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)

Melanoma Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05665595
• Other study ID #: 7684A-010
• Secondary ID: MK-7684A-010KEYV
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 19, 2023
• Est. completion date: March 31, 2031

Study information

• Verified date: May 2024
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1594
• Est. completion date: March 31, 2031
• Est. primary completion date: March 6, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma

Intervention

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
• Pembrolizumab
Pembrolizumab 25 mg/mL administered as IV infusion for up to 17 administrations

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Chile,  China,  Colombia,  France,  Germany,  India,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  New Zealand,  Poland,  South Africa,  Spain,  Sweden,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence-Free Survival (RFS)	RFS is defined as the time from randomization to any recurrence (local, locoregional, regional, or distant) as assessed by the investigator, or death due to any cause, whichever occurs first. The RFS as assessed by the investigator will be reported for all randomized participants.	Up to approximately 52 months
Secondary	Distant Metastasis-Free Survival (DMFS)	DMFS is defined as the time from randomization to the first diagnosis of a distant metastasis, or death due to any cause, whichever occurs first. Distant metastasis refers to cancer that has spread from the original (primary) tumor and beyond local tissues and lymph nodes to distant organs or distant lymph nodes. The DMFS as assessed by the investigator will be reported for all randomized participants.	Up to approximately 68 months
Secondary	Overall Survival (OS)	OS is defined as the time from randomization to death due to any cause.	Up to approximately 96 months
Secondary	Number of Participants Who Experienced at Least One Adverse Event (AE)	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.	Up to approximately 15 months
Secondary	Number of Participants Who Discontinued Study Treatment Due to an AE	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.	Up to approximately 12 months
Secondary	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	The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. Change from baseline in the score of EORTC QLQ-C30 Items 29 and 30 will be presented.	Baseline and up to approximately 72 months
Secondary	Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score	The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. Change from baseline in the score of EORTC QLQ-C30 Items 1-5 will be presented.	Baseline and up to approximately 72 months
Secondary	Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score	The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 2 questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. Change from baseline in the score of EORTC QLQ-C30 Items 6-7 will be presented.	Baseline and up to approximately 72 months

External Links

•   Merck Clinical Trials Information
•   Plain Language Summary