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)
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)
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.
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.
Inclusion Criteria:
Exclusion Criteria:
Los Angeles, California 90025, United States
Los Angeles, California 90095, United States
San Francisco, California 94115, United States
Washington D.C., District of Columbia 20007, United States
Miami, Florida 33136, United States
Tampa, Florida 33612, United States
Iowa City, Iowa 52242, United States
Lake Success, New York 11042, United States
Mineola, New York 11501, United States
New York, New York 10016, United States
Ciudad Autónoma de Buenos Aires, Buenos Aires C1027AAP, Argentina
Ciudad Autónoma de Buenos Aires, Buenos Aires C1426ANZ, Argentina
Buenos Aires, Buenos Aires F.D. C1431FWO, Argentina
CABA, C1430EGF, Argentina
Blacktown, New South Wales 2148, Australia
Wollstonecraft, New South Wales 2065, Australia
Brisbane, Queensland 4029, Australia
Melbourne, Victoria 3000, Australia
Sankt Pölten, Lower Austria 3100, Austria
Vienna, State of Vienna 1090, Austria
Graz, Styria 8036, Austria
Innsbruck, Tyrol 6020, Austria
Brussels, Bruxelles-Capitale, Region de 1200, Belgium
Yvoir, Namur 5530, Belgium
Belo Horizonte, Minas Gerais 30130090, Brazil
Londrina, Paraná 86015-520, Brazil
Passo Fundo, Rio Grande do Sul 99010-080, Brazil
Santo André, São Paulo 09060-870, Brazil
Ottawa, Ontario K1H 8L6, Canada
Beijing, Beijing Municipality 100142, China
Changsha, Hunan 410011, China
Nanjing, Jiangsu 210000, China
Chengdu, Sichuan 610041, China
Tianjin, Tianjin Municipality, China
Ürümqi, Xinjiang 830000, China
Bogotá, Bogota D.C. 111321, Colombia
Lille, Hauts-de-France 59037, France
Nantes, Loire-Atlantique 44093, France
Saint-Herblain, Loire-Atlantique 44805, France
Marseille, Provence-Alpes-Côte d'Azur Region 13005, France
München, Bavaria 80337, Germany
Buxtehude, Lower Saxony 21614, Germany
Essen, North Rhine-Westphalia 45147, Germany
Minden, North Rhine-Westphalia 32429, Germany
Dresden, Saxony 01307, Germany
Kiel, Schleswig-Holstein 24105, Germany
Berlin, 10117, Germany
New Delhi, National Capital Territory of Delhi 110029, India
Dublin, Dublin 9, Ireland
Meldola, Emilia-Romagna 47014, Italy
Palermo, Sicily 90129, Italy
Nagaizumi-cho,Sunto-gun, Shizuoka 411-8777, Japan
Chuo-ku, Tokyo 104-0045, Japan
Tauranga, Bay of Plenty 3112, New Zealand
Poznan, Greater Poland Voivodeship 60-780, Poland
Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-796, Poland
Siedlce, Masovian Voivodeship 08-110, Poland
Warsaw, Masovian Voivodeship 02-781, Poland
Gdansk, Pomeranian Voivodeship 80-214, Poland
Słupsk, Pomeranian Voivodeship 76-200, Poland
Gliwice, Silesian Voivodeship 44-101, Poland
Szczecin, West Pomeranian Voivodeship 71-730, Poland
Kielce, Świętokrzyskie Voivodeship 25-734, Poland
Port Elizabeth, Eastern Cape 6055, South Africa
Rondebosch, Western Cape 7700, South Africa
Seoul, 03722, South Korea
L'Hospitalet de Llobregat, Barcelona 08908, Spain
Doniostia - San Sebastian, Gipuzkoa 20014, Spain
Madrid, Madrid, Comunidad de 28034, Spain
Seville, 41009, Spain
Geneva, Canton of Geneva 1211, Switzerland
Lausanne, Canton of Vaud 1011, Switzerland
Zürich Flughafen, Canton of Zurich 8058, Switzerland
Izmir, Karsiyaka, İzmir 009035575, Turkey (Türkiye)
Istanbul, 34722, Turkey (Türkiye)