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TERMINATED
NCT05665595
PHASE3

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)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1594

Start Date

2023-01-19

Completion Date

2025-09-26

Last Updated

2026-08-18

Healthy Volunteers

No

Conditions

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

Locations (205)

Moores Cancer Center ( Site 0116)

La Jolla, California, United States

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

Los Angeles, California, United States

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

Los Angeles, California, United States

California Pacific Medical Center - Pacific Campus ( Site 0111)

San Francisco, California, United States

UCSF Medical Center at Mission Bay ( Site 0130)

San Francisco, California, United States

The Melanoma & Skin Cancer Institute ( Site 0120)

Englewood, Colorado, United States

Georgetown University Medical Center ( Site 0144)

Washington D.C., District of Columbia, United States

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

Miami, Florida, United States

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

Tampa, Florida, United States

Northwestern Memorial Hospital ( Site 0109)

Chicago, Illinois, United States

Advocate Medical Group-Oncology ( Site 0102)

Park Ridge, Illinois, United States

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

Iowa City, Iowa, United States

Henry Ford Hospital ( Site 0133)

Detroit, Michigan, United States

Comprehensive Cancer Centers of Nevada ( Site 0142)

Las Vegas, Nevada, United States

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

Lake Success, New York, United States

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

Mineola, New York, United States

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

New York, New York, United States

Icahn School of Medicine at Mount Sinai ( Site 0118)

New York, New York, United States

Weill Cornell Medical College ( Site 0115)

New York, New York, United States

Levine Cancer Institute ( Site 0138)

Charlotte, North Carolina, United States

Sanford Fargo Medical Center ( Site 0127)

Fargo, North Dakota, United States

Children's Hospital of Pittsburgh ( Site 0141)

Pittsburgh, Pennsylvania, United States

UPMC Hillman Cancer Center ( Site 0135)

Pittsburgh, Pennsylvania, United States

Sanford Cancer Center ( Site 0125)

Sioux Falls, South Dakota, United States

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

Germantown, Tennessee, United States

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

Memphis, Tennessee, United States

Vanderbilt University Medical Center ( Site 0139)

Nashville, Tennessee, United States

University of Texas MD Anderson Cancer Center ( Site 0145)

Houston, Texas, United States

Inova Schar Cancer Institute ( Site 0103)

Fairfax, Virginia, United States

University of Wisconsin Hospital and Clinics ( Site 0108)

Madison, Wisconsin, United States

Centro de Investigaciones Metabólicas (CINME)-Oncology ( Site 0204)

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Instituto Alexander Fleming-Alexander Fleming ( Site 0209)

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

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

Buenos Aires, Buenos Aires F.D., Argentina

Instituto de Oncología de Rosario ( Site 0206)

Rosario, Santa Fe Province, Argentina

Sanatorio Finochietto ( Site 0212)

Buenos Aires, Argentina

Clinica Adventista Belgrano-Oncology ( Site 0211)

CABA, Argentina

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

Blacktown, New South Wales, Australia

Calvary Mater Newcastle-Medical Oncology ( Site 1462)

Waratah, New South Wales, Australia

Melanoma Institute Australia-Clinical Trials Unit ( Site 1450)

Wollstonecraft, New South Wales, Australia

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

Brisbane, Queensland, Australia

Cairns Hospital-Clinical Research Unit ( Site 1458)

Cairns, Queensland, Australia

Gallipoli Medical Research Ltd-GMRF CTU ( Site 1451)

Greenslopes, Queensland, Australia

Tasman Oncology Research ( Site 1456)

Southport, Queensland, Australia

Royal Adelaide Hospital-RAH Cancer Centre ( Site 1457)

Adelaide, South Australia, Australia

Icon Cancer Centre Hobart ( Site 1465)

Hobart, Tasmania, Australia

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

Melbourne, Victoria, Australia

One Clinical Research ( Site 1460)

Nedlands, Western Australia, Australia

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

Sankt Pölten, Lower Austria, Austria

Medizinische Universität Wien-Department of Dermatology ( Site 0600)

Vienna, State of Vienna, Austria

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

Graz, Styria, Austria

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

Innsbruck, Tyrol, Austria

Ordensklinikum Linz GmbH Elisabethinen-Dermatologie ( Site 0602)

Linz, Upper Austria, Austria

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

Salzburg, Austria

GZA Ziekenhuizen campus Sint-Augustinus ( Site 0655)

Wilrijk, Antwerpen, Belgium

Cliniques universitaires Saint-Luc ( Site 0652)

Brussels, Bruxelles-Capitale, Region de, Belgium

Jessa Ziekenhuis ( Site 0656)

Hasselt, Limburg, Belgium

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

Yvoir, Namur, Belgium

VITAZ-Medical Oncology ( Site 0654)

Sint-Niklaas, Oost-Vlaanderen, Belgium

UZ Leuven-General Medical Oncology ( Site 0650)

Leuven, Vlaams-Brabant, Belgium

Centro Avançado de Tratamento Oncológico- CENANTRON ( Site 0256)

Belo Horizonte, Minas Gerais, Brazil

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

Londrina, Paraná, Brazil

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

Passo Fundo, Rio Grande do Sul, Brazil

ANIMI - Unidade de Tratamento Oncologico ( Site 0255)

Lages, Santa Catarina, Brazil

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

Santo André, São Paulo, Brazil

A. C. Camargo Cancer Center ( Site 0258)

São Paulo, Brazil

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

Ottawa, Ontario, Canada

Sunnybrook Research Institute ( Site 0003)

Toronto, Ontario, Canada

Princess Margaret Cancer Centre ( Site 0006)

Toronto, Ontario, Canada

Oncocentro Valdivia ( Site 0307)

Valdivia, Los Ríos Region, Chile

FALP-UIDO ( Site 0303)

Santiago, Region M. de Santiago, Chile

Oncovida ( Site 0304)

Santiago, Region M. de Santiago, Chile

Clínica UC San Carlos de Apoquindo ( Site 0305)

Santiago, Region M. de Santiago, Chile

Bradfordhill-Clinical Area ( Site 0302)

Santiago, Region M. de Santiago, Chile

ONCOCENTRO APYS-ACEREY ( Site 0300)

Viña del Mar, Valparaiso, Chile

Bradford Hill Norte ( Site 0308)

Antofagasta, Chile

Beijing Ji Shui Tan Hospital ( Site 1657)

Beijing, Beijing Municipality, China

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

Beijing, Beijing Municipality, China

Chongqing University Cancer Hospital ( Site 1651)

Chongqing, Chongqing Municipality, China

Fujian Provincial Cancer Hospital ( Site 1659)

Fuzhou, Fujian, China

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

Guangzhou, Guangdong, China

Guangxi Medical University Affiliated Tumor Hospital ( Site 1668)

Nanning, Guangxi, China

Fourth Hospital of Hebei Medical University ( Site 1669)

Shijiazhuang, Hebei, China

The Third Hospital of Zhengzhou-Oncology ( Site 1653)

Zhengzhou, Henan, China

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

Wuhan, Hubei, China

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

Changsha, Hunan, China

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

Nanjing, Jiangsu, China

Jiangsu Province Hospital-Oncology Department ( Site 1663)

Nanjing, Jiangsu, China

The First Affiliated Hospital of Nanchang University ( Site 1652)

Nanchang, Jiangxi, China

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

Changchun, Jilin, China

Fudan University Shanghai Cancer Center ( Site 1658)

Shanghai, Shanghai Municipality, China

Shanxi Bethune Hospital ( Site 1660)

Taiyuan, Shanxi, China

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

Chengdu, Sichuan, China

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

Tianjin, Tianjin Municipality, China

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

Ürümqi, Xinjiang, China

Yunnan Province Cancer Hospital-Biotherapy Center ( Site 1666)

Kunming, Yunnan, China

Zhejiang Cancer Hospital-Oncology ( Site 1661)

Hangzhou, Zhejiang, China

Instituto de Cancerología ( Site 0356)

Medellín, Antioquia, Colombia

Fundación Colombiana de Cancerología Clínica Vida ( Site 0355)

Medellín, Antioquia, Colombia

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

Bogotá, Bogota D.C., Colombia

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

Ibague, Tolima Department, Colombia

Fundación Valle del Lili ( Site 0352)

Cali, Valle del Cauca Department, Colombia

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

Valence, Drome, France

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

Lille, Hauts-de-France, France

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

Nantes, Loire-Atlantique, France

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

Saint-Herblain, Loire-Atlantique, France

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

Marseille, Provence-Alpes-Côte d'Azur Region, France

Centre Hospitalier de Pau ( Site 0708)

Pau, Pyrenees-Atlantiques, France

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

Pierre-Bénite, Rhone, France

Gustave Roussy-Dermatologie ( Site 0713)

Villejuif, Val-de-Marne, France

Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0711)

Paris, France

Universitaetsklinikum Heidelberg ( Site 0765)

Heidelberg, Baden-Wurttemberg, Germany

Universitätsmedizin Mannheim ( Site 0751)

Mannheim, Baden-Wurttemberg, Germany

Universitaetsklinikum Erlangen-Hautklinik ( Site 0750)

Erlangen, Bavaria, Germany

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

München, Bavaria, Germany

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

Buxtehude, Lower Saxony, Germany

Medizinische Hochschule Hannover ( Site 0758)

Hanover, Lower Saxony, Germany

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

Essen, North Rhine-Westphalia, Germany

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

Minden, North Rhine-Westphalia, Germany

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

Dresden, Saxony, Germany

Universitätsklinikum Leipzig ( Site 0762)

Leipzig, Saxony, Germany

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

Kiel, Schleswig-Holstein, Germany

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

Berlin, Germany

Universitaetsklinikum Hamburg-Eppendorf ( Site 0752)

Hamburg, Germany

Artemis hospital ( Site 1551)

Gurugram, Haryana, India

Tata Memorial Hospital-Medical Oncology ( Site 1550)

Mumbai, Maharashtra, India

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

New Delhi, National Capital Territory of Delhi, India

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

Dublin, Ireland

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

Dublin, Ireland

Emek Medical Center-oncology ( Site 0952)

Afula, Israel

Soroka Medical Center ( Site 0953)

Beersheba, Israel

Rambam Health Care Campus-Oncology Division ( Site 0955)

Haifa, Israel

Hadassah Medical Center ( Site 0951)

Jerusalem, Israel

Rabin Medical Center-Oncology ( Site 0954)

Petah Tikva, Israel

Sheba Medical Center-ONCOLOGY ( Site 0950)

Ramat Gan, Israel

Instituto Tumori Giovanni Paolo II ( Site 1003)

Bari, Apulia, Italy

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

Meldola, Emilia-Romagna, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1000)

Milan, Lombardy, Italy

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

Palermo, Sicily, Italy

Azienda Ospedaliero Universitaria Senese ( Site 1005)

Siena, Tuscany, Italy

AO Santa Maria della Misericordia ( Site 1006)

Perugia, Umbria, Italy

Istituto Europeo di Oncologia IRCCS ( Site 1008)

Milan, Italy

Azienda Ospedaliero Universitaria ( Site 1002)

Modena, Italy

Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1001)

Naples, Italy

Nagoya University Hospital ( Site 1753)

Nagoya, Aichi-ken, Japan

Sapporo Medical University Hospital ( Site 1755)

Sapporo, Hokkaido, Japan

Niigata Cancer Center Hospital ( Site 1751)

Niigata, Niigata, Japan

Shizuoka Cancer Center ( Site 1752)

Nagaizumi-cho,Sunto-gun, Shizuoka, Japan

National Cancer Center Hospital ( Site 1750)

Chuo-ku, Tokyo, Japan

Osaka International Cancer Institute ( Site 1754)

Osaka, Japan

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

Tauranga, Bay of Plenty, New Zealand

New Zealand Clinical Research (Christchurch) ( Site 1509)

Christchurch, Canterbury, New Zealand

P3 Research - Palmerston North ( Site 1510)

Palmerston North, Manawatu-Wanganui, New Zealand

Dunedin Hospital ( Site 1511)

Dunedin, Otago, New Zealand

Harbour Cancer & Wellness ( Site 1508)

Auckland, New Zealand

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

Poznan, Greater Poland Voivodeship, Poland

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

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Pratia MCM Krakow ( Site 1053)

Krakow, Lesser Poland Voivodeship, Poland

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

Siedlce, Masovian Voivodeship, Poland

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

Warsaw, Masovian Voivodeship, Poland

Bialostockie Centrum Onkologii ( Site 1065)

Bialystok, Podlaskie Voivodeship, Poland

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

Gdansk, Pomeranian Voivodeship, Poland

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

Słupsk, Pomeranian Voivodeship, Poland

Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1056)

Gliwice, Silesian Voivodeship, Poland

Zachodniopomorskie Centrum Onkologii ( Site 1063)

Szczecin, West Pomeranian Voivodeship, Poland

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

Kielce, Świętokrzyskie Voivodeship, Poland

CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 1161)

Port Elizabeth, Eastern Cape, South Africa

Medical Oncology Centre of Rosebank ( Site 1160)

Johannesburg, Gauteng, South Africa

Wilgers Oncology Centre ( Site 1154)

Pretoria, Gauteng, South Africa

Curo Oncology ( Site 1158)

Pretoria, Gauteng, South Africa

LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 1152)

Pretoria, Gauteng, South Africa

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

Sandton, Gauteng, South Africa

The Oncology Centre ( Site 1157)

Durban, KwaZulu-Natal, South Africa

Abraham Oncology ( Site 1150)

Richards Bay, KwaZulu-Natal, South Africa

Cape Town Oncology Trials ( Site 1155)

Cape Town, Western Cape, South Africa

Cancercare Rondebosch Oncology-Clinical trials ( Site 1159)

Rondebosch, Western Cape, South Africa

Seoul National University Hospital-Oncology ( Site 1600)

Seoul, South Korea

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

Seoul, South Korea

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

Seoul, South Korea

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

L'Hospitalet de Llobregat, Barcelona, Spain

Onkologikoa - Instituto Oncologico de San Sebastian ( Site 1203)

Doniostia - San Sebastian, Gipuzkoa, Spain

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

Madrid, Madrid, Comunidad de, Spain

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

Málaga, Malaga, Spain

Hospital General Universitario de Valencia ( Site 1200)

Valencia, Valenciana, Comunitat, Spain

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

Seville, Spain

Länssjukhuset Ryhov-Onkologkliniken ( Site 1253)

Jönköping, Jönköping County, Sweden

Karolinska Universitetssjukhuset Solna ( Site 1252)

Stockholm, Stockholm County, Sweden

University Hospital Basel ( Site 1303)

Basel, Canton of Basel-City, Switzerland

Inselspital Bern ( Site 1301)

Bern, Canton of Bern, Switzerland

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

Geneva, Canton of Geneva, Switzerland

CHUV (centre hospitalier universitaire vaudois) ( Site 1304)

Lausanne, Canton of Vaud, Switzerland

UniversitätsSpital Zürich-Dermatology ( Site 1300)

Zürich Flughafen, Canton of Zurich, Switzerland

Ospedale Regionale Bellinzona e Valli ( Site 1308)

Bellinzona, Canton Ticino, Switzerland

Hôpital de Sion ( Site 1305)

Sion, Valais, Switzerland

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

Sankt Gallen, Switzerland

Ankara City Hospital-Medical Oncology ( Site 1357)

Çankaya, Ankara, Turkey (Türkiye)

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

Izmir, Karsiyaka, İzmir, Turkey (Türkiye)

Hacettepe Universite Hastaneleri ( Site 1363)

Ankara, Turkey (Türkiye)

Liv Hospital Ankara-Oncology ( Site 1353)

Ankara, Turkey (Türkiye)

Akdeniz Universitesi Hastanesi-Medical Oncology ( Site 1355)

Antalya, Turkey (Türkiye)

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

Istanbul, Turkey (Türkiye)

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

Mersin, Turkey (Türkiye)

Ondokuz Mayıs Universitesi-Oncology department ( Site 1359)

Samsun, Turkey (Türkiye)

Addenbrooke's Hospital ( Site 1400)

Cambridge, Cambridgeshire, United Kingdom

University College London Hospital ( Site 1405)

London, England, United Kingdom

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

London, London, City of, United Kingdom