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)
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)
6 other identifiers
interventional
1,594
25 countries
194
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2023
Typical duration for phase_3
194 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2022
CompletedFirst Posted
Study publicly available on registry
December 27, 2022
CompletedStudy Start
First participant enrolled
January 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 6, 2024
CompletedResults Posted
Study results publicly available
April 6, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 26, 2025
CompletedOctober 15, 2025
October 1, 2025
1.1 years
December 16, 2022
February 7, 2025
October 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 is presented for all randomized participants. Protocol pre-specified final analysis for this outcome measure was conducted with the primary completion data cut-off.
Up to approximately 13 months
Secondary Outcomes (2)
Number of Participants Who Experienced at Least One Adverse Event (AE)
Up to approximately 31 months
Number of Participants Who Discontinued Study Treatment Due to an AE
Up to approximately 31 months
Study Arms (2)
Pembrolizumab/Vibostolimab
EXPERIMENTALParticipants 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).
Pembrolizumab
ACTIVE COMPARATORParticipants receive 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).
Interventions
Co-formulation of pembrolizumab 200 mg/20 mL vial and vibostolimab 200 mg administered as IV infusion for up to 17 administrations
Pembrolizumab 25 mg/mL administered as IV infusion for up to 17 administrations
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (205)
Moores Cancer Center ( Site 0116)
La Jolla, California, 92093-0698, United States
The Angeles Clinic and Research Institute - West Los Angeles Office ( Site 0123)
Los Angeles, California, 90025, United States
UCLA Hematology/Oncology - Westwood (Building 100) ( Site 0131)
Los Angeles, California, 90095, United States
California Pacific Medical Center - Pacific Campus ( Site 0111)
San Francisco, California, 94115, United States
UCSF Medical Center at Mission Bay ( Site 0130)
San Francisco, California, 94158, United States
The Melanoma & Skin Cancer Institute ( Site 0120)
Englewood, Colorado, 80113, United States
Georgetown University Medical Center ( Site 0144)
Washington D.C., District of Columbia, 20007, United States
University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0110)
Miami, Florida, 33136, United States
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center ( Site 0124)
Tampa, Florida, 33612, United States
Northwestern Memorial Hospital ( Site 0109)
Chicago, Illinois, 60611, United States
Advocate Medical Group-Oncology ( Site 0102)
Park Ridge, Illinois, 60068, United States
University of Iowa-Holden Comprehensive Cancer Center ( Site 0107)
Iowa City, Iowa, 52242, United States
Henry Ford Hospital ( Site 0133)
Detroit, Michigan, 48202, United States
Comprehensive Cancer Centers of Nevada ( Site 0142)
Las Vegas, Nevada, 89169, United States
R.J. Zuckerberg Cancer Center-Medical Oncology ( Site 0132)
Lake Success, New York, 11042, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0146)
Mineola, New York, 11501, United States
Laura and Isaac Perlmutter Cancer Center-Hematology and Oncology ( Site 0113)
New York, New York, 10016, United States
Icahn School of Medicine at Mount Sinai ( Site 0118)
New York, New York, 10029, United States
Weill Cornell Medical College ( Site 0115)
New York, New York, 10065, United States
Levine Cancer Institute ( Site 0138)
Charlotte, North Carolina, 28204, United States
Sanford Fargo Medical Center ( Site 0127)
Fargo, North Dakota, 58102, United States
Children's Hospital of Pittsburgh ( Site 0141)
Pittsburgh, Pennsylvania, 15224, United States
UPMC Hillman Cancer Center ( Site 0135)
Pittsburgh, Pennsylvania, 15232, United States
Sanford Cancer Center ( Site 0125)
Sioux Falls, South Dakota, 57104, United States
The West Clinic, PLLC dba West Cancer Center ( Site 0119)
Germantown, Tennessee, 38138, United States
St. Jude Children's Research Hospital ( Site 0106)
Memphis, Tennessee, 38105, United States
Vanderbilt University Medical Center ( Site 0139)
Nashville, Tennessee, 37232, United States
University of Texas MD Anderson Cancer Center ( Site 0145)
Houston, Texas, 77030, United States
Inova Schar Cancer Institute ( Site 0103)
Fairfax, Virginia, 22031, United States
University of Wisconsin Hospital and Clinics ( Site 0108)
Madison, Wisconsin, 53792, United States
Centro de Investigaciones Metabólicas (CINME)-Oncology ( Site 0204)
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1027AAP, Argentina
Instituto Alexander Fleming-Alexander Fleming ( Site 0209)
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ, Argentina
Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0200)
Buenos Aires, Buenos Aires F.D., C1431FWO, Argentina
Instituto de Oncología de Rosario ( Site 0206)
Rosario, Santa Fe Province, S2000KZE, Argentina
Sanatorio Finochietto ( Site 0212)
Buenos Aires, C1187AAN, Argentina
Clinica Adventista Belgrano-Oncology ( Site 0211)
CABA, C1430EGF, Argentina
Blacktown Hospital-Blacktown Cancer and Haematology Centre - Medical Oncology ( Site 1464)
Blacktown, New South Wales, 2148, Australia
Calvary Mater Newcastle-Medical Oncology ( Site 1462)
Waratah, New South Wales, 2298, Australia
Melanoma Institute Australia-Clinical Trials Unit ( Site 1450)
Wollstonecraft, New South Wales, 2065, Australia
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si
Brisbane, Queensland, 4029, Australia
Cairns Hospital-Clinical Research Unit ( Site 1458)
Cairns, Queensland, 4870, Australia
Gallipoli Medical Research Ltd-GMRF CTU ( Site 1451)
Greenslopes, Queensland, 4120, Australia
Tasman Oncology Research ( Site 1456)
Southport, Queensland, 4215, Australia
Royal Adelaide Hospital-RAH Cancer Centre ( Site 1457)
Adelaide, South Australia, 5000, Australia
Icon Cancer Centre Hobart ( Site 1465)
Hobart, Tasmania, 7000, Australia
Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 1455)
Melbourne, Victoria, 3000, Australia
One Clinical Research ( Site 1460)
Nedlands, Western Australia, 6009, Australia
Universitätsklinikum St. Pölten-Department of Dermatology ( Site 0606)
Sankt Pölten, Lower Austria, 3100, Austria
Medizinische Universität Graz-Innere Medizin Klin. Abt. Onkologie ( Site 0601)
Graz, Styria, 8036, Austria
Medizinische Universitaet Innsbruck-Univ Klinik für Dermatologie, Venerologie und Allergologie ( Sit
Innsbruck, Tyrol, 6020, Austria
Ordensklinikum Linz GmbH Elisabethinen-Dermatologie ( Site 0602)
Linz, Upper Austria, 4020, Austria
Medizinische Universität Wien-Department of Dermatology ( Site 0600)
Vienna, Vienna, 1090, Austria
Uniklinikum Salzburg-Department of Dermatology and Allergology ( Site 0604)
Salzburg, 5020, Austria
GZA Ziekenhuizen campus Sint-Augustinus ( Site 0655)
Wilrijk, Antwerpen, 2610, Belgium
Cliniques universitaires Saint-Luc ( Site 0652)
Brussels, Bruxelles-Capitale, Region de, 1200, Belgium
Jessa Ziekenhuis ( Site 0656)
Hasselt, Limburg, 3500, Belgium
Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 0653)
Yvoir, Namur, 5530, Belgium
VITAZ-Medical Oncology ( Site 0654)
Sint-Niklaas, Oost-Vlaanderen, B-9100, Belgium
UZ Leuven-General Medical Oncology ( Site 0650)
Leuven, Vlaams-Brabant, 3000, Belgium
Centro Avançado de Tratamento Oncológico- CENANTRON ( Site 0256)
Belo Horizonte, Minas Gerais, 30130090, Brazil
Hospital de Cancer de Londrina-Clinical Research Unit ( Site 0252)
Londrina, Paraná, 86015-520, Brazil
Associação Hospitalar Beneficente São Vicente de Paulo-Instituto do Câncer ( Site 0259)
Passo Fundo, Rio Grande do Sul, 99010-080, Brazil
ANIMI - Unidade de Tratamento Oncologico ( Site 0255)
Lages, Santa Catarina, 88501001, Brazil
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia ( Site 0262)
Santo André, São Paulo, 09060-870, Brazil
A. C. Camargo Cancer Center ( Site 0258)
São Paulo, 01509-010, Brazil
The Ottawa Hospital - General Campus-The Ottawa Hospital Cancer Centre ( Site 0004)
Ottawa, Ontario, K1H 8L6, Canada
Sunnybrook Research Institute ( Site 0003)
Toronto, Ontario, M4N 3M5, Canada
Princess Margaret Cancer Centre ( Site 0006)
Toronto, Ontario, M5G 2M9, Canada
Oncocentro Valdivia ( Site 0307)
Valdivia, Los Ríos Region, 5112129, Chile
FALP-UIDO ( Site 0303)
Santiago, Region M. de Santiago, 7500921, Chile
Oncovida ( Site 0304)
Santiago, Region M. de Santiago, 7510032, Chile
Clínica UC San Carlos de Apoquindo ( Site 0305)
Santiago, Region M. de Santiago, 7620002, Chile
Bradfordhill-Clinical Area ( Site 0302)
Santiago, Region M. de Santiago, 8420383, Chile
ONCOCENTRO APYS-ACEREY ( Site 0300)
Viña del Mar, Región de Valparaíso, 2520598, Chile
Bradford Hill Norte ( Site 0308)
Antofagasta, 1240000, Chile
Beijing Ji Shui Tan Hospital ( Site 1657)
Beijing, Beijing Municipality, 100035, China
Beijing Cancer hospital-Renal carcinoma and melanoma ( Site 1650)
Beijing, Beijing Municipality, 100142, China
Chongqing University Cancer Hospital ( Site 1651)
Chongqing, Chongqing Municipality, 400030, China
Fujian Provincial Cancer Hospital ( Site 1659)
Fuzhou, Fujian, 350014, China
Sun Yat-sen University Cancer Center-melanoma ( Site 1655)
Guangzhou, Guangdong, 510060, China
Guangxi Medical University Affiliated Tumor Hospital ( Site 1668)
Nanning, Guangxi, 530021, China
Fourth Hospital of Hebei Medical University ( Site 1669)
Shijiazhuang, Hebei, 050035, China
The Third Hospital of Zhengzhou-Oncology ( Site 1653)
Zhengzhou, Henan, 450001, China
Wuhan Union Hospital Cancer Center-Cancer Center ( Site 1664)
Wuhan, Hubei, 430022, China
The Second Xiangya Hospital of Central South University-Oncology ( Site 1673)
Changsha, Hunan, 410011, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology (
Nanjing, Jiangsu, 210000, China
Jiangsu Province Hospital-Oncology Department ( Site 1663)
Nanjing, Jiangsu, 210029, China
The First Affiliated Hospital of Nanchang University ( Site 1652)
Nanchang, Jiangxi, 330006, China
The First Hospital of Jilin University-Oncology ( Site 1665)
Changchun, Jilin, 130021, China
Fudan University Shanghai Cancer Center ( Site 1658)
Shanghai, Shanghai Municipality, 200032, China
Shanxi Bethune Hospital ( Site 1660)
Taiyuan, Shanxi, 030032, China
West China Hospital, Sichuan University-Head and Neck Oncology ( Site 1667)
Chengdu, Sichuan, 610041, 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, 830000, China
Yunnan Province Cancer Hospital-Biotherapy Center ( Site 1666)
Kunming, Yunnan, 650106, China
Zhejiang Cancer Hospital-Oncology ( Site 1661)
Hangzhou, Zhejiang, 310022, China
Instituto de Cancerología ( Site 0356)
Medellín, Antioquia, 050025, Colombia
Fundación Colombiana de Cancerología Clínica Vida ( Site 0355)
Medellín, Antioquia, 050030, Colombia
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0358)
Bogotá, Bogota D.C., 111321, Colombia
Mediservis del Tolima IPS S.A.S ( Site 0357)
Ibagué, Tolima Department, 730006, Colombia
Fundación Valle del Lili ( Site 0352)
Cali, Valle del Cauca Department, 760032, Colombia
Centre Hospitalier de Valence-Service de Dermatologie ( Site 0702)
Valence, Drome, 26953, France
Hopital Claude Huriez - CHU de Lille-Clinique de Dermatologie ( Site 0700)
Lille, Hauts-de-France, 59037, France
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu-Onco-Dermatology ( Site 0707)
Nantes, Loire-Atlantique, 44093, France
Institut de Cancérologie de l'Ouest-Oncologie Médicale ( Site 0706)
Saint-Herblain, Loire-Atlantique, 44805, France
Assistance Publique Hôpitaux de Marseille - Hôpital de la Ti-Service de Dermatologie et Cancérologi
Marseille, Provence-Alpes-Côte d'Azur Region, 13005, France
Centre Hospitalier de Pau ( Site 0708)
Pau, Pyrenees-Atlantiques, 64000, France
centre hospitalier lyon sud-Service de dermatologie ( Site 0714)
Pierre-Bénite, Rhone, 69310, France
Gustave Roussy-Dermatologie ( Site 0713)
Villejuif, Val-de-Marne, 94800, France
Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0711)
Paris, 75014, France
Universitaetsklinikum Heidelberg ( Site 0765)
Heidelberg, Baden-Wurttemberg, 69120, Germany
Universitätsmedizin Mannheim ( Site 0751)
Mannheim, Baden-Wurttemberg, 68167, Germany
Universitaetsklinikum Erlangen-Hautklinik ( Site 0750)
Erlangen, Bavaria, 91054, Germany
Klinik und Poliklinik für Dermatologie und Allergologie-Dermato-oncology ( Site 0757)
München, Bavaria, 80337, Germany
Elbe Kliniken Stade-Buxtehude, Klinikum Buxtehude-Dermatologisches Zentrum ( Site 0754)
Buxtehude, Lower Saxony, 21614, Germany
Medizinische Hochschule Hannover ( Site 0758)
Hanover, Lower Saxony, 30625, Germany
Universitaetsklinikum Essen-Klinik für Dermatologie, Venerologie und Allergologie ( Site 0761)
Essen, North Rhine-Westphalia, 45147, Germany
Johannes Wesling Klinikum Minden-Skin Cancer Center Minden ( Site 0759)
Minden, North Rhine-Westphalia, 32429, Germany
Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Dermatologie ( Site 0766)
Dresden, Saxony, 01307, Germany
Universitätsklinikum Leipzig ( Site 0762)
Leipzig, Saxony, 04103, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel-Hautklinik ( Site 0767)
Kiel, Schleswig-Holstein, 24105, Germany
Charité Universitaetsmedizin Berlin - Campus Mitte-Hauttumorcentrum Charité (HTCC) ( Site 0756)
Berlin, 10117, Germany
Universitaetsklinikum Hamburg-Eppendorf ( Site 0752)
Hamburg, 20246, Germany
Artemis hospital ( Site 1551)
Gurugram, Haryana, 122001, India
Tata Memorial Hospital-Medical Oncology ( Site 1550)
Mumbai, Maharashtra, 400012, India
All India Institute of Medical Sciences-Medical oncology ( Site 1552)
New Delhi, National Capital Territory of Delhi, 110029, India
St. James's Hospital-Cancer clinical trials office ( Site 0900)
Dublin, D08 E9P6, Ireland
Beaumont Hospital, Dublin-Cancer Clinical Trials & Research Unit ( Site 0902)
Dublin, Dublin 9, Ireland
Emek Medical Center-oncology ( Site 0952)
Afula, 1834111, Israel
Soroka Medical Center ( Site 0953)
Beersheba, 8410101, Israel
Rambam Health Care Campus-Oncology Division ( Site 0955)
Haifa, 3109601, Israel
Hadassah Medical Center ( Site 0951)
Jerusalem, 9112001, Israel
Rabin Medical Center-Oncology ( Site 0954)
Petah Tikva, 4941492, Israel
Sheba Medical Center-ONCOLOGY ( Site 0950)
Ramat Gan, 5265601, Israel
Instituto Tumori Giovanni Paolo II ( Site 1003)
Bari, Apulia, 70124, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 1004)
Meldola, Emilia-Romagna, 47014, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1000)
Milan, Lombardy, 20133, Italy
A.O.U. Policlinico Paolo Giaccone-Depatment of Discipline Chirurgiche, Oncologiche e Stomatologiche
Palermo, Sicily, 90129, Italy
Azienda Ospedaliero Universitaria Senese ( Site 1005)
Siena, Tuscany, 53100, Italy
AO Santa Maria della Misericordia ( Site 1006)
Perugia, Umbria, 06129, Italy
Istituto Europeo di Oncologia IRCCS ( Site 1008)
Milan, 20141, Italy
Azienda Ospedaliero Universitaria ( Site 1002)
Modena, 41125, Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1001)
Napoli, 80131, Italy
Nagoya University Hospital ( Site 1753)
Nagoya, Aichi-ken, 466-8560, Japan
Sapporo Medical University Hospital ( Site 1755)
Sapporo, Hokkaido, 060-8543, Japan
Niigata Cancer Center Hospital ( Site 1751)
Niigata, Niigata, 951-8566, Japan
Shizuoka Cancer Center ( Site 1752)
Nagaizumi-cho,Sunto-gun, Shizuoka, 411-8777, Japan
National Cancer Center Hospital ( Site 1750)
Chuo-ku, Tokyo, 104-0045, Japan
Osaka International Cancer Institute ( Site 1754)
Osaka, 541-8567, Japan
Tauranga Hospital-Bay of Plenty Clinical Trials Unit ( Site 1501)
Tauranga, Bay of Plenty, 3112, New Zealand
New Zealand Clinical Research (Christchurch) ( Site 1509)
Christchurch, Canterbury, 8011, New Zealand
P3 Research - Palmerston North ( Site 1510)
Palmerston North, Manawatu-Wanganui, 4414, New Zealand
Dunedin Hospital ( Site 1511)
Dunedin, Otago, 9016, New Zealand
Harbour Cancer & Wellness ( Site 1508)
Auckland, 0627, New Zealand
Szpital Kliniczny im. H. Swiecickiego nr 2-Oddział Kliniczny Onkologii Klinicznej i Doświadczalnej (
Poznan, Greater Poland Voivodeship, 60-780, Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1061)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland
Pratia MCM Krakow ( Site 1053)
Krakow, Lesser Poland Voivodeship, 30-727, Poland
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1058)
Siedlce, Masovian Voivodeship, 08-110, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
Warsaw, Masovian Voivodeship, 02-781, Poland
Bialostockie Centrum Onkologii ( Site 1065)
Bialystok, Podlaskie Voivodeship, 15-027, Poland
Uniwersyteckie Centrum Kliniczne-Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólnej ( Site
Gdansk, Pomeranian Voivodeship, 80-214, Poland
Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Słupsku-Oncologii, Chemioterapii ( Site 1064)
Słupsk, Pomeranian Voivodeship, 76-200, Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1056)
Gliwice, Silesian Voivodeship, 44-101, Poland
Zachodniopomorskie Centrum Onkologii ( Site 1063)
Szczecin, West Pomeranian Voivodeship, 71-730, Poland
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 1054)
Kielce, Świętokrzyskie Voivodeship, 25-734, Poland
CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 1161)
Port Elizabeth, Eastern Cape, 6055, South Africa
Medical Oncology Centre of Rosebank ( Site 1160)
Johannesburg, Gauteng, 2196, South Africa
Wilgers Oncology Centre ( Site 1154)
Pretoria, Gauteng, 0040, South Africa
Curo Oncology ( Site 1158)
Pretoria, Gauteng, 0084, South Africa
LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 1152)
Pretoria, Gauteng, 0181, South Africa
Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 1151)
Sandton, Gauteng, 2196, South Africa
The Oncology Centre ( Site 1157)
Durban, KwaZulu-Natal, 4091, South Africa
Abraham Oncology ( Site 1150)
Richards Bay, KwaZulu-Natal, 3900, South Africa
Cape Town Oncology Trials ( Site 1155)
Cape Town, Western Cape, 7570, South Africa
Cancercare Rondebosch Oncology-Clinical trials ( Site 1159)
Rondebosch, Western Cape, 7700, South Africa
Seoul National University Hospital-Oncology ( Site 1600)
Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1601)
Seoul, 03722, South Korea
Samsung Medical Center-Division of Hematology/Oncology ( Site 1602)
Seoul, 06351, South Korea
Institut Català d'Oncologia - L'Hospitalet ( Site 1202)
L'Hospitalet de Llobregat, Barcelona, 08908, Spain
Onkologikoa - Instituto Oncologico de San Sebastian ( Site 1203)
Doniostia - San Sebastian, Gipuzkoa, 20014, Spain
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1204)
Madrid, Madrid, Comunidad de, 28034, Spain
H.R.U Málaga - Hospital General-Oncology ( Site 1201)
Málaga, Malaga, 29011, Spain
Hospital General Universitario de Valencia ( Site 1200)
Valencia, Valenciana, Comunitat, 46014, Spain
Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1205)
Seville, 41009, Spain
Länssjukhuset Ryhov-Onkologkliniken ( Site 1253)
Jönköping, Jönköping County, 553 05, Sweden
Karolinska Universitetssjukhuset Solna ( Site 1252)
Stockholm, Stockholm County, 171 64, Sweden
University Hospital Basel ( Site 1303)
Basel, Canton of Basel-City, 4056, Switzerland
Inselspital Bern ( Site 1301)
Bern, Canton of Bern, 3010, Switzerland
Hôpitaux Universitaires de Genève (HUG)-Oncology ( Site 1307)
Geneva, Canton of Geneva, 1211, Switzerland
CHUV (centre hospitalier universitaire vaudois) ( Site 1304)
Lausanne, Canton of Vaud, 1011, Switzerland
UniversitätsSpital Zürich-Dermatology ( Site 1300)
Zürich Flughafen, Canton of Zurich, 8058, Switzerland
Ospedale Regionale Bellinzona e Valli ( Site 1308)
Bellinzona, Canton Ticino, 6500, Switzerland
Hôpital de Sion ( Site 1305)
Sion, Valais, 1951, Switzerland
Cantonal Hospital St.Gallen-Oncology & Hematology ( Site 1306)
Sankt Gallen, 9007, Switzerland
Ankara City Hospital-Medical Oncology ( Site 1357)
Çankaya, Ankara, 06800, Turkey (Türkiye)
I.E.U. Medical Point Hastanesi-Oncology ( Site 1360)
Izmir, Karsiyaka, İzmir, 009035575, Turkey (Türkiye)
Hacettepe Universite Hastaneleri ( Site 1363)
Ankara, 06230, Turkey (Türkiye)
Liv Hospital Ankara-Oncology ( Site 1353)
Ankara, 06680, Turkey (Türkiye)
Akdeniz Universitesi Hastanesi-Medical Oncology ( Site 1355)
Antalya, 07059, Turkey (Türkiye)
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1358)
Istanbul, 34722, Turkey (Türkiye)
Mersin Sehir Eğitim ve Araştırma Hastanesi-Oncology ( Site 1361)
Mersin, 33240, Turkey (Türkiye)
Ondokuz Mayıs Universitesi-Oncology department ( Site 1359)
Samsun, 55139, Turkey (Türkiye)
Addenbrooke's Hospital ( Site 1400)
Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom
University College London Hospital ( Site 1405)
London, England, NW1 2PG, United Kingdom
Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 1401)
London, London, City of, SE1 9RT, United Kingdom
Related Publications (1)
Shapira-Frommer R, Niu J, Perets R, Peters S, Shouse G, Lugowska I, Garassino MC, Sands J, Keenan T, Zhao B, Healy J, Ahn MJ. The KEYVIBE program: vibostolimab and pembrolizumab for the treatment of advanced malignancies. Future Oncol. 2024;20(27):1983-1991. doi: 10.1080/14796694.2024.2343272. Epub 2024 Sep 4.
PMID: 39230120DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme LLC
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2022
First Posted
December 27, 2022
Study Start
January 19, 2023
Primary Completion
March 6, 2024
Study Completion
September 26, 2025
Last Updated
October 15, 2025
Results First Posted
April 6, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf