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)

NCT ID: NCT05665595

Last Updated: 2025-10-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1594 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-19

Study Completion Date

2025-09-26

Brief Summary

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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

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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.

Conditions

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Melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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).

Group Type EXPERIMENTAL

Pembrolizumab/Vibostolimab

Intervention Type BIOLOGICAL

Co-formulation of pembrolizumab 200 mg/20 mL vial and vibostolimab 200 mg administered as IV infusion for up to 17 administrations

Pembrolizumab

Participants 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).

Group Type ACTIVE_COMPARATOR

Pembrolizumab

Intervention Type BIOLOGICAL

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

Interventions

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Pembrolizumab/Vibostolimab

Co-formulation of pembrolizumab 200 mg/20 mL vial and vibostolimab 200 mg administered as IV infusion for up to 17 administrations

Intervention Type BIOLOGICAL

Pembrolizumab

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

Intervention Type BIOLOGICAL

Other Intervention Names

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MK-7684A MK-3475 KEYTRUDA®

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Moores Cancer Center ( Site 0116)

La Jolla, California, United States

Site Status

The Angeles Clinic and Research Institute - West Los Angeles Office ( Site 0123)

Los Angeles, California, United States

Site Status

UCLA Hematology/Oncology - Westwood (Building 100) ( Site 0131)

Los Angeles, California, United States

Site Status

California Pacific Medical Center - Pacific Campus ( Site 0111)

San Francisco, California, United States

Site Status

UCSF Medical Center at Mission Bay ( Site 0130)

San Francisco, California, United States

Site Status

The Melanoma & Skin Cancer Institute ( Site 0120)

Englewood, Colorado, United States

Site Status

Georgetown University Medical Center ( Site 0144)

Washington D.C., District of Columbia, United States

Site Status

University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0110)

Miami, Florida, United States

Site Status

Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center ( Site 0124)

Tampa, Florida, United States

Site Status

Northwestern Memorial Hospital ( Site 0109)

Chicago, Illinois, United States

Site Status

Advocate Medical Group-Oncology ( Site 0102)

Park Ridge, Illinois, United States

Site Status

University of Iowa-Holden Comprehensive Cancer Center ( Site 0107)

Iowa City, Iowa, United States

Site Status

Henry Ford Hospital ( Site 0133)

Detroit, Michigan, United States

Site Status

Comprehensive Cancer Centers of Nevada ( Site 0142)

Las Vegas, Nevada, United States

Site Status

R.J. Zuckerberg Cancer Center-Medical Oncology ( Site 0132)

Lake Success, New York, United States

Site Status

Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0146)

Mineola, New York, United States

Site Status

Laura and Isaac Perlmutter Cancer Center-Hematology and Oncology ( Site 0113)

New York, New York, United States

Site Status

Icahn School of Medicine at Mount Sinai ( Site 0118)

New York, New York, United States

Site Status

Weill Cornell Medical College ( Site 0115)

New York, New York, United States

Site Status

Levine Cancer Institute ( Site 0138)

Charlotte, North Carolina, United States

Site Status

Sanford Fargo Medical Center ( Site 0127)

Fargo, North Dakota, United States

Site Status

Children's Hospital of Pittsburgh ( Site 0141)

Pittsburgh, Pennsylvania, United States

Site Status

UPMC Hillman Cancer Center ( Site 0135)

Pittsburgh, Pennsylvania, United States

Site Status

Sanford Cancer Center ( Site 0125)

Sioux Falls, South Dakota, United States

Site Status

The West Clinic, PLLC dba West Cancer Center ( Site 0119)

Germantown, Tennessee, United States

Site Status

St. Jude Children's Research Hospital ( Site 0106)

Memphis, Tennessee, United States

Site Status

Vanderbilt University Medical Center ( Site 0139)

Nashville, Tennessee, United States

Site Status

University of Texas MD Anderson Cancer Center ( Site 0145)

Houston, Texas, United States

Site Status

Inova Schar Cancer Institute ( Site 0103)

Fairfax, Virginia, United States

Site Status

University of Wisconsin Hospital and Clinics ( Site 0108)

Madison, Wisconsin, United States

Site Status

Centro de Investigaciones Metabólicas (CINME)-Oncology ( Site 0204)

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Site Status

Instituto Alexander Fleming-Alexander Fleming ( Site 0209)

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Site Status

Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0200)

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

Instituto de Oncología de Rosario ( Site 0206)

Rosario, Santa Fe Province, Argentina

Site Status

Sanatorio Finochietto ( Site 0212)

Buenos Aires, , Argentina

Site Status

Clinica Adventista Belgrano-Oncology ( Site 0211)

CABA, , Argentina

Site Status

Blacktown Hospital-Blacktown Cancer and Haematology Centre - Medical Oncology ( Site 1464)

Blacktown, New South Wales, Australia

Site Status

Calvary Mater Newcastle-Medical Oncology ( Site 1462)

Waratah, New South Wales, Australia

Site Status

Melanoma Institute Australia-Clinical Trials Unit ( Site 1450)

Wollstonecraft, New South Wales, Australia

Site Status

Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si

Brisbane, Queensland, Australia

Site Status

Cairns Hospital-Clinical Research Unit ( Site 1458)

Cairns, Queensland, Australia

Site Status

Gallipoli Medical Research Ltd-GMRF CTU ( Site 1451)

Greenslopes, Queensland, Australia

Site Status

Tasman Oncology Research ( Site 1456)

Southport, Queensland, Australia

Site Status

Royal Adelaide Hospital-RAH Cancer Centre ( Site 1457)

Adelaide, South Australia, Australia

Site Status

Icon Cancer Centre Hobart ( Site 1465)

Hobart, Tasmania, Australia

Site Status

Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 1455)

Melbourne, Victoria, Australia

Site Status

One Clinical Research ( Site 1460)

Nedlands, Western Australia, Australia

Site Status

Universitätsklinikum St. Pölten-Department of Dermatology ( Site 0606)

Sankt Pölten, Lower Austria, Austria

Site Status

Medizinische Universität Graz-Innere Medizin Klin. Abt. Onkologie ( Site 0601)

Graz, Styria, Austria

Site Status

Medizinische Universitaet Innsbruck-Univ Klinik für Dermatologie, Venerologie und Allergologie ( Sit

Innsbruck, Tyrol, Austria

Site Status

Ordensklinikum Linz GmbH Elisabethinen-Dermatologie ( Site 0602)

Linz, Upper Austria, Austria

Site Status

Medizinische Universität Wien-Department of Dermatology ( Site 0600)

Vienna, Vienna, Austria

Site Status

Uniklinikum Salzburg-Department of Dermatology and Allergology ( Site 0604)

Salzburg, , Austria

Site Status

GZA Ziekenhuizen campus Sint-Augustinus ( Site 0655)

Wilrijk, Antwerpen, Belgium

Site Status

Cliniques universitaires Saint-Luc ( Site 0652)

Brussels, Bruxelles-Capitale, Region de, Belgium

Site Status

Jessa Ziekenhuis ( Site 0656)

Hasselt, Limburg, Belgium

Site Status

Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 0653)

Yvoir, Namur, Belgium

Site Status

VITAZ-Medical Oncology ( Site 0654)

Sint-Niklaas, Oost-Vlaanderen, Belgium

Site Status

UZ Leuven-General Medical Oncology ( Site 0650)

Leuven, Vlaams-Brabant, Belgium

Site Status

Centro Avançado de Tratamento Oncológico- CENANTRON ( Site 0256)

Belo Horizonte, Minas Gerais, Brazil

Site Status

Hospital de Cancer de Londrina-Clinical Research Unit ( Site 0252)

Londrina, Paraná, Brazil

Site Status

Associação Hospitalar Beneficente São Vicente de Paulo-Instituto do Câncer ( Site 0259)

Passo Fundo, Rio Grande do Sul, Brazil

Site Status

ANIMI - Unidade de Tratamento Oncologico ( Site 0255)

Lages, Santa Catarina, Brazil

Site Status

CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia ( Site 0262)

Santo André, São Paulo, Brazil

Site Status

A. C. Camargo Cancer Center ( Site 0258)

São Paulo, , Brazil

Site Status

The Ottawa Hospital - General Campus-The Ottawa Hospital Cancer Centre ( Site 0004)

Ottawa, Ontario, Canada

Site Status

Sunnybrook Research Institute ( Site 0003)

Toronto, Ontario, Canada

Site Status

Princess Margaret Cancer Centre ( Site 0006)

Toronto, Ontario, Canada

Site Status

Oncocentro Valdivia ( Site 0307)

Valdivia, Los Ríos Region, Chile

Site Status

FALP-UIDO ( Site 0303)

Santiago, Region M. de Santiago, Chile

Site Status

Oncovida ( Site 0304)

Santiago, Region M. de Santiago, Chile

Site Status

Clínica UC San Carlos de Apoquindo ( Site 0305)

Santiago, Region M. de Santiago, Chile

Site Status

Bradfordhill-Clinical Area ( Site 0302)

Santiago, Region M. de Santiago, Chile

Site Status

ONCOCENTRO APYS-ACEREY ( Site 0300)

Viña del Mar, Región de Valparaíso, Chile

Site Status

Bradford Hill Norte ( Site 0308)

Antofagasta, , Chile

Site Status

Beijing Ji Shui Tan Hospital ( Site 1657)

Beijing, Beijing Municipality, China

Site Status

Beijing Cancer hospital-Renal carcinoma and melanoma ( Site 1650)

Beijing, Beijing Municipality, China

Site Status

Chongqing University Cancer Hospital ( Site 1651)

Chongqing, Chongqing Municipality, China

Site Status

Fujian Provincial Cancer Hospital ( Site 1659)

Fuzhou, Fujian, China

Site Status

Sun Yat-sen University Cancer Center-melanoma ( Site 1655)

Guangzhou, Guangdong, China

Site Status

Guangxi Medical University Affiliated Tumor Hospital ( Site 1668)

Nanning, Guangxi, China

Site Status

Fourth Hospital of Hebei Medical University ( Site 1669)

Shijiazhuang, Hebei, China

Site Status

The Third Hospital of Zhengzhou-Oncology ( Site 1653)

Zhengzhou, Henan, China

Site Status

Wuhan Union Hospital Cancer Center-Cancer Center ( Site 1664)

Wuhan, Hubei, China

Site Status

The Second Xiangya Hospital of Central South University-Oncology ( Site 1673)

Changsha, Hunan, China

Site Status

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology (

Nanjing, Jiangsu, China

Site Status

Jiangsu Province Hospital-Oncology Department ( Site 1663)

Nanjing, Jiangsu, China

Site Status

The First Affiliated Hospital of Nanchang University ( Site 1652)

Nanchang, Jiangxi, China

Site Status

The First Hospital of Jilin University-Oncology ( Site 1665)

Changchun, Jilin, China

Site Status

Fudan University Shanghai Cancer Center ( Site 1658)

Shanghai, Shanghai Municipality, China

Site Status

Shanxi Bethune Hospital ( Site 1660)

Taiyuan, Shanxi, China

Site Status

West China Hospital, Sichuan University-Head and Neck Oncology ( Site 1667)

Chengdu, Sichuan, China

Site Status

Tianjin Medical University Cancer Institute & Hospital-Biotherapy ( Site 1671)

Tianjin, Tianjin Municipality, China

Site Status

Xinjiang Medical University Cancer Hospital - Urumqi-Bone and Soft Tissue Department ( Site 1674)

Ürümqi, Xinjiang, China

Site Status

Yunnan Province Cancer Hospital-Biotherapy Center ( Site 1666)

Kunming, Yunnan, China

Site Status

Zhejiang Cancer Hospital-Oncology ( Site 1661)

Hangzhou, Zhejiang, China

Site Status

Instituto de Cancerología ( Site 0356)

Medellín, Antioquia, Colombia

Site Status

Fundación Colombiana de Cancerología Clínica Vida ( Site 0355)

Medellín, Antioquia, Colombia

Site Status

Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0358)

Bogotá, Bogota D.C., Colombia

Site Status

Mediservis del Tolima IPS S.A.S ( Site 0357)

Ibagué, Tolima Department, Colombia

Site Status

Fundación Valle del Lili ( Site 0352)

Cali, Valle del Cauca Department, Colombia

Site Status

Centre Hospitalier de Valence-Service de Dermatologie ( Site 0702)

Valence, Drome, France

Site Status

Hopital Claude Huriez - CHU de Lille-Clinique de Dermatologie ( Site 0700)

Lille, Hauts-de-France, France

Site Status

Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu-Onco-Dermatology ( Site 0707)

Nantes, Loire-Atlantique, France

Site Status

Institut de Cancérologie de l'Ouest-Oncologie Médicale ( Site 0706)

Saint-Herblain, Loire-Atlantique, France

Site Status

Assistance Publique Hôpitaux de Marseille - Hôpital de la Ti-Service de Dermatologie et Cancérologi

Marseille, Provence-Alpes-Côte d'Azur Region, France

Site Status

Centre Hospitalier de Pau ( Site 0708)

Pau, Pyrenees-Atlantiques, France

Site Status

centre hospitalier lyon sud-Service de dermatologie ( Site 0714)

Pierre-Bénite, Rhone, France

Site Status

Gustave Roussy-Dermatologie ( Site 0713)

Villejuif, Val-de-Marne, France

Site Status

Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0711)

Paris, , France

Site Status

Universitaetsklinikum Heidelberg ( Site 0765)

Heidelberg, Baden-Wurttemberg, Germany

Site Status

Universitätsmedizin Mannheim ( Site 0751)

Mannheim, Baden-Wurttemberg, Germany

Site Status

Universitaetsklinikum Erlangen-Hautklinik ( Site 0750)

Erlangen, Bavaria, Germany

Site Status

Klinik und Poliklinik für Dermatologie und Allergologie-Dermato-oncology ( Site 0757)

München, Bavaria, Germany

Site Status

Elbe Kliniken Stade-Buxtehude, Klinikum Buxtehude-Dermatologisches Zentrum ( Site 0754)

Buxtehude, Lower Saxony, Germany

Site Status

Medizinische Hochschule Hannover ( Site 0758)

Hanover, Lower Saxony, Germany

Site Status

Universitaetsklinikum Essen-Klinik für Dermatologie, Venerologie und Allergologie ( Site 0761)

Essen, North Rhine-Westphalia, Germany

Site Status

Johannes Wesling Klinikum Minden-Skin Cancer Center Minden ( Site 0759)

Minden, North Rhine-Westphalia, Germany

Site Status

Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Dermatologie ( Site 0766)

Dresden, Saxony, Germany

Site Status

Universitätsklinikum Leipzig ( Site 0762)

Leipzig, Saxony, Germany

Site Status

Universitaetsklinikum Schleswig-Holstein Campus Kiel-Hautklinik ( Site 0767)

Kiel, Schleswig-Holstein, Germany

Site Status

Charité Universitaetsmedizin Berlin - Campus Mitte-Hauttumorcentrum Charité (HTCC) ( Site 0756)

Berlin, , Germany

Site Status

Universitaetsklinikum Hamburg-Eppendorf ( Site 0752)

Hamburg, , Germany

Site Status

Artemis hospital ( Site 1551)

Gurugram, Haryana, India

Site Status

Tata Memorial Hospital-Medical Oncology ( Site 1550)

Mumbai, Maharashtra, India

Site Status

All India Institute of Medical Sciences-Medical oncology ( Site 1552)

New Delhi, National Capital Territory of Delhi, India

Site Status

St. James's Hospital-Cancer clinical trials office ( Site 0900)

Dublin, , Ireland

Site Status

Beaumont Hospital, Dublin-Cancer Clinical Trials & Research Unit ( Site 0902)

Dublin, , Ireland

Site Status

Emek Medical Center-oncology ( Site 0952)

Afula, , Israel

Site Status

Soroka Medical Center ( Site 0953)

Beersheba, , Israel

Site Status

Rambam Health Care Campus-Oncology Division ( Site 0955)

Haifa, , Israel

Site Status

Hadassah Medical Center ( Site 0951)

Jerusalem, , Israel

Site Status

Rabin Medical Center-Oncology ( Site 0954)

Petah Tikva, , Israel

Site Status

Sheba Medical Center-ONCOLOGY ( Site 0950)

Ramat Gan, , Israel

Site Status

Instituto Tumori Giovanni Paolo II ( Site 1003)

Bari, Apulia, Italy

Site Status

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 1004)

Meldola, Emilia-Romagna, Italy

Site Status

Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1000)

Milan, Lombardy, Italy

Site Status

A.O.U. Policlinico Paolo Giaccone-Depatment of Discipline Chirurgiche, Oncologiche e Stomatologiche

Palermo, Sicily, Italy

Site Status

Azienda Ospedaliero Universitaria Senese ( Site 1005)

Siena, Tuscany, Italy

Site Status

AO Santa Maria della Misericordia ( Site 1006)

Perugia, Umbria, Italy

Site Status

Istituto Europeo di Oncologia IRCCS ( Site 1008)

Milan, , Italy

Site Status

Azienda Ospedaliero Universitaria ( Site 1002)

Modena, , Italy

Site Status

Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1001)

Napoli, , Italy

Site Status

Nagoya University Hospital ( Site 1753)

Nagoya, Aichi-ken, Japan

Site Status

Sapporo Medical University Hospital ( Site 1755)

Sapporo, Hokkaido, Japan

Site Status

Niigata Cancer Center Hospital ( Site 1751)

Niigata, Niigata, Japan

Site Status

Shizuoka Cancer Center ( Site 1752)

Nagaizumi-cho,Sunto-gun, Shizuoka, Japan

Site Status

National Cancer Center Hospital ( Site 1750)

Chuo-ku, Tokyo, Japan

Site Status

Osaka International Cancer Institute ( Site 1754)

Osaka, , Japan

Site Status

Tauranga Hospital-Bay of Plenty Clinical Trials Unit ( Site 1501)

Tauranga, Bay of Plenty, New Zealand

Site Status

New Zealand Clinical Research (Christchurch) ( Site 1509)

Christchurch, Canterbury, New Zealand

Site Status

P3 Research - Palmerston North ( Site 1510)

Palmerston North, Manawatu-Wanganui, New Zealand

Site Status

Dunedin Hospital ( Site 1511)

Dunedin, Otago, New Zealand

Site Status

Harbour Cancer & Wellness ( Site 1508)

Auckland, , New Zealand

Site Status

Szpital Kliniczny im. H. Swiecickiego nr 2-Oddział Kliniczny Onkologii Klinicznej i Doświadczalnej (

Poznan, Greater Poland Voivodeship, Poland

Site Status

Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1061)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Site Status

Pratia MCM Krakow ( Site 1053)

Krakow, Lesser Poland Voivodeship, Poland

Site Status

Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1058)

Siedlce, Masovian Voivodeship, Poland

Site Status

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (

Warsaw, Masovian Voivodeship, Poland

Site Status

Bialostockie Centrum Onkologii ( Site 1065)

Bialystok, Podlaskie Voivodeship, Poland

Site Status

Uniwersyteckie Centrum Kliniczne-Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólnej ( Site

Gdansk, Pomeranian Voivodeship, Poland

Site Status

Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Słupsku-Oncologii, Chemioterapii ( Site 1064)

Słupsk, Pomeranian Voivodeship, Poland

Site Status

Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1056)

Gliwice, Silesian Voivodeship, Poland

Site Status

Zachodniopomorskie Centrum Onkologii ( Site 1063)

Szczecin, West Pomeranian Voivodeship, Poland

Site Status

Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 1054)

Kielce, Świętokrzyskie Voivodeship, Poland

Site Status

CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 1161)

Port Elizabeth, Eastern Cape, South Africa

Site Status

Medical Oncology Centre of Rosebank ( Site 1160)

Johannesburg, Gauteng, South Africa

Site Status

Wilgers Oncology Centre ( Site 1154)

Pretoria, Gauteng, South Africa

Site Status

Curo Oncology ( Site 1158)

Pretoria, Gauteng, South Africa

Site Status

LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 1152)

Pretoria, Gauteng, South Africa

Site Status

Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 1151)

Sandton, Gauteng, South Africa

Site Status

The Oncology Centre ( Site 1157)

Durban, KwaZulu-Natal, South Africa

Site Status

Abraham Oncology ( Site 1150)

Richards Bay, KwaZulu-Natal, South Africa

Site Status

Cape Town Oncology Trials ( Site 1155)

Cape Town, Western Cape, South Africa

Site Status

Cancercare Rondebosch Oncology-Clinical trials ( Site 1159)

Rondebosch, Western Cape, South Africa

Site Status

Seoul National University Hospital-Oncology ( Site 1600)

Seoul, , South Korea

Site Status

Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1601)

Seoul, , South Korea

Site Status

Samsung Medical Center-Division of Hematology/Oncology ( Site 1602)

Seoul, , South Korea

Site Status

Institut Català d'Oncologia - L'Hospitalet ( Site 1202)

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Onkologikoa - Instituto Oncologico de San Sebastian ( Site 1203)

Doniostia - San Sebastian, Gipuzkoa, Spain

Site Status

Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1204)

Madrid, Madrid, Comunidad de, Spain

Site Status

H.R.U Málaga - Hospital General-Oncology ( Site 1201)

Málaga, Malaga, Spain

Site Status

Hospital General Universitario de Valencia ( Site 1200)

Valencia, Valenciana, Comunitat, Spain

Site Status

Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1205)

Seville, , Spain

Site Status

Länssjukhuset Ryhov-Onkologkliniken ( Site 1253)

Jönköping, Jönköping County, Sweden

Site Status

Karolinska Universitetssjukhuset Solna ( Site 1252)

Stockholm, Stockholm County, Sweden

Site Status

University Hospital Basel ( Site 1303)

Basel, Canton of Basel-City, Switzerland

Site Status

Inselspital Bern ( Site 1301)

Bern, Canton of Bern, Switzerland

Site Status

Hôpitaux Universitaires de Genève (HUG)-Oncology ( Site 1307)

Geneva, Canton of Geneva, Switzerland

Site Status

CHUV (centre hospitalier universitaire vaudois) ( Site 1304)

Lausanne, Canton of Vaud, Switzerland

Site Status

UniversitätsSpital Zürich-Dermatology ( Site 1300)

Zürich Flughafen, Canton of Zurich, Switzerland

Site Status

Ospedale Regionale Bellinzona e Valli ( Site 1308)

Bellinzona, Canton Ticino, Switzerland

Site Status

Hôpital de Sion ( Site 1305)

Sion, Valais, Switzerland

Site Status

Cantonal Hospital St.Gallen-Oncology & Hematology ( Site 1306)

Sankt Gallen, , Switzerland

Site Status

Ankara City Hospital-Medical Oncology ( Site 1357)

Çankaya, Ankara, Turkey (Türkiye)

Site Status

I.E.U. Medical Point Hastanesi-Oncology ( Site 1360)

Izmir, Karsiyaka, İzmir, Turkey (Türkiye)

Site Status

Hacettepe Universite Hastaneleri ( Site 1363)

Ankara, , Turkey (Türkiye)

Site Status

Liv Hospital Ankara-Oncology ( Site 1353)

Ankara, , Turkey (Türkiye)

Site Status

Akdeniz Universitesi Hastanesi-Medical Oncology ( Site 1355)

Antalya, , Turkey (Türkiye)

Site Status

TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1358)

Istanbul, , Turkey (Türkiye)

Site Status

Mersin Sehir Eğitim ve Araştırma Hastanesi-Oncology ( Site 1361)

Mersin, , Turkey (Türkiye)

Site Status

Ondokuz Mayıs Universitesi-Oncology department ( Site 1359)

Samsun, , Turkey (Türkiye)

Site Status

Addenbrooke's Hospital ( Site 1400)

Cambridge, Cambridgeshire, United Kingdom

Site Status

University College London Hospital ( Site 1405)

London, England, United Kingdom

Site Status

Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 1401)

London, London, City of, United Kingdom

Site Status

Countries

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

References

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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.

Reference Type DERIVED
PMID: 39230120 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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MK-7684A-010

Identifier Type: OTHER

Identifier Source: secondary_id

KEYVIBE-010

Identifier Type: OTHER

Identifier Source: secondary_id

2022-501417-31-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

jRCT2031230099

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1280-3661

Identifier Type: REGISTRY

Identifier Source: secondary_id

7684A-010

Identifier Type: -

Identifier Source: org_study_id

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