Main Menu
Main Menu
This website uses cookies that help the website function and that help us understand how you interact with it. Please read our privacy policy for more information.
The purpose of this study is to learn if V940 which is an individualized neoantigen therapy (INT; formerly, called messenger ribonucleic acid [mRNA]-4157) with pembrolizumab (MK-3475) is safe and prevents cancer from returning in people with high-risk melanoma. Researchers want to know if V940 with pembrolizumab is better than receiving pembrolizumab alone at preventing the cancer from returning.
|
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
|
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 18 Years and Over |
| Gender | All |
|
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05933577 |
|
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
|
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Merck Sharp & Dohme LLC |
|
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Medical Director |
| Principal Investigator Affiliation | Merck Sharp & Dohme LLC |
|
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Active, not recruiting |
| Countries | Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, Denmark, France, Germany, Greece, Israel, Italy, Japan, Korea, Republic of, New Zealand, Poland, Portugal, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Melanoma |
| Study Website: | View Trial Website |
Experimental: V940 + Pembrolizumab
Participants receive up to 9 doses of V940 via an intramuscular (IM) injection (every 3 weeks) plus up to 9 doses of pembrolizumab via an intravenous (IV) infusion (once every 6 weeks) until disease recurrence or unacceptable toxicity, or for a total treatment duration of up to approximately 56 weeks, whichever is sooner.
Active Comparator: Placebo + Pembrolizumab
Participants receive up to 9 doses of dose matched placebo to V940 via an IM injection (every 3 weeks) plus up to 9 doses of pembrolizumab via an IV infusion (once every 6 weeks) until disease recurrence or unacceptable toxicity, or for a total treatment duration of up to approximately 56 weeks, whichever is sooner.
Biological: - V940
IM injection
Biological: - Pembrolizumab
IV infusion
Other: - Placebo
IM injection
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Address
Highlands Oncology Group ( Site 1943)
Springdale, Arkansas, 72762
Status
Address
UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1918)
Los Angeles, California, 90095
Status
Address
UCSF Medical Center at Mission Bay ( Site 1929)
San Francisco, California, 94158
Status
Address
Yale-New Haven Hospital-Yale Cancer Center ( Site 1933)
New Haven, Connecticut, 06510
Status
Address
Orlando Health Cancer Institute ( Site 1937)
Orlando, Florida, 32806
Status
Address
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center ( Site 1945)
Tampa, Florida, 33612
Status
Address
Winship Cancer Institute of Emory University ( Site 1940)
Atlanta, Georgia, 30322
Status
Address
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 1950)
Marietta, Georgia, 30060
Status
Address
University of Iowa-Holden Comprehensive Cancer Center ( Site 1935)
Iowa City, Iowa, 52242
Status
Address
Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Melanoma ( Site 1912)
Baltimore, Maryland, 21287
Status
Address
Massachusetts General Hospital ( Site 1927)
Boston, Massachusetts, 02114
Status
Address
Beth Israel Deaconess Medical Center ( Site 1957)
Boston, Massachusetts, 02215
Status
Address
Dana-Farber Cancer Institute ( Site 1956)
Boston, Massachusetts, 02215
Status
Address
University of Michigan ( Site 1915)
Ann Arbor, Michigan, 48109
Status
Address
Cancer and Hematology Centers of Western Michigan ( Site 1932)
Grand Rapids, Michigan, 49503
Status
Address
John Theurer Cancer Center at Hackensack University Medical Center ( Site 1944)
Hackensack, New Jersey, 07601
Status
Address
Atlantic Health System ( Site 1925)
Morristown, New Jersey, 07960
Status
Address
Valley Health Systems - Ridgewood Campus ( Site 1947)
Ridgewood, New Jersey, 07450
Status
Address
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 1958)
Mineola, New York, 11501
Status
Address
NYU Langone Health-Perlmutter Cancer Center ( Site 1917)
New York, New York, 10016
Status
Address
Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical
New York, New York, 10032
Status
Address
Memorial Sloan Kettering Cancer Center ( Site 1914)
New York, New York, 10065
Status
Address
University of North Carolina Medical Center-Lineberger Comprehensive Cancer Center ( Site 1949)
Chapel Hill, North Carolina, 27599
Status
Address
Duke Cancer Institute ( Site 1911)
Durham, North Carolina, 27710
Status
Address
Hospital of the University of Pennsylvania Perelman Center for Advanced Medicine ( Site 1905)
Philadelphia, Pennsylvania, 19104
Status
Address
UPMC Hillman Cancer Center ( Site 1909)
Pittsburgh, Pennsylvania, 15232
Status
Address
Medical University of South Carolina-Hollings Cancer Center ( Site 1934)
Charleston, South Carolina, 29425
Status
Address
Sanford Cancer Center ( Site 1951)
Sioux Falls, South Dakota, 57104
Status
Address
SCRI Oncology Partners ( Site 1910)
Nashville, Tennessee, 37203
Status
Address
Texas Oncology - Austin ( Site 1903)
Austin, Texas, 78731
Status
Address
Texas Oncology - Dallas (Sammons) ( Site 1902)
Dallas, Texas, 75246
Status
Address
University of Texas MD Anderson Cancer Center ( Site 1920)
Houston, Texas, 77030
Status
Address
Inova Schar Cancer Institute ( Site 1900)
Fairfax, Virginia, 22031
Status
Address
Fred Hutchinson Cancer Center ( Site 1901)
Seattle, Washington, 98109
Status
Address
Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 2202)
Caba, Buenos Aires, C1199ABB
Status
Address
Instituto Alexander Fleming-Alexander Fleming ( Site 2203)
Ciudad Autónoma de Buenos Aires, Caba, 1426
Status
Address
Centro Privado de RMI Río Cuarto S.A. II ( Site 2201)
Río Cuarto, Cordoba, X5800ALB
Status
Address
Hospital Aleman ( Site 2200)
Buenos Aires, , C1118AAT
Status
Address
Sanatorio Finochietto ( Site 2205)
Buenos Aires, , C1187AAN
Status
Address
Clinica Adventista Belgrano-Oncology ( Site 2204)
Caba, , 1430
Status
Address
Westmead Hospital-Department of Medical Oncology ( Site 1001)
Westmead, New South Wales, 2145
Status
Address
Melanoma Institute Australia-Clinical Trials Unit ( Site 1000)
Wollstonecraft, New South Wales, 2065
Status
Address
Princess Alexandra Hospital ( Site 1003)
Brisbane, Queensland, 4102
Status
Address
Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 1005)
Melbourne, Victoria, 3000
Status
Address
Paula Fox Melanoma & Cancer Centre ( Site 1004)
Melbourne, Victoria, 3004
Status
Address
One Clinical Research ( Site 1002)
Nedlands, Western Australia, 6009
Status
Address
UZ Brussel-Medische oncologie ( Site 3405)
Brussels, Bruxelles-Capitale, Region De, 1090
Status
Address
Ziekenhuis Oost-Limburg, Campus St.-Jan ( Site 3402)
Genk, Limburg, 3600
Status
Address
UZ Gent ( Site 3403)
Gent, Oost-Vlaanderen, 9000
Status
Address
UZ Leuven ( Site 3400)
Leuven, Vlaams-Brabant, 3000
Status
Address
AZ Groeninge Campus Kennedylaan-Oncology ( Site 3401)
Kortrijk, West-Vlaanderen, 8500
Status
Address
Centro Avançado de Tratamento Oncológico- CENANTRON ( Site 2303)
Belo Horizonte, Minas Gerais, 30130-090
Status
Address
ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 2302)
Ijui, Rio Grande Do Sul, 98700-000
Status
Address
Hospital Nossa Senhora da Conceição ( Site 2309)
Porto Alegre, Rio Grande Do Sul, 91350-200
Status
Address
Instituto Nacional de Câncer - INCA-Pesquisa Clinica HC II ( Site 2305)
Rio de Janeiro, , 20220-410
Status
Address
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 2300)
Sao Paulo, , 01246-000
Status
Address
Cross Cancer Institute ( Site 1104)
Edmonton, Alberta, T6G 1Z2
Status
Address
BC Cancer Vancouver-Clinical Trials Unit ( Site 1106)
Vancouver, British Columbia, V5Z 4E6
Status
Address
William Osler Health System ( Site 1105)
Brampton, Ontario, L6R 3J7
Status
Address
Sunnybrook Research Institute ( Site 1103)
Toronto, Ontario, M4N 3M5
Status
Address
Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 1102)
Toronto, Ontario, M5G 2M9
Status
Address
Centre Hospitalier de l'Université de Montréal-Unité de Recherche Clinique en Oncologie et Hématolo
Montréal, Quebec, H2X 0X9
Status
Address
Centre intégré de cancérologie du CHU de Québec Université L-Hemato-Oncology ( Site 1101)
Quebec City, Quebec, G1J 1Z4
Status
Address
FALP-UIDO ( Site 2400)
Santiago, Region M. De Santiago, 7500921
Status
Address
Clínica UC San Carlos de Apoquindo-Hemato-Oncology ( Site 2402)
Santiago, Region M. De Santiago, 7620002
Status
Address
Bradfordhill ( Site 2401)
Santiago, Region M. De Santiago, 8420383
Status
Address
Clinica Somer-Unidad de Investigacion y Docencia ( Site 2506)
Rionegro, Antioquia, 054040
Status
Address
Oncomedica S.A.S ( Site 2503)
Montería, Cordoba, 230002
Status
Address
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 2500)
Bogota, Distrito Capital De Bogota, 111321
Status
Address
Fundación Valle del Lili ( Site 2505)
Cali, Valle Del Cauca, 760032
Status
Address
Herlev and Gentofte Hospital ( Site 3301)
Copenhagen, Hovedstaden, 2730
Status
Address
Aalborg Universitetshospital, Syd ( Site 3302)
Aalborg, Nordjylland, 9000
Status
Address
Odense Universitetshospital ( Site 3300)
Odense C, Syddanmark, 5000
Status
Address
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Dermatology Department ( Site 1211)
Nice cedex 3, Alpes-Maritimes, 06200
Status
Address
Assistance Publique Hôpitaux de Marseille - Hôpital de la Ti-Service de Dermatologie et Cancérologi
Marseille, Bouches-du-Rhone, 13385
Status
Address
Centre Georges François Leclerc ( Site 1210)
Dijon, Cote-d Or, 21079
Status
Address
CHU Besançon ( Site 1209)
Besançon, Doubs, 25030
Status
Address
CHU de Bordeaux Hop St ANDRE-Service de Dermatologie ( Site 1204)
Bordeaux, Gironde, 33075
Status
Address
Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 1206)
Rennes, Ille-et-Vilaine, 35042
Status
Address
Hopital Claude Huriez - CHU de Lille ( Site 1207)
Lille, Nord, 59037
Status
Address
centre hospitalier lyon sud-Service de dermatologie ( Site 1202)
Pierre-Bénite, Rhone, 69310
Status
Address
CHU d'Amiens-Picardie - Hôpital Sud-Dermatologie ( Site 1208)
Amiens, Somme, 80054
Status
Address
Gustave Roussy-Dermatologie ( Site 1201)
Villejuif, Val-de-Marne, 94800
Status
Address
Hôpital Saint-Louis ( Site 1200)
Paris, , 75010
Status
Address
Universitätsmedizin Mannheim ( Site 1305)
Mannheim, Baden-Wurttemberg, 68167
Status
Address
Universitaetsklinikum Augsburg ( Site 1312)
Augsburg, Bayern, 86156
Status
Address
Klinik und Poliklinik für Dermatologie und Allergologie-Dermato-oncology ( Site 1315)
München, Bayern, 80337
Status
Address
Universitätsmedizin Rostock-Klinik und Poliklinik für Dermatologie und Venerologie ( Site 1310)
Rostock, Mecklenburg-Vorpommern, 18057
Status
Address
Universitätsmedizin Göttingen - Georg-August-Universität-Dermatology ( Site 1308)
Göttingen, Niedersachsen, 37075
Status
Address
Universitaetsklinikum Essen-Klinik für Dermatologie, Venerologie und Allergologie ( Site 1300)
Essen, Nordrhein-Westfalen, 45147
Status
Address
Universitaetsklinikum Koeln ( Site 1307)
Köln, Nordrhein-Westfalen, 50937
Status
Address
Johannes Wesling Klinikum Minden-Skin Cancer Center Minden ( Site 1301)
Minden, Nordrhein-Westfalen, 32429
Status
Address
Universitaetsklinikum des Saarlandes ( Site 1313)
Homburg, Saarland, 66424
Status
Address
SRH Wald-Klinikum Gera-Zentrum für klinische Studien ( Site 1306)
Gera, Thuringen, 07548
Status
Address
Charité Universitaetsmedizin Berlin - Campus Mitte-Hauttumorcentrum Charité (HTCC) ( Site 1302)
Berlin, , 10115
Status
Address
Universitaetsklinikum Hamburg-Eppendorf ( Site 1309)
Hamburg, , 20246
Status
Address
General Hospital of Athens "Laiko"-First Department of Internal Medicine ( Site 3700)
Athens, Attiki, 115 26
Status
Address
Metropolitan Hospital-A' Oncology Dpt ( Site 3701)
Neo Faliro, Attiki, 185 47
Status
Address
Bioclinic Thessalonikis Private Clinic Single Member S.A.-Oncology ( Site 3703)
Thessaloniki, Kentriki Makedonia, 546 22
Status
Address
European Interbalkan Medical Center-Oncology Department ( Site 3702)
Thessaloniki, , 57001
Status
Address
Emek Medical Center ( Site 2003)
Afula, , 1834111
Status
Address
Hadassah Medical Center ( Site 2004)
Jerusalem, , 9112001
Status
Address
Rabin Medical Center ( Site 2000)
Petah Tikva, , 4941492
Status
Address
Sheba Medical Center ( Site 2001)
Ramat Gan, , 5265601
Status
Address
Istituto Europeo di Oncologia IRCCS ( Site 1404)
Milano, Lombardia, 20141
Status
Address
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1401)
Milan, Lombardia, 20133
Status
Address
Azienda Ospedaliero Universitaria Senese-U.O.C. Immunoterapia Oncologica ( Site 1402)
Siena, Toscana, 53100
Status
Address
AO Santa Maria della Misericordia ( Site 1403)
Perugia, Umbria, 06129
Status
Address
Istituto Nazionale Tumori IRCCS Fondazione Pascale-s.c. melanoma, immunoterapia oncologica e terapi
Napoli, , 80131
Status
Address
Nagoya University Hospital ( Site 4201)
Nagoya, Aichi, 466-8560
Status
Address
Shizuoka Cancer Center ( Site 4202)
Nagaizumi-cho,Sunto-gun, Shizuoka, 411-8777
Status
Address
National Cancer Center Hospital ( Site 4200)
Chuo, Tokyo, 104-0045
Status
Address
Kyungpook National University Chilgok Hospital-Hematology/oncology ( Site 3904)
Daegu, Taegu-Kwangyokshi, 41404
Status
Address
Chungnam national university hospital-Department of Internal Medicine ( Site 3903)
Daejeon, Taejon-Kwangyokshi, 35015
Status
Address
Seoul National University Hospital-Oncology ( Site 3902)
Seoul, , 03080
Status
Address
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 3901)
Seoul, , 03722
Status
Address
Samsung Medical Center-Division of Hematology/Oncology ( Site 3900)
Seoul, , 06351
Status
Address
Capital, Coast and Hutt Valley District - Wellington Regional Hospital ( Site 1502)
Newtown, Wellington, 6021
Status
Address
Harbour Cancer & Wellness ( Site 1500)
Auckland, , 1023
Status
Address
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2908)
Bydgoszcz, Kujawsko-pomorskie, 85-796
Status
Address
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2903)
Siedlce, Mazowieckie, 08-110
Status
Address
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
Warszawa, Mazowieckie, 02-781
Status
Address
Bialostockie Centrum Onkologii ( Site 2905)
Bialystok, Podlaskie, 15-027
Status
Address
Uniwersyteckie Centrum Kliniczne-Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólnej ( Site
Gdańsk, Pomorskie, 80-214
Status
Address
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2907)
Gliwice, Slaskie, 44-101
Status
Address
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Onkologii Klinicznej, Dzial Ch
Kielce, Swietokrzyskie, 25-734
Status
Address
Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 2909)
Poznan, Wielkopolskie, 60-569
Status
Address
Zachodniopomorskie Centrum Onkologii ( Site 2904)
Szczecin, Zachodniopomorskie, 71-730
Status
Address
Instituto Português de Oncologia de Lisboa Francisco Gentil ( Site 3601)
Lisbon, Lisboa, 1099-023
Status
Address
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 3603)
Lisbon, Lisboa, 1649-035
Status
Address
Unidade Local de Saude Lisboa Ocidental - Hospital de São Francisco Xavier ( Site 3602)
Lisboa, , 1449-005
Status
Address
Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 3604)
Porto, , 4200-072
Status
Address
Medical Oncology Centre of Rosebank ( Site 4106)
Johannesburg, Gauteng, 2196
Status
Address
Wilgers Oncology Centre ( Site 4103)
Pretoria, Gauteng, 0040
Status
Address
Cape Town Oncology Trials ( Site 4100)
Cape Town, Western Cape, 7570
Status
Address
HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Sit
Barcelona, Cataluna, 08036
Status
Address
Hospital Universitario Ramón y Cajal ( Site 1602)
Madrid, Madrid, Comunidad De, 28034
Status
Address
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1603)
Pozuelo de Alarcon, Madrid, 28223
Status
Address
H.R.U Málaga - Hospital General-Oncology ( Site 1605)
Málaga, Malaga, 29011
Status
Address
HOSPITAL CLINICO DE VALENCIA ( Site 1604)
Valencia, Valenciana, Comunitat, 46010
Status
Address
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1601)
Barcelona, , 08035
Status
Address
Skånes Universitetssjukhus Lund ( Site 3201)
Lund, Skane Lan, 22185
Status
Address
Sahlgrenska Universitetssjukhuset ( Site 3200)
Gothenburg, Vastra Gotalands Lan, 413 45
Status
Address
Kantonsspital Graubünden-Medizin ( Site 1703)
Chur, Grisons, 7000
Status
Address
UniversitätsSpital Zürich-Dermatology ( Site 1700)
Zürich Flughafen, Zurich, 8058
Status
Address
Chang Gung Memorial Hospital at Kaohsiung (Site 4000)
Kaohsiung, , 83301
Status
Address
National Cheng Kung University Hospital-Clinical Trial Center ( Site 4004)
Tainan, , 704
Status
Address
National Taiwan University Hospital (Site 4001)
Taipei, , 10002
Status
Address
Chang Gung Medical Foundation-Linkou Branch ( Site 4003)
Taoyuan, , 33305
Status
Address
Hacettepe Universite Hastaneleri ( Site 3006)
Ankara, , 06230
Status
Address
Memorial Ankara Hastanesi-Medical Oncology ( Site 3010)
Ankara, , 06520
Status
Address
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 3002)
Ankara, , 06800
Status
Address
Acibadem Universitesi Atakent Hastanesi-Medical Oncology ( Site 3008)
Istanbul, , 34303
Status
Address
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 3003)
Istanbul, , 34722
Status
Address
Ege University Medical Faculty Hospital ( Site 3011)
Izmir, , 35100
Status
Address
I.E.U. Medical Point Hastanesi-Oncology ( Site 3005)
Izmir, , 35575
Status
Address
Bristol Haematology and Oncology Centre ( Site 1811)
Bristol, Bristol, City Of, BS2 8ED
Status
Address
Addenbrooke's Hospital ( Site 1800)
Cambridge, Cambridgeshire, CB2 2QQ
Status
Address
Norfolk and Norwich University Hospitals NHS Foundation Trust ( Site 1813)
Cringleford, England, NR4 7UY
Status
Address
ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 1804)
London, Kensington And Chelsea, SW3 6JJ
Status
Address
University College London Hospital ( Site 1807)
London, London, City Of, NW1 2PG
Status
Address
Western General Hospital ( Site 1806)
Edinburgh, Midlothian, EH4 2XU
Status
Address
The Churchill Hospital ( Site 1805)
Oxford, Oxfordshire, OX3 7LE
Status
Address
St James's University Hospital-Leeds Cancer Centre ( Site 1808)
Leeds, , LS9 7TF
Status
Address
The Christie NHS Foundation Trust ( Site 1814)
Manchester, , m20 4bx
