, Region M. De Santiago, Chile, 8420383
        • Recruiting
        • Bradfordhill-Clinical Area ( Site 0302)
        • Contact:
          • Study Coordinator
          • Phone Number: +56 9 84859580
      • Santiago, Region M. De Santiago, Chile, 7510032
        • Recruiting
        • Oncovida ( Site 0304)
        • Contact:
          • Study Coordinator
          • Phone Number: 56986303096
      • Santiago, Region M. De Santiago, Chile, 7500921
        • Recruiting
        • FALP-UIDO ( Site 0303)
        • Contact:
          • Study Coordinator
          • Phone Number: 56224457254
    • Valparaiso
      • Viña del Mar, Valparaiso, Chile, 2520598
        • Recruiting
        • ONCOCENTRO APYS-ACEREY ( Site 0300)
        • Contact:
          • Study Coordinator
          • Phone Number: +56992369820
  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Beijing Cancer hospital-Renal carcinoma and melanoma ( Site 1650)
        • Contact:
          • Study Coordinator
          • Phone Number: 8613911233048
      • Beijing, Beijing, China, 100035
        • Recruiting
        • Beijing Ji Shui Tan Hospital ( Site 1657)
        • Contact:
          • Study Coordinator
          • Phone Number: 13801132522
    • Chongqing
      • Chongqing, Chongqing, China, 400030
        • Recruiting
        • Chongqing University Cancer Hospital ( Site 1651)
        • Contact:
          • Study Coordinator
          • Phone Number: +8615923245950
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Recruiting
        • Fujian Provincial Cancer Hospital ( Site 1659)
        • Contact:
          • Study Coordinator
          • Phone Number: 8613859089836
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center-melanoma ( Site 1655)
        • Contact:
          • Study Coordinator
          • Phone Number: 15915733209
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Recruiting
        • Guangxi Medical University Affiliated Tumor Hospital ( Site 1668)
        • Contact:
          • Study Coordinator
          • Phone Number: 18677102309
    • Hebei
      • Shijiazhuang, Hebei, China, 050035
        • Recruiting
        • Fourth Hospital of Hebei Medical University ( Site 1669)
        • Contact:
          • Study Coordinator
          • Phone Number: +86 13831195070
    • Henan
      • Zhengzhou Shi, Henan, China, 450001
        • Recruiting
        • The Third Hospital of Zhengzhou-Oncology ( Site 1653)
        • Contact:
          • Study Coordinator
          • Phone Number: 13937130192
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Wuhan Union Hospital Cancer Center-Cancer Center ( Site 1664)
        • Contact:
          • Study Coordinator
          • Phone Number: 15807183251
    • Hunan
      • Changsha, Hunan, China, 410011
        • Recruiting
        • The Second Xiangya Hospital of Central South University-Oncology ( Site 1673)
        • Contact:
          • Study Coordinator
          • Phone Number: 13973130429
    • Jiangsu
      • NanJing, Jiangsu, China, 210000
        • Recruiting
        • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology (
        • Contact:
          • Study Coordinator
          • Phone Number: 8615951956162
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • Jiangsu Province Hospital-Oncology Department ( Site 1663)
        • Contact:
          • Study Coordinator
          • Phone Number: +8613951807457
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The First Affiliated Hospital of Nanchang University ( Site 1652)
        • Contact:
          • Study Coordinator
          • Phone Number: 13870051522
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • The First Hospital of Jilin University-Oncology ( Site 1665)
        • Contact:
          • Study Coordinator
          • Phone Number: 8613944888991
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center ( Site 1658)
        • Contact:
          • Study Coordinator
          • Phone Number: 8613916860586
    • Shanxi
      • Taiyuan, Shanxi, China, 030032
        • Recruiting
        • Shanxi Bethune Hospital ( Site 1660)
        • Contact:
          • Study Coordinator
          • Phone Number: 02783663425
    • Sichuan
      • Cheng Du, Sichuan, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University-Head and Neck Oncology ( Site 1667)
        • Contact:
          • Study Coordinator
          • Phone Number: +86 18980601130
    • Tianjin
      • Tianjin, Tianjin, China
        • Recruiting
        • Tianjin Medical University Cancer Institute & Hospital-Biotherapy ( Site 1671)
        • Contact:
          • Study Coordinator
          • Phone Number: 8618622221235
    • Xinjiang
      • Urumqi, Xinjiang, China, 830000
        • Recruiting
        • Xinjiang Medical University Cancer Hospital - Urumqi-Bone and Soft Tissue Department ( Site 1674)
        • Contact:
          • Study Coordinator
          • Phone Number: 13999153829
    • Yunnan
      • Kunming, Yunnan, China, 650106
        • Recruiting
        • Yunnan Province Cancer Hospital-Biotherapy Center ( Site 1666)
        • Contact:
          • Study Coordinator
          • Phone Number: +8613888052830
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital-Oncology ( Site 1661)
        • Contact:
          • Study Coordinator
          • Phone Number: 8613750851650
  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia, 050030
        • Recruiting
        • Fundación Colombiana de Cancerología Clínica Vida ( Site 0355)
        • Contact:
          • Study Coordinator
          • Phone Number: 573126867004
      • Medellin, Antioquia, Colombia, 050025
        • Recruiting
        • Instituto de Cancerología ( Site 0356)
        • Contact:
          • Study Coordinator
          • Phone Number: 340 93 93
    • Distrito Capital De Bogota
      • Bogota, Distrito Capital De Bogota, Colombia, 111321
        • Recruiting
        • Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0358)
        • Contact:
          • Study Coordinator
          • Phone Number: 573103469453
    • Tolima
      • Ibague, Tolima, Colombia, 730006
        • Recruiting
        • Mediservis del Tolima IPS S.A.S ( Site 0357)
        • Contact:
          • Study Coordinator
          • Phone Number: +576082809432
    • Valle Del Cauca
      • Cali, Valle Del Cauca, Colombia, 760032
        • Recruiting
        • Fundación Valle del Lili ( Site 0352)
        • Contact:
          • Study Coordinator
          • Phone Number: 573148883972
  • France
      • Paris, France, 75014
        • Recruiting
        • Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0711)
        • Contact:
          • Study Coordinator
          • Phone Number: +3358411765
    • Drome
      • Valence, Drome, France, 26953
        • Recruiting
        • Centre Hospitalier de Valence-Service de Dermatologie ( Site 0702)
        • Contact:
          • Study Coordinator
          • Phone Number: +33 475757549
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, France, 44093
        • Recruiting
        • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu-Onco-Dermatology ( Site 0707)
        • Contact:
          • Study Coordinator
          • Phone Number: 02 40 08 31 44
      • Saint Herblain, Loire-Atlantique, France, 44805
        • Recruiting
        • Institut de Cancérologie de l'Ouest-Oncologie Médicale ( Site 0706)
        • Contact:
          • Study Coordinator
          • Phone Number: 33240679900
    • Nord-Pas-de-Calais
      • Lille, Nord-Pas-de-Calais, France, 59037
        • Recruiting
        • Hopital Claude Huriez - CHU de Lille-Clinique de Dermatologie ( Site 0700)
        • Contact:
          • Study Coordinator
          • Phone Number: 33320444193
    • Provence-Alpes-Cote-d Azur
      • Marseille, Provence-Alpes-Cote-d Azur, France, 13005
        • Recruiting
        • Assistance Publique Hôpitaux de Marseille - Hôpital de la Ti-Service de Dermatologie et Cancérologi
        • Contact:
          • Study Coordinator
          • Phone Number: 33491387991
    • Pyrenees-Atlantiques
      • Pau, Pyrenees-Atlantiques, France, 64000
        • Recruiting
        • Centre Hospitalier de Pau ( Site 0708)
        • Contact:
          • Study Coordinator
          • Phone Number: 33559924848
    • Rhone
      • Pierre-Bénite, Rhone, France, 69310
        • Recruiting
        • centre hospitalier lyon sud-Service de dermatologie ( Site 0714)
        • Contact:
          • Study Coordinator
          • Phone Number: 33478861679
    • Val-de-Marne
      • Villejuif, Val-de-Marne, France, 94800
        • Recruiting
        • Gustave Roussy-Dermatologie ( Site 0713)
        • Contact:
          • Study Coordinator
          • Phone Number: 33142114210
  • Germany
      • Berlin, Germany, 10117
        • Recruiting
        • Charité Universitaetsmedizin Berlin - Campus Mitte-Hauttumorcentrum Charité (HTCC) ( Site 0756)
        • Contact:
          • Study Coordinator
          • Phone Number: +4930450518002
      • Hamburg, Germany, 20246
        • Recruiting
        • Universitaetsklinikum Hamburg-Eppendorf ( Site 0752)
        • Contact:
          • Study Coordinator
          • Phone Number: +49 (0)40 7410-53651
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Germany, 69120
        • Recruiting
        • Universitaetsklinikum Heidelberg ( Site 0765)
        • Contact:
          • Study Coordinator
          • Phone Number: +49 6221 56-36871
      • Mannheim, Baden-Wurttemberg, Germany, 68167
        • Recruiting
        • Universitätsmedizin Mannheim ( Site 0751)
        • Contact:
          • Study Coordinator
          • Phone Number: 496213834461
    • Bayern
      • Erlangen, Bayern, Germany, 91054
        • Recruiting
        • Universitaetsklinikum Erlangen-Hautklinik ( Site 0750)
        • Contact:
          • Study Coordinator
          • Phone Number: 0049-9131-8545810
      • München, Bayern, Germany, 80337
        • Recruiting
        • Klinik und Poliklinik für Dermatologie und Allergologie-Dermato-oncology ( Site 0757)
        • Contact:
          • Study Coordinator
          • Phone Number: +4989440056065
    • Niedersachsen
      • Buxtehude, Niedersachsen, Germany, 21614
        • Recruiting
        • Elbe Kliniken Stade-Buxtehude, Klinikum Buxtehude-Dermatologisches Zentrum ( Site 0754)
        • Contact:
          • Study Coordinator
          • Phone Number: +49 (0)4161 703 6212
      • Hannover, Niedersachsen, Germany, 30625
        • Recruiting
        • Medizinische Hochschule Hannover ( Site 0758)
        • Contact:
          • Study Coordinator
          • Phone Number: +49 (0) 511 532 7678
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germany, 45147
        • Recruiting
        • Universitaetsklinikum Essen-Klinik für Dermatologie, Venerologie und Allergologie ( Site 0761)
        • Contact:
          • Study Coordinator
          • Phone Number: 00492017232325
      • Minden, Nordrhein-Westfalen, Germany, 32429
        • Recruiting
        • Johannes Wesling Klinikum Minden-Skin Cancer Center Minden ( Site 0759)
        • Contact:
          • Study Coordinator
          • Phone Number: 495717094501
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
        • Recruiting
        • Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Dermatologie ( Site 0766)
        • Contact:
          • Study Coordinator
          • Phone Number: 4935145819782
      • Leipzig, Sachsen, Germany, 04103
        • Recruiting
        • Universitätsklinikum Leipzig ( Site 0762)
        • Contact:
          • Study Coordinator
          • Phone Number: 00493419718600
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Recruiting
        • Universitaetsklinikum Schleswig-Holstein Campus Kiel-Hautklinik ( Site 0767)
        • Contact:
          • Study Coordinator
          • Phone Number: 4943150021130
  • India
    • Delhi
      • New Delhi, Delhi, India, 110029
        • Recruiting
        • All India Institute of Medical Sciences-Medical oncology ( Site 1552)
        • Contact:
          • Study Coordinator
          • Phone Number: 919958975343
    • Haryana
      • Gurugram, Haryana, India, 122001
        • Recruiting
        • Artemis hospital ( Site 1551)
        • Contact:
          • Study Coordinator
          • Phone Number: 8377828241
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Recruiting
        • Tata Memorial Hospital-Medical Oncology ( Site 1550)
        • Contact:
          • Study Coordinator
          • Phone Number: 919920640040
  • Ireland
      • Dublin, Ireland, Dublin 9
        • Recruiting
        • Beaumont Hospital, Dublin-Cancer Clinical Trials & Research Unit ( Site 0902)
        • Contact:
          • Study Coordinator
          • Phone Number: 01-8092010
      • Dublin, Ireland, D08 E9P6
        • Recruiting
        • St. James's Hospital-Cancer clinical trials office ( Site 0900)
        • Contact:
          • Study Coordinator
          • Phone Number: 35314144299
  • Israel
      • Afula, Israel, 1834111
        • Recruiting
        • Emek Medical Center-oncology ( Site 0952)
        • Contact:
          • Study Coordinator
          • Phone Number: 97246495723
      • Be'er Sheva, Israel, 8410101
        • Recruiting
        • Soroka Medical Center ( Site 0953)
        • Contact:
          • Study Coordinator
          • Phone Number: 97286400797
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus-Oncology Division ( Site 0955)
        • Contact:
          • Study Coordinator
          • Phone Number: 04-777-6700
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah Medical Center ( Site 0951)
        • Contact:
          • Study Coordinator
          • Phone Number: 972505172537
      • Petah Tikva, Israel, 4941492
        • Recruiting
        • Rabin Medical Center-Oncology ( Site 0954)
        • Contact:
          • Study Coordinator
          • Phone Number: +972-3-9378077
      • Ramat Gan, Israel, 5265601
        • Recruiting
        • Sheba Medical Center-ONCOLOGY ( Site 0950)
        • Contact:
          • Study Coordinator
          • Phone Number: 97235302243
  • Italy
      • Milano, Italy, 20141
        • Recruiting
        • Istituto Europeo di Oncologia IRCCS ( Site 1008)
        • Contact:
          • Study Coordinator
          • Phone Number: +390294372754
      • Modena, Italy, 41125
        • Recruiting
        • Azienda Ospedaliero Universitaria ( Site 1002)
        • Contact:
          • Study Coordinator
          • Phone Number: +39 059 422 3200
      • Napoli, Italy, 80131
        • Recruiting
        • Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1001)
        • Contact:
          • Study Coordinator
          • Phone Number: +3908159031886S
    • Emilia-Romagna
      • Meldola, Emilia-Romagna, Italy, 47014
        • Recruiting
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 1004)
        • Contact:
          • Study Coordinator
          • Phone Number: +390543739274
    • Lombardia
      • Milan, Lombardia, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1000)
        • Contact:
          • Study Coordinator
          • Phone Number: 390223902557
    • Puglia
      • Bari, Puglia, Italy, 70124
        • Recruiting
        • Instituto Tumori Giovanni Paolo II ( Site 1003)
        • Contact:
          • Study Coordinator
          • Phone Number: +39 0805555138
    • Sicilia
      • Palermo, Sicilia, Italy, 90129
        • Recruiting
        • A.O.U. Policlinico Paolo Giaccone-Depatment of Discipline Chirurgiche, Oncologiche e Stomatologiche
        • Contact:
          • Study Coordinator
          • Phone Number: 390916552507
    • Toscana
      • Siena, Toscana, Italy, 53100
        • Recruiting
        • Azienda Ospedaliero Universitaria Senese ( Site 1005)
        • Contact:
          • Study Coordinator
          • Phone Number: 390577586335
    • Umbria
      • Perugia, Umbria, Italy, 06129
        • Recruiting
        • AO Santa Maria della Misericordia ( Site 1006)
        • Contact:
          • Study Coordinator
          • Phone Number: 00393386605619
  • Japan
      • Osaka, Japan, 541-8567
        • Active, not recruiting
        • Osaka International Cancer Institute ( Site 1754)
    • Aichi
      • Nagoya-Shi, Aichi, Japan, 466-8560
        • Active, not recruiting
        • Nagoya University Hospital ( Site 1753)
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8543
        • Recruiting
        • Sapporo Medical University Hospital ( Site 1755)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-11-611-2111
    • Niigata
      • Niigata-shi, Niigata, Japan, 951-8566
        • Active, not recruiting
        • Niigata Cancer Center Hospital ( Site 1751)
    • Shizuoka
      • Nagaizumi-cho,Sunto-gun, Shizuoka, Japan, 411-8777
        • Active, not recruiting
        • Shizuoka Cancer Center ( Site 1752)
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • Recruiting
        • National Cancer Center Hospital ( Site 1750)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3542-2511
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1601)
        • Contact:
          • Study Coordinator
          • Phone Number: 82222288138
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center-Division of Hematology/Oncology ( Site 1602)
        • Contact:
          • Study Coordinator
          • Phone Number: +82-2-3410-6820
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital-Oncology ( Site 1600)
        • Contact:
          • Study Coordinator
          • Phone Number: 82220724035
  • New Zealand
      • Auckland, New Zealand, 0627
        • Recruiting
        • Harbour Cancer & Wellness ( Site 1508)
        • Contact:
          • Study Coordinator
          • Phone Number: 6421783590
    • Bay Of Plenty
      • Tauranga, Bay Of Plenty, New Zealand, 3112
        • Recruiting
        • Tauranga Hospital-Bay of Plenty Clinical Trials Unit ( Site 1501)
        • Contact:
          • Study Coordinator
          • Phone Number: 0278004008
    • Canterbury
      • Christchurch, Canterbury, New Zealand, 8011
        • Recruiting
        • New Zealand Clinical Research (Christchurch) ( Site 1509)
        • Contact:
          • Study Coordinator
          • Phone Number: 6433640020
    • Manawatu-Wanganui
      • Palmerston North, Manawatu-Wanganui, New Zealand, 4414
        • Recruiting
        • P3 Research - Palmerston North ( Site 1510)
        • Contact:
          • Study Coordinator
          • Phone Number: 6463508130
    • Otago
      • Dunedin, Otago, New Zealand, 9016
        • Recruiting
        • Dunedin Hospital ( Site 1511)
        • Contact:
          • Study Coordinator
          • Phone Number: 6437470999
  • Poland
    • Kujawsko-pomorskie
      • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-796
        • Recruiting
        • Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1061)
        • Contact:
          • Study Coordinator
          • Phone Number: 0048523743029
    • Malopolskie
      • Krakow, Malopolskie, Poland, 30-727
        • Recruiting
        • Pratia MCM Krakow ( Site 1053)
        • Contact:
          • Study Coordinator
          • Phone Number: +48607941715
    • Mazowieckie
      • Siedlce, Mazowieckie, Poland, 08-110
        • Recruiting
        • Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1058)
        • Contact:
          • Study Coordinator
          • Phone Number: +48256403493
      • Warszawa, Mazowieckie, Poland, 02-781
        • Recruiting
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
        • Contact:
          • Study Coordinator
          • Phone Number: +48226439375
    • Podlaskie
      • Bialystok, Podlaskie, Poland, 15-027
        • Recruiting
        • Bialostockie Centrum Onkologii ( Site 1065)
        • Contact:
          • Study Coordinator
          • Phone Number: +48856646888
    • Pomorskie
      • Gdańsk, Pomorskie, Poland, 80-214
        • Recruiting
        • Uniwersyteckie Centrum Kliniczne-Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólnej ( Site
        • Contact:
          • Study Coordinator
          • Phone Number: 0048585846280
      • Słupsk, Pomorskie, Poland, 76-200
        • Recruiting
        • Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Słupsku-Oncologii, Chemioterapii ( Site 1064)
        • Contact:
          • Study Coordinator
          • Phone Number: +48604975136
    • Slaskie
      • Gliwice, Slaskie, Poland, 44-101
        • Recruiting
        • Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1056)
        • Contact:
          • Study Coordinator
          • Phone Number: 48784981888
    • Swietokrzyskie
      • Kielce, Swietokrzyskie, Poland, 25-734
        • Recruiting
        • Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 1054)
        • Contact:
          • Study Coordinator
          • Phone Number: +48413674315
    • Wielkopolskie
      • Poznan, Wielkopolskie, Poland, 60-780
        • Recruiting
        • Szpital Kliniczny im. H. Swiecickiego nr 2-Oddział Kliniczny Onkologii Klinicznej i Doświadczalnej (
        • Contact:
          • Study Coordinator
          • Phone Number: 48606228277
    • Zachodniopomorskie
      • Szczecin, Zachodniopomorskie, Poland, 71-730
        • Recruiting
        • Zachodniopomorskie Centrum Onkologii ( Site 1063)
        • Contact:
          • Study Coordinator
          • Phone Number: +48914251410
  • South Africa
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa, 6055
        • Recruiting
        • CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 1161)
        • Contact:
          • Study Coordinator
          • Phone Number: 27413630581
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2196
        • Recruiting
        • Medical Oncology Centre of Rosebank ( Site 1160)
        • Contact:
          • Study Coordinator
          • Phone Number: 0824445473
      • Pretoria, Gauteng, South Africa, 0084
        • Recruiting
        • Curo Oncology ( Site 1158)
        • Contact:
          • Study Coordinator
          • Phone Number: +27 82 822 5556
      • Pretoria, Gauteng, South Africa, 0040
        • Recruiting
        • Wilgers Oncology Centre ( Site 1154)
        • Contact:
          • Study Coordinator
          • Phone Number: +27128072744
      • Pretoria, Gauteng, South Africa, 0181
        • Recruiting
        • LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 1152)
        • Contact:
          • Study Coordinator
          • Phone Number: 27123466701
      • Sandton, Gauteng, South Africa, 2196
        • Recruiting
        • Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 1151)
        • Contact:
          • Study Coordinator
          • Phone Number: 27118830900
    • Kwazulu-Natal
      • Durban, Kwazulu-Natal, South Africa, 4091
        • Recruiting
        • The Oncology Centre ( Site 1157)
        • Contact:
          • Study Coordinator
          • Phone Number: 27312099030
      • Richards Bay, Kwazulu-Natal, South Africa, 3900
        • Recruiting
        • Abraham Oncology ( Site 1150)
        • Contact:
          • Study Coordinator
          • Phone Number: 0845493493
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7570
        • Recruiting
        • Cape Town Oncology Trials ( Site 1155)
        • Contact:
          • Study Coordinator
          • Phone Number: 27219443832
      • Rondebosch, Western Cape, South Africa, 7700
        • Recruiting
        • Cancercare Rondebosch Oncology-Clinical trials ( Site 1159)
        • Contact:
          • Study Coordinator
          • Phone Number: 27219443700
  • Spain
      • Sevilla, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1205)
        • Contact:
          • Study Coordinator
          • Phone Number: 34600162731
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
        • Recruiting
        • Institut Català d'Oncologia - L'Hospitalet ( Site 1202)
        • Contact:
          • Study Coordinator
          • Phone Number: 34932607333
    • Gipuzkoa
      • Doniostia - San Sebastian, Gipuzkoa, Spain, 20014
        • Recruiting
        • Onkologikoa - Instituto Oncologico de San Sebastian ( Site 1203)
        • Contact:
          • Study Coordinator
          • Phone Number: 34943328315
    • Madrid, Comunidad De
      • Madrid, Madrid, Comunidad De, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1204)
        • Contact:
          • Study Coordinator
          • Phone Number: (+34) 913368263
    • Malaga
      • Málaga, Malaga, Spain, 29011
        • Recruiting
        • H.R.U Málaga - Hospital General-Oncology ( Site 1201)
        • Contact:
          • Study Coordinator
          • Phone Number: 34951291425
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46014
        • Recruiting
        • Hospital General Universitario de Valencia ( Site 1200)
        • Contact:
          • Study Coordinator
          • Phone Number: 34963131800437635
  • Sweden
    • Jonkopings Lan
      • Jönköping, Jonkopings Lan, Sweden, 553 05
        • Recruiting
        • Länssjukhuset Ryhov-Onkologkliniken ( Site 1253)
        • Contact:
          • Study Coordinator
          • Phone Number: 46102429483
    • Stockholms Lan
      • Stockholm, Stockholms Lan, Sweden, 171 64
        • Recruiting
        • Karolinska Universitetssjukhuset Solna ( Site 1252)
        • Contact:
          • Study Coordinator
          • Phone Number: 46851770000
  • Switzerland
      • Sankt Gallen, Switzerland, 9007
        • Recruiting
        • Cantonal Hospital St.Gallen-Oncology & Hematology ( Site 1306)
        • Contact:
          • Study Coordinator
          • Phone Number: 41714941111
    • Basel-Stadt
      • Basel, Basel-Stadt, Switzerland, 4056
        • Recruiting
        • University Hospital Basel ( Site 1303)
        • Contact:
          • Study Coordinator
          • Phone Number: +41 61 32 8 60 16
    • Berne
      • Bern, Berne, Switzerland, 3010
        • Recruiting
        • Inselspital Bern ( Site 1301)
        • Contact:
          • Study Coordinator
          • Phone Number: 031 632 41 14
    • Geneve
      • Genève, Geneve, Switzerland, 1211
        • Recruiting
        • Hôpitaux Universitaires de Genève (HUG)-Oncology ( Site 1307)
        • Contact:
          • Study Coordinator
          • Phone Number: 0041223729862
    • Ticino
      • Bellinzona, Ticino, Switzerland, 6500
        • Recruiting
        • Ospedale Regionale Bellinzona e Valli ( Site 1308)
        • Contact:
          • Study Coordinator
          • Phone Number: 00418119411
    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • Recruiting
        • CHUV (centre hospitalier universitaire vaudois) ( Site 1304)
        • Contact:
          • Study Coordinator
          • Phone Number: 41795562698
    • Wallis
      • Sion, Wallis, Switzerland, 1951
        • Recruiting
        • Hôpital de Sion ( Site 1305)
        • Contact:
          • Study Coordinator
          • Phone Number: 41795567881
    • Zurich
      • Zürich Flughafen, Zurich, Switzerland, 8058
        • Recruiting
        • UniversitätsSpital Zürich-Dermatology ( Site 1300)
        • Contact:
          • Study Coordinator
          • Phone Number: 41442552588
  • Turkey
      • Ankara, Turkey, 06230
        • Recruiting
        • Hacettepe Universite Hastaneleri ( Site 1363)
        • Contact:
          • Study Coordinator
          • Phone Number: 905326880089
      • Ankara, Turkey, 06680
        • Recruiting
        • Liv Hospital Ankara-Oncology ( Site 1353)
        • Contact:
          • Study Coordinator
          • Phone Number: 905056604536
      • Antalya, Turkey, 07059
        • Recruiting
        • Akdeniz Universitesi Hastanesi-Medical Oncology ( Site 1355)
        • Contact:
          • Study Coordinator
          • Phone Number: 905052312377
      • Istanbul, Turkey, 34722
        • Recruiting
        • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1358)
        • Contact:
          • Study Coordinator
          • Phone Number: 00905063509061
      • Mersin, Turkey, 33240
        • Recruiting
        • Mersin Sehir Eğitim ve Araştırma Hastanesi-Oncology ( Site 1361)
        • Contact:
          • Study Coordinator
          • Phone Number: +9005458259095
      • Samsun, Turkey, 55139
        • Recruiting
        • Ondokuz Mayıs Universitesi-Oncology department ( Site 1359)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 53 25992825
    • Ankara
      • Cankaya, Ankara, Turkey, 06800
        • Recruiting
        • Ankara City Hospital-Medical Oncology ( Site 1357)
        • Contact:
          • Study Coordinator
          • Phone Number: 905052933234
    • Izmir
      • Izmir, Karsiyaka, Izmir, Turkey, 009035575
        • Recruiting
        • I.E.U. Medical Point Hastanesi-Oncology ( Site 1360)
        • Contact:
          • Study Coordinator
          • Phone Number: +905052642353
  • United Kingdom
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
        • Recruiting
        • Addenbrooke's Hospital ( Site 1400)
        • Contact:
          • Study Coordinator
          • Phone Number: 441223274401
    • England
      • London, England, United Kingdom, NW1 2PG
        • Recruiting
        • University College London Hospital ( Site 1405)
        • Contact:
          • Study Coordinator
          • Phone Number: 4402034475085
    • London, City Of
      • London, London, City Of, United Kingdom, SE1 9RT
        • Recruiting
        • Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 1401)
        • Contact:
          • Study Coordinator
          • Phone Number: 44 020 7188 3386
  • United States
    • California
      • La Jolla, California, United States, 92093-0698
        • Recruiting
        • Moores Cancer Center ( Site 0116)
        • Contact:
          • Study Coordinator
          • Phone Number: 858-349-2651
      • Los Angeles, California, United States, 90025
        • Recruiting
        • The Angeles Clinic and Research Institute - West Los Angeles Office ( Site 0123)
        • Contact:
          • Study Coordinator
          • Phone Number: 310-231-2153
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA Hematology/Oncology - Westwood (Building 100) ( Site 0131)
        • Contact:
          • Study Coordinator
          • Phone Number: 310-794-6892
      • San Francisco, California, United States, 94158
        • Recruiting
        • UCSF Medical Center at Mission Bay ( Site 0130)
        • Contact:
          • Study Coordinator
          • Phone Number: 415-353-7392
      • San Francisco, California, United States, 94115
        • Recruiting
        • California Pacific Medical Center - Pacific Campus ( Site 0111)
        • Contact:
          • Study Coordinator
          • Phone Number: 415-885-8600
    • Colorado
      • Englewood, Colorado, United States, 80113
        • Recruiting
        • The Melanoma & Skin Cancer Institute ( Site 0120)
        • Contact:
          • Study Coordinator
          • Phone Number: 720-316-8091
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Recruiting
        • Georgetown University Medical Center ( Site 0144)
        • Contact:
          • Study Coordinator
          • Phone Number: 202-444-2198
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0110)
        • Contact:
          • Study Coordinator
          • Phone Number: 305-243-4981
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center ( Site 0124)
        • Contact:
          • Study Coordinator
          • Phone Number: 813-745-8581
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern Memorial Hospital ( Site 0109)
        • Contact:
          • Study Coordinator
          • Phone Number: 312-472-1234
      • Park Ridge, Illinois, United States, 60068
        • Recruiting
        • Advocate Medical Group-Oncology ( Site 0102)
        • Contact:
          • Study Coordinator
          • Phone Number: 847268-8200
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa-Holden Comprehensive Cancer Center ( Site 0107)
        • Contact:
          • Study Coordinator
          • Phone Number: 319-356-2324
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital ( Site 0133)
        • Contact:
          • Study Coordinator
          • Phone Number: 313-725-7636
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Recruiting
        • Comprehensive Cancer Centers of Nevada ( Site 0142)
        • Contact:
          • Study Coordinator
          • Phone Number: 702-952-1242
    • New York
      • Lake Success, New York, United States, 11042
        • Recruiting
        • R.J. Zuckerberg Cancer Center-Medical Oncology ( Site 0132)
        • Contact:
          • Study Coordinator
          • Phone Number: 516-734-8866
      • Mineola, New York, United States, 11501
        • Recruiting
        • Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0146)
        • Contact:
          • Study Coordinator
          • Phone Number: 212-731-5431
      • New York, New York, United States, 10016
        • Recruiting
        • Laura and Isaac Perlmutter Cancer Center-Hematology and Oncology ( Site 0113)
        • Contact:
          • Study Coordinator
          • Phone Number: 212-731-5431
      • New York, New York, United States, 10065
        • Recruiting
        • Weill Cornell Medical College ( Site 0115)
        • Contact:
          • Study Coordinator
          • Phone Number: 646-962-6444
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai ( Site 0118)
        • Contact:
          • Study Coordinator
          • Phone Number: 212-824-7312
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Levine Cancer Institute ( Site 0138)
        • Contact:
          • Study Coordinator
          • Phone Number: 980-442-2000
    • North Dakota
      • Fargo, North Dakota, United States, 58102
        • Recruiting
        • Sanford Fargo Medical Center ( Site 0127)
        • Contact:
          • Study Coordinator
          • Phone Number: 701-234-7551
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • UPMC Hillman Cancer Center ( Site 0135)
        • Contact:
          • Study Coordinator
          • Phone Number: 412-623-4511
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • Children's Hospital of Pittsburgh ( Site 0141)
        • Contact:
          • Study Coordinator
          • Phone Number: 412-623-4511
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Recruiting
        • Sanford Cancer Center ( Site 0125)
        • Contact:
          • Study Coordinator
          • Phone Number: 605-328-8000
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Recruiting
        • The West Clinic, PLLC dba West Cancer Center ( Site 0119)
        • Contact:
          • Study Coordinator
          • Phone Number: 901-683-0055
      • Memphis, Tennessee, United States, 38105
        • Recruiting
        • St. Jude Children's Research Hospital ( Site 0106)
        • Contact:
          • Study Coordinator
          • Phone Number: 866-278-5833
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center ( Site 0139)
        • Contact:
          • Study Coordinator
          • Phone Number: 615-936-3524
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas MD Anderson Cancer Center ( Site 0145)
        • Contact:
          • Study Coordinator
          • Phone Number: 713-792-4185
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Inova Schar Cancer Institute ( Site 0103)
        • Contact:
          • Study Coordinator
          • Phone Number: 202-615-8535
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin Hospital and Clinics ( Site 0108)
        • Contact:
          • Study Coordinator
          • Phone Number: 608-265-1700

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Has surgically resected and histologically or pathologically confirmed diagnosis of Stage IIB and IIC (pathological or clinical), III, or IV cutaneous melanoma per the American Joint Committee on Cancer (AJCC) eighth edition guidelines
  • Has not received any prior systemic therapy for melanoma beyond surgical resection
  • Has had no more than 12 weeks between final surgical resection and randomization
  • Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)
  • Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization
  • Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening

Exclusion Criteria:

  • Has ocular, mucosal, or conjunctival melanoma
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
  • Has not adequately recovered from major surgical procedure or has ongoing surgical complications
  • Has received prior radiotherapy within 2 weeks of start of study intervention or has had a history of radiation pneumonitis
  • Received a live or live attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
  • Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has an active autoimmune disease that has required systemic treatment in past 2 years
  • Has an active infection requiring systemic therapy
  • Has had an allogenic tissue/solid organ transplant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pembrolizumab/Vibostolimab
Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 17 cycles (up to ~1 year).
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
Other Names:
  • MK-7684A
Active Comparator: Pembrolizumab
Adult participants receive 200 mg and adolescent participants ≥40 kg receive 2 mg/kg (up to a max of 200 mg) pembrolizumab via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 17 cycles (up to ~1 year).
Biological: Pembrolizumab
Pembrolizumab 25 mg/mL administered as IV infusion for up to 17 administrations
Other Names:
  • MK-3475
  • KEYTRUDA®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence-Free Survival (RFS)
Time Frame: Up to approximately 52 months
RFS is defined as the time from randomization to any recurrence (local, locoregional, regional, or distant) as assessed by the investigator, or death due to any cause, whichever occurs first. The RFS as assessed by the investigator will be reported for all randomized participants.
Up to approximately 52 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to approximately 96 months
OS is defined as the time from randomization to death due to any cause.
Up to approximately 96 months
Number of Participants Who Experienced at Least One Adverse Event (AE)
Time Frame: Up to approximately 15 months
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.
Up to approximately 15 months
Number of Participants Who Discontinued Study Treatment Due to an AE
Time Frame: Up to approximately 12 months
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.
Up to approximately 12 months
Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score
Time Frame: Baseline and up to approximately 72 months
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. Change from baseline in the score of EORTC QLQ-C30 Items 29 and 30 will be presented.
Baseline and up to approximately 72 months
Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score
Time Frame: Baseline and up to approximately 72 months
The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. Change from baseline in the score of EORTC QLQ-C30 Items 1-5 will be presented.
Baseline and up to approximately 72 months
Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score
Time Frame: Baseline and up to approximately 72 months
The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 2 questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. Change from baseline in the score of EORTC QLQ-C30 Items 6-7 will be presented.
Baseline and up to approximately 72 months
Distant Metastasis-Free Survival (DMFS)
Time Frame: Up to approximately 68 months
DMFS is defined as the time from randomization to the first diagnosis of a distant metastasis, or death due to any cause, whichever occurs first. Distant metastasis refers to cancer that has spread from the original (primary) tumor and beyond local tissues and lymph nodes to distant organs or distant lymph nodes. The DMFS as assessed by the investigator will be reported for all randomized participants.
Up to approximately 68 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2023

Primary Completion (Estimated)

October 22, 2027

Study Completion (Estimated)

March 31, 2031

Study Registration Dates

First Submitted

December 16, 2022

First Submitted That Met QC Criteria

December 16, 2022

First Posted (Actual)

December 27, 2022

Study Record Updates

Last Update Posted (Actual)

April 5, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7684A-010
  • MK-7684A-010 (Other Identifier: Merck)
  • KEYVIBE-010 (Other Identifier: Merck)
  • 2022-501417-31-00 (Registry Identifier: EU CT)
  • jRCT2031230099 (Registry Identifier: jRCT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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