Clinical trial • Phase II • Oncology
N/A for Melanoma
Phase II trial of N/A for Melanoma.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Melanoma
- Trial Stage
- Phase II
- Drug Modality
- mRNA|Monoclonal antibody|Other
Key dates
- Initial CTIS Submission Date
- 14-03-2025
- First CTIS Authorization Date
- 30-07-2025
Trial design
Randomised, arms: v940 (mrna-4157) plus pembrolizumab versus placebo plus pembrolizumab (keytruda 25 mg/ml concentrate for solution for infusion). dosing/schedule not specified in the ctis record (product information shows pembrolizumab as an iv infusion product and mrna-4157 as intramuscular).-controlled Phase II trial in Italy, Portugal, Greece and others.
- Randomised
- Yes
- Comparator
- Arms: V940 (mRNA-4157) plus pembrolizumab versus placebo plus pembrolizumab (KEYTRUDA 25 mg/mL concentrate for solution for infusion). Dosing/schedule not specified in the CTIS record (product information shows pembrolizumab as an IV infusion product and mRNA-4157 as intramuscular).
- Target Sample Size
- 79
Eligibility
Recruits 79 No vulnerable populations selected. Informed consent is required from participants; subject information and informed consent forms are provided (country-specific ICF documents available, and optional consents for genetic sampling and pregnancy follow-up are listed). No assent or minor/child consent procedures are described..
- Vulnerable Population
- No vulnerable populations selected. Informed consent is required from participants; subject information and informed consent forms are provided (country-specific ICF documents available, and optional consents for genetic sampling and pregnancy follow-up are listed). No assent or minor/child consent procedures are described.
Inclusion criteria
- {"criterion_text":"- Has unresectable and histologically confirmed Stage III or IV cutaneous melanoma per American Joint Committee on Cancer (AJCC) Eighth Edition guidelines.\n- Has been untreated for melanoma except if participant received prior adjuvant or neoadjuvant therapy with targeted therapy or immunotherapy (such as anti-cytotoxic T-lymphocyte-associated protein [CTLA-4], anti-programmed cell death 1 protein [PD-1] therapy or interferon), and only if relapse did not occur within 12 months after treatment discontinuation.\n- Have documentation of serine/threonine-protein kinase B-raf (BRAF) V600-activating mutation status or had BRAF V600 mutation testing per local institutional standards during the screening period (participants with BRAF mutation positive melanoma as well as BRAF wild-type or unknown are eligible).\n- Have the presence of at least 1 measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1 as determined by the local site investigator/radiology assessment.\n- Provides tumor tissue (preferably from a metastatic site and, if not available, from the primary tumor) that is suitable for next generation sequencing and biomarker analysis as required for this study.\n- Participants with human immunodeficiency virus (HIV) must have well controlled HIV on antiretroviral 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":"- Has clinically significant heart failure, defined as New York Heart Association class III or IV, within the past 6 months, unless the disease is well controlled in the opinion of the investigator.\n- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.\n- Has ocular or mucosal melanoma.\n- Received transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 2 weeks of the Screening blood sample (including the blood sample for V940 generation).\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, LAG-3, OX-40, CD137), with some exceptions.\n- Received prior systemic anticancer therapy for melanoma before randomization, with some exceptions.\n- Received prior radiotherapy within 2 weeks of start of study intervention or has ongoing radiation related toxicities.\n- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.\n- Received prior treatment with another universal or personalized cancer vaccine."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Progression-free survival (PFS)","definition_or_measurement_approach":"PFS per RECIST 1.1 as assessed by the investigator (as stated in main objective: \"To compare V940 plus pembrolizumab to placebo plus pembrolizumab with respect to PFS per RECIST 1.1 as assessed by the investigator.\")"}
Secondary endpoints
- {"endpoint_text":"- Objective Response (OR)","definition_or_measurement_approach":"ORR per RECIST 1.1 as assessed by the investigator (stated in secondary objectives)."}
- {"endpoint_text":"- Duration of Response (DOR)","definition_or_measurement_approach":"DOR per RECIST 1.1 as assessed by the investigator (stated in secondary objectives)."}
- {"endpoint_text":"- Overall Survival (OS)","definition_or_measurement_approach":"Overall survival; no additional measurement detail provided in the record."}
- {"endpoint_text":"- Number of participants with ≥1 adverse event (AE)","definition_or_measurement_approach":"Count/percentage of participants with ≥1 AE; safety/tolerability endpoint as described."}
- {"endpoint_text":"- Number of participants discontinuing from study therapy due to AE","definition_or_measurement_approach":"Count/percentage of participants who discontinue study therapy due to AE."}
Recruitment
- Planned Sample Size
- 79
- Recruitment Window Months
- 35
- Consent Approach
- Informed consent obtained from participants; subject information and informed consent forms are provided for each country (country-specific ICF documents listed for Italy, Portugal, Greece, France, Poland, Germany, Spain and English materials). Optional consent addenda (e.g., genetic consent, pregnancy follow-up, optional samples) are available. No assent or minor consent procedures are described.
Geography
- Total Number Of Sites
- 23
- Total Number Of Participants
- 97
Italy
- Earliest CTIS Part Ii Submission Date
- 06-06-2025
- Latest Decision Or Authorization Date
- 24-03-2026
- Processing Time Days
- 291
- Number Of Sites
- 4
- Number Of Participants
- 20
Sites
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- Melanoma. Unità di immunoterapia e sviluppo del cancro
- Principal Investigator Name
- Paolo Antonio Ascierto
- Principal Investigator Email
- p.ascierto@istitutotumori.na.it
- Contact Person Name
- Paolo Antonio Ascierto
- Contact Person Email
- p.ascierto@istitutotumori.na.it
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Dipartimento di Oncologia Medica ed Ematologia - SC Oncologia Medica 1
- Principal Investigator Name
- Michele Del Vecchio
- Principal Investigator Email
- michele.delvecchio@istitutotumori.mi.it
- Contact Person Name
- Michele Del Vecchio
- Contact Person Email
- michele.delvecchio@istitutotumori.mi.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOC Oncologia Medica
- Principal Investigator Name
- Gianpaolo Tortora
- Principal Investigator Email
- giampaolo.tortora@policlinicogemelli.it
- Contact Person Name
- Gianpaolo Tortora
- Contact Person Email
- giampaolo.tortora@policlinicogemelli.it
- Site Name
- Istituto Oncologico Veneto
- Department Name
- UOC Oncology 2
- Principal Investigator Name
- Jacopo Pigozzo
- Principal Investigator Email
- jacopo.pigozzo@iov.veneto.it
- Contact Person Name
- Jacopo Pigozzo
- Contact Person Email
- jacopo.pigozzo@iov.veneto.it
Portugal
- Earliest CTIS Part Ii Submission Date
- 25-06-2025
- Latest Decision Or Authorization Date
- 24-03-2026
- Processing Time Days
- 272
- Number Of Sites
- 3
- Number Of Participants
- 6
Sites
- Site Name
- Unidade Local De Saude De Santa Maria E.P.E.
- Department Name
- Medical Oncology
- Principal Investigator Name
- Rita Sousa
- Principal Investigator Email
- cic@chln.min-saude.pt
- Contact Person Name
- Rita Sousa
- Contact Person Email
- cic@chln.min-saude.pt
- Site Name
- Unidade Local De Saude De Lisboa Ocidental E.P.E.
- Department Name
- Oncology
- Principal Investigator Name
- Mariana Malheiro
- Principal Investigator Email
- mmrodrigues@chlo.min-saude.pt
- Contact Person Name
- Mariana Malheiro
- Contact Person Email
- mmrodrigues@chlo.min-saude.pt
- Site Name
- Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
- Department Name
- Medical Oncology
- Principal Investigator Name
- Paula Ferreira
- Principal Investigator Email
- Clinicalstudies@ipoporto.min-saude.pt
- Contact Person Name
- Paula Ferreira
- Contact Person Email
- Clinicalstudies@ipoporto.min-saude.pt
Greece
- Earliest CTIS Part Ii Submission Date
- 04-04-2025
- Latest Decision Or Authorization Date
- 30-03-2026
- Processing Time Days
- 360
- Number Of Sites
- 3
- Number Of Participants
- 18
Sites
- Site Name
- Laiko General Hospital Of Athens
- Department Name
- 1st Department of Internal Medicine
- Principal Investigator Name
- Helen Gogas
- Principal Investigator Email
- helgogas@gmail.com
- Contact Person Name
- Helen Gogas
- Contact Person Email
- helgogas@gmail.com
- Site Name
- Metropolitan Hospital
- Department Name
- A Oncology Department
- Principal Investigator Name
- Dimitrios Bafaloukos
- Principal Investigator Email
- dimmp@otenet.gr
- Contact Person Name
- Dimitrios Bafaloukos
- Contact Person Email
- dimmp@otenet.gr
- Site Name
- Athens Medical Center S.A.
- Department Name
- Oncology Department
- Principal Investigator Name
- Sofia Baka
- Principal Investigator Email
- bakasofia@hotmail.com
- Contact Person Name
- Sofia Baka
- Contact Person Email
- bakasofia@hotmail.com
France
- Earliest CTIS Part Ii Submission Date
- 04-04-2025
- Latest Decision Or Authorization Date
- 24-03-2026
- Processing Time Days
- 354
- Number Of Sites
- 3
- Number Of Participants
- 15
Sites
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Dermatology
- Principal Investigator Name
- Henri Montaudié
- Principal Investigator Email
- montaudie.h@chu-nice.fr
- Contact Person Name
- Henri Montaudié
- Contact Person Email
- montaudie.h@chu-nice.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Dermatology
- Principal Investigator Name
- Celeste Lebbé
- Principal Investigator Email
- celeste.lebbe@aphp.fr
- Contact Person Name
- Celeste Lebbé
- Contact Person Email
- celeste.lebbe@aphp.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Dermatology
- Principal Investigator Name
- Caroline Robert
- Principal Investigator Email
- caroline.robert@gustaveroussy.fr
- Contact Person Name
- Caroline Robert
- Contact Person Email
- caroline.robert@gustaveroussy.fr
Poland
- Earliest CTIS Part Ii Submission Date
- 04-06-2025
- Latest Decision Or Authorization Date
- 27-03-2026
- Processing Time Days
- 296
- Number Of Sites
- 2
- Number Of Participants
- 8
Sites
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Klinika Nowotworów Tkanek Miękkich, Kości i Czerniaków
- Principal Investigator Name
- Piotr Rutkowski
- Principal Investigator Email
- badaniakliniczne@nio.gov.pl
- Contact Person Name
- Piotr Rutkowski
- Contact Person Email
- badaniakliniczne@nio.gov.pl
- Site Name
- Uniwersytecki Szpital Kliniczny W Poznaniu
- Department Name
- Oddział Kliniczny Onkologii Klinicznej i Doświadczalnej
- Principal Investigator Name
- Jacek Mackiewicz
- Principal Investigator Email
- badania.ucwbk@ump.edu.pl
- Contact Person Name
- Jacek Mackiewicz
- Contact Person Email
- badania.ucwbk@ump.edu.pl
Germany
- Earliest CTIS Part Ii Submission Date
- 26-06-2025
- Latest Decision Or Authorization Date
- 25-03-2026
- Processing Time Days
- 272
- Number Of Sites
- 5
- Number Of Participants
- 20
Sites
- Site Name
- University Hospital Cologne AöR
- Department Name
- Dermatologie und Venerologie - Hauttumorzentrum
- Principal Investigator Name
- Cindy Franklin
- Principal Investigator Email
- ivonne.fischer@uk-koeln.de
- Contact Person Name
- Cindy Franklin
- Contact Person Email
- ivonne.fischer@uk-koeln.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- Klinik und Poliklinik für Dermatologie und Venerologie
- Principal Investigator Name
- Christoffer Gebhardt
- Principal Investigator Email
- studien-htz@uke.de
- Contact Person Name
- Christoffer Gebhardt
- Contact Person Email
- studien-htz@uke.de
- Site Name
- Goethe University Frankfurt
- Department Name
- Klinik für Dermatologie, Venerologie und Allergologie
- Principal Investigator Name
- Bastian Schilling
- Principal Investigator Email
- b.schilling@med.uni-frankfurt.de
- Contact Person Name
- Bastian Schilling
- Contact Person Email
- b.schilling@med.uni-frankfurt.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Klinik für Dermatologie, Venerologie und Allergologie
- Principal Investigator Name
- Dirk Schadendorf
- Principal Investigator Email
- Dirk.Schadendorf@uk-essen.de
- Contact Person Name
- Dirk Schadendorf
- Contact Person Email
- Dirk.Schadendorf@uk-essen.de
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- Dermatoonkologie am Nationalen Centrum für Tumorerkrankungen (NCT)
- Principal Investigator Name
- Jessica Hassel
- Principal Investigator Email
- nct.dermaonko@med.uni-heidelberg.de
- Contact Person Name
- Jessica Hassel
- Contact Person Email
- nct.dermaonko@med.uni-heidelberg.de
Spain
- Earliest CTIS Part Ii Submission Date
- 03-06-2025
- Latest Decision Or Authorization Date
- 25-03-2026
- Processing Time Days
- 295
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncología
- Principal Investigator Name
- Eva Muñoz Couselo
- Principal Investigator Email
- emunoz@vhio.net
- Contact Person Name
- Eva Muñoz Couselo
- Contact Person Email
- emunoz@vhio.net
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Oncología
- Principal Investigator Name
- Ainara Soria Rivas
- Principal Investigator Email
- ainara.soria@salud.madrid.org
- Contact Person Name
- Ainara Soria Rivas
- Contact Person Email
- ainara.soria@salud.madrid.org
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Medical Oncology
- Principal Investigator Name
- Ana Arance Fernandez
- Principal Investigator Email
- melanoma_assaigs@recerca.clinic.cat
- Contact Person Name
- Ana Arance Fernandez
- Contact Person Email
- melanoma_assaigs@recerca.clinic.cat
Sponsor
Primary sponsor
- Full Name
- Merck Sharp & Dohme LLC
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Pharmaceutical Product Development LLC
- Responsibilities
- sponsorDuties code: 4
- Name
- Parexel International Corp.
- Responsibilities
- sponsorDuties code: 15 (EUB services (call center and medical services))
- Name
- PPD Global Central Labs
- Responsibilities
- sponsorDuties code: 4
- Name
- Charles River Laboratories International Inc.
- Responsibilities
- sponsorDuties code: 4
Third parties
- {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties code: 7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Charles River Laboratories International Inc.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"sponsorDuties code: 15 (Long term storage lab)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"sponsorDuties code: 15 (Patient reimbursement)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"sponsorDuties code: 3","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"sponsorDuties code: 15 (Imaging (collect, clean, and hold))","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Discovery Life Sciences LLC","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"sponsorDuties code: 15 (EUB services (call center and medical services))","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Infinity Biologix LLC","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Personalis Inc.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"","full_name":"Additional third parties listed (e.g., various laboratories and service providers)","duties_or_roles":"","organisation_type":""}
Investigational products
- Investigational Product Name
- Placebo to V940
- 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
- Authorised (marketing authorisation EU/1/15/1024/002)
- Maximum Dose
- Max daily dose 400 mg; max total dose 6800 mg
- Investigational Product Name
- mRNA-4157
- Active Substance
- MRNA-4157
- Modality
- mRNA
- Routes Of Administration
- INTRAMUSCULAR
- Route
- Intramuscular
- Authorisation Status
- Investigational (prodAuthStatus: 1)
- Maximum Dose
- Max daily dose 1 mg; max total dose 9 mg
- Combination Treatment
- Yes
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