Clinical trial • Phase III • Oncology

MRNA-4157 for Non-small cell lung cancer | Resectable non-small cell lung cancer

Phase III trial of MRNA-4157 for Non-small cell lung cancer | Resectable non-small cell lung cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-small cell lung cancer | Resectable non-small cell lung cancer
Trial Stage
Phase III
Drug Modality
mRNA | Monoclonal antibody | Small molecule

Key dates

Initial CTIS Submission Date
30-07-2024
First CTIS Authorization Date
18-11-2024

Trial design

Randomised, placebo plus pembrolizumab (placebo for mrna-4157 + pembrolizumab intravenous infusion); comparator arm is placebo for mrna-4157 plus pembrolizumab (details: placebo for mrna-4157 listed as product 'placebo for mrna-4157'; pembrolizumab product keytruda 25 mg/ml concentrate for solution for infusion is used in study).-controlled Phase III trial in Poland, Sweden, Ireland and others.

Randomised
Yes
Comparator
Placebo plus pembrolizumab (placebo for mRNA-4157 + pembrolizumab intravenous infusion); comparator arm is placebo for mRNA-4157 plus pembrolizumab (details: placebo for mRNA-4157 listed as product 'placebo for mRNA-4157'; pembrolizumab product KEYTRUDA 25 mg/mL concentrate for solution for infusion is used in study).
Target Sample Size
422

Eligibility

Recruits 422 No vulnerable population selected (isVulnerablePopulationSelected:false). Trial enrols adult patients; informed consent is obtained from adult participants. No paediatric consent/assent procedures indicated..

Vulnerable Population
No vulnerable population selected (isVulnerablePopulationSelected:false). Trial enrols adult patients; informed consent is obtained from adult participants. No paediatric consent/assent procedures indicated.

Inclusion criteria

  • {"criterion_text":"- Has histologically/cytologically confirmed diagnosis of previously untreated and pathologically confirmed resectable Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC) [American Joint Committee on Cancer (AJCC) 8th Edition]\n- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study intervention\n- Participants who have not achieved a pCR following completion of neoadjuvant chemotherapy and pembrolizumab followed by surgery will be eligible\n- Confirmation that EGFR-directed therapy is not indicated as primary therapy (documentation of absence of tumor-activating EGFR mutations [eg, DEL19 or L858R])\n- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)\n- 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\n- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening"}

Exclusion criteria

  • {"criterion_text":"- Diagnosis of SCLC or, for mixed tumors, presence of small cell elements, or has a neuroendocrine tumor with large-cell components, or a sarcomatoid carcinoma, or a pancoast tumor\n- Documentation by local test report indicating presence of ALK gene rearrangements\n- Received prior neoadjuvant therapy for their current NSCLC diagnosis\n- Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).\n- Received prior systemic anticancer therapy including investigational agents other than what is specified in this protocol\n- Received prior treatment with a cancer vaccine\n- Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids\n- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Disease- Free Survival (DFS)","definition_or_measurement_approach":"DFS as assessed by the investigator"}

Secondary endpoints

  • {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Distant Metastasis-Free Survival (DMFS)","definition_or_measurement_approach":"DMFS as assessed by the investigator"}
  • {"endpoint_text":"- Disease- Free Survival 2 (DFS2)","definition_or_measurement_approach":"DFS2 as assessed by the investigator"}
  • {"endpoint_text":"- Lung Cancer Specific Survival (LCSS)","definition_or_measurement_approach":"LCSS as assessed by the investigator"}
  • {"endpoint_text":"- 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)","definition_or_measurement_approach":"Change from baseline measured using EORTC QLQ-C30 and EORTC QLQ-LC24 instruments"}
  • {"endpoint_text":"- Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5)","definition_or_measurement_approach":"Change from baseline measured using EORTC QLQ-C30 physical functioning items 1-5"}
  • {"endpoint_text":"- Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7)","definition_or_measurement_approach":"Change from baseline measured using EORTC QLQ-C30 role functioning items 6-7"}
  • {"endpoint_text":"- Number of participants with ≥1 adverse event (AE)","definition_or_measurement_approach":"Count of participants experiencing ≥1 AE"}
  • {"endpoint_text":"- Number of participants discontinuing from study therapy due to AE(s)","definition_or_measurement_approach":"Count of participants who discontinue study therapy because of AE(s)"}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
422
Recruitment Window Months
152
Consent Approach
Informed consent is obtained from adult participants using country-specific ICFs. Country/I CF language versions are provided (examples: POL_PL for Poland; SWE_SV for Sweden; IRL_EN for Ireland; ITA_IT/ITA_EN for Italy; ESP_ES for Spain; BEL_EN/FR/NL for Belgium; DEU_DE for Germany; FRA_FR for France; NLD_NL for Netherlands; BGR_BG for Bulgaria; HUN_HU for Hungary; ROU_RO for Romania; FIN_FI for Finland). Optional consent addenda and optional consents (e.g., pregnancy follow-up, genetic consent, reimbursement, emergency card, Greenphire participant services) are available per country. No paediatric/assent procedures indicated.

Methods

  • Patient brochures (country-specific patient brochures present in submission documents: Ireland, Belgium, Spain, Poland, Finland, France, Germany, Netherlands, Romania, Bulgaria, Hungary, Italy, Sweden)
  • Patient flyers and posters (country-specific patient flyers/posters present: Belgium, Spain, Romania, Poland, Netherlands, etc.)
  • Recruitment webpages / website materials (document titled 'Recruitment Doc Website' present for Poland)
  • Patient visit guides, patient calendars and thank-you cards (documents present for Ireland, Belgium and other countries)
  • Advertisements (document titles include 'Advertisement' or 'Recruitment Doc Advertisement' e.g. Netherlands)

Geography

Total Number Of Sites
85
Total Number Of Participants
260

Poland

Earliest CTIS Part Ii Submission Date
13-10-2024
Latest Decision Or Authorization Date
08-02-2026
Processing Time Days
483
Number Of Sites
10
Number Of Participants
30

Sites

Site Name
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Department Name
Centrum Innowacyjnych Terapii
Contact Person Name
Tomasz Jankowski
Contact Person Email
cwbk@umlub.pl
Site Name
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
Department Name
Ośrodek Chemioterapii Dziennej
Contact Person Name
Małgorzata Majecka
Site Name
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow
Department Name
Oddział Onkologii Klinicznej z Pododdziałem Dziennej Chemioterapii
Contact Person Name
Katarzyna Stencel
Contact Person Email
kstencel@wcpit.org
Site Name
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
Department Name
Oddział Onkologii z Pododdziałem Chemioterapii
Contact Person Name
Jarosław Kołb-Sielecki
Site Name
Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
Department Name
Oddział Kliniczny Chirurgii Klatki Piersiowej i Chirurgii Onkologicznej
Contact Person Name
Piotr Kocoń
Site Name
Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
Department Name
Oddział Onkologiczny z Pododdziałem Dziennej Chemioterapii
Contact Person Name
Kamil Kuć
Contact Person Email
kkuc@wszp.pl
Site Name
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
Department Name
Oddział Onkologii Klinicznej
Contact Person Name
Krzysztof Rogoziewicz
Contact Person Email
onkocwbk@dcopih.pl
Site Name
Instytut Gruźlicy i Chorób Płuc
Department Name
III Klinika Chorób Płuc i Onkologii
Contact Person Name
Mateusz Polaczek
Contact Person Email
bk3@igichp.edu.pl
Site Name
Uniwersytecki Szpital Kliniczny W Bialymstoku
Department Name
II Klinika Chorób Płuc, Raka Płuca i Chorób Wewnętrznych
Contact Person Name
Robert Mróz
Contact Person Email
pulmonolog2@uskwb.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Onkologii i Radioterapii
Contact Person Name
Rafał Dziadziuszko
Contact Person Email
onkol@gumed.edu.pl

Sweden

Earliest CTIS Part Ii Submission Date
24-08-2024
Latest Decision Or Authorization Date
05-02-2026
Processing Time Days
530
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Karolinska University Hospital
Department Name
Cancerstudieenheten
Contact Person Name
Olof Hjorthorn

Ireland

Earliest CTIS Part Ii Submission Date
06-10-2024
Latest Decision Or Authorization Date
04-02-2026
Processing Time Days
486
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
St James's Hospital
Department Name
Oncology Department
Contact Person Name
Sinead Cuffe
Contact Person Email
SCuffe@stjames.ie
Site Name
Tallaght University Hospital
Department Name
Oncology Department
Contact Person Name
Sebastian Trainor
Contact Person Email
Sebastian.Trainor@tuh.ie
Site Name
Cork University Hospital
Department Name
Oncology Department
Contact Person Name
Sinead Noonan
Contact Person Email
Sinead.noonan@hse.ie

Italy

Earliest CTIS Part Ii Submission Date
14-10-2024
Latest Decision Or Authorization Date
09-02-2026
Processing Time Days
483
Number Of Sites
11
Number Of Participants
39

Sites

Site Name
Centro Ricerche Cliniche Di Verona S.r.l.
Department Name
Unità di Oncologia
Contact Person Name
Sara Pilotto
Contact Person Email
sara.pilotto@univr.it
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
SC Oncologia Clinica Sperimentale Toraco - Polmonare
Contact Person Name
Alessandro Morabito
Site Name
Istituto Oncologico Veneto
Department Name
DEPARTMENT OF CLINICAL AND EXPERIMENTAL ONCOLOGY
Contact Person Name
Giulia Pasello
Contact Person Email
giulia.pasello@iov.veneto.it
Site Name
Azienda Ospedaliero Universitaria Renato Dulbecco
Department Name
Oncoematologia
Contact Person Name
Vito Barbieri
Contact Person Email
vitobarbieri@yahoo.it
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
Oncologia Medica 2
Contact Person Name
Federico Cappuzzo
Contact Person Email
federico.cappuzzo@ifo.gov.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Oncologia Medica 1
Contact Person Name
Giuseppe Lo Russo
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
Unità di Oncologia
Contact Person Name
Chiara Bennati
Contact Person Email
chiara.bennati@auslromagna.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC Oncologia Medica
Contact Person Name
Emilio Bria
Site Name
Fondazione Policlinico Universitario Campus Bio-medico
Department Name
Oncologia Medica
Contact Person Name
Alessio Cortellini
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS
Department Name
Dipartimento Malattie Oncologiche ed Ematologiche
Contact Person Name
Andrea Ardizzoni
Contact Person Email
andrea.ardizzoni@aosp.bo.it
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Divisione di Oncologia Toracica
Contact Person Name
Ilaria Attili
Contact Person Email
ilaria.attili@ieo.it

Spain

Earliest CTIS Part Ii Submission Date
21-10-2024
Latest Decision Or Authorization Date
06-02-2026
Processing Time Days
473
Number Of Sites
8
Number Of Participants
40

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Medical Oncology
Contact Person Name
Alexandre Martinez Marti
Contact Person Email
amarinezmarti@vhio.net
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Medical Oncology
Contact Person Name
Antonio Calles Blanco
Site Name
Hospital Quironsalud Malaga
Department Name
Oncología
Contact Person Name
Manuel Cobo Dols
Contact Person Email
manuelcobodols@yahoo.es
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Oncology
Contact Person Name
Belen Rubio Vaqueira
Site Name
Hospital Clinic De Barcelona
Department Name
Oncologia Médica
Contact Person Name
Laura Mezquita Perez
Contact Person Email
LMEZQUITA@clinic.cat
Site Name
Hospital Universitario Quironsalud Madrid (Pozuelo De Alarcon)
Department Name
Servicio de Oncología Médica
Contact Person Name
Belen Rubio Vaqueira
Site Name
Complejo Hospitalario Universitario Insular Materno Infantil
Department Name
Oncología Médica
Contact Person Name
Delvys Rodriguez Abreu
Contact Person Email
drodabr@gobiernodecanarias.org
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Oncology
Contact Person Name
María Rosario García Campelo

Finland

Earliest CTIS Part Ii Submission Date
15-10-2024
Latest Decision Or Authorization Date
06-05-2026
Processing Time Days
568
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Turku University Hospital
Department Name
Department of pulmonary diseases
Contact Person Name
Maria Silvoniemi
Contact Person Email
maria.silvoniemi@varha.fi
Site Name
Oulu University Hospital
Department Name
Department of Oncology
Contact Person Name
Jussi Koivunen
Contact Person Email
jussi.koivunen@pohde.fi

Belgium

Earliest CTIS Part Ii Submission Date
15-10-2024
Latest Decision Or Authorization Date
05-05-2026
Processing Time Days
567
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Cliniques Universitaires Saint-Luc
Department Name
Pneumology
Contact Person Name
Frank Aboubakar
Contact Person Email
frank.aboubakar@uclouvain.be
Site Name
Jessa Ziekenhuis
Department Name
Lung Diseases
Contact Person Name
Kristof Cuppens
Contact Person Email
kristof.cuppens@jessazh.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Lung Diseases
Contact Person Name
Karim Vermaelen
Contact Person Email
karim.vermaelen@ugent.be

Greece

Earliest CTIS Part Ii Submission Date
24-08-2024
Latest Decision Or Authorization Date
07-05-2026
Processing Time Days
621
Number Of Sites
9
Number Of Participants
18

Sites

Site Name
General Hospital Of Thessaloniki Papageorgiou
Department Name
Molecular Medicine Clinical Trials Department
Contact Person Name
Sofia Baka
Contact Person Email
bakasofia@hotmail.com
Site Name
General University Hospital Of Patras
Department Name
Division of Oncology
Contact Person Name
Angelos Koutras
Contact Person Email
angkoutr@otenet.gr
Site Name
University General Hospital Of Heraklion
Department Name
Internal Medicine - Oncology Department
Contact Person Name
Dimitrios Mavroudis
Contact Person Email
medoncsec@med.uoc.gr
Site Name
Henry Dunant Hospital Center
Department Name
4th Oncology - Internal Medicine Department
Contact Person Name
Ioannis Mountzios
Contact Person Email
gmountzios@gmail.com
Site Name
General University Hospital Of Larissa
Department Name
Oncology Clinic
Contact Person Name
Athanasios Kotsakis
Contact Person Email
kotsakisthan@gmail.com
Site Name
Metropolitan Hospital
Department Name
4th Oncology Department
Contact Person Name
Helena Linardou
Contact Person Email
elinardou@icloud.com
Site Name
University General Hospital Attikon
Department Name
2nd Propedeutic Internal Medicine Clinic - Oncology Department
Contact Person Name
Amanda Psyrri
Contact Person Email
psyrri237@yahoo.com
Site Name
Thoracic General Hospital Of Athens I Sotiria
Department Name
3rd Department of Internal Medicine and Laboratory, Oncology Dpt.
Contact Person Name
Konstantinos Syrigos
Contact Person Email
ksyrigos.trials@gmail.com
Site Name
General Hospital Of Thessaloniki Papageorgiou (additional site entry)

Germany

Earliest CTIS Part Ii Submission Date
20-10-2024
Latest Decision Or Authorization Date
11-05-2026
Processing Time Days
568
Number Of Sites
8
Number Of Participants
33

Sites

Site Name
Marienhaus Klinikum Mainz GmbH
Department Name
Marienhaus Klinikum Mainz GmbH
Contact Person Name
Andreas Budahn
Contact Person Email
andreas.budahn@marienhaus.de
Site Name
Robert Bosch Gesellschaft fuer medizinische Forschung mbH
Department Name
Robert Bosch Gesellschaft für medizinische Forschung mbH
Contact Person Name
Hans-Georg Kopp
Contact Person Email
ZOSE@rbk.de
Site Name
Justus-Liebig-Universitaet Giessen
Department Name
Medizinische Klinik IV
Contact Person Name
Bastian Eul
Contact Person Email
oon-studienzentrum@uk-gm.de
Site Name
Klinikverbund Allgaeu gGmbH
Department Name
Klinikum Kempten
Contact Person Name
Christian Schumann
Site Name
St.-Antonius-Hospital gGmbH
Department Name
St. Antonius Hospital
Contact Person Name
Peter Staib
Contact Person Email
studiensekretariat.onkologie@sah-eschweiler
Site Name
Thoraxklinik Heidelberg gGmbH
Department Name
Thoraxklinik Heidelberg gGmbH
Contact Person Name
Michael Thomas
Site Name
Universitaet Muenster
Department Name
Medizinische Klinik A - Hämatologie, Onkologie und Pneumologie
Contact Person Name
Georg Evers
Site Name
Pius-Hospital Oldenburg
Department Name
Klinik für Hämatologie und Onkologie
Contact Person Name
Frank Griesinger

Romania

Earliest CTIS Part Ii Submission Date
15-10-2024
Latest Decision Or Authorization Date
11-05-2026
Processing Time Days
573
Number Of Sites
5
Number Of Participants
9

Sites

Site Name
Institutul Regional De Oncologie Iasi
Department Name
Dept. of Oncology
Contact Person Name
Dana Clement
Contact Person Email
manager@iroiasi.ro
Site Name
Medicover S.R.L.
Department Name
Oncologie Medicala
Contact Person Name
Radu-Emanuel Berceanu-Ion
Contact Person Email
ofice@medicover.ro
Site Name
Oncomed S.R.L.
Department Name
Oncologie Medicala
Contact Person Name
Daniela-Elvira Sirbu
Contact Person Email
cabinet_oncomed@yahoo.com
Site Name
Sigmedical Services S.R.L.
Department Name
Oncologie Medicala
Contact Person Name
Doina Elena Ganea
Contact Person Email
office@sigmed.ro
Site Name
Institutul Regional De Oncologie Iasi (additional site address)
Department Name
Dept. of Oncology
Contact Person Name
Dana Clement
Contact Person Email
manager@iroiasi.ro

Netherlands

Earliest CTIS Part Ii Submission Date
30-10-2024
Latest Decision Or Authorization Date
11-05-2026
Processing Time Days
558
Number Of Sites
8
Number Of Participants
14

Sites

Site Name
Stichting Radboud universitair medisch centrum
Department Name
Afdeling Longziekten
Contact Person Name
Olga Schuurbiers-Siebers
Site Name
Medisch Centrum Leeuwarden B.V.
Department Name
Afdeling Longziekten
Contact Person Name
Femke van Vollenhoven
Site Name
Isala Klinieken Stichting
Department Name
Afdeling Longgeneeskunde
Contact Person Name
Peter Plomp
Contact Person Email
p.m.j.plomp@isala.nl
Site Name
Jeroen Bosch Ziekenhuis Stichting
Department Name
Afdeling Longgeneeskunde
Contact Person Name
Bianca Van Veggel
Contact Person Email
b.v.veggel@jbz.nl
Site Name
Meander Medisch Centrum Stichting
Department Name
Afdeling Longziekten
Contact Person Name
Judith Herder
Contact Person Email
GJM.Herder@meandermc.nl
Site Name
Universitair Medisch Centrum Groningen
Department Name
Afdeling Longoncologie
Contact Person Name
Jeroen Hiltermann
Contact Person Email
t.j.n.hiltermann@umcg.nl
Site Name
Academisch Ziekenhuis Maastricht
Department Name
Dept. of Pulmonary Diseases
Contact Person Name
Lizza Hendriks
Contact Person Email
Trials.Longoncologie@mumc.nl
Site Name
Isala Klinieken / additional site entry

Bulgaria

Earliest CTIS Part Ii Submission Date
20-10-2024
Latest Decision Or Authorization Date
07-05-2026
Processing Time Days
564
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
Multi-profile Hospital for Active Treatment Heart and Brain EAD
Department Name
Clinic of Medical Oncology
Contact Person Name
Nataliya Chilingirova
Contact Person Email
info@cardiacinstitute.bg
Site Name
Multiprofile Hospital For Active Treatment-Uni Hospital Ltd.
Department Name
Department of medical oncology
Contact Person Name
Rossitza Ruseva
Contact Person Email
uni@unihospitalbg.bg

Hungary

Earliest CTIS Part Ii Submission Date
24-08-2024
Latest Decision Or Authorization Date
06-05-2026
Processing Time Days
620
Number Of Sites
8
Number Of Participants
13

Sites

Site Name
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
Department Name
I. Pulmonologia
Contact Person Name
Zsolt Papai-Szekely
Contact Person Email
zsoltpapai@yahoo.com
Site Name
Reformatus Pulmonologiai Centrum
Department Name
Onkopulmonológiai Járóbeteg Centrum
Contact Person Name
Gabriella Gálffy
Contact Person Email
galffy.gabriella@rpckorhaz.hu
Site Name
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Department Name
Onkologiai Kozpont
Contact Person Name
Eva Dr. Somogyine Dr. Ezer
Contact Person Email
ezer.eva@kmmk.hu
Site Name
Nograd Varmegyei Szent Lazar Korhaz
Department Name
Onkológiai és Sugárterápiás Centrum
Contact Person Name
László Urbán
Contact Person Email
drurban.laszlo@szlmk.hu
Site Name
University Of Debrecen
Department Name
Tüdőgyógyászati Klinika
Contact Person Name
Ildiko Horvath
Contact Person Email
horvath.ildiko@med.unideb.hu
Site Name
Matrai Gyogyintezet
Department Name
Pulmonologia Osztaly
Contact Person Name
Laszlo Urban
Contact Person Email
drurban.laszlo@magy.eu
Site Name
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Department Name
Pulmonologiai Osztaly
Contact Person Name
Zsuzsanna Szalai
Contact Person Email
clinstudy@gmail.com
Site Name
Orszagos Koranyi Pulmonologiai Intezet
Department Name
XIV. Pulmonologiai Osztaly
Contact Person Name
Gyula Ostoros
Contact Person Email
drostorosgyula@gmail.com

France

Earliest CTIS Part Ii Submission Date
31-10-2024
Latest Decision Or Authorization Date
11-05-2026
Processing Time Days
557
Number Of Sites
7
Number Of Participants
33

Sites

Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Pneumologie
Contact Person Name
Delphine Carmier
Contact Person Email
d.carmier@chu-tours.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
Oncologie médicale
Contact Person Name
Sandrine Hiret
Site Name
Institut Gustave Roussy
Department Name
Oncologie médicale
Contact Person Name
David Planchard
Site Name
Centre Hospitalier Universitaire De Caen Normandie
Department Name
Service de Pneumologie & d'Oncologie Thoracique
Contact Person Name
Simon DESHAYES
Contact Person Email
deshayes-si@chu-caen.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Service de Pneumologie et d'Oncologie Thoracique
Contact Person Name
Arnaud Scherpereel
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Oncologie médicale
Contact Person Name
Baptiste ABBAR
Contact Person Email
baptiste.abbar@aphp.fr
Site Name
Centre Leon Berard
Department Name
Cancérologie Médicale
Contact Person Name
Maurice Perol

Sponsor

Primary sponsor

Full Name
Merck Sharp & Dohme LLC
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Bioclinica Inc.
Responsibilities
Central imaging
Name
Parexel International Corp.
Responsibilities
Medical information (Physician Consulting)
Name
Fortrea Inc.
Responsibilities
Unblinded monitoring service
Name
PPD Global Central Labs
Responsibilities
Central laboratory services
Name
Labcorp Central Laboratory Services LP
Responsibilities
Central laboratory services

Third parties

  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central imaging","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"Medical information (Physician Consulting)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Hematogenix Laboratory Services LLC","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"Unblinded monitoring service","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Personalis Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}

Investigational products

Investigational Product Name
mRNA-4157
Active Substance
MRNA-4157
Modality
mRNA
Routes Of Administration
INTRAMUSCULAR
Route
Intramuscular
Authorisation Status
Investigational (ATMP) - product record prodAuthStatus:1
Starting Dose
1 mg
Maximum Dose
9 mg
Investigational Product Name
mRNA-4157 placebo (placebo for mRNA-4157)
Modality
Other
Investigational Product Name
KEYTRUDA 25 mg/mL concentrate for solution for infusion
Active Substance
PEMBROLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Marketing authorisation EU/1/15/1024/002
Maximum Dose
200 mg (product record lists maxDailyDoseAmount 200 mg for one product entry; other entries show up to 400 mg)
Combination Treatment
Yes

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