Study Comparing MK-7684A (Vibostolimab and Pembrolizumab) with Pembrolizumab for Adults and Children with High-Risk Melanoma

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What is this study about?

This clinical trial is focused on studying treatments for high-risk melanoma, a type of skin cancer that has been surgically removed but still poses a risk of returning. The study is comparing two treatments: one is a combination of two medications, pembrolizumab and vibostolimab, known together as MK-7684A, and the other is pembrolizumab alone. Pembrolizumab is a medication that helps the immune system fight cancer cells, while vibostolimab is another drug that works with pembrolizumab to enhance this effect.

The purpose of the study is to see which treatment is more effective in preventing the cancer from coming back. Participants in the study will receive one of these treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will last for up to 12 months, during which time participants will be monitored regularly to check for any signs of the cancer returning and to assess their overall health and well-being.

Throughout the study, researchers will also keep track of any side effects experienced by participants and how these might affect their quality of life. The goal is to gather information that will help determine the best treatment option for people with high-risk melanoma, aiming to improve their chances of staying cancer-free for as long as possible.

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 pembrolizumab and vibostolimab, while the other group will receive only pembrolizumab.

This process is double-blind, meaning neither you nor the study team will know which group you are in to ensure unbiased results.

2 treatment administration

You will receive the treatment through an intravenous infusion, which means the medication will be given directly into your vein.

The dosage and frequency of the medication will be determined by the study protocol, and you will be informed about the schedule and duration of your treatment.

3 monitoring and follow-up

Throughout the study, you will have regular check-ups to monitor your health and the effects of the treatment.

These check-ups will include physical examinations, blood tests, and possibly other assessments to ensure your safety and to gather data for the study.

4 completion of treatment

Once the treatment period is over, you will have a final evaluation to assess your response to the treatment.

You may be asked to continue with follow-up visits to monitor your long-term health and any potential late effects of the treatment.

Who Can Join the Study?

  • Must have had surgery to remove melanoma and have a confirmed diagnosis of Stage IIB, IIC, III, or IV cutaneous melanoma according to the American Joint Committee on Cancer (AJCC) guidelines.
  • Must not have received any prior treatment for melanoma other than surgery.
  • Must have had no more than 12 weeks between the final surgery and the start of the study.
  • If the participant is infected with HIV (Human Immunodeficiency Virus), their condition must be well controlled with anti-retroviral therapy (ART).
  • Open to both male and female participants.
  • Includes participants from vulnerable populations.

Who Cannot Join the Study?

  • Patients with any other type of cancer that is not high-risk resected melanoma cannot participate.
  • Patients who have had a different cancer treatment in the past that might interfere with the study cannot participate.
  • Patients with a serious infection or illness that could affect their ability to participate safely cannot join the study.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have a known allergy to any of the study medications cannot participate.
  • Patients who are unable to follow the study procedures or attend the required visits cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible.

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
Centre Hospitalier Universitaire De Lille Lille France
Medical University Of Graz Graz Austria
Medizinische Universitaet Innsbruck Innsbruck Austria
Oncopole Claudius Regaud Toulouse France
Technische Universitaet Dresden Dresden Germany
Katholieke Universiteit te Leuven Leuven Belgium
Medizinische Hochschule Hannover Hanover Germany

Other Sites

Site Name City Country Status
Karolinska University Hospital Solna Sweden
Hospital General Universitario De Valencia Valencia Spain
Centre Hospitalier Universitaire De Nantes Nantes France
Istituto Europeo Di Oncologia S.r.l. Milan Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Zachodniopomorskie Centrum Onkologii Szczecin Poland
Heidelberg University Mannheim Germany
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o. Siedlce Poland
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o. Slupsk Poland
Cmbosemtp Uitifupccgjbby Skpqlgoci Woluwe-Saint-Lambert Belgium
Nvn Ldl Gchwqdkdin Rqgfxa Mmnhg Gdcw St. Poelten Austria
Bedlvzjw Hybymlkt Dublin Ireland
Ubexoyxjhciosversgasp Ejmrsvrh Akf Erlangen Germany
Izbsyreq Rpjcuzdve Pnh Lk Spacht Dbg Taqgfh Dkvg Andlcrd Istb Sgvcws Meldola Italy
Afvotrgsnx Pciauumu Hivpoukf Dn Mxrtcqttq Marseille France
Nnqsjahl Ieaoaeec Omqxwflkj Ibk Mwmxn Sulccvifybbhwjihiwfqyplrpetv Iudotwvg Bxbyjuuu Warsaw Poland
Juqgh Zduhbwqwui Hasselt Belgium
Gcrvigjbnrbxmeo Arkdrmexu Antwerp Belgium
Uvkmipjlvzcgzfebwakbh Hgktxjwpxi Aco Heidelberg Germany
Rwlpgl Jfopbfrghcne Leys Jönköping Sweden
Udnpmbpmncjj Lftwmqa Leipzig Germany
Uwnobsuobwluhs Cpqsqsg Kdkgpxjcs Gdansk Poland
Uxbajjkdkn Mvqpbko Cvbvpl Hztoqdgyzvjbnvwye Hamburg Germany
Uhzhoilyxuvtchgbutadb Egzlt Akw Essen Germany
Oyikjsweeibplv Lwgz Glrf Linz Austria
Iavhzeyo Cdfiqt Dnsizwpqamjsylgyg L'hospitalet De Llobregat Spain
Iwaxbemc Tbhrzy Bbqj Gdryjmls Pcqtl Ic Bari Italy
Cyvaro Hlcouzrfjik Uibblqwjzjagm Dligst Guxnknr Sdvcprlyuobekionmqgfnmyjuh Namur Belgium
Vpsag Sint-Niklaas Belgium
Fgisjcgdsp Ikrjghehbv Ikhethbt Nrtgqvrhybx Bsnpl Milan Italy
Utnfmwmhqpr Skqfojih Salzburg Austria
Ikpeqmsb Oelxctokdm Vwbtbu Padua Italy
Cdoufr Hdypemoekbb Dy Puu Pau France
Aeyqayfujj Pbjznfkq Hgxgpvmn Dx Pwhpq Paris France
Lwdsxm Mrwbobhzlj Uqlbbrnxdx Om Miyohv Munich Germany
Strfqgdffntilt Cfxqjfd Ohzwujhsp Sqmhuefzhbh Psbtuylwh Zeacrv Oraesj Zmjjzktyvk W Kvjyumss Kielce Poland
Uqpbwclkobcgc Scsgkef Kuwgvrhds W Pvmhxtee Poznan Poland
Csznuyt Otlhyakdu Imy Pkwqa Fnbnpflcxz Lgmjpvlkcwf W Bletwkagmy Bydgoszcz Poland
Cfzqss Hvymtbcluby Uelqiwknvaijs Dz Pojnjnfc Poitiers France
Ersd Ksgbdijs Svmhdrbmdqeuten gjvev Buxtehude Germany
Cwuislx Rcxerlbs Oquivbmbsxkp Ghku Berlin Germany
Hquftxno Sghas Mdoqq Drnoj Mmjbvtuebblo Perugia Italy
Mpseglcdikoxtbshcvjf Amx Minden Germany
Dfkxknqrnint Cfvetrc Oggmbyfuw Pwnbtkjqarsn I Hmurybveskh Wroclaw Poland
Cimjix Hsfuvpoakeu Vtojbkd Valence France
Bszyaukyxtlk Courcpq Ovycgaxkt Ivj Mogja Shdasjqxxrjavhechm W Bvvanfrwcuw Bialystok Poland
Fhsvpqggp Oyxbxvkidto Fzcyasbcg Donostia / San Sebastian Spain
Iqhuekge db Cczfnzolwpeu dv lqcxssyzkckso Saint-Herblain France
Pblnfwojydw Lo Smmvxf Siena Italy
Pwdmcy Mxc Kiqehy Cracow Poland

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

Trial status

Country Status Recruitment Start
Austria Austria
Not yet recruiting
22.02.2023
Belgium Belgium
Not yet recruiting
22.02.2023
France France
Not yet recruiting
22.02.2023
Germany Germany
Not yet recruiting
22.02.2023
Ireland Ireland
Not yet recruiting
22.02.2023
Italy Italy
Not yet recruiting
22.02.2023
Poland Poland
Not yet recruiting
22.02.2023
Spain Spain
Not yet recruiting
22.02.2023
Sweden Sweden
Not yet recruiting
22.02.2023

Trial locations

MK-7684A is a combination of two medications, Vibostolimab and Pembrolizumab. This combination is being tested to see if it can help people with high-risk melanoma, a type of skin cancer, by preventing the cancer from coming back after surgery. Vibostolimab is a type of medication that helps the immune system recognize and attack cancer cells. Pembrolizumab, which is already used to treat melanoma, works in a similar way by boosting the immune system’s ability to fight cancer.

Pembrolizumab is a medication that helps the body’s immune system fight cancer. It is already used to treat melanoma and works by blocking a specific protein that prevents the immune system from attacking cancer cells. In this study, Pembrolizumab is being used as a comparison to see if the combination of Vibostolimab and Pembrolizumab (MK-7684A) is more effective in preventing the return of melanoma after surgery.

Investigated Diseases:

High-risk Resected Melanoma – High-risk resected melanoma is a type of skin cancer that has been surgically removed but has a high chance of returning. It originates in the melanocytes, which are the cells responsible for producing pigment in the skin. After surgical removal, the disease may progress by spreading to nearby lymph nodes or distant organs if not completely eradicated. The risk of recurrence is higher in cases where the melanoma was thick, ulcerated, or had spread to the lymph nodes at the time of initial diagnosis. Monitoring for recurrence is crucial, as the disease can reappear in the same area or metastasize to other parts of the body. The progression of the disease is influenced by various factors, including the original tumor’s characteristics and the patient’s immune response.

Trial ID:
2022-501417-31-00
Protocol code:
MK-7684A-010
Trial Phase:
Therapeutic confirmatory (Phase III)

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