Study of mRNA-4157 and Pembrolizumab for Patients with High-Risk Stage II-IV Melanoma

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What is this study about?

This clinical trial is focused on studying a type of skin cancer called Melanoma. The study is investigating a new treatment combination for patients who have had their melanoma surgically removed but are at high risk of the cancer returning. The treatment being tested includes a new investigational drug called V940 (mRNA-4157) and an existing medication known as Pembrolizumab, which is also referred to by its brand name, KEYTRUDA. Pembrolizumab is a type of medication that helps the immune system fight cancer cells. The study will compare the effects of V940 plus Pembrolizumab against a placebo plus Pembrolizumab to see which is more effective in preventing the cancer from coming back.

The purpose of this study is to determine if the combination of V940 and Pembrolizumab can improve the time patients remain free from cancer recurrence, known as Recurrence-Free Survival (RFS). Participants in the study will receive either the combination of V940 and Pembrolizumab or a placebo and Pembrolizumab. The study is designed to be “double-blind,” meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo, to ensure unbiased results.

Throughout the study, participants will receive regular treatments and check-ups to monitor their health and the status of their melanoma. The study will also track other important outcomes, such as the time until the cancer spreads to distant parts of the body, known as Distant Metastasis Free Survival (DMFS), overall survival rates, and any side effects experienced by participants. The study aims to provide valuable information on the effectiveness and safety of the new treatment combination for melanoma patients.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying that the melanoma has been surgically removed and that there is no evidence of disease.

A tumor sample is required for sequencing, and organ function tests are performed to ensure adequate health status.

2 randomization

Participants are randomly assigned to one of two groups: one receiving the experimental treatment and the other receiving a placebo.

Both groups will receive pembrolizumab, a medication administered through an intravenous infusion.

3 treatment administration

The experimental group receives V940 (mRNA-4157) via intramuscular injection, while the control group receives a placebo injection.

Pembrolizumab is administered as a 25 mg/mL solution for infusion. The frequency and duration of administration are determined by the study protocol.

4 monitoring and follow-up

Participants are monitored for recurrence-free survival, which is the primary goal of the study.

Secondary outcomes include distant metastasis-free survival, overall survival, and the occurrence of any adverse events.

Quality of life and physical functioning are also evaluated through specific questionnaires.

5 completion and analysis

The study is expected to conclude by September 2030. Data collected will be analyzed to determine the effectiveness and safety of the treatment.

Participants’ health and well-being are assessed throughout the study to ensure safety and gather comprehensive results.

Who Can Join the Study?

  • The patient must have had a type of skin cancer called melanoma that has been surgically removed and confirmed to be at stage IIB to IV.
  • If the patient has a Hepatitis C virus (HCV) infection, the virus must not be detectable in their blood at the time of screening.
  • If the patient is infected with HIV, their infection must be well controlled with medication.
  • The patient must not have received any treatment for their melanoma other than surgery.
  • The patient must have had surgery that completely removed the cancer, leaving them free of the disease, within 13 weeks before starting the study medication.
  • The patient must have a sample of their tumor preserved in a specific way (called formalin fixed paraffin embedded) that can be used for genetic testing.
  • The patient must be free of cancer at the start of the study, with no return of cancer in the original area or spread to other parts of the body, including the brain.
  • Any suspicious areas that can be biopsied must be confirmed to not be cancerous.
  • The patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, which means they are fully active or have some symptoms but do not need bed rest during the day.
  • The patient must have organs that are functioning well, with tests done within 7 days before starting the study treatment.
  • If the patient has a Hepatitis B virus (HBV)</b) infection, they must have been on antiviral treatment for at least 4 weeks and have no detectable virus in their blood before being assigned to a treatment group.
  • The study is open to both male and female patients.
  • The study is for patients who are not considered part of a vulnerable population.

Who Cannot Join the Study?

  • Patients with any other type of cancer besides melanoma cannot participate. Melanoma is a type of skin cancer.
  • Patients who have had a different cancer in the past, unless it was successfully treated and has not come back, are excluded.
  • Patients with serious heart problems, such as heart failure or a recent heart attack, are not eligible.
  • Patients with uncontrolled high blood pressure cannot join the study.
  • Patients with active infections, like hepatitis or HIV, are excluded.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have had an organ transplant are not eligible.
  • Patients who are taking certain medications that might interfere with the study treatment are excluded.
  • Patients with autoimmune diseases, where the immune system attacks the body, are not eligible.
  • Patients who have received another experimental treatment within the last 4 weeks cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Universitaetsmedizin Goettingen Goettingen Germany
Rostock University Medical Center Rostock Germany
Centre Hospitalier Universitaire De Lille Lille France
Institut Gustave Roussy Villejuif France
Centr Georges Francois Leclerc Dijon France
Katholieke Universiteit te Leuven Leuven Belgium
Unidade Local De Saude De Lisboa Ocidental E.P.E. Carnaxide Portugal
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal

Other Sites

Site Name City Country Status
Hospital Universitario Ramon Y Cajal Madrid Spain
Centre Hospitalier Regional Universitaire Besançon France
Zachodniopomorskie Centrum Onkologii Szczecin Poland
Region Skane Skanes Universitetssjukhus Lund Sweden
Universitaetsklinikum Mannheim GmbH Mannheim Germany
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E. Lisbon Portugal
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Centre Hospitalier Universitaire De Nice Nice France
Ziekenhuis Oost Limburg Genk Belgium
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach Kielce Poland
Hospital Clinico Universitario De Valencia Valencia Spain
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy Warsaw Poland
Saarland University Hospital Homburg Germany
Aalborg University Hospital Aalborg Denmark
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Bydgoszcz Poland
Istituto Europeo Di Oncologia S.r.l. Milan Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
Universitair Ziekenhuis Gent Gent Belgium
SRH Wald-Klinikum Gera GmbH Gera Germany
Charite Research Organisation GmbH Berlin Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital Santa Maria Della Misericordia Perugia Italy
Vrije Universiteit Brussel Jette Belgium
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Muehlenkreiskliniken AöR Minden Germany
Algemeen Ziekenhuis Groeninge Kortrijk Belgium
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o. Siedlce Poland
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku Bialystok Poland
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Odense University Hospital Odense Denmark
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Metropolitan Hospital Athens Greece
Genesis Mikti Idiotiki Kliniki Gynaikas A.E. Maieutiki Gynaikologiki Cheirourgiki Thessaloniki Greece
Hlrlkpjt Uhzncggocuvum Rshdczab Dh Mczakj Malaga Spain
Cjfcmp Hcdzihqudzm Uhgziepmmcfqn Akncvo Pylnhtlu Amiens France
Aisyybltvo Pktrijue Hbrsoghl Dj Pjmsl Paris France
Aaxqws Mluscum Clpxdy Sxup Thessaloniki Greece
Lhfvg Gjcowof Hpgwfxki Or Aanvvt Athens Greece
Ufprzmobei Hjqeiajn Ciwgfxh Cologne Germany
Hhncvv Hrmorkky Herlev Denmark
Asuffugbgc Pjvtmtpb Hllyzrbp Db Mscmhbxue Marseille France
Arkxyoc Ovttnnzmhui Ukqamixlqxeat Sjonlq Siena Italy
Llrfgx Mljhkzmcnr Uopqzgfead On Moauxe Munich Germany
Sdqevtxuehe Ucnkvfqmgu Hcztbsledvsamhq Gwqxqcphumyqfmtxn Gothenburg Sweden
Uiqxtafuqnwnmb Ckaxhhm Kbgnkjnap Gdansk Poland
Upnchiwymv Mleeufq Ckxzgs Hvqwrfequikuuskkb Hamburg Germany
Ugoaiqzwresyrjudpyvrh Egzoj Aia Essen Germany
Hbqouqxf Vwah ddjmlfdc Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
25.07.2023
Denmark Denmark
Not recruiting
25.07.2023
France France
Not recruiting
25.07.2023
Germany Germany
Not recruiting
25.07.2023
Greece Greece
Not recruiting
25.07.2023
Italy Italy
Not recruiting
25.07.2023
Poland Poland
Not recruiting
25.07.2023
Portugal Portugal
Not recruiting
25.07.2023
Spain Spain
Not recruiting
25.07.2023
Sweden Sweden
Not recruiting
25.07.2023

Trial locations

Investigated drugs:

V940 (mRNA-4157) is an investigational vaccine designed to help the immune system recognize and attack melanoma cells. It is being studied to see if it can improve outcomes for patients with high-risk melanoma when used in combination with another medication.

Pembrolizumab is a medication that helps the immune system fight cancer by blocking a specific protein that prevents the immune system from attacking cancer cells. It is used in this trial to see if it can work better when combined with the investigational vaccine V940.

Melanoma – Melanoma is a type of skin cancer that develops from the pigment-producing cells known as melanocytes. It often appears as a new mole or a change in an existing mole, typically with irregular borders and multiple colors. Melanoma can occur anywhere on the body but is most common on areas exposed to the sun, such as the back, legs, arms, and face. As it progresses, melanoma can grow deeper into the skin and spread to other parts of the body, including lymph nodes and internal organs. Early detection is crucial, as melanoma can be more effectively managed when identified at an early stage. Regular skin checks and awareness of changes in moles or skin appearance are important for early identification.

Trial ID:
2023-503652-27-00
Protocol code:
V940-001
Trial Phase:
Therapeutic confirmatory (Phase III)

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