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) Summary 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 .
View Eligibility Criteria Eligibility Criteria 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
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There are 179 Locations for this study
The Angeles Clinic and Research Institute - West Los Angeles Office ( Site 0123) Los Angeles California, 90025, United States
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UCLA Hematology/Oncology - Westwood (Building 100) ( Site 0131) Los Angeles California, 90095, United States
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California Pacific Medical Center - Pacific Campus ( Site 0111) San Francisco California, 94115, United States
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UCSF Medical Center at Mission Bay ( Site 0130) San Francisco California, 94158, United States
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The Melanoma & Skin Cancer Institute ( Site 0120) Englewood Colorado, 80113, United States
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Georgetown University Medical Center ( Site 0144) Washington District of Columbia, 20007, United States
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University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0110) Miami Florida, 33136, United States
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Northwestern Memorial Hospital ( Site 0109) Chicago Illinois, 60611, United States
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Advocate Medical Group-Oncology ( Site 0102) Park Ridge Illinois, 60068, United States
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University of Iowa-Holden Comprehensive Cancer Center ( Site 0107) Iowa City Iowa, 52242, United States
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Henry Ford Hospital ( Site 0133) Detroit Michigan, 48202, United States
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Comprehensive Cancer Centers of Nevada ( Site 0142) Las Vegas Nevada, 89169, United States
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R.J. Zuckerberg Cancer Center-Medical Oncology ( Site 0132) Lake Success New York, 11042, United States
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Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0146) Mineola New York, 11501, United States
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Laura and Isaac Perlmutter Cancer Center-Hematology and Oncology ( Site 0113) New York New York, 10016, United States
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Levine Cancer Institute ( Site 0138) Charlotte North Carolina, 28204, United States
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Sanford Fargo Medical Center ( Site 0127) Fargo North Dakota, 58102, United States
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Children's Hospital of Pittsburgh ( Site 0141) Pittsburgh Pennsylvania, 15224, United States
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UPMC Hillman Cancer Center ( Site 0135) Pittsburgh Pennsylvania, 15232, United States
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Sanford Cancer Center ( Site 0125) Sioux Falls South Dakota, 57104, United States
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The West Clinic, PLLC dba West Cancer Center ( Site 0119) Germantown Tennessee, 38138, United States
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Inova Schar Cancer Institute ( Site 0103) Fairfax Virginia, 22031, United States
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University of Wisconsin Hospital and Clinics ( Site 0108) Madison Wisconsin, 53792, United States
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Centro de Investigaciones Metabólicas (CINME)-Oncology ( Site 0204) Ciudad Autónoma de Buenos Aires Buenos Aires, C1027, Argentina
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Instituto Alexander Fleming-Alexander Fleming ( Site 0209) Ciudad Autónoma de Buenos Aires Buenos Aires, C1426, Argentina
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Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0200) Buenos Aires Caba, C1431, Argentina
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Instituto de Oncología de Rosario ( Site 0206) Rosario Santa Fe, S2000, Argentina
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Sanatorio Finochietto ( Site 0212) Buenos Aires , C1187, Argentina
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Clinica Adventista Belgrano-Oncology ( Site 0211) Caba , C1430, Argentina
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Blacktown Hospital-Blacktown Cancer and Haematology Centre - Medical Oncology ( Site 1464) Blacktown New South Wales, 2148, Australia
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Calvary Mater Newcastle-Medical Oncology ( Site 1462) Waratah New South Wales, 2298, Australia
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Melanoma Institute Australia-Clinical Trials Unit ( Site 1450) Wollstonecraft New South Wales, 2065, Australia
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Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si Brisbane Queensland, 4029, Australia
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Gallipoli Medical Research Foundation-GMRF CTU ( Site 1451) Brisbane Queensland, 4120, Australia
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Cairns Hospital-Clinical Research Unit ( Site 1458) Cairns Queensland, 4870, Australia
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Tasman Oncology Research ( Site 1456) Southport Queensland, 4215, Australia
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Royal Adelaide Hospital-RAH Cancer Centre ( Site 1457) Adelaide South Australia, 5000, Australia
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Icon Cancer Centre Hobart ( Site 1465) Hobart Tasmania, 7000, Australia
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Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 1455) Melbourne Victoria, 3000, Australia
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One Clinical Research ( Site 1460) Nedlands Western Australia, 6009, Australia
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Universitätsklinikum St. Pölten-Department of Dermatology ( Site 0606) St. Polten Niederosterreich, 3100, Austria
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Ordensklinikum Linz GmbH Elisabethinen-Dermatologie ( Site 0602) Linz Oberosterreich, 4020, Austria
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Medizinische Universität Graz-Innere Medizin Klin. Abt. Onkologie ( Site 0601) Graz Steiermark, 8036, Austria
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Medizinische Universitaet Innsbruck-Univ Klinik für Dermatologie, Venerologie und Allergologie ( Sit Innsbruck Tirol, 6020, Austria
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Medizinische Universität Wien-Department of Dermatology ( Site 0600) Vienna Wien, 1090, Austria
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Uniklinikum Salzburg-Department of Dermatology and Allergology ( Site 0604) Salzburg , 5020, Austria
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GZA Ziekenhuizen campus Sint-Augustinus ( Site 0655) Wilrijk Antwerpen, 2610, Belgium
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Jessa Ziekenhuis ( Site 0656) Hasselt Limburg, 3500, Belgium
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Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 0653) Yvoir Namur, 5530, Belgium
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VITAZ-Medical Oncology ( Site 0654) Sint-Niklaas Oost-Vlaanderen, B-910, Belgium
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UZ Leuven-General Medical Oncology ( Site 0650) Leuven Vlaams-Brabant, 3000, Belgium
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Centro Avançado de Tratamento Oncológico- CENANTRON ( Site 0256) Belo Horizonte Minas Gerais, 30130, Brazil
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Hospital de Cancer de Londrina-Clinical Research Unit ( Site 0252) Londrina Parana, 86015, Brazil
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Associação Hospitalar Beneficente São Vicente de Paulo-Instituto do Câncer ( Site 0259) Passo Fundo Rio Grande Do Sul, 99010, Brazil
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ANIMI - Unidade de Tratamento Oncologico ( Site 0255) Lages Santa Catarina, 88501, Brazil
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CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia ( Site 0262) Santo André Sao Paulo, 09060, Brazil
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A. C. Camargo Cancer Center ( Site 0258) Sao Paulo , 01509, Brazil
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The Ottawa Hospital - General Campus-The Ottawa Hospital Cancer Centre ( Site 0004) Ottawa Ontario, K1H 8, Canada
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Princess Margaret Cancer Centre ( Site 0006) Toronto Ontario, M5G 2, Canada
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Oncocentro Valdivia ( Site 0307) Valdivia Los Rios, 51121, Chile
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FALP-UIDO ( Site 0303) Santiago Region M. De Santiago, 75009, Chile
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Oncovida ( Site 0304) Santiago Region M. De Santiago, 75100, Chile
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Clínica UC San Carlos de Apoquindo ( Site 0305) Santiago Region M. De Santiago, 76200, Chile
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Bradfordhill-Clinical Area ( Site 0302) Santiago Region M. De Santiago, 84203, Chile
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ONCOCENTRO APYS-ACEREY ( Site 0300) Viña del Mar Valparaiso, 25205, Chile
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Bradford Hill Norte ( Site 0308) Antofagasta , 12400, Chile
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Beijing Cancer hospital-Renal carcinoma and melanoma ( Site 1650) Beijing Beijing, 10014, China
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Chongqing University Cancer Hospital ( Site 1651) Chongqing Chongqing, 40003, China
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Fujian Provincial Cancer Hospital ( Site 1659) Fuzhou Fujian, 35001, China
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Sun Yat-sen University Cancer Center-melanoma ( Site 1655) Guangzhou Guangdong, 51006, China
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Guangxi Medical University Affiliated Tumor Hospital ( Site 1668) Nanning Guangxi, 53002, China
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Fourth Hospital of Hebei Medical University ( Site 1669) Shijiazhuang Hebei, 05003, China
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The Third Hospital of Zhengzhou-Oncology ( Site 1653) Zhengzhou Shi Henan, 45000, China
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Wuhan Union Hospital Cancer Center-Cancer Center ( Site 1664) Wuhan Hubei, 43002, China
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Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology ( Nanjing Jiangsu, 21000, China
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Jiangsu Province Hospital-Oncology Department ( Site 1663) Nanjing Jiangsu, 21002, China
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The First Affiliated Hospital of Nanchang University ( Site 1652) Nanchang Jiangxi, 33000, China
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The First Hospital of Jilin University-Oncology ( Site 1665) Changchun Jilin, 13002, China
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Fudan University Shanghai Cancer Center ( Site 1658) Shanghai Shanghai, 20003, China
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Shanxi Bethune Hospital ( Site 1660) Taiyuan Shanxi, 03003, China
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West China Hospital, Sichuan University-Head and Neck Oncology ( Site 1667) Cheng Du Sichuan, 61004, China
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Xinjiang Medical University Cancer Hospital - Urumqi-Bone and Soft Tissue Department ( Site 1674) Urumqi Xinjiang, 83000, China
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Zhejiang Cancer Hospital-Oncology ( Site 1661) Hangzhou Zhejiang, 31002, China
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Fundación Colombiana de Cancerología Clínica Vida ( Site 0355) Medellin Antioquia, 05003, Colombia
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Mediservis del Tolima IPS S.A.S ( Site 0357) Ibague Tolima, 73000, Colombia
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Fundación Valle del Lili ( Site 0352) Cali Valle Del Cauca, 76003, Colombia
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Centre Hospitalier de Valence-Service de Dermatologie ( Site 0702) Valence Drome, 26953, France
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Institut de Cancérologie de l'Ouest-Oncologie Médicale ( Site 0706) Saint Herblain Loire-Atlantique, 44805, France
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Hopital Claude Huriez - CHU de Lille-Clinique de Dermatologie ( Site 0700) Lille Nord-Pas-de-Calais, 59037, France
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Assistance Publique Hôpitaux de Marseille - Hôpital de la Ti-Service de Dermatologie et Cancérologi Marseille Provence-Alpes-Cote-d Azur, 13005, France
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Centre Hospitalier de Pau ( Site 0708) Pau Pyrenees-Atlantiques, 64000, France
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centre hospitalier lyon sud-Service de dermatologie ( Site 0714) Pierre-Bénite Rhone, 69310, France
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Gustave Roussy-Dermatologie ( Site 0713) Villejuif Val-de-Marne, 94800, France
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Universitaetsklinikum Heidelberg ( Site 0765) Heidelberg Baden-Wurttemberg, 69120, Germany
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Universitätsmedizin Mannheim ( Site 0751) Mannheim Baden-Wurttemberg, 68167, Germany
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Universitaetsklinikum Erlangen-Hautklinik ( Site 0750) Erlangen Bayern, 91054, Germany
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Elbe Kliniken Stade-Buxtehude, Klinikum Buxtehude-Dermatologisches Zentrum ( Site 0754) Buxtehude Niedersachsen, 21614, Germany
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Medizinische Hochschule Hannover ( Site 0758) Hannover Niedersachsen, 30625, Germany
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Universitaetsklinikum Essen-Klinik für Dermatologie, Venerologie und Allergologie ( Site 0761) Essen Nordrhein-Westfalen, 45147, Germany
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Johannes Wesling Klinikum Minden-Skin Cancer Center Minden ( Site 0759) Minden Nordrhein-Westfalen, 32429, Germany
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Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Dermatologie ( Site 0766) Dresden Sachsen, 01307, Germany
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Universitätsklinikum Leipzig ( Site 0762) Leipzig Sachsen, 04103, Germany
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Charité Universitaetsmedizin Berlin - Campus Mitte-Hauttumorcentrum Charité (HTCC) ( Site 0756) Berlin , 10117, Germany
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Universitaetsklinikum Hamburg-Eppendorf ( Site 0752) Hamburg , 20246, Germany
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All India Institute of Medical Sciences-Medical oncology ( Site 1552) New Delhi Delhi, 11002, India
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Artemis hospital ( Site 1551) Gurugram Haryana, 12200, India
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Tata Memorial Hospital-Medical Oncology ( Site 1550) Mumbai Maharashtra, 40001, India
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Beaumont Hospital, Dublin-Cancer Clinical Trials & Research Unit ( Site 0902) Dublin , Dubli, Ireland
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Emek Medical Center-oncology ( Site 0952) Afula , 18341, Israel
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Soroka Medical Center ( Site 0953) Be'er Sheva , 84101, Israel
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Rambam Health Care Campus-Oncology Division ( Site 0955) Haifa , 31096, Israel
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Hadassah Medical Center ( Site 0951) Jerusalem , 91120, Israel
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Rabin Medical Center-Oncology ( Site 0954) Petah Tikva , 49414, Israel
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Sheba Medical Center-ONCOLOGY ( Site 0950) Ramat Gan , 52656, Israel
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Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 1004) Meldola Emilia-Romagna, 47014, Italy
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Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1000) Milan Lombardia, 20133, Italy
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Instituto Tumori Giovanni Paolo II ( Site 1003) Bari Puglia, 70124, Italy
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A.O.U. Policlinico Paolo Giaccone-Depatment of Discipline Chirurgiche, Oncologiche e Stomatologiche Palermo Sicilia, 90129, Italy
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Azienda Ospedaliero Universitaria Senese ( Site 1005) Siena Toscana, 53100, Italy
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AO Santa Maria della Misericordia ( Site 1006) Perugia Umbria, 06129, Italy
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Istituto Europeo di Oncologia IRCCS ( Site 1008) Milano , 20141, Italy
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Azienda Ospedaliero Universitaria ( Site 1002) Modena , 41125, Italy
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Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1001) Napoli , 80131, Italy
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Nagoya University Hospital ( Site 1753) Nagoya-Shi Aichi, 466-8, Japan
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Niigata Cancer Center Hospital ( Site 1751) Niigata-shi Niigata, 951-8, Japan
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Shizuoka Cancer Center ( Site 1752) Nagaizumi-cho,Sunto-gun Shizuoka, 411-8, Japan
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National Cancer Center Hospital ( Site 1750) Chuo-ku Tokyo, 104-0, Japan
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Osaka International Cancer Institute ( Site 1754) Osaka , 541-8, Japan
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Seoul National University Hospital-Oncology ( Site 1600) Seoul , 03080, Korea, Republic of
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Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1601) Seoul , 03722, Korea, Republic of
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Samsung Medical Center-Division of Hematology/Oncology ( Site 1602) Seoul , 06351, Korea, Republic of
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Tauranga Hospital-Bay of Plenty Clinical Trials Unit ( Site 1501) Tauranga Bay Of Plenty, 3112, New Zealand
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New Zealand Clinical Research (Christchurch) ( Site 1509) Christchurch Canterbury, 8011, New Zealand
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P3 Research - Palmerston North ( Site 1510) Palmerston North Manawatu-Wanganui, 4414, New Zealand
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Dunedin Hospital ( Site 1511) Dunedin Otago, 9016, New Zealand
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Harbour Cancer & Wellness ( Site 1508) Auckland , 0627, New Zealand
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Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1061) Bydgoszcz Kujawsko-pomorskie, 85-79, Poland
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Pratia MCM Krakow ( Site 1053) Krakow Malopolskie, 30-72, Poland
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Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1058) Siedlce Mazowieckie, 08-11, Poland
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Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Warszawa Mazowieckie, 02-78, Poland
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Bialostockie Centrum Onkologii ( Site 1065) Bialystok Podlaskie, 15-02, Poland
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Uniwersyteckie Centrum Kliniczne-Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólnej ( Site Gdańsk Pomorskie, 80-21, Poland
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Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Słupsku-Oncologii, Chemioterapii ( Site 1064) Słupsk Pomorskie, 76-20, Poland
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Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1056) Gliwice Slaskie, 44-10, Poland
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Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 1054) Kielce Swietokrzyskie, 25-73, Poland
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Szpital Kliniczny im. H. Swiecickiego nr 2-Oddział Kliniczny Onkologii Klinicznej i Doświadczalnej ( Poznan Wielkopolskie, 60-78, Poland
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CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 1161) Port Elizabeth Eastern Cape, 6055, South Africa
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Medical Oncology Centre of Rosebank ( Site 1160) Johannesburg Gauteng, 2196, South Africa
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Wilgers Oncology Centre ( Site 1154) Pretoria Gauteng, 0040, South Africa
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Curo Oncology ( Site 1158) Pretoria Gauteng, 0084, South Africa
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LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 1152) Pretoria Gauteng, 0181, South Africa
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Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 1151) Sandton Gauteng, 2196, South Africa
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Abraham Oncology ( Site 1150) Richards Bay Kwazulu-Natal, 3900, South Africa
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Cape Town Oncology Trials ( Site 1155) Cape Town Western Cape, 7570, South Africa
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Cancercare Rondebosch Oncology-Clinical trials ( Site 1159) Rondebosch Western Cape, 7700, South Africa
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Institut Català d'Oncologia - L'Hospitalet ( Site 1202) L'Hospitalet de Llobregat Barcelona, 08908, Spain
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Onkologikoa - Instituto Oncologico de San Sebastian ( Site 1203) Doniostia - San Sebastian Gipuzkoa, 20014, Spain
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Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1204) Madrid Madrid, Comunidad De, 28034, Spain
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H.R.U Málaga - Hospital General-Oncology ( Site 1201) Málaga Malaga, 29011, Spain
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Hospital General Universitario de Valencia ( Site 1200) Valencia Valenciana, Comunitat, 46014, Spain
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Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1205) Sevilla , 41009, Spain
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Länssjukhuset Ryhov-Onkologkliniken ( Site 1253) Jönköping Jonkopings Lan, 553 0, Sweden
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Karolinska Universitetssjukhuset Solna ( Site 1252) Solna Stockholms Lan, 171 6, Sweden
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University Hospital Basel ( Site 1303) Basel Basel-Stadt, 4056, Switzerland
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Inselspital Bern ( Site 1301) Bern Berne, 3010, Switzerland
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Hôpitaux Universitaires de Genève (HUG)-Oncology ( Site 1307) Genève Geneve, 1211, Switzerland
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Ospedale Regionale Bellinzona e Valli ( Site 1308) Bellinzona Ticino, 6500, Switzerland
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CHUV (centre hospitalier universitaire vaudois) ( Site 1304) Lausanne Vaud, 1011, Switzerland
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Hôpital de Sion ( Site 1305) Sion Wallis, 1951, Switzerland
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UniversitätsSpital Zürich-Dermatology ( Site 1300) Zürich Flughafen Zurich, 8058, Switzerland
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Cantonal Hospital St.Gallen-Oncology & Hematology ( Site 1306) Sankt Gallen , 9007, Switzerland
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Ankara City Hospital-Medical Oncology ( Site 1357) Cankaya Ankara, 06800, Turkey
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I.E.U. Medical Point Hastanesi-Oncology ( Site 1360) Izmir, Karsiyaka Izmir, 00903, Turkey
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Hacettepe Universite Hastaneleri ( Site 1363) Ankara , 06230, Turkey
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Liv Hospital Ankara-Oncology ( Site 1353) Ankara , 06680, Turkey
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Akdeniz Universitesi Hastanesi-Medical Oncology ( Site 1355) Antalya , 07059, Turkey
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TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1358) Istanbul , 34722, Turkey
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Mersin Sehir Eğitim ve Araştırma Hastanesi-Oncology ( Site 1361) Mersin , 33240, Turkey
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Ondokuz Mayıs Universitesi-Oncology department ( Site 1359) Samsun , 55139, Turkey
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Addenbrooke's Hospital ( Site 1400) Cambridge Cambridgeshire, CB2 0, United Kingdom
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University College London Hospital ( Site 1405) London England, NW1 2, United Kingdom
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Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 1401) London London, City Of, SE1 9, United Kingdom
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