Study on Fianlimab and Cemiplimab for Adults with Resectable Stage III and IV Melanoma

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What is this study about?

This clinical trial is focused on studying the treatment of Melanoma, a type of skin cancer. The study will explore the effectiveness and safety of a combination of two medications, Fianlimab and Cemiplimab, compared to using a single medication called Pembrolizumab. Fianlimab, also known by its code name REGN3767, is a solution for injection, while Cemiplimab is a concentrate for infusion. The trial aims to determine if the combination of Fianlimab and Cemiplimab works better than Pembrolizumab alone in treating patients with melanoma that can be surgically removed.

The study will be conducted in two phases. In the first phase, the focus will be on comparing the combination of Fianlimab and Cemiplimab to Cemiplimab alone to see how well they work as a treatment before and after surgery. The second phase will assess how long patients remain free of events like cancer recurrence when treated with the combination of Fianlimab and Cemiplimab compared to Pembrolizumab alone. The trial will involve regular monitoring and assessments to ensure the safety and effectiveness of the treatments.

Participants in the study will receive their assigned treatment and undergo various evaluations, including imaging tests like MRI to monitor the progress of their condition. The trial will help determine the best dose of Fianlimab to use in combination with Cemiplimab for future treatments. The study is expected to provide valuable information on the potential benefits of combining these medications for patients with resectable melanoma.

1 Initial Assessment

Undergo a complete physical examination and imaging studies. This includes a CT scan of the chest, abdomen, pelvis, and brain MRI. These tests confirm the stage of melanoma and ensure it is resectable.

The pathology report must confirm the presence of melanoma, and the treatment plan, including surgery date, is documented.

2 Randomization

Participants are randomly assigned to receive either the combination of fianlimab and cemiplimab or pembrolizumab alone.

This step determines the specific treatment regimen to be followed during the trial.

3 Treatment Administration

Receive the assigned treatment through IV infusion. The specific medications and their combinations depend on the randomization outcome.

The treatment is administered as a peri-operative therapy, meaning it is given around the time of surgery.

4 Surgical Procedure

Undergo surgery to remove the melanoma. The goal is to achieve complete resection with negative margins, meaning no cancer cells are left at the edges of the removed tissue.

5 Post-Surgery Monitoring

Regular follow-up visits are scheduled to monitor recovery and assess the effectiveness of the treatment.

These visits include physical examinations and possibly additional imaging studies to check for any signs of cancer recurrence.

6 Long-term Follow-up

Continue to be monitored for several years to assess long-term outcomes such as event-free survival and overall survival.

This phase includes evaluating any side effects or adverse events related to the treatment.

Who Can Join the Study?

Patients must have melanoma, a type of skin cancer.
Patients should be in stage III (IIIB, IIIC, IIID) or stage IV (M1a, M1b, M1c) according to the American Joint Committee on Cancer (AJCC) 8th edition. This means the cancer is advanced but can still be removed by surgery.
For those with stage III melanoma, the disease must be visible and confirmed as cancerous in a pathology report, which is a detailed examination of tissue samples.
Patients must be suitable for complete surgical removal of the cancer with the goal of curing it. The surgery should leave no cancerous tissue behind.
Before joining the study, patients need a full check-up and imaging tests like a CT scan (a detailed X-ray) of the chest, abdomen, and pelvis, and a brain MRI (a scan using magnets) to check for cancer spread.
Patients must have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
Other specific criteria defined in the study protocol may also apply.

Who Cannot Join the Study?

Patients who have a different type of cancer other than melanoma cannot participate. Melanoma is a type of skin cancer.
Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements.
Patients who are not able to undergo surgery to remove the melanoma cannot participate. Resectable means the cancer can be surgically removed.
Patients who are part of a vulnerable population, which may include groups like children or pregnant women, cannot participate.
Patients who have other medical conditions that might interfere with the study treatment cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients who have had a recent major surgery or are recovering from a major surgery cannot participate.
Patients who have a history of severe allergic reactions to similar medications cannot participate.
Patients who are unable to follow the study procedures or attend the required visits cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medizinische Universitaet Innsbruck	Innsbruck	Austria
Institut Gustave Roussy	Villejuif	France
Centr Georges Francois Leclerc	Dijon	France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy
Medical University Of Vienna	Vienna	Austria
Hospital Universitario De Salamanca	Salamanca	Spain
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France
Medical University Of Graz	Graz	Austria
Technische Universitaet Dresden	Dresden	Germany
Azienda Ospedaliero Universitaria Di Sassari	Sassari	Italy
CHU Grenoble Alpes	La Tronche	France
IRCCS Humanitas Research Hospital	Rozzano	Italy

Other Sites

Site Name	City	Country
Noe LGA Gesundheit Region Mitte GmbH	St. Poelten	Austria
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	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
SRH Wald-Klinikum Gera GmbH	Gera	Germany
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitari Dexeus Grupo Quironsalud	Barcelona	Spain
Istituto Tumori Bari Giovanni Paolo II	Bari	Italy
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Katholisches Klinikum Bochum gGmbH	Bochum	Germany
University Hospital Waterford	Waterford	Ireland
Gesundheit Nord gGmbH Klinikverbund Bremen	Bremen	Germany
Hospital Universitario Virgen De Las Nieves	Granada	Spain
Ospedale San Vincenzo Taormina	Taormina (Italy)	Italy
Bioclinic S.A.	Thessaloniki	Greece
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.	Slupsk	Poland
Elbe Kliniken Stade-Buxtehude gGmbH	Buxtehude	Germany
General University Hospital Of Larissa	Larissa	Greece
Universitaetsklinikum Regensburg AöR	Regensburg	Germany
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Hopital Ambroise Pare	Boulogne-Billancourt	France
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Nice	Nice	France
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan	Poland
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Centre Hospitalier Lyon Sud	Pierre Benite	France
Universita’ Degli Studi Di Ferrara	Ferrara	Italy
Servei De Salut De Les Illes Balears	Palma	Spain
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Beaumont Hospital	Dublin	Ireland
Centre Francois Baclesse	Caen	France
Universitaetsklinikum Leipzig AöR	Leipzig	Germany
Metropolitan Hospital	Athens	Greece
Azienda Ospedaliero Universitaria Pisana	Pisa	Italy
Uzaaieqlvjqgznfunzaeq Ekvxl Ate	Essen	Germany
Humwebrp Ulcjrtsbmhnvj Mmicbkz Du Vynsswzkaj	Santander	Spain
Uqpeowphmp Hljnxxvn Gmvkvkv Uyymxlcbbyeglbtenarn Geyrerv uok Mnlhqxz Gqny	Giessen	Germany
Ltogk Gndqgkd Hnopqest Ob Awecul	Athens	Greece
Cebyam Hknktmwclmw Ueoztygckfrgg Df Dcgnf	Dijon	France
Apfjgwnxzd Pbedvggz Hreioljg De Puysc	Paris	France
Akynwwtmvu Pmjwbzvd Hizemyqj Db Milngixia	Marseille	France
Ckewtz Hrxgbpatsab Rttvyumq Ucqpiemxvrzlf Ds Tfxle	Tours	France
Ngviqwgq Iemlyevy Omlfzvfmp Isw Mkras Ssfrhkqoqwiupqbrhhbrlxvrkbdw Ipagurow Bostqhho	Cracow	Poland
Kyufxhkl dwn Uqdcjnaaayyj Mfkwvmgc Apq	Munich	Germany
Ughwrqprvqmhzugmdvmyw Wdtxgarti Amp	Wuerzburg	Germany
Su Vzpbgbnmklfocsu Ubvaycjdzr Hnnqwtck	Dublin	Ireland
Ivugdeif Cnrztk Dtlnahepfthkaqyzf	L'hospitalet De Llobregat	Spain
Hcywdrgt Vtzp dcvnqbul	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	02.01.2025
France	Not recruiting	02.01.2025
Germany	Not recruiting	02.01.2025
Greece	Not recruiting	02.01.2025
Ireland	Not recruiting	02.01.2025
Italy	Not recruiting	02.01.2025
Poland	Not recruiting	02.01.2025
Spain	Not recruiting	02.01.2025

Trial locations

Investigated drugs:

Fianlimab is an investigational medication being studied for its potential to help treat melanoma, a type of skin cancer. In this trial, it is used in combination with another medication to see if it can improve treatment outcomes for patients with melanoma that can be surgically removed.

Cemiplimab is a medication used to treat certain types of skin cancer, including melanoma. It works by helping the immune system recognize and attack cancer cells. In this trial, it is used both alone and in combination with fianlimab to evaluate its effectiveness in treating melanoma.

Pembrolizumab is a medication that helps the immune system fight cancer by blocking a specific pathway that cancer cells use to hide from immune cells. In this trial, it is used as a comparison to the combination of fianlimab and cemiplimab to determine which treatment is more effective for patients with melanoma that can be surgically removed.

Investigated diseases:

Malignant melanoma

Melanoma – Melanoma is a type of skin cancer that begins in the melanocytes, which are the cells responsible for producing the pigment melanin. It often appears as a new mole or a change in an existing mole, and it can be identified by its irregular shape, multiple colors, and larger size. Melanoma can grow quickly and has the potential to spread to other parts of the body if not detected early. The progression of melanoma involves the cancer cells invading deeper layers of the skin and potentially entering the lymphatic system or bloodstream. This spread can lead to the formation of new tumors in distant organs, a process known as metastasis. Early detection and monitoring of changes in the skin are crucial in managing the progression of melanoma.

Trial ID:

2022-502825-17-00

Protocol code:

R3767-ONC-2208

NCT ID:

NCT06190951

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Fianlimab and Cemiplimab for Adults with Resectable Stage III and IV Melanoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?