Study Comparing MK-7684A (Vibostolimab and Pembrolizumab) with Pembrolizumab for Adults and Children 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 known as melanoma. The study is comparing two treatments: one is a combination of two medications, MK-7684A (which includes pembrolizumab and vibostolimab), and the other is pembrolizumab alone. Both treatments are given as a solution through an intravenous infusion, which means they are administered directly into the bloodstream through a vein.

The purpose of the study is to see how well the combination treatment works compared to the single medication in preventing the return of melanoma after it has been surgically removed. Participants in the study will be randomly assigned to receive either the combination treatment or the single medication. Some participants may receive a placebo, which is a substance with no active medication. The study will last for up to 12 months, during which time participants will receive regular infusions and be monitored for any changes in their condition.

Throughout the study, researchers will keep track of how long participants remain free from melanoma returning, as well as other important health outcomes. These include how long participants live without the cancer spreading to other parts of the body, overall survival rates, and any side effects experienced. The study will also assess changes in participants’ quality of life and physical functioning. This information will help determine the effectiveness and safety of the combination treatment compared to the single medication.

1 joining the study

Upon joining the study, you will be randomly assigned to one of two groups. One group will receive the combination of MK-7684A (vibostolimab with pembrolizumab), and the other group will receive pembrolizumab alone.

This assignment is done randomly, like flipping a coin, to ensure fairness and objectivity in the study.

2 treatment administration

You will receive the assigned medication through an intravenous infusion. This means the medication will be given directly into your vein using a needle.

The infusion will be administered at regular intervals as determined by the study protocol. The exact schedule and duration will be explained to you by the study team.

3 monitoring and follow-up

Throughout the study, your health will be closely monitored. This includes regular check-ups and tests to assess your response to the treatment and to ensure your safety.

You will be asked to report any side effects or changes in your health to the study team immediately.

4 completion of the study

At the end of the study period, you will undergo a final evaluation to assess the outcomes of the treatment.

The study team will discuss the results with you and provide guidance on any further steps or treatments that may be necessary.

Who Can Join the Study?

  • Must have a diagnosis of Stage IIB, IIC, III, or IV cutaneous melanoma that has been confirmed by examining tissue samples under a microscope.
  • Must have had surgery to remove the melanoma.
  • Must not have received any treatment for melanoma other than surgery.
  • Must have had no more than 12 weeks between the last surgery and the start of the study.
  • If the participant has HIV (Human Immunodeficiency Virus), it must be well controlled with medication.
  • Open to both male and female participants.
  • Participants of all age groups are eligible.

Who Cannot Join the Study?

  • Patients who have a different type of cancer other than melanoma.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to give informed consent or understand the study requirements.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a serious medical condition that might interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a recent surgery or major medical procedure.
  • Patients who have an allergy to the study medication or its ingredients.
  • Patients who have a history of substance abuse or addiction.
  • Patients who have an active infection that requires treatment.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medical University Of Vienna Vienna Austria
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Centre Hospitalier Universitaire De Lille Lille France
Medical University Of Graz Graz Austria
Universitaet Leipzig Leipzig Germany
Medizinische Universitaet Innsbruck Innsbruck Austria
Institut Gustave Roussy Villejuif France
Technische Universitaet Dresden Dresden Germany
Katholieke Universiteit te Leuven Leuven Belgium
Medizinische Hochschule Hannover Hanover Germany

Other Sites

Site Name City Country Status
Noe LGA Gesundheit Region Mitte GmbH St. Poelten Austria
Zachodniopomorskie Centrum Onkologii Szczecin Poland
Centre Hospitalier De Pau Pau France
Universitaetsklinikum Erlangen AöR Erlangen Germany
Karolinska University Hospital Solna Sweden
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy Warsaw Poland
Hospital General Universitario De Valencia Valencia Spain
Jessa Ziekenhuis Hasselt Belgium
Gasthuiszusters Antwerpen Antwerp Belgium
Pratia S.A. Skorzewo Poland
Centre Hospitalier Universitaire De Nantes Nantes France
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach Kielce Poland
Region Joenkoepings Laen Jönköping Sweden
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
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Elbe Kliniken Stade-Buxtehude gGmbH Buxtehude Germany
Charite Research Organisation GmbH Berlin Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital Santa Maria Della Misericordia Perugia Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
Heidelberg University Mannheim Germany
Istituto Tumori Bari Giovanni Paolo II Bari Italy
Muehlenkreiskliniken AöR Minden Germany
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Vitaz Sint-Niklaas Belgium
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku Bialystok Poland
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o. Slupsk Poland
Fundacion Onkologikoa Fundazioa Donostia / San Sebastian Spain
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Institut de Cancérologie de l’Ouest Saint-Herblain France
Policlinico Le Scotte Siena Italy
Uniklinikum Salzburg Salzburg Austria
Cerplontr Uufxvnejilgerm Spermgzdu Woluwe-Saint-Lambert Belgium
Ahhmiafwiz Pptqghfy Hfrlikvq Dk Pajjz Paris France
Irtltffl Ratfwhaee Psh Lt Spbrge Dks Tapmdz Dndw Afqrpdq Iufy Sywltt Meldola Italy
Atfvmfvjwv Porsayzt Hetfegst Du Mrtagaugg Marseille France
Lllnbo Mjixyvkfbj Ubroelrtas Ok Mltzbd Munich Germany
Uaotfxzwltpxop Ccaghsq Kfpozeigy Gdansk Poland
Ueinrpqlkv Mcgvkjr Cjnrgm Htjqxwzxcqramxbhv Hamburg Germany
Uzvlarfwxbyshkzjcdwss Evhsa Arz Essen Germany
Ouyasmzhmaqgmi Louw Gbgi Linz Austria
Ivzxaiyf Ceznmo Duxarvmgvmxckqwcz L'hospitalet De Llobregat Spain
Cvxtkp Hcrycyzfqlm Viccnpf Valence France

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
06.06.2023
Belgium Belgium
Not recruiting
06.06.2023
France France
Not recruiting
06.06.2023
Germany Germany
Not recruiting
06.06.2023
Ireland Ireland
Not recruiting
06.06.2023
Italy Italy
Not recruiting
06.06.2023
Poland Poland
Not recruiting
06.06.2023
Spain Spain
Not recruiting
06.06.2023
Sweden Sweden
Not recruiting
06.06.2023

Trial locations

MK-7684A is a combination of two medications, Vibostolimab and Pembrolizumab, used together to help the body’s immune system fight cancer. This combination is being tested to see if it can help prevent melanoma, a type of skin cancer, from coming back after surgery. Vibostolimab is a type of drug that helps activate the immune system to attack cancer cells, while Pembrolizumab is already used to treat various cancers by blocking a pathway that cancer cells use to hide from the immune system.

Pembrolizumab is a medication that helps the immune system detect and fight cancer cells. It works by blocking a specific pathway that cancer cells use to avoid being attacked by the immune system. This medication is already used in treating several types of cancer, including melanoma, and is being tested in this trial to see how well it works compared to the combination of Vibostolimab and Pembrolizumab.

Melanoma – Melanoma is a type of skin cancer that originates in the melanocytes, the cells responsible for producing melanin, the pigment that gives skin its color. It often begins as a mole that changes in size, shape, or color, but it can also appear on skin that looks normal. As melanoma progresses, it can grow deeper into the skin and spread to other parts of the body, including lymph nodes and internal organs. The disease is known for its ability to metastasize, or spread, rapidly if not detected early. Melanoma can occur on any skin surface, but it is more common in areas exposed to the sun, such as the back, legs, arms, and face. Early detection and monitoring of changes in the skin are crucial in managing the progression of melanoma.

Trial ID:
2022-501417-31-01
Protocol code:
MK-7684A-010
NCT ID:
NCT05665595
Trial Phase:
Therapeutic confirmatory (Phase III)

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