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 Resected Stage II, IIIA, IIIB (N2) Non-small Cell Lung Cancer (INTerpath-002)
Status: Recruiting
Location: See all (208) locations...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The goal of this study is to evaluate intismeran autogene plus pembrolizumab versus placebo plus pembrolizumab for the adjuvant treatment of margin negative, completely resected Stage II, IIIA, IIIB (with nodal involvement \[N2\]) non-small cell lung cancer (NSCLC). The primary hypothesis is that intismeran autogene plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ The main inclusion criteria include but are not limited to the following:
• Has undergone margin negative, completely resected non-small cell lung cancer (NSCLC), and has pathological Stage II, IIIA, IIIB (N2) squamous or nonsquamous tumor, node, metastasis (TNM) staging per American Joint Committee on Cancer (AJCC) Eighth Edition guidelines.
• Has no evidence of disease before randomization.
• Has received at least one dose of adjuvant treatment with standard of care platinum doublet chemotherapy.
• No more than 24 weeks have elapsed between surgical resection of curative intent and the first dose of pembrolizumab.
• 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 prior to randomization.
• Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.
• Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART).
Locations
United States
Alaska
Alaska Oncology and Hematology ( Site 0039)
RECRUITING
Anchorage
Arizona
The University of Arizona Cancer Center - North Campus ( Site 0071)
RECRUITING
Tucson
YUMA REGIONAL MEDICAL CENTER CANCER CENTER ( Site 0020)
COMPLETED
Yuma
California
UCLA Clinical & Translational Research Center (CTRC) ( Site 0059)
RECRUITING
Los Angeles
Hoag Memorial Hospital Presbyterian ( Site 4042)
RECRUITING
Newport Beach
Hoag Memorial Hospital Presbyterian ( Site 4048)
RECRUITING
Newport Beach
St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 0074)
RECRUITING
Orange
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0030)
RECRUITING
Orange
Colorado
UCHealth Memorial Hospital-Heme Onc ( Site 0052)
COMPLETED
Colorado Springs
Florida
Mayo Clinic Florida ( Site 4043)
RECRUITING
Jacksonville
Mid Florida Hematology and Oncology Center ( Site 0014)
RECRUITING
Orange City
AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0013)
RECRUITING
Orlando
Moffitt Cancer Center ( Site 0078)
RECRUITING
Tampa
Georgia
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0012)
COMPLETED
Marietta
Southeastern Regional Medical Center ( Site 0098)
RECRUITING
Newnan
Iowa
University of Iowa-Holden Comprehensive Cancer Center ( Site 0062)
RECRUITING
Iowa City
Idaho
Beacon Cancer Care ( Site 0044)
COMPLETED
Post Falls
Kentucky
Saint Elizabeth Healthcare ( Site 0092)
RECRUITING
Edgewood
The University of Louisville, James Graham Brown Cancer Center ( Site 0037)
RECRUITING
Louisville
Michigan
University of Michigan Clinical Trials Office ( Site 0058)
RECRUITING
Ann Arbor
Cancer and Hematology Centers of Western Michigan ( Site 4003)
RECRUITING
Grand Rapids
Montana
St. Vincent Frontier Cancer Center ( Site 0043)
COMPLETED
Billings
North Dakota
Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0063)
RECRUITING
Fargo
Altru Health System ( Site 0040)
RECRUITING
Grand Forks
Nebraska
NHO Revive Research Institute, LLC ( Site 4009)
RECRUITING
Lincoln
New Jersey
Memorial Sloan Kettering - Basking Ridge ( Site 4056)
RECRUITING
Basking Ridge
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0036)
RECRUITING
Hackensack
Memorial Sloan Kettering - Monmouth ( Site 4057)
RECRUITING
Middletown
Memorial Sloan Kettering - Bergen ( Site 4059)
RECRUITING
Montvale
Atlantic Health Morristown Medical Center ( Site 4018)
RECRUITING
Morristown
New York
New York Oncology Hematology, P.C. ( Site 4012)
RECRUITING
Albany
Memorial Sloan-Kettering Cancer Center at Commack ( Site 4055)
RECRUITING
Commack
Memorial Sloan Kettering - Westchester ( Site 4058)
RECRUITING
Harrison
Perlmutter Cancer Center at NYU Langone Hospital - Long Island-Clinical Research Department ( Site 0095)
RECRUITING
Mineola
Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 0054)
COMPLETED
New York
Icahn School of Medicine at Mount Sinai ( Site 0034)
RECRUITING
New York
Laura and Isaac Perlmutter Cancer Center ( Site 0010)
RECRUITING
New York
Memorial Sloan Kettering Cancer Center ( Site 0029)
RECRUITING
New York
The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 4053)
RECRUITING
New York
Stony Brook University-Cancer Center ( Site 0072)
RECRUITING
Stony Brook
Montefiore Medical Center- Montefiore Medical Park-Oncology ( Site 0080)
RECRUITING
The Bronx
Memorial Sloan Kettering - Nassau ( Site 4060)
RECRUITING
Uniondale
Ohio
Summa Health ( Site 4011)
RECRUITING
Akron
University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0028)
RECRUITING
Cincinnati
University Hospitals Cleveland Medical Center ( Site 0023)
RECRUITING
Cleveland
OSU Brain and Spine Hospital ( Site 0016)
RECRUITING
Columbus
Oregon
Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0082)
RECRUITING
Corvallis
Pennsylvania
Thomas Jefferson University - Clinical Research Institute ( Site 0006)
RECRUITING
Philadelphia
South Carolina
Medical University of South Carolina-Hollings Cancer Center ( Site 0050)
RECRUITING
Charleston
South Dakota
Sanford Cancer Center ( Site 0075)
COMPLETED
Sioux Falls
Tennessee
Thompson Cancer Survival Center ( Site 0097)
RECRUITING
Knoxville
One Oncology - Tennessee Oncology ( Site 4019)
RECRUITING
Nashville
SCRI Oncology Partners ( Site 7001)
RECRUITING
Nashville
Texas
UT Southwestern Medical Center ( Site 0061)
RECRUITING
Dallas
Virginia
Inova Schar Cancer Institute ( Site 0003)
RECRUITING
Fairfax
Virginia Cancer Specialists (VCS) ( Site 4004)
RECRUITING
Fairfax
Washington
Fred Hutchinson Cancer Center ( Site 0002)
RECRUITING
Seattle
Swedish Medical Center-Swedish Cancer Institute ( Site 0088)
RECRUITING
Seattle
West Virginia
Edwards Comprehensive Cancer Center ( Site 4015)
RECRUITING
Huntington
Other Locations
Argentina
Clinica Adventista Belgrano-Oncology ( Site 2901)
RECRUITING
Caba.
Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 2912)
RECRUITING
Ciudad Autonoma De Buenos Aires
Instituto Alexander Fleming ( Site 2911)
RECRUITING
Ciudad Autónoma De Buenos Aires
Instituto de Investigaciones Clínicas Mar del Plata ( Site 2908)
RECRUITING
Mar Del Plata
Fundacion Estudios Clinicos-Oncology ( Site 2907)
RECRUITING
Rosario
Sanatorio Parque ( Site 2904)
RECRUITING
Rosario
Australia
Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0203)
RECRUITING
Melbourne
St Vincent's Hospital-Oncology Clinical Trials ( Site 0202)
RECRUITING
Melbourne
One Clinical Research ( Site 0200)
RECRUITING
Nedlands
Belgium
AZORG Campus Aalst-Moorselbaan ( Site 0604)
RECRUITING
Aalst
Antwerp University Hospital-Thoracic Oncology ( Site 0603)
RECRUITING
Edegem
VITAZ ( Site 0600)
RECRUITING
Sint-niklaas
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godi ( Site 0602)
RECRUITING
Yvoir
Brazil
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 3004)
RECRUITING
Barretos
CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA-Pesquisa Clínica ( Site 3007)
RECRUITING
Fortaleza
Liga Norte Riograndense Contra o Câncer ( Site 3001)
RECRUITING
Natal
Hospital Nossa Senhora da Conceição ( Site 3002)
RECRUITING
Porto Alegre
Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 3003)
RECRUITING
Porto Alegre
Instituto Nacional de Câncer - INCA ( Site 3000)
RECRUITING
Rio De Janeiro
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 3013)
RECRUITING
São José Do Rio Preto
Hospital Samaritano De Sao Paulo ( Site 3006)
RECRUITING
São Paulo
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 3005)
RECRUITING
São Paulo
Canada
William Osler Health System ( Site 0101)
RECRUITING
Brampton
Cross Cancer Institute ( Site 0105)
RECRUITING
Edmonton
Centre Hospitalier de l'Université de Montréal ( Site 0104)
RECRUITING
Montreal
McGill University Health Centre ( Site 0100)
RECRUITING
Montreal
Princess Margaret Cancer Centre ( Site 0102)
RECRUITING
Toronto
Chile
Bradfordhill-Clinical Area ( Site 3103)
RECRUITING
Santiago
FALP-UIDO ( Site 3100)
RECRUITING
Santiago
Orlandi Oncologia-Oncology ( Site 3102)
RECRUITING
Santiago
Pontificia Universidad Catolica de Chile ( Site 3104)
RECRUITING
Santiago
ONCOCENTRO APYS ( Site 3105)
RECRUITING
Viña Del Mar
Costa Rica
CIMCA ( Site 3300)
RECRUITING
San José
ICIMED ( Site 3301)
RECRUITING
San José
Denmark
Rigshospitalet ( Site 0801)
RECRUITING
Copenhagen
Odense Universitetshospital ( Site 0800)
RECRUITING
Odense C
Estonia
North Estonia Medical Centre Foundation-Chemotherapy ( Site 0901)
RECRUITING
Tallinn
Tartu University Hospital-Radiotherapy and oncology ( Site 0900)
RECRUITING
Tartu
Finland
Oulun yliopistollinen sairaala-Oncology and Hematology ( Site 1003)
RECRUITING
Oulu
Tampereen yliopistollinen sairaala-Oncology ( Site 1001)
RECRUITING
Tampere
Turku University Hospital-The Department of Pulmonary Medicine ( Site 1000)
RECRUITING
Turku
Vaasan Keskussairaala-Department of Clinical Oncology ( Site 1004)
RECRUITING
Vaasa
France
Institut de Cancérologie de l'Ouest ( Site 1101)
RECRUITING
Angers
Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre ( Site 1107)
RECRUITING
Caen
CHU GABRIEL MONTPIED ( Site 1105)
RECRUITING
Clermont-ferrand
Assistance Publique Hôpitaux de Marseille - Hôpital Nord ( Site 1108)
RECRUITING
Marseille
Hôpital Arnaud de Villeneuve - CHU Montpellier ( Site 1102)
RECRUITING
Montpellier
Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 1104)
RECRUITING
Paris
CHU Bordeaux Haut-Leveque ( Site 1106)
RECRUITING
Pessac
Nouvel Hôpital Civil (NHC)-Service de pneumologie ( Site 1100)
RECRUITING
Strasbourg
Germany
Helios Klinikum Emil von Behring Berlin-Zehlendorf-Lungenklinik Heckeshorn ( Site 1208)
RECRUITING
Berlin
Augusta-Kranken-Anstalt ( Site 1213)
RECRUITING
Bochum
Klinikum Esslingen-Klinik für Kardiologie und Pneumologie ( Site 1201)
RECRUITING
Esslingen Am Neckar
Asklepios Klinik Gauting GmbH-Oncology ( Site 1209)
RECRUITING
Gauting
SRH Wald-Klinikum Gera-Lungenkrebszentrum ( Site 1200)
RECRUITING
Gera
Klinikverbund Allgäu gGmbH ( Site 1205)
RECRUITING
Kempten (allgäu)
Gemeinschaftspraxis für Hämatologie und Onkologie Münster ( Site 1202)
RECRUITING
Münster
Brüderkrankenhaus St. Josef Paderborn-Klinik für Hämatologie und Onkologie ( Site 1214)
RECRUITING
Paderborn
Universitaetsklinikum Regensburg ( Site 1204)
RECRUITING
Regensburg
Greece
Errikos Dunant Hospital Center-Fourth Department of Oncology and Clinical Trials Unit ( Site 1301)
RECRUITING
Athens
THORACIC GENERAL HOSPITAL OF ATHENS I SOTIRIA-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 1300)
RECRUITING
Athens
European Interbalkan Medical Center-Oncology Department ( Site 1302)
RECRUITING
Thessaloniki
Hungary
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz - Pulmonologia Osztaly ( Site 1404)
RECRUITING
Győr
Somogy Varmegyei Kaposi Mor Oktato Korhaz -Onkologiai Kozpont ( Site 1407)
RECRUITING
Kaposvár
Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 1401)
RECRUITING
Kecskemét
Pécsi Tudományegyetem Klinikai Központ-Onkoterápiás Intézet ( Site 1402)
RECRUITING
Pécs
Reformatus Pulmonologiai Centrum ( Site 1405)
RECRUITING
Törökbálint
Ireland
Tallaght University Hospital ( Site 3903)
RECRUITING
Dublin
Italy
CRO-IRCCS-Clinical Oncology ( Site 1510)
RECRUITING
Aviano
Instituto Tumori Giovanni Paolo II-SSD Oncologia Medica per la Patologia Toracica ( Site 1507)
RECRUITING
Bari
POLICLINICO G. RODOLICO-UOC Oncologia Medica ( Site 1503)
RECRUITING
Catania
Azienda Ospedaliera Santa Croce e Carle ( Site 1500)
RECRUITING
Cuneo
ASST Grande Ospedale Metropolitano Niguarda-Oncologia Falck ( Site 1511)
RECRUITING
Milan
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1504)
RECRUITING
Milan
A.O.R.N. Ospedale dei Colli - Monaldi V.-U.O.C Pneumologia Oncologica DH PNL ONC ( Site 1508)
RECRUITING
Naples
Azienda Ospedaliero Universitaria Maggiore della Carità ( Site 1502)
RECRUITING
Novara
AO Santa Maria della Misericordia-Oncology Department ( Site 1501)
RECRUITING
Perugia
P.O. S. Maria della Misericordia Azienda Sanitaria Univers-Oncology Department ( Site 1506)
RECRUITING
Udine
Japan
Kansai Medical University Hospital ( Site 3806)
RECRUITING
Hirakata
Hiroshima University Hospital ( Site 3804)
RECRUITING
Hiroshima
National Cancer Center Hospital East ( Site 3800)
RECRUITING
Kashiwa
St. Marianna University Hospital ( Site 3802)
RECRUITING
Kawasaki
Okayama University Hospital ( Site 3807)
RECRUITING
Okayama
Kindai University Hospital ( Site 3803)
RECRUITING
Sayama
Sendai Kousei Hospital ( Site 3805)
RECRUITING
Sendai
Kanagawa Cancer Center ( Site 3801)
RECRUITING
Yokohama
Latvia
RIGA EAST UNIVERSITY HOSPITAL ,Oncology Centre of Latvia ( Site 1600)
RECRUITING
Riga
Lithuania
Hospital of Lithuanian University of Health Sciences Kauno klinikos-Pulmonology ( Site 1701)
RECRUITING
Kaunas
Vilnius University Hospital Santaros Clinics Affiliate - National Cancer Center ( Site 1700)
RECRUITING
Vilnius
Malaysia
Hospital Pulau Pinang ( Site 3505)
RECRUITING
George Town
Hospital Tengku Ampuan Afzan ( Site 3504)
RECRUITING
Kuantan
Sarawak General Hospital ( Site 3500)
RECRUITING
Kuching
University Malaya Medical Centre ( Site 3502)
RECRUITING
Lembah Pantai
National Cancer Institute-Radiotherapy and Oncology ( Site 3506)
RECRUITING
Putrajaya
Mexico
Mediadvance Clinical ( Site 3404)
RECRUITING
Chihuahua City
Unidad de Mastologia Avanzada de Chihuahua S.A de C.V ( Site 3402)
RECRUITING
Chihuahua City
CIO - Centro de Inmuno-Oncología de Occidente ( Site 3403)
RECRUITING
Guadalajara
Hospital Universitario Dr. Jose Eleuterio Gonzalez-Hematologia and Oncologia ( Site 3408)
RECRUITING
Monterrey
Centro de Investigacion Clinica de Oaxaca ( Site 3401)
RECRUITING
Oaxaca City
Oaxaca Site Management Organization S.C. ( Site 3407)
RECRUITING
Oaxaca City
New Zealand
Harbour Cancer & Wellness ( Site 0301)
RECRUITING
Auckland
New Zealand Clinical Research (Christchurch) ( Site 0300)
COMPLETED
Christchurch
Norway
Drammen Sykehus, Vestre Viken HF ( Site 1903)
RECRUITING
Drammen
Akershus Universitetssykehus-Avdeling for lungesykdommer ( Site 1900)
RECRUITING
Lørenskog
Stavanger Universitetssykehus ( Site 1901)
RECRUITING
Stavanger
Philippines
Metro Davao Medical and Research Center ( Site 3602)
RECRUITING
Davao City
ST. LUKE'S MEDICAL CENTER ( Site 3606)
RECRUITING
Quezon City
CARDINAL SANTOS MEDICAL CENTER-Research Room ( Site 3601)
RECRUITING
San Juan City, Metro Manila
Poland
Bialostockie Centrum Onkologii ( Site 2005)
RECRUITING
Bialystok
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2003)
RECRUITING
Bydgoszcz
Uniwersyteckie Centrum Kliniczne ( Site 2013)
RECRUITING
Gdansk
Krakowski Szpital Specjalistyczny im. Jana Pawła II-Oddział Kliniczny Chirurgii Klatki Piersiowej i ( Site 2011)
RECRUITING
Krakow
Warmińsko - Mazurskie Centrum Chorób Płuc w Olsztynie-Oddzial Onkologii z Pododdzialem Chemioterapii ( Site 2008)
RECRUITING
Olsztyn
Wielkopolskie Centrum Pulmonologii i Torakochirurgii-Oddzial Onkologii Klinicznej z Pododdzialem Dz ( Site 2002)
RECRUITING
Poznan
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 2001)
RECRUITING
Przemyśl
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 2000)
RECRUITING
Warsaw
Portugal
Unidade Local de Saude de Santa Maria - Hospital Pulido Valente ( Site 2703)
RECRUITING
Lisbon
Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 2702)
RECRUITING
Porto
Republic of Korea
Chungbuk National University Hospital-Internal medicine ( Site 0402)
RECRUITING
Cheongju-si
Keimyung University Dongsan Hospital CRC room 1 ( Site 0407)
RECRUITING
Daegu
National Cancer Center-Lung Cancer Center ( Site 0403)
RECRUITING
Goyang-si
Seoul National University Bundang Hospital-Medical Oncology ( Site 0404)
RECRUITING
Seongnam
Asan Medical Center-Department of Oncology ( Site 0405)
RECRUITING
Seoul
Samsung Medical Center ( Site 0401)
RECRUITING
Seoul
Seoul National University Hospital ( Site 0400)
RECRUITING
Seoul
The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 0406)
RECRUITING
Suwon
Slovakia
Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica ( Site 2202)
RECRUITING
Banská Bystrica
Univerzitná nemocnica Bratislava - Nemocnica Ružinov ( Site 2201)
RECRUITING
Bratislava
Vychodoslovensky Onkologicky ustav a.s. ( Site 2200)
RECRUITING
Košice
Spain
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2400)
RECRUITING
Barcelona
Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2401)
RECRUITING
L'hospitalet De Llobregat
HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA-Medical Oncology ( Site 2403)
RECRUITING
Majadahonda
Hospital Quirón Málaga ( Site 2405)
RECRUITING
Málaga
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2402)
RECRUITING
Pozuelo De Alarcón
Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 2404)
RECRUITING
Seville
Taiwan
Changhua Christian Hospital ( Site 0504)
RECRUITING
Changhua
National Taiwan University Hospital - Hsinchu branch ( Site 0501)
RECRUITING
Hsinchu
Taichung Veterans General Hospital-Chest ( Site 0503)
RECRUITING
Taichung
National Cheng Kung University Hospital-Clinical Trial Center ( Site 0505)
RECRUITING
Tainan City
National Taiwan University Hospital-Oncology ( Site 0506)
RECRUITING
Taipei
Taipei Medical University Hospital ( Site 0502)
RECRUITING
Taipei
National Taiwan University Cancer Center (NTUCC) ( Site 0500)
RECRUITING
Taipei City
Turkey
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 2101)
RECRUITING
Ankara
Hacettepe Universite Hastaneleri-oncology hospital ( Site 2100)
RECRUITING
Ankara
Liv Hospital Ankara-Oncology ( Site 2104)
RECRUITING
Ankara
Memorial Ankara Hastanesi-Medical Oncology ( Site 2103)
RECRUITING
Ankara
Ege Universitesi Hastanesi-Chest Diseases Department ( Site 2107)
RECRUITING
Bornova
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2102)
RECRUITING
Istanbul
Medipol Mega Universite Hastanesi-oncology ( Site 2105)
RECRUITING
Stanbul
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2023-12-06
Estimated Completion Date: 2035-12-21
Participants
Target number of participants: 868
Treatments
Experimental: Intismeran autogene + Pembrolizumab
Participants will receive 1 mg of intismeran autogene via intramuscular (IM) injection once every 3 weeks for 9 doses PLUS 400 mg of pembrolizumab via intravenous (IV) infusion once every 6 weeks for up to 9 doses until disease recurrence or unacceptable toxicity or for a total treatment duration of up to approximately 1 year, whichever is sooner.
Active_comparator: Placebo + Pembrolizumab
Participants will receive intismeran autogene-matched placebo via IM injection once every 3 weeks for 9 doses PLUS 400 mg of pembrolizumab via IV infusion once every 6 weeks for up to 9 doses until disease recurrence or unacceptable toxicity or for a total treatment duration of up to approximately 1 year, whichever is sooner.
Related Therapeutic Areas
Sponsors
Collaborators: ModernaTX, Inc.
Leads: Merck Sharp & Dohme LLC