Clinical trial NCT05665595: 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)
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Melanoma
Keywords: Programmed Cell Death-1 (PD1, PD-1)
T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domains (TIGIT)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2022-12-27
Enrollment: 1594
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

The protocol-specified futility analysis of the primary outcome measure was completed with a data cut-off of 06-Mar-2024 (Primary Completion Date) and served as the final analysis of the primary outcome measure. Per protocol, 192 participants enrolled after the primary completion date and will be analyzed in the End of Trial analysis.

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

Primary outcomes:
measure: Recurrence-Free Survival (RFS)
timeFrame: Up to approximately 13 months
Secondary outcomes:
measure: Distant Metastasis-Free Survival (DMFS)
timeFrame: Up to approximately 98 months
measure: Overall Survival (OS)
timeFrame: Up to approximately 98 months
measure: Number of Participants Who Experienced at Least One Adverse Event (AE)
timeFrame: Up to approximately 98 months
measure: Number of Participants Who Discontinued Study Treatment Due to an AE
timeFrame: Up to approximately 98 months
measure: 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
timeFrame: Baseline and up to approximately 98 months
measure: Change From Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score
timeFrame: Baseline and up to approximately 98 months
measure: Change From Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score
timeFrame: Baseline and up to approximately 98 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Moores Cancer Center ( Site 0116)
state: California
city: Los Angeles
country: United States
facility: The Angeles Clinic and Research Institute - West Los Angeles Office ( Site 0123)
state: California
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology - Westwood (Building 100) ( Site 0131)
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center - Pacific Campus ( Site 0111)
state: California
city: San Francisco
country: United States
facility: UCSF Medical Center at Mission Bay ( Site 0130)
state: California
city: Englewood
country: United States
facility: The Melanoma & Skin Cancer Institute ( Site 0120)
state: Colorado
city: Washington
country: United States
facility: Georgetown University Medical Center ( Site 0144)
state: District of Columbia
city: Miami
country: United States
facility: University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0110)
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center ( Site 0124)
state: Florida
city: Chicago
country: United States
facility: Northwestern Memorial Hospital ( Site 0109)
state: Illinois
city: Park Ridge
country: United States
facility: Advocate Medical Group-Oncology ( Site 0102)
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa-Holden Comprehensive Cancer Center ( Site 0107)
state: Iowa
city: Detroit
country: United States
facility: Henry Ford Hospital ( Site 0133)
state: Michigan
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada ( Site 0142)
state: Nevada
city: Lake Success
country: United States
facility: R.J. Zuckerberg Cancer Center-Medical Oncology ( Site 0132)
state: New York
city: Mineola
country: United States
facility: Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0146)
state: New York
city: New York
country: United States
facility: Laura and Isaac Perlmutter Cancer Center-Hematology and Oncology ( Site 0113)
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai ( Site 0118)
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College ( Site 0115)
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Institute ( Site 0138)
state: North Carolina
city: Fargo
country: United States
facility: Sanford Fargo Medical Center ( Site 0127)
state: North Dakota
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh ( Site 0141)
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center ( Site 0135)
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Sanford Cancer Center ( Site 0125)
state: South Dakota
city: Germantown
country: United States
facility: The West Clinic, PLLC dba West Cancer Center ( Site 0119)
state: Tennessee
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital ( Site 0106)
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center ( Site 0139)
state: Tennessee
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center ( Site 0145)
state: Texas
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute ( Site 0103)
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics ( Site 0108)
state: Wisconsin
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Centro de Investigaciones Metabólicas (CINME)-Oncology ( Site 0204)
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Instituto Alexander Fleming-Alexander Fleming ( Site 0209)
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0200)
state: Caba
city: Rosario
country: Argentina
facility: Instituto de Oncología de Rosario ( Site 0206)
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Sanatorio Finochietto ( Site 0212)
city: Caba
country: Argentina
facility: Clinica Adventista Belgrano-Oncology ( Site 0211)
city: Blacktown
country: Australia
facility: Blacktown Hospital-Blacktown Cancer and Haematology Centre - Medical Oncology ( Site 1464)
state: New South Wales
city: Waratah
country: Australia
facility: Calvary Mater Newcastle-Medical Oncology ( Site 1462)
state: New South Wales
city: Wollstonecraft
country: Australia
facility: Melanoma Institute Australia-Clinical Trials Unit ( Site 1450)
state: New South Wales
city: Brisbane
country: Australia
facility: Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si
state: Queensland
city: Cairns
country: Australia
facility: Cairns Hospital-Clinical Research Unit ( Site 1458)
state: Queensland
city: Greenslopes
country: Australia
facility: Gallipoli Medical Research Ltd-GMRF CTU ( Site 1451)
state: Queensland
city: Southport
country: Australia
facility: Tasman Oncology Research ( Site 1456)
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital-RAH Cancer Centre ( Site 1457)
state: South Australia
city: Hobart
country: Australia
facility: Icon Cancer Centre Hobart ( Site 1465)
state: Tasmania
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 1455)
state: Victoria
city: Nedlands
country: Australia
facility: One Clinical Research ( Site 1460)
state: Western Australia
city: St. Polten
country: Austria
facility: Universitätsklinikum St. Pölten-Department of Dermatology ( Site 0606)
state: Niederosterreich
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen-Dermatologie ( Site 0602)
state: Oberosterreich
city: Graz
country: Austria
facility: Medizinische Universität Graz-Innere Medizin Klin. Abt. Onkologie ( Site 0601)
state: Steiermark
city: Innsbruck
country: Austria
facility: Medizinische Universitaet Innsbruck-Univ Klinik für Dermatologie, Venerologie und Allergologie ( Sit
state: Tirol
city: Vienna
country: Austria
facility: Medizinische Universität Wien-Department of Dermatology ( Site 0600)
state: Wien
city: Salzburg
country: Austria
facility: Uniklinikum Salzburg-Department of Dermatology and Allergology ( Site 0604)
city: Wilrijk
country: Belgium
facility: GZA Ziekenhuizen campus Sint-Augustinus ( Site 0655)
state: Antwerpen
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc ( Site 0652)
state: Bruxelles-Capitale, Region De
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis ( Site 0656)
state: Limburg
city: Yvoir
country: Belgium
facility: Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 0653)
state: Namur
city: Sint-Niklaas
country: Belgium
facility: VITAZ-Medical Oncology ( Site 0654)
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: UZ Leuven-General Medical Oncology ( Site 0650)
state: Vlaams-Brabant
city: Belo Horizonte
country: Brazil
facility: Centro Avançado de Tratamento Oncológico- CENANTRON ( Site 0256)
state: Minas Gerais
city: Londrina
country: Brazil
facility: Hospital de Cancer de Londrina-Clinical Research Unit ( Site 0252)
state: Parana
city: Passo Fundo
country: Brazil
facility: Associação Hospitalar Beneficente São Vicente de Paulo-Instituto do Câncer ( Site 0259)
state: Rio Grande Do Sul
city: Lages
country: Brazil
facility: ANIMI - Unidade de Tratamento Oncologico ( Site 0255)
state: Santa Catarina
city: Santo André
country: Brazil
facility: CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia ( Site 0262)
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: A. C. Camargo Cancer Center ( Site 0258)
city: Ottawa
country: Canada
facility: The Ottawa Hospital - General Campus-The Ottawa Hospital Cancer Centre ( Site 0004)
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Research Institute ( Site 0003)
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre ( Site 0006)
state: Ontario
city: Valdivia
country: Chile
facility: Oncocentro Valdivia ( Site 0307)
state: Los Rios
city: Santiago
country: Chile
facility: FALP-UIDO ( Site 0303)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Oncovida ( Site 0304)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Clínica UC San Carlos de Apoquindo ( Site 0305)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Bradfordhill-Clinical Area ( Site 0302)
state: Region M. De Santiago
city: Viña del Mar
country: Chile
facility: ONCOCENTRO APYS-ACEREY ( Site 0300)
state: Valparaiso
city: Antofagasta
country: Chile
facility: Bradford Hill Norte ( Site 0308)
city: Beijing
country: China
facility: Beijing Ji Shui Tan Hospital ( Site 1657)
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer hospital-Renal carcinoma and melanoma ( Site 1650)
state: Beijing
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital ( Site 1651)
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Provincial Cancer Hospital ( Site 1659)
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center-melanoma ( Site 1655)
state: Guangdong
city: Nanning
country: China
facility: Guangxi Medical University Affiliated Tumor Hospital ( Site 1668)
state: Guangxi
city: Shijiazhuang
country: China
facility: Fourth Hospital of Hebei Medical University ( Site 1669)
state: Hebei
city: Zhengzhou Shi
country: China
facility: The Third Hospital of Zhengzhou-Oncology ( Site 1653)
state: Henan
city: Wuhan
country: China
facility: Wuhan Union Hospital Cancer Center-Cancer Center ( Site 1664)
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University-Oncology ( Site 1673)
state: Hunan
city: NanJing
country: China
facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology (
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province Hospital-Oncology Department ( Site 1663)
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University ( Site 1652)
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University-Oncology ( Site 1665)
state: Jilin
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center ( Site 1658)
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital ( Site 1660)
state: Shanxi
city: Cheng Du
country: China
facility: West China Hospital, Sichuan University-Head and Neck Oncology ( Site 1667)
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital-Biotherapy ( Site 1671)
state: Tianjin
city: Urumqi
country: China
facility: Xinjiang Medical University Cancer Hospital - Urumqi-Bone and Soft Tissue Department ( Site 1674)
state: Xinjiang
city: Kunming
country: China
facility: Yunnan Province Cancer Hospital-Biotherapy Center ( Site 1666)
state: Yunnan
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital-Oncology ( Site 1661)
state: Zhejiang
city: Medellin
country: Colombia
facility: Instituto de Cancerología ( Site 0356)
state: Antioquia
city: Medellin
country: Colombia
facility: Fundación Colombiana de Cancerología Clínica Vida ( Site 0355)
state: Antioquia
city: Bogota
country: Colombia
facility: Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0358)
state: Distrito Capital De Bogota
city: Ibague
country: Colombia
facility: Mediservis del Tolima IPS S.A.S ( Site 0357)
state: Tolima
city: Cali
country: Colombia
facility: Fundación Valle del Lili ( Site 0352)
state: Valle Del Cauca
city: Valence
country: France
facility: Centre Hospitalier de Valence-Service de Dermatologie ( Site 0702)
state: Drome
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu-Onco-Dermatology ( Site 0707)
state: Loire-Atlantique
city: Saint Herblain
country: France
facility: Institut de Cancérologie de l'Ouest-Oncologie Médicale ( Site 0706)
state: Loire-Atlantique
city: Lille
country: France
facility: Hopital Claude Huriez - CHU de Lille-Clinique de Dermatologie ( Site 0700)
state: Nord-Pas-de-Calais
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille - Hôpital de la Ti-Service de Dermatologie et Cancérologi
state: Provence-Alpes-Cote-d Azur
city: Pau
country: France
facility: Centre Hospitalier de Pau ( Site 0708)
state: Pyrenees-Atlantiques
city: Pierre-Bénite
country: France
facility: centre hospitalier lyon sud-Service de dermatologie ( Site 0714)
state: Rhone
city: Villejuif
country: France
facility: Gustave Roussy-Dermatologie ( Site 0713)
state: Val-de-Marne
city: Paris
country: France
facility: Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0711)
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg ( Site 0765)
state: Baden-Wurttemberg
city: Mannheim
country: Germany
facility: Universitätsmedizin Mannheim ( Site 0751)
state: Baden-Wurttemberg
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen-Hautklinik ( Site 0750)
state: Bayern
city: München
country: Germany
facility: Klinik und Poliklinik für Dermatologie und Allergologie-Dermato-oncology ( Site 0757)
state: Bayern
city: Buxtehude
country: Germany
facility: Elbe Kliniken Stade-Buxtehude, Klinikum Buxtehude-Dermatologisches Zentrum ( Site 0754)
state: Niedersachsen
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover ( Site 0758)
state: Niedersachsen
city: Essen
country: Germany
facility: Universitaetsklinikum Essen-Klinik für Dermatologie, Venerologie und Allergologie ( Site 0761)
state: Nordrhein-Westfalen
city: Minden
country: Germany
facility: Johannes Wesling Klinikum Minden-Skin Cancer Center Minden ( Site 0759)
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Dermatologie ( Site 0766)
state: Sachsen
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig ( Site 0762)
state: Sachsen
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel-Hautklinik ( Site 0767)
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Charité Universitaetsmedizin Berlin - Campus Mitte-Hauttumorcentrum Charité (HTCC) ( Site 0756)
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf ( Site 0752)
city: New Delhi
country: India
facility: All India Institute of Medical Sciences-Medical oncology ( Site 1552)
state: Delhi
city: Gurugram
country: India
facility: Artemis hospital ( Site 1551)
state: Haryana
city: Mumbai
country: India
facility: Tata Memorial Hospital-Medical Oncology ( Site 1550)
state: Maharashtra
city: Dublin
country: Ireland
facility: St. James's Hospital-Cancer clinical trials office ( Site 0900)
city: Dublin
country: Ireland
facility: Beaumont Hospital, Dublin-Cancer Clinical Trials & Research Unit ( Site 0902)
city: Afula
country: Israel
facility: Emek Medical Center-oncology ( Site 0952)
city: Be'er Sheva
country: Israel
facility: Soroka Medical Center ( Site 0953)
city: Haifa
country: Israel
facility: Rambam Health Care Campus-Oncology Division ( Site 0955)
city: Jerusalem
country: Israel
facility: Hadassah Medical Center ( Site 0951)
city: Petah Tikva
country: Israel
facility: Rabin Medical Center-Oncology ( Site 0954)
city: Ramat Gan
country: Israel
facility: Sheba Medical Center-ONCOLOGY ( Site 0950)
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 1004)
state: Emilia-Romagna
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1000)
state: Lombardia
city: Bari
country: Italy
facility: Instituto Tumori Giovanni Paolo II ( Site 1003)
state: Puglia
city: Palermo
country: Italy
facility: A.O.U. Policlinico Paolo Giaccone-Depatment of Discipline Chirurgiche, Oncologiche e Stomatologiche
state: Sicilia
city: Siena
country: Italy
facility: Azienda Ospedaliero Universitaria Senese ( Site 1005)
state: Toscana
city: Perugia
country: Italy
facility: AO Santa Maria della Misericordia ( Site 1006)
state: Umbria
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia IRCCS ( Site 1008)
city: Modena
country: Italy
facility: Azienda Ospedaliero Universitaria ( Site 1002)
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1001)
city: Nagoya-Shi
country: Japan
facility: Nagoya University Hospital ( Site 1753)
state: Aichi
city: Sapporo
country: Japan
facility: Sapporo Medical University Hospital ( Site 1755)
state: Hokkaido
city: Niigata-shi
country: Japan
facility: Niigata Cancer Center Hospital ( Site 1751)
state: Niigata
city: Nagaizumi-cho,Sunto-gun
country: Japan
facility: Shizuoka Cancer Center ( Site 1752)
state: Shizuoka
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital ( Site 1750)
state: Tokyo
city: Osaka
country: Japan
facility: Osaka International Cancer Institute ( Site 1754)
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital-Oncology ( Site 1600)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1601)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center-Division of Hematology/Oncology ( Site 1602)
city: Tauranga
country: New Zealand
facility: Tauranga Hospital-Bay of Plenty Clinical Trials Unit ( Site 1501)
state: Bay Of Plenty
city: Christchurch
country: New Zealand
facility: New Zealand Clinical Research (Christchurch) ( Site 1509)
state: Canterbury
city: Palmerston North
country: New Zealand
facility: P3 Research - Palmerston North ( Site 1510)
state: Manawatu-Wanganui
city: Dunedin
country: New Zealand
facility: Dunedin Hospital ( Site 1511)
state: Otago
city: Auckland
country: New Zealand
facility: Harbour Cancer & Wellness ( Site 1508)
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1061)
state: Kujawsko-pomorskie
city: Krakow
country: Poland
facility: Pratia MCM Krakow ( Site 1053)
state: Malopolskie
city: Siedlce
country: Poland
facility: Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1058)
state: Mazowieckie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
state: Mazowieckie
city: Bialystok
country: Poland
facility: Bialostockie Centrum Onkologii ( Site 1065)
state: Podlaskie
city: Gdańsk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne-Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólnej ( Site
state: Pomorskie
city: Słupsk
country: Poland
facility: Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Słupsku-Oncologii, Chemioterapii ( Site 1064)
state: Pomorskie
city: Gliwice
country: Poland
facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1056)
state: Slaskie
city: Kielce
country: Poland
facility: Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 1054)
state: Swietokrzyskie
city: Poznan
country: Poland
facility: Szpital Kliniczny im. H. Swiecickiego nr 2-Oddział Kliniczny Onkologii Klinicznej i Doświadczalnej (
state: Wielkopolskie
city: Szczecin
country: Poland
facility: Zachodniopomorskie Centrum Onkologii ( Site 1063)
state: Zachodniopomorskie
city: Port Elizabeth
country: South Africa
facility: CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 1161)
state: Eastern Cape
city: Johannesburg
country: South Africa
facility: Medical Oncology Centre of Rosebank ( Site 1160)
state: Gauteng
city: Pretoria
country: South Africa
facility: Wilgers Oncology Centre ( Site 1154)
state: Gauteng
city: Pretoria
country: South Africa
facility: Curo Oncology ( Site 1158)
state: Gauteng
city: Pretoria
country: South Africa
facility: LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 1152)
state: Gauteng
city: Sandton
country: South Africa
facility: Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 1151)
state: Gauteng
city: Durban
country: South Africa
facility: The Oncology Centre ( Site 1157)
state: Kwazulu-Natal
city: Richards Bay
country: South Africa
facility: Abraham Oncology ( Site 1150)
state: Kwazulu-Natal
city: Cape Town
country: South Africa
facility: Cape Town Oncology Trials ( Site 1155)
state: Western Cape
city: Rondebosch
country: South Africa
facility: Cancercare Rondebosch Oncology-Clinical trials ( Site 1159)
state: Western Cape
city: L'Hospitalet de Llobregat
country: Spain
facility: Institut Català d'Oncologia - L'Hospitalet ( Site 1202)
state: Barcelona
city: Doniostia - San Sebastian
country: Spain
facility: Onkologikoa - Instituto Oncologico de San Sebastian ( Site 1203)
state: Gipuzkoa
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1204)
state: Madrid, Comunidad De
city: Málaga
country: Spain
facility: H.R.U Málaga - Hospital General-Oncology ( Site 1201)
state: Malaga
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia ( Site 1200)
state: Valenciana, Comunitat
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1205)
city: Jönköping
country: Sweden
facility: Länssjukhuset Ryhov-Onkologkliniken ( Site 1253)
state: Jonkopings Lan
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Solna ( Site 1252)
state: Stockholms Lan
city: Basel
country: Switzerland
facility: University Hospital Basel ( Site 1303)
state: Basel-Stadt
city: Bern
country: Switzerland
facility: Inselspital Bern ( Site 1301)
state: Berne
city: Genève
country: Switzerland
facility: Hôpitaux Universitaires de Genève (HUG)-Oncology ( Site 1307)
state: Geneve
city: Bellinzona
country: Switzerland
facility: Ospedale Regionale Bellinzona e Valli ( Site 1308)
state: Ticino
city: Lausanne
country: Switzerland
facility: CHUV (centre hospitalier universitaire vaudois) ( Site 1304)
state: Vaud
city: Sion
country: Switzerland
facility: Hôpital de Sion ( Site 1305)
state: Wallis
city: Zürich Flughafen
country: Switzerland
facility: UniversitätsSpital Zürich-Dermatology ( Site 1300)
state: Zurich
city: Sankt Gallen
country: Switzerland
facility: Cantonal Hospital St.Gallen-Oncology & Hematology ( Site 1306)
city: Cankaya
country: Turkey
facility: Ankara City Hospital-Medical Oncology ( Site 1357)
state: Ankara
city: Izmir, Karsiyaka
country: Turkey
facility: I.E.U. Medical Point Hastanesi-Oncology ( Site 1360)
state: Izmir
city: Ankara
country: Turkey
facility: Hacettepe Universite Hastaneleri ( Site 1363)
city: Ankara
country: Turkey
facility: Liv Hospital Ankara-Oncology ( Site 1353)
city: Antalya
country: Turkey
facility: Akdeniz Universitesi Hastanesi-Medical Oncology ( Site 1355)
city: Istanbul
country: Turkey
facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1358)
city: Mersin
country: Turkey
facility: Mersin Sehir Eğitim ve Araştırma Hastanesi-Oncology ( Site 1361)
city: Samsun
country: Turkey
facility: Ondokuz Mayıs Universitesi-Oncology department ( Site 1359)
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital ( Site 1400)
state: Cambridgeshire
city: London
country: United Kingdom
facility: University College London Hospital ( Site 1405)
state: England
city: London
country: United Kingdom
facility: Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 1401)
state: London, City Of
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: