A Clinical Study of Intismeran Autogene (V940) Plus Pembrolizumab in People With High-Risk Melanoma (V940-001)
A Phase 3, Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With High-Risk Stage II-IV Melanoma (INTerpath-001)
4 other identifiers
interventional
1,089
26 countries
165
Brief Summary
The purpose of this study is to learn if intismeran autogene 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 intismeran autogene with pembrolizumab is better than receiving pembrolizumab alone at preventing the cancer from returning.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2023
Longer than P75 for phase_3
165 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
June 27, 2023
CompletedFirst Posted
Study publicly available on registry
July 6, 2023
CompletedStudy Start
First participant enrolled
July 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 26, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 26, 2030
September 24, 2025
September 1, 2025
6.3 years
June 27, 2023
September 22, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Recurrence-Free Survival (RFS)
RFS is defined as the length of time from when the participant starts the study until either the cancer comes back, or the cancer spreads as assessed by the investigator, or death due to any cause.
Up to approximately 74 months
Secondary Outcomes (7)
Distant Metastasis-Free Survival (DMFS)
Up to approximately 85 months
Overall-Survival (OS)
Up to approximately 85 months
Number of Participants Who Experience an Adverse Event (AE)
Up to approximately 68 weeks
Number of Participants Who Discontinue Study Treatment Due to an AE
Up to approximately 56 weeks
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
Baseline and up to approximately 85 months
- +2 more secondary outcomes
Study Arms (2)
Intismeran autogene + Pembrolizumab
EXPERIMENTALParticipants receive up to 9 doses of intismeran autogene 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.
Placebo + Pembrolizumab
ACTIVE COMPARATORParticipants receive up to 9 doses of dose matched placebo to intismeran autogene 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.
Interventions
IM injection
IV infusion
Eligibility Criteria
You may qualify if:
- Has surgically resected and histologically/pathologically confirmed diagnosis of Stage IIB or IIC, III, or IV cutaneous melanoma
- Has not received any prior systemic therapy for their melanoma beyond surgical resection
- No more than 13 weeks have passed between final surgical resection that rendered the participant disease-free and the first dose of pembrolizumab
- Is disease free at the time of providing documented consent for the study
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)
You may not qualify if:
- Has ocular or mucosal melanoma
- Has cancer that has spread to other parts of the body and cannot be removed with surgery
- Has heart failure within the past 6 months
- Has received prior cancer therapy or another cancer vaccine
- Has another known cancer that that has spread to other parts of the body or has required treatment within the past 3 years
- Has severe reaction to study medications or any of their substance used to prepare a drug
- Have not recovered from major surgery or have ongoing surgical complications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Merck Sharp & Dohme LLClead
- ModernaTX, Inc.collaborator
Study Sites (165)
Highlands Oncology Group ( Site 1943)
Springdale, Arkansas, 72762, United States
UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1918)
Los Angeles, California, 90095, United States
UCSF Medical Center at Mission Bay ( Site 1929)
San Francisco, California, 94158, United States
Yale-New Haven Hospital-Yale Cancer Center ( Site 1933)
New Haven, Connecticut, 06510, United States
Orlando Health Cancer Institute ( Site 1937)
Orlando, Florida, 32806, United States
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center ( Site 1945)
Tampa, Florida, 33612, United States
Winship Cancer Institute of Emory University ( Site 1940)
Atlanta, Georgia, 30322, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 1950)
Marietta, Georgia, 30060, United States
University of Iowa-Holden Comprehensive Cancer Center ( Site 1935)
Iowa City, Iowa, 52242, United States
Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Melanoma ( Site 1912)
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital ( Site 1927)
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center ( Site 1957)
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute ( Site 1956)
Boston, Massachusetts, 02215, United States
University of Michigan ( Site 1915)
Ann Arbor, Michigan, 48109, United States
Cancer and Hematology Centers of Western Michigan ( Site 1932)
Grand Rapids, Michigan, 49503, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 1944)
Hackensack, New Jersey, 07601, United States
Atlantic Health System ( Site 1925)
Morristown, New Jersey, 07960, United States
Valley Health Systems - Ridgewood Campus ( Site 1947)
Ridgewood, New Jersey, 07450, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 1958)
Mineola, New York, 11501, United States
NYU Langone Health-Perlmutter Cancer Center ( Site 1917)
New York, New York, 10016, United States
Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 1908)
New York, New York, 10032, United States
Memorial Sloan Kettering Cancer Center ( Site 1914)
New York, New York, 10065, United States
University of North Carolina Medical Center-Lineberger Comprehensive Cancer Center ( Site 1949)
Chapel Hill, North Carolina, 27599, United States
Duke Cancer Institute ( Site 1911)
Durham, North Carolina, 27710, United States
Hospital of the University of Pennsylvania Perelman Center for Advanced Medicine ( Site 1905)
Philadelphia, Pennsylvania, 19104, United States
UPMC Hillman Cancer Center ( Site 1909)
Pittsburgh, Pennsylvania, 15232, United States
Medical University of South Carolina-Hollings Cancer Center ( Site 1934)
Charleston, South Carolina, 29425, United States
Sanford Cancer Center ( Site 1951)
Sioux Falls, South Dakota, 57104, United States
SCRI Oncology Partners ( Site 1910)
Nashville, Tennessee, 37203, United States
Texas Oncology - Austin ( Site 1903)
Austin, Texas, 78731, United States
Texas Oncology - Dallas (Sammons) ( Site 1902)
Dallas, Texas, 75246, United States
University of Texas MD Anderson Cancer Center ( Site 1920)
Houston, Texas, 77030, United States
Inova Schar Cancer Institute ( Site 1900)
Fairfax, Virginia, 22031, United States
Fred Hutchinson Cancer Center ( Site 1901)
Seattle, Washington, 98109, United States
Clinica Adventista Belgrano-Oncology ( Site 2204)
Caba., Buenos Aires, C1430EGF, Argentina
Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 2202)
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1199ABB, Argentina
Instituto Alexander Fleming-Alexander Fleming ( Site 2203)
Buenos Aires, Buenos Aires F.D., 1426ANZ, Argentina
Centro Privado de RMI Río Cuarto S.A. II ( Site 2201)
Río Cuarto, Córdoba Province, X5800ALB, Argentina
Hospital Aleman ( Site 2200)
Buenos Aires, C1118AAT, Argentina
Sanatorio Finochietto ( Site 2205)
Buenos Aires, C1187AAN, Argentina
Westmead Hospital ( Site 1001)
Westmead, New South Wales, 2145, Australia
Melanoma Institute Australia-Clinical Trials Unit ( Site 1000)
Wollstonecraft, New South Wales, 2065, Australia
Princess Alexandra Hospital ( Site 1003)
Brisbane, Queensland, 4102, Australia
Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 1005)
Melbourne, Victoria, 3000, Australia
Paula Fox Melanoma & Cancer Centre ( Site 1004)
Melbourne, Victoria, 3004, Australia
One Clinical Research ( Site 1002)
Nedlands, Western Australia, 6009, Australia
UZ Brussel-Medische oncologie ( Site 3405)
Brussels, Bruxelles-Capitale, Region de, 1090, Belgium
Ziekenhuis Oost-Limburg, Campus St.-Jan ( Site 3402)
Genk, Limburg, 3600, Belgium
UZ Gent ( Site 3403)
Ghent, Oost-Vlaanderen, 9000, Belgium
UZ Leuven ( Site 3400)
Leuven, Vlaams-Brabant, 3000, Belgium
AZ Groeninge Campus Kennedylaan-Oncology ( Site 3401)
Kortrijk, West-Vlaanderen, 8500, Belgium
Centro Avançado de Tratamento Oncológico- CENANTRON ( Site 2303)
Belo Horizonte, Minas Gerais, 30130-090, Brazil
ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 2302)
Ijuí, Rio Grande do Sul, 98700-000, Brazil
Hospital Nossa Senhora da Conceição ( Site 2309)
Porto Alegre, Rio Grande do Sul, 91350-200, Brazil
Instituto Nacional de Câncer - INCA-Pesquisa Clinica HC II ( Site 2305)
Rio de Janeiro, 20220-410, Brazil
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 2300)
São Paulo, 01246-000, Brazil
Cross Cancer Institute ( Site 1104)
Edmonton, Alberta, T6G 1Z2, Canada
BC Cancer Vancouver-Clinical Trials Unit ( Site 1106)
Vancouver, British Columbia, V5Z 4E6, Canada
William Osler Health System ( Site 1105)
Brampton, Ontario, L6R 3J7, Canada
Sunnybrook Research Institute ( Site 1103)
Toronto, Ontario, M4N 3M5, Canada
Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 1102)
Toronto, Ontario, M5G 2M9, Canada
Centre Hospitalier de l'Université de Montréal-Unité de Recherche Clinique en Oncologie et Hématolo ( Site 1100)
Montreal, Quebec, H2X 0X9, Canada
Centre intégré de cancérologie du CHU de Québec Université L-Hemato-Oncology ( Site 1101)
Québec, Quebec, G1J 1Z4, Canada
FALP-UIDO ( Site 2400)
Santiago, Region M. de Santiago, 7500921, Chile
Clínica UC San Carlos de Apoquindo-Hemato-Oncology ( Site 2402)
Santiago, Region M. de Santiago, 7620002, Chile
Bradfordhill ( Site 2401)
Santiago, Region M. de Santiago, 8420383, Chile
Clinica Somer-Unidad de Investigacion y Docencia ( Site 2506)
Rionegro, Antioquia, 054040, Colombia
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 2500)
Bogotá, Bogota D.C., 111321, Colombia
IMAT S.A.S ( Site 2503)
Montería, Departamento de Córdoba, 230002, Colombia
Fundación Valle del Lili ( Site 2505)
Cali, Valle del Cauca Department, 760032, Colombia
Herlev and Gentofte Hospital ( Site 3301)
Copenhagen, Capital Region, 2730, Denmark
Aalborg Universitetshospital, Syd ( Site 3302)
Aalborg, North Denmark, 9000, Denmark
Odense Universitetshospital ( Site 3300)
Odense C, Region Syddanmark, 5000, Denmark
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Dermatology Department ( Site 1211)
Nice, Alpes-Maritimes, 06200, France
Assistance Publique Hôpitaux de Marseille - Hôpital de la Ti-Service de Dermatologie et Cancérologi ( Site 1203)
Marseille, Bouches-du-Rhone, 13385, France
Centre Georges François Leclerc ( Site 1210)
Dijon, Cote-d Or, 21079, France
CHU Besançon ( Site 1209)
Besançon, Doubs, 25030, France
CHU de Bordeaux Hop St ANDRE-Service de Dermatologie ( Site 1204)
Bordeaux, Gironde, 33075, France
Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 1206)
Rennes, Ille-et-Vilaine, 35042, France
Hopital Claude Huriez - CHU de Lille ( Site 1207)
Lille, Nord, 59037, France
centre hospitalier lyon sud-Service de dermatologie ( Site 1202)
Pierre-Bénite, Rhone, 69310, France
CHU d'Amiens-Picardie - Hôpital Sud-Dermatologie ( Site 1208)
Amiens, Somme, 80054, France
Gustave Roussy-Dermatologie ( Site 1201)
Villejuif, Val-de-Marne, 94800, France
Hôpital Saint-Louis ( Site 1200)
Paris, 75010, France
Universitätsmedizin Mannheim ( Site 1305)
Mannheim, Baden-Wurttemberg, 68167, Germany
Universitaetsklinikum Augsburg ( Site 1312)
Augsburg, Bavaria, 86156, Germany
Klinik und Poliklinik für Dermatologie und Allergologie-Dermato-oncology ( Site 1315)
München, Bavaria, 80337, Germany
Universitätsmedizin Göttingen - Georg-August-Universität-Dermatology ( Site 1308)
Göttingen, Lower Saxony, 37075, Germany
Universitätsmedizin Rostock-Klinik und Poliklinik für Dermatologie und Venerologie ( Site 1310)
Rostock, Mecklenburg-Vorpommern, 18057, Germany
Universitaetsklinikum Koeln ( Site 1307)
Cologne, North Rhine-Westphalia, 50937, Germany
Universitaetsklinikum Essen-Klinik für Dermatologie, Venerologie und Allergologie ( Site 1300)
Essen, North Rhine-Westphalia, 45147, Germany
Johannes Wesling Klinikum Minden-Skin Cancer Center Minden ( Site 1301)
Minden, North Rhine-Westphalia, 32429, Germany
Universitaetsklinikum des Saarlandes ( Site 1313)
Homburg, Saarland, 66424, Germany
SRH Wald-Klinikum Gera-Zentrum für klinische Studien ( Site 1306)
Gera, Thuringia, 07548, Germany
Charité Universitaetsmedizin Berlin - Campus Mitte-Hauttumorcentrum Charité (HTCC) ( Site 1302)
Berlin, 10115, Germany
Universitaetsklinikum Hamburg-Eppendorf ( Site 1309)
Hamburg, 20246, Germany
General Hospital of Athens "Laiko"-First Department of Internal Medicine ( Site 3700)
Athens, Attica, 115 26, Greece
Metropolitan Hospital-A' Oncology Dpt ( Site 3701)
Neo Faliro, Attica, 185 47, Greece
Bioclinic Thessalonikis Private Clinic Single Member S.A.-Oncology ( Site 3703)
Thessaloniki, Central Macedonia, 546 22, Greece
European Interbalkan Medical Center-Oncology Department ( Site 3702)
Thessaloniki, 570 01, Greece
Emek Medical Center ( Site 2003)
Afula, 1834111, Israel
Hadassah Medical Center ( Site 2004)
Jerusalem, 9112001, Israel
Rabin Medical Center ( Site 2000)
Petah Tikva, 4941492, Israel
Sheba Medical Center ( Site 2001)
Ramat Gan, 5265601, Israel
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1401)
Milan, Lombardy, 20133, Italy
Istituto Europeo di Oncologia IRCCS ( Site 1404)
Milan, Lombardy, 20141, Italy
Azienda Ospedaliero Universitaria Senese-U.O.C. Immunoterapia Oncologica ( Site 1402)
Siena, Tuscany, 53100, Italy
AO Santa Maria della Misericordia ( Site 1403)
Perugia, Umbria, 06129, Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale-s.c. melanoma, immunoterapia oncologica e terapi ( Site 1400)
Napoli, 80131, Italy
Nagoya University Hospital ( Site 4201)
Nagoya, Aichi-ken, 466-8560, Japan
Shizuoka Cancer Center ( Site 4202)
Nagaizumi-cho,Sunto-gun, Shizuoka, 411-8777, Japan
National Cancer Center Hospital ( Site 4200)
Chūō, Tokyo, 104-0045, Japan
Capital, Coast and Hutt Valley District - Wellington Regional Hospital ( Site 1502)
Newtown, Wellington Region, 6021, New Zealand
Harbour Cancer & Wellness ( Site 1500)
Auckland, 1023, New Zealand
Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 2909)
Poznan, Greater Poland Voivodeship, 60-569, Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2908)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2903)
Siedlce, Masovian Voivodeship, 08-110, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 2900)
Warsaw, Masovian Voivodeship, 02-781, Poland
Bialostockie Centrum Onkologii ( Site 2905)
Bialystok, Podlaskie Voivodeship, 15-027, Poland
Uniwersyteckie Centrum Kliniczne-Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólnej ( Site 2906)
Gdansk, Pomeranian Voivodeship, 80-214, Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2907)
Gliwice, Silesian Voivodeship, 44-101, Poland
Zachodniopomorskie Centrum Onkologii ( Site 2904)
Szczecin, West Pomeranian Voivodeship, 71-730, Poland
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Onkologii Klinicznej, Dzial Ch ( Site 2902)
Kielce, Świętokrzyskie Voivodeship, 25-734, Poland
Instituto Português de Oncologia de Lisboa Francisco Gentil ( Site 3601)
Lisbon, Lisbon District, 1099-023, Portugal
Unidade Local de Saude Lisboa Ocidental - Hospital de São Francisco Xavier ( Site 3602)
Lisbon, 1449-005, Portugal
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 3603)
Lisbon, 1649-035, Portugal
Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 3604)
Porto, 4200-072, Portugal
Medical Oncology Centre of Rosebank ( Site 4106)
Johannesburg, Gauteng, 2196, South Africa
Wilgers Oncology Centre ( Site 4103)
Pretoria, Gauteng, 0040, South Africa
Cape Town Oncology Trials ( Site 4100)
Cape Town, Western Cape, 7570, South Africa
Kyungpook National University Chilgok Hospital-Hematology/oncology ( Site 3904)
Daegu, Taegu-Kwangyokshi, 41404, South Korea
Chungnam national university hospital-Department of Internal Medicine ( Site 3903)
Daejeon, Taejon-Kwangyokshi, 35015, South Korea
Seoul National University Hospital-Oncology ( Site 3902)
Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 3901)
Seoul, 03722, South Korea
Samsung Medical Center-Division of Hematology/Oncology ( Site 3900)
Seoul, 06351, South Korea
HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Site 1600)
Barcelona, Catalonia, 08036, Spain
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1603)
Pozuelo de Alarcón, Madrid, 28223, Spain
Hospital Universitario Ramón y Cajal ( Site 1602)
Madrid, Madrid, Comunidad de, 28034, Spain
H.R.U Málaga - Hospital General-Oncology ( Site 1605)
Málaga, Malaga, 29011, Spain
HOSPITAL CLINICO DE VALENCIA ( Site 1604)
Valencia, Valenciana, Comunitat, 46010, Spain
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1601)
Barcelona, 08035, Spain
Skånes Universitetssjukhus Lund ( Site 3201)
Lund, Skåne County, 22185, Sweden
Sahlgrenska Universitetssjukhuset ( Site 3200)
Gothenburg, Västra Götaland County, 413 45, Sweden
UniversitätsSpital Zürich-Dermatology ( Site 1700)
Zürich Flughafen, Canton of Zurich, 8058, Switzerland
Kantonsspital Graubünden-Medizin ( Site 1703)
Chur, Kanton Graubünden, 7000, Switzerland
Chang Gung Memorial Hospital at Kaohsiung ( Site 4000)
Kaohsiung City, 83301, Taiwan
National Cheng Kung University Hospital-Clinical Trial Center ( Site 4004)
Tainan, 704, Taiwan
National Taiwan University Hospital ( Site 4001)
Taipei, 10002, Taiwan
Chang Gung Medical Foundation-Linkou Branch ( Site 4003)
Taoyuan District, 33305, Taiwan
Hacettepe Universite Hastaneleri ( Site 3006)
Ankara, 06230, Turkey (Türkiye)
Memorial Ankara Hastanesi-Medical Oncology ( Site 3010)
Ankara, 06520, Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 3002)
Ankara, 06800, Turkey (Türkiye)
Acibadem Universitesi Atakent Hastanesi-Medical Oncology ( Site 3008)
Istanbul, 34303, Turkey (Türkiye)
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 3003)
Istanbul, 34722, Turkey (Türkiye)
Ege University Medical Faculty Hospital ( Site 3011)
Izmir, 35100, Turkey (Türkiye)
I.E.U. Medical Point Hastanesi-Oncology ( Site 3005)
Izmir, 35575, Turkey (Türkiye)
Bristol Haematology and Oncology Centre ( Site 1811)
Bristol, Bristol, City of, BS2 8ED, United Kingdom
Addenbrooke's Hospital ( Site 1800)
Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust ( Site 1813)
Cringleford, England, NR4 7UY, United Kingdom
University College London Hospital ( Site 1807)
London, London, City of, NW1 2PG, United Kingdom
ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 1804)
London, London, City of, SW3 6JJ, United Kingdom
Western General Hospital ( Site 1806)
Edinburgh, Midlothian, EH4 2XU, United Kingdom
The Churchill Hospital ( Site 1805)
Oxford, Oxfordshire, OX3 7LE, United Kingdom
St James's University Hospital-Leeds Cancer Centre ( Site 1808)
Leeds, LS9 7TF, United Kingdom
The Christie NHS Foundation Trust ( Site 1814)
Manchester, m20 4bx, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2023
First Posted
July 6, 2023
Study Start
July 19, 2023
Primary Completion (Estimated)
October 26, 2029
Study Completion (Estimated)
September 26, 2030
Last Updated
September 24, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf