Study to Compare Fianlimab and Cemiplimab Combination with Pembrolizumab in Patients with High-Risk Melanoma After Surgery

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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 aims to find out if a combination of two medications, fianlimab and cemiplimab, is more effective than another medication called pembrolizumab in preventing or delaying the return of melanoma after it has been completely removed through surgery. Fianlimab is also known by its code name REGN3767, and cemiplimab is sometimes referred to as REGN2810. Pembrolizumab is also known by the code names MK-3475 and Lambrolizumab.

The purpose of the study is to see if the combination of fianlimab and cemiplimab can improve the time patients remain free from melanoma returning, which is known as relapse-free survival. Participants in the study will receive either the combination of fianlimab and cemiplimab or pembrolizumab alone. The medications are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein. The study will last for a period of up to 51 weeks, during which the effects of the treatments will be monitored.

Throughout the study, researchers will observe how well the treatments work in keeping melanoma from coming back and will also monitor for any side effects or adverse reactions. The study will help determine if the new combination of medications offers a better option for patients who have had melanoma surgically removed. The ultimate goal is to improve the chances of staying cancer-free for a longer period after surgery.

1 joining the trial

Upon joining the trial, you will be randomly assigned to one of two groups. One group will receive a combination of fianlimab and cemiplimab, while the other group will receive pembrolizumab.

This assignment is random, meaning it is like flipping a coin to decide which treatment you will receive.

2 treatment administration

If you are in the group receiving fianlimab and cemiplimab, these medications will be given to you through an intravenous infusion. This means the medicine will be delivered directly into your bloodstream through a vein.

If you are in the group receiving pembrolizumab, this medication will also be administered through an intravenous infusion.

The exact dosage and frequency of these infusions will be determined by the study protocol and your healthcare team.

3 monitoring and follow-up

Throughout the trial, you will have regular check-ups to monitor your health and the effects of the treatment. This will include physical examinations and imaging studies.

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

4 completion of the trial

The trial is expected to continue until April 2028. Your participation may last for a different duration depending on your individual circumstances and the study’s requirements.

At the end of your participation, you will have a final evaluation to assess your health and the outcomes of the treatment.

Who Can Join the Study?

  • Patients must have melanoma that is completely removed by surgery. Melanoma is a type of skin cancer.
  • The melanoma must be classified as stage IIB, IIC, III, or IV according to the American Joint Committee on Cancer (AJCC) 8th edition. These stages describe the extent of the cancer.
  • Surgery to remove the melanoma must have been done within 12 weeks before joining the study, and the surgical wound must be healed.
  • Patients must be disease-free, meaning no signs of cancer, as confirmed by a full physical exam and imaging tests within 4 weeks before joining the study.
  • Both male and female patients can participate.
  • Patients 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 have participated in another clinical trial recently.
  • Patients who have an allergy or severe reaction to the study drugs.
  • Patients who are taking medications that might interfere with the study drugs.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Hospital Universitario Central De Asturias Oviedo Spain
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Universitaetsklinikum Regensburg AöR Regensburg Germany
Centre Hospitalier Le Mans Le Mans France
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Hopital Ambroise Pare Boulogne-Billancourt France
University Hospital Galway Galway Ireland
Oncomed S.R.L. Timisoara Romania
Hospital Universitario Lucus Augusti Lugo Spain
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Centre Hospitalier Universitaire De Nice Nice France
Gesundheit Nord gGmbH Klinikverbund Bremen Bremen Germany
Oncocenter Oncologie Clinica S.R.L. Timisoara Romania
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Centre Hospitalier Universitaire Rouen Rouen France
Hôpital Avicenne Bobigny France
Hospital Clinico Universitario De Valencia Valencia Spain
Centrul De Oncologie-Euroclinic S.R.L. Iasi Romania
Hospital Universitario Virgen Macarena Sevilla Spain
Universitaetsklinikum Erlangen AöR Erlangen Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Universita’ Campus Bio-medico Di Roma Rome Italy
Universitaetsklinikum Mannheim GmbH Mannheim Germany
Universita’ Politecnica Delle Marche Ancona Italy
Centre Hospitalier Universitaire De Nantes Nantes France
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Istituto Europeo Di Oncologia S.r.l. Milan Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Azienda Provinciale Per I Servizi Sanitari Trento Italy
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
Universita’ Degli Studi Di Perugia Perugia Italy
Fondazione Luigi Maria Monti Rome Italy
Harzklinikum Dorothea Christiane Erxleben GmbH Quedlinburg Germany
Klinikum der Stadt Ludwigshafen am Rhein gGmbH Ludwigshafen Am Rhein Germany
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
HELIOS Klinikum Erfurt GmbH Erfurt Germany
Charite Research Organisation GmbH Berlin Germany
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Masarykuv Onkologicky Ustav Brno-Stred Czechia
Universita’ Degli Studi Di Ferrara Ferrara Italy
Istituto Tumori Bari Giovanni Paolo II Bari Italy
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Bioclinic S.A. Thessaloniki Greece
Katholisches Klinikum Bochum gGmbH Bochum Germany
Algemeen Ziekenhuis Groeninge Kortrijk Belgium
Vitaz Sint-Niklaas Belgium
Radiotherapy Center Cluj S.R.L. Floresti Romania
Institut Sainte Catherine Avignon France
Hospital Universitario Virgen De Las Nieves Granada Spain
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o. Siedlce Poland
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti Bucharest Romania
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o. Slupsk Poland
Hopital Saint Eloi Montpellier France
University Hospital Ostrava Ostrava Czechia
Beaumont Hospital Dublin Ireland
Centre Francois Baclesse Caen France
Metropolitan Hospital Athens Greece
Fachklinik Hornheide e.V. Munster Germany
Clmeed Hkagwhtqzej Uwehrrdntkpwc Atoetc Pycnngkd Amiens France
Ccmmec Hheksxvxpho Ucgznzkllwauw Dh Ditnv Dijon France
Avvauz Moljtdx Ccjoyy Skto Thessaloniki Greece
Izrddqip Cxzhei Dwosevtyhqjkqcaiq L'hospitalet De Llobregat Spain
Clwzry Hvbsmdkjbya Vbjfdim Valence France
Hoeicd Kgjcpibx Siwcgoqd Gflx Schwerin Germany
Cnkhfaghd Sfn Cluj Napoca Romania
Cbgrlagbm Uriylegibasxwf Semokaguw Woluwe-Saint-Lambert Belgium
Trirpgqtwc Cyieee Huyachze Thessaloniki Greece
Ldqfp Gltsyql Hkqadgiu Ou Adhwxt Athens Greece
Aessnfqtvt Pgzvdlfy Hzrvqdts Dh Purxq Paris France
Bthqicvk Uaifftuyaq Hvnpvhxj Czvswx Besançon France
Ljpmkr Moqiadxnwt Unvmpjxnqe Om Mcraif Munich Germany
Ukxmcximlmhrshkueoakj Mbyudfzw Ara Munster Germany
Cjmegozocm Pkzuzaw Lyibglasi Sxe z onft Gdansk Poland
Gvddwa Ufnetkpjso Fytoczusp Frankfurt Germany
Uobavlqgvyksmh Cwzuacb Kqstplwxb Gdansk Poland
Sm Vyuzuexvxfnksri Uqiziohqyo Hrufhpil Dublin Ireland
Uvhasnrmhgiuzvjwnhcgd Encis Ain Essen Germany
Hatxapdi Ulsxkantytref Mczfcfu Dv Vuhrsuclrw Santander Spain
Cbjj Ureexivuut Hpobqbtg Cork Ireland
Fqkumjzay Pyah Lp Ipkgbuvshmtfv Bhjzhxxjx Dwt Hcmilhqq Uclyqbofkhmwy Lu Pdq Madrid Spain
Icnuzslyb Oukfqafunf Dmy Rgwmxj Spjs Barcelona Spain
Hpyycug Htcdf Movyha &cvrkbx 1 rzb Gxupcnt Esdshl Creteil France
Hntawsey Vwds dmdcqlox 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
28.04.2023
Czechia Czechia
Not recruiting
28.04.2023
France France
Not recruiting
28.04.2023
Germany Germany
Recruiting
28.04.2023
Greece Greece
Not recruiting
28.04.2023
Ireland Ireland
Not recruiting
28.04.2023
Italy Italy
Not recruiting
28.04.2023
Poland Poland
Recruiting
28.04.2023
Romania Romania
Not recruiting
28.04.2023
Spain Spain
Not recruiting
28.04.2023

Trial locations

Fianlimab is a medication being studied for its potential to help the immune system fight cancer. It works by blocking a specific protein called LAG-3, which can slow down the immune system’s ability to attack cancer cells. By blocking this protein, fianlimab may help the immune system work better in finding and destroying cancer cells, particularly in patients who have had surgery to remove melanoma, a type of skin cancer.

Cemiplimab is another medication used in this trial that helps the immune system target and destroy cancer cells. It is known as an immune checkpoint inhibitor, which means it helps the immune system recognize and attack cancer cells more effectively. Cemiplimab is used in combination with fianlimab to see if the two medications together can improve outcomes for patients with high-risk melanoma after surgery.

Pembrolizumab is a medication that is already used to treat various types of cancer, including melanoma. It also works as an immune checkpoint inhibitor, helping the immune system to better identify and attack cancer cells. In this trial, pembrolizumab is being used as a comparison to see if the combination of fianlimab and cemiplimab is more effective in preventing the return of melanoma after surgery.

Investigated diseases:

Melanoma – Melanoma is a type of skin cancer that originates in the melanocytes, which are 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:
2022-501576-25-00
Protocol code:
R3767-ONC-2055
NCT ID:
NCT05608291
Trial Phase:
Therapeutic confirmatory (Phase III)

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