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)

Phase 3

Active, not recruiting

• Conditions: Melanoma
• Interventions: Biological: Pembrolizumab; Biological: Pembrolizumab/Vibostolimab

• Registration Number: NCT05665595
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Detailed Description

With Amendment 4, participants will discontinue treatment with pembrolizumab/vibostolimab. No formal analysis of RFS will occur and no analysis of distant metastasis-free survival (DMFS), overall survival (OS), or change from baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) outcome measures will occur.

Study Timeline

• Study First Submitted: 2022-12-16
• Study First Submitted QC: 2022-12-16
• Study First Posted: 2022-12-27
• Study Start: 2023-01-19
• Primary Completion: 2024-03-06
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-19
• Study Completion: 2031-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1594

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pembrolizumab	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).
Pembrolizumab/Vibostolimab	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).

Primary Outcome Measures

Name	Time	Method
Recurrence-Free Survival (RFS)	Up to approximately 13 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.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score	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.
Overall Survival (OS)	Up to approximately 92 months	OS is defined as the time from randomization to death due to any cause.
Number of Participants Who Experienced at Least One Adverse Event (AE)	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.
Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score	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.
Number of Participants Who Discontinued Study Treatment Due to an AE	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.
Distant Metastasis-Free Survival (DMFS)	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.
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	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.

Trial Locations

Locations (205)

Clinica Adventista Belgrano-Oncology ( Site 0211); 🇦🇷 Caba, Argentina

West China Hospital, Sichuan University-Head and Neck Oncology ( Site 1667); 🇨🇳 Cheng Du, Sichuan, China

The Angeles Clinic and Research Institute - West Los Angeles Office ( Site 0123); 🇺🇸 Los Angeles, California, United States

UPMC Hillman Cancer Center ( Site 0135); 🇺🇸 Pittsburgh, Pennsylvania, United States

Inova Schar Cancer Institute ( Site 0103); 🇺🇸 Fairfax, Virginia, United States

Children's Hospital of Pittsburgh ( Site 0141); 🇺🇸 Pittsburgh, Pennsylvania, United States

UCLA Hematology/Oncology - Westwood (Building 100) ( Site 0131); 🇺🇸 Los Angeles, California, United States

Northwestern Memorial Hospital ( Site 0109); 🇺🇸 Chicago, Illinois, United States

University of Texas MD Anderson Cancer Center ( Site 0145); 🇺🇸 Houston, Texas, United States

Sunnybrook Research Institute ( Site 0003); 🇨🇦 Toronto, Ontario, Canada

Tata Memorial Hospital-Medical Oncology ( Site 1550); 🇮🇳 Mumbai, Maharashtra, India

Cape Town Oncology Trials ( Site 1155); 🇿🇦 Cape Town, Western Cape, South Africa

Levine Cancer Institute ( Site 0138); 🇺🇸 Charlotte, North Carolina, United States

Soroka Medical Center ( Site 0953); 🇮🇱 Be'er Sheva, Israel

Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 0653); 🇧🇪 Yvoir, Namur, Belgium

AO Santa Maria della Misericordia ( Site 1006); 🇮🇹 Perugia, Umbria, Italy

Associação Hospitalar Beneficente São Vicente de Paulo-Instituto do Câncer ( Site 0259); 🇧🇷 Passo Fundo, Rio Grande Do Sul, Brazil

The Oncology Centre ( Site 1157); 🇿🇦 Durban, Kwazulu-Natal, South Africa

Abraham Oncology ( Site 1150); 🇿🇦 Richards Bay, Kwazulu-Natal, South Africa

The Melanoma & Skin Cancer Institute ( Site 0120); 🇺🇸 Englewood, Colorado, United States

Sanford Fargo Medical Center ( Site 0127); 🇺🇸 Fargo, North Dakota, United States

One Clinical Research ( Site 1460); 🇦🇺 Nedlands, Western Australia, Australia

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

Centro Avançado de Tratamento Oncológico- CENANTRON ( Site 0256); 🇧🇷 Belo Horizonte, Minas Gerais, Brazil

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

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

Henry Ford Hospital ( Site 0133); 🇺🇸 Detroit, Michigan, United States

Vanderbilt University Medical Center ( Site 0139); 🇺🇸 Nashville, Tennessee, United States

Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0200); 🇦🇷 Buenos Aires, Caba, Argentina

Medizinische Universität Wien-Department of Dermatology ( Site 0600); 🇦🇹 Vienna, Wien, Austria

VITAZ-Medical Oncology ( Site 0654); 🇧🇪 Sint-Niklaas, Oost-Vlaanderen, Belgium

Icon Cancer Centre Hobart ( Site 1465); 🇦🇺 Hobart, Tasmania, Australia

Fourth Hospital of Hebei Medical University ( Site 1669); 🇨🇳 Shijiazhuang, Hebei, China

The First Affiliated Hospital of Nanchang University ( Site 1652); 🇨🇳 Nanchang, Jiangxi, China

Institut de Cancérologie de l'Ouest-Oncologie Médicale ( Site 0706); 🇫🇷 Saint Herblain, Loire-Atlantique, France

Gustave Roussy-Dermatologie ( Site 0713); 🇫🇷 Villejuif, Val-de-Marne, France

Universitaetsklinikum Heidelberg ( Site 0765); 🇩🇪 Heidelberg, Baden-Wurttemberg, Germany

Universitaetsklinikum Erlangen-Hautklinik ( Site 0750); 🇩🇪 Erlangen, Bayern, Germany

Klinik und Poliklinik für Dermatologie und Allergologie-Dermato-oncology ( Site 0757); 🇩🇪 München, Bayern, Germany

Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Dermatologie ( Site 0766); 🇩🇪 Dresden, Sachsen, Germany

Harbour Cancer & Wellness ( Site 1508); 🇳🇿 Auckland, New Zealand

Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1058); 🇵🇱 Siedlce, Mazowieckie, Poland

Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 1054); 🇵🇱 Kielce, Swietokrzyskie, Poland

Inselspital Bern ( Site 1301); 🇨🇭 Bern, Berne, Switzerland

Cantonal Hospital St.Gallen-Oncology & Hematology ( Site 1306); 🇨🇭 Sankt Gallen, Switzerland

Ankara City Hospital-Medical Oncology ( Site 1357); 🇹🇷 Cankaya, Ankara, Turkey

CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 1161); 🇿🇦 Port Elizabeth, Eastern Cape, South Africa

Comprehensive Cancer Centers of Nevada ( Site 0142); 🇺🇸 Las Vegas, Nevada, United States

Instituto Alexander Fleming-Alexander Fleming ( Site 0209); 🇦🇷 Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Medizinische Universität Graz-Innere Medizin Klin. Abt. Onkologie ( Site 0601); 🇦🇹 Graz, Steiermark, Austria

Medizinische Universitaet Innsbruck-Univ Klinik für Dermatologie, Venerologie und Allergologie ( Sit; 🇦🇹 Innsbruck, Tirol, Austria

Georgetown University Medical Center ( Site 0144); 🇺🇸 Washington, District of Columbia, United States

The West Clinic, PLLC dba West Cancer Center ( Site 0119); 🇺🇸 Germantown, Tennessee, United States

Instituto de Oncología de Rosario ( Site 0206); 🇦🇷 Rosario, Santa Fe, Argentina

Sanatorio Finochietto ( Site 0212); 🇦🇷 Buenos Aires, Argentina

St. Jude Children's Research Hospital ( Site 0106); 🇺🇸 Memphis, Tennessee, United States

Sanford Cancer Center ( Site 0125); 🇺🇸 Sioux Falls, South Dakota, United States

University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0110); 🇺🇸 Miami, Florida, United States

Universitätsklinikum St. Pölten-Department of Dermatology ( Site 0606); 🇦🇹 St. Polten, Niederosterreich, Austria

Ordensklinikum Linz GmbH Elisabethinen-Dermatologie ( Site 0602); 🇦🇹 Linz, Oberosterreich, Austria

GZA Ziekenhuizen campus Sint-Augustinus ( Site 0655); 🇧🇪 Wilrijk, Antwerpen, Belgium

FALP-UIDO ( Site 0303); 🇨🇱 Santiago, Region M. De Santiago, Chile

Royal Adelaide Hospital-RAH Cancer Centre ( Site 1457); 🇦🇺 Adelaide, South Australia, Australia

Bradford Hill Norte ( Site 0308); 🇨🇱 Antofagasta, Chile

The Third Hospital of Zhengzhou-Oncology ( Site 1653); 🇨🇳 Zhengzhou Shi, Henan, China

Centre Hospitalier de Valence-Service de Dermatologie ( Site 0702); 🇫🇷 Valence, Drome, France

Universitätsmedizin Mannheim ( Site 0751); 🇩🇪 Mannheim, Baden-Wurttemberg, Germany

Sheba Medical Center-ONCOLOGY ( Site 0950); 🇮🇱 Ramat Gan, Israel

Azienda Ospedaliero Universitaria ( Site 1002); 🇮🇹 Modena, Italy

Nagoya University Hospital ( Site 1753); 🇯🇵 Nagoya-Shi, Aichi, Japan

Johannes Wesling Klinikum Minden-Skin Cancer Center Minden ( Site 0759); 🇩🇪 Minden, Nordrhein-Westfalen, Germany

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

Emek Medical Center-oncology ( Site 0952); 🇮🇱 Afula, Israel

Azienda Ospedaliero Universitaria Senese ( Site 1005); 🇮🇹 Siena, Toscana, Italy

Niigata Cancer Center Hospital ( Site 1751); 🇯🇵 Niigata-shi, Niigata, Japan

Shizuoka Cancer Center ( Site 1752); 🇯🇵 Nagaizumi-cho,Sunto-gun, Shizuoka, Japan

The Ottawa Hospital - General Campus-The Ottawa Hospital Cancer Centre ( Site 0004); 🇨🇦 Ottawa, Ontario, Canada

Tasman Oncology Research ( Site 1456); 🇦🇺 Southport, Queensland, Australia

Universitaetsklinikum Hamburg-Eppendorf ( Site 0752); 🇩🇪 Hamburg, Germany

Beijing Ji Shui Tan Hospital ( Site 1657); 🇨🇳 Beijing, Beijing, China

Fujian Provincial Cancer Hospital ( Site 1659); 🇨🇳 Fuzhou, Fujian, China

Guangxi Medical University Affiliated Tumor Hospital ( Site 1668); 🇨🇳 Nanning, Guangxi, China

The Second Xiangya Hospital of Central South University-Oncology ( Site 1673); 🇨🇳 Changsha, Hunan, China

The First Hospital of Jilin University-Oncology ( Site 1665); 🇨🇳 Changchun, Jilin, China

Mediservis del Tolima IPS S.A.S ( Site 0357); 🇨🇴 Ibague, Tolima, Colombia

Hopital Claude Huriez - CHU de Lille-Clinique de Dermatologie ( Site 0700); 🇫🇷 Lille, Nord-Pas-de-Calais, France

Beaumont Hospital, Dublin-Cancer Clinical Trials & Research Unit ( Site 0902); 🇮🇪 Dublin, Ireland

Centre Hospitalier de Pau ( Site 0708); 🇫🇷 Pau, Pyrenees-Atlantiques, France

Princess Margaret Cancer Centre ( Site 0006); 🇨🇦 Toronto, Ontario, Canada

Seoul National University Hospital-Oncology ( Site 1600); 🇰🇷 Seoul, Korea, Republic of

Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0711); 🇫🇷 Paris, France

Charité Universitaetsmedizin Berlin - Campus Mitte-Hauttumorcentrum Charité (HTCC) ( Site 0756); 🇩🇪 Berlin, Germany

Cancercare Rondebosch Oncology-Clinical trials ( Site 1159); 🇿🇦 Rondebosch, Western Cape, South Africa

Ospedale Regionale Bellinzona e Valli ( Site 1308); 🇨🇭 Bellinzona, Ticino, Switzerland

Oncocentro Valdivia ( Site 0307); 🇨🇱 Valdivia, Los Rios, Chile

Instituto Tumori Giovanni Paolo II ( Site 1003); 🇮🇹 Bari, Puglia, Italy

A.O.U. Policlinico Paolo Giaccone-Depatment of Discipline Chirurgiche, Oncologiche e Stomatologiche; 🇮🇹 Palermo, Sicilia, Italy

Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1001); 🇮🇹 Napoli, Italy

Sun Yat-sen University Cancer Center-melanoma ( Site 1655); 🇨🇳 Guangzhou, Guangdong, China

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 1004); 🇮🇹 Meldola, Emilia-Romagna, Italy

Wuhan Union Hospital Cancer Center-Cancer Center ( Site 1664); 🇨🇳 Wuhan, Hubei, China

Zhejiang Cancer Hospital-Oncology ( Site 1661); 🇨🇳 Hangzhou, Zhejiang, China

Sapporo Medical University Hospital ( Site 1755); 🇯🇵 Sapporo, Hokkaido, Japan

P3 Research - Palmerston North ( Site 1510); 🇳🇿 Palmerston North, Manawatu-Wanganui, New Zealand

Uniwersyteckie Centrum Kliniczne-Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólnej ( Site; 🇵🇱 Gdańsk, Pomorskie, Poland

Onkologikoa - Instituto Oncologico de San Sebastian ( Site 1203); 🇪🇸 Doniostia - San Sebastian, Gipuzkoa, Spain

Liv Hospital Ankara-Oncology ( Site 1353); 🇹🇷 Ankara, Turkey

National Cancer Center Hospital ( Site 1750); 🇯🇵 Chuo-ku, Tokyo, Japan

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (; 🇵🇱 Warszawa, Mazowieckie, Poland

Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Słupsku-Oncologii, Chemioterapii ( Site 1064); 🇵🇱 Słupsk, Pomorskie, Poland

Curo Oncology ( Site 1158); 🇿🇦 Pretoria, Gauteng, South Africa

CHUV (centre hospitalier universitaire vaudois) ( Site 1304); 🇨🇭 Lausanne, Vaud, Switzerland

Szpital Kliniczny im. H. Swiecickiego nr 2-Oddział Kliniczny Onkologii Klinicznej i Doświadczalnej (; 🇵🇱 Poznan, Wielkopolskie, Poland

Hôpital de Sion ( Site 1305); 🇨🇭 Sion, Wallis, Switzerland

Mersin Sehir Eğitim ve Araştırma Hastanesi-Oncology ( Site 1361); 🇹🇷 Mersin, Turkey

University College London Hospital ( Site 1405); 🇬🇧 London, England, United Kingdom

Ondokuz Mayıs Universitesi-Oncology department ( Site 1359); 🇹🇷 Samsun, Turkey

Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1205); 🇪🇸 Sevilla, Spain

Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center ( Site 0124); 🇺🇸 Tampa, Florida, United States

Moores Cancer Center ( Site 0116); 🇺🇸 La Jolla, California, United States

University of Iowa-Holden Comprehensive Cancer Center ( Site 0107); 🇺🇸 Iowa City, Iowa, United States

Advocate Medical Group-Oncology ( Site 0102); 🇺🇸 Park Ridge, Illinois, United States

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

Weill Cornell Medical College ( Site 0115); 🇺🇸 New York, New York, United States

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

Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si; 🇦🇺 Brisbane, Queensland, Australia

Melanoma Institute Australia-Clinical Trials Unit ( Site 1450); 🇦🇺 Wollstonecraft, New South Wales, Australia

Cairns Hospital-Clinical Research Unit ( Site 1458); 🇦🇺 Cairns, Queensland, Australia

Gallipoli Medical Research Ltd-GMRF CTU ( Site 1451); 🇦🇺 Greenslopes, Queensland, Australia

Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 1455); 🇦🇺 Melbourne, Victoria, Australia

Uniklinikum Salzburg-Department of Dermatology and Allergology ( Site 0604); 🇦🇹 Salzburg, Austria

Jessa Ziekenhuis ( Site 0656); 🇧🇪 Hasselt, Limburg, Belgium

Cliniques universitaires Saint-Luc ( Site 0652); 🇧🇪 Brussels, Bruxelles-Capitale, Region De, Belgium

UZ Leuven-General Medical Oncology ( Site 0650); 🇧🇪 Leuven, Vlaams-Brabant, Belgium

ANIMI - Unidade de Tratamento Oncologico ( Site 0255); 🇧🇷 Lages, Santa Catarina, Brazil

Hospital de Cancer de Londrina-Clinical Research Unit ( Site 0252); 🇧🇷 Londrina, Parana, Brazil

CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia ( Site 0262); 🇧🇷 Santo André, Sao Paulo, Brazil

A. C. Camargo Cancer Center ( Site 0258); 🇧🇷 Sao Paulo, Brazil

ONCOCENTRO APYS-ACEREY ( Site 0300); 🇨🇱 Viña del Mar, Valparaiso, Chile

Clínica UC San Carlos de Apoquindo ( Site 0305); 🇨🇱 Santiago, Region M. De Santiago, Chile

Oncovida ( Site 0304); 🇨🇱 Santiago, Region M. De Santiago, Chile

Bradfordhill-Clinical Area ( Site 0302); 🇨🇱 Santiago, Region M. De Santiago, Chile

Beijing Cancer hospital-Renal carcinoma and melanoma ( Site 1650); 🇨🇳 Beijing, Beijing, China

Chongqing University Cancer Hospital ( Site 1651); 🇨🇳 Chongqing, Chongqing, 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

Fudan University Shanghai Cancer Center ( Site 1658); 🇨🇳 Shanghai, Shanghai, China

Xinjiang Medical University Cancer Hospital - Urumqi-Bone and Soft Tissue Department ( Site 1674); 🇨🇳 Urumqi, Xinjiang, China

Shanxi Bethune Hospital ( Site 1660); 🇨🇳 Taiyuan, Shanxi, China

Tianjin Medical University Cancer Institute & Hospital-Biotherapy ( Site 1671); 🇨🇳 Tianjin, Tianjin, China

Yunnan Province Cancer Hospital-Biotherapy Center ( Site 1666); 🇨🇳 Kunming, Yunnan, China

Instituto de Cancerología ( Site 0356); 🇨🇴 Medellin, Antioquia, Colombia

Fundación Valle del Lili ( Site 0352); 🇨🇴 Cali, Valle Del Cauca, Colombia

Fundación Colombiana de Cancerología Clínica Vida ( Site 0355); 🇨🇴 Medellin, Antioquia, Colombia

Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0358); 🇨🇴 Bogota, Distrito Capital De Bogota, Colombia

Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu-Onco-Dermatology ( Site 0707); 🇫🇷 Nantes, Loire-Atlantique, France

Assistance Publique Hôpitaux de Marseille - Hôpital de la Ti-Service de Dermatologie et Cancérologi; 🇫🇷 Marseille, Provence-Alpes-Cote-d Azur, France

centre hospitalier lyon sud-Service de dermatologie ( Site 0714); 🇫🇷 Pierre-Bénite, Rhone, France

Medizinische Hochschule Hannover ( Site 0758); 🇩🇪 Hannover, Niedersachsen, Germany

Elbe Kliniken Stade-Buxtehude, Klinikum Buxtehude-Dermatologisches Zentrum ( Site 0754); 🇩🇪 Buxtehude, Niedersachsen, Germany

Universitaetsklinikum Essen-Klinik für Dermatologie, Venerologie und Allergologie ( Site 0761); 🇩🇪 Essen, Nordrhein-Westfalen, Germany

Universitaetsklinikum Schleswig-Holstein Campus Kiel-Hautklinik ( Site 0767); 🇩🇪 Kiel, Schleswig-Holstein, Germany

Universitätsklinikum Leipzig ( Site 0762); 🇩🇪 Leipzig, Sachsen, Germany

Artemis hospital ( Site 1551); 🇮🇳 Gurugram, Haryana, India

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

Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1000); 🇮🇹 Milan, Lombardia, Italy

Istituto Europeo di Oncologia IRCCS ( Site 1008); 🇮🇹 Milano, Italy

Osaka International Cancer Institute ( Site 1754); 🇯🇵 Osaka, Japan

Samsung Medical Center-Division of Hematology/Oncology ( Site 1602); 🇰🇷 Seoul, Korea, Republic of

Tauranga Hospital-Bay of Plenty Clinical Trials Unit ( Site 1501); 🇳🇿 Tauranga, Bay Of Plenty, New Zealand

Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1601); 🇰🇷 Seoul, Korea, Republic of

New Zealand Clinical Research (Christchurch) ( Site 1509); 🇳🇿 Christchurch, Canterbury, New Zealand

Dunedin Hospital ( Site 1511); 🇳🇿 Dunedin, Otago, New Zealand

Pratia MCM Krakow ( Site 1053); 🇵🇱 Krakow, Malopolskie, Poland

Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1061); 🇵🇱 Bydgoszcz, Kujawsko-pomorskie, Poland

Bialostockie Centrum Onkologii ( Site 1065); 🇵🇱 Bialystok, Podlaskie, Poland

Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1056); 🇵🇱 Gliwice, Slaskie, Poland

Zachodniopomorskie Centrum Onkologii ( Site 1063); 🇵🇱 Szczecin, Zachodniopomorskie, Poland

Medical Oncology Centre of Rosebank ( Site 1160); 🇿🇦 Johannesburg, Gauteng, South Africa

Wilgers Oncology Centre ( Site 1154); 🇿🇦 Pretoria, Gauteng, South Africa

Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 1151); 🇿🇦 Sandton, Gauteng, South Africa

LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 1152); 🇿🇦 Pretoria, Gauteng, South Africa

Institut Català d'Oncologia - L'Hospitalet ( Site 1202); 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Spain

H.R.U Málaga - Hospital General-Oncology ( Site 1201); 🇪🇸 Málaga, Malaga, Spain

Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1204); 🇪🇸 Madrid, Madrid, Comunidad De, Spain

Hospital General Universitario de Valencia ( Site 1200); 🇪🇸 Valencia, Valenciana, Comunitat, Spain

Länssjukhuset Ryhov-Onkologkliniken ( Site 1253); 🇸🇪 Jönköping, Jonkopings Lan, Sweden

Karolinska Universitetssjukhuset Solna ( Site 1252); 🇸🇪 Stockholm, Stockholms Lan, Sweden

University Hospital Basel ( Site 1303); 🇨🇭 Basel, Basel-Stadt, Switzerland

Hôpitaux Universitaires de Genève (HUG)-Oncology ( Site 1307); 🇨🇭 Genève, Geneve, Switzerland

UniversitätsSpital Zürich-Dermatology ( Site 1300); 🇨🇭 Zürich Flughafen, Zurich, Switzerland

Hacettepe Universite Hastaneleri ( Site 1363); 🇹🇷 Ankara, Turkey

Akdeniz Universitesi Hastanesi-Medical Oncology ( Site 1355); 🇹🇷 Antalya, Turkey

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

Addenbrooke's Hospital ( Site 1400); 🇬🇧 Cambridge, Cambridgeshire, United Kingdom

Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 1401); 🇬🇧 London, London, City Of, United Kingdom

University of Wisconsin Hospital and Clinics ( Site 0108); 🇺🇸 Madison, Wisconsin, United States