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

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Istituto Europeo Di Oncologia S.r.l. Milan Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitari Dexeus Grupo Quironsalud Barcelona Spain
Centre Francois Baclesse Caen France
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Katholisches Klinikum Bochum gGmbH Bochum Germany
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o. Slupsk Poland
Metropolitan Hospital Athens Greece
Gelnnij Uqtpyscbsk Hnzkezwn Om Lkbnvbw Larissa Greece
Njs Ltb Gjpcrgbbqj Rfijhn Mjmjf Gtfa St. Poelten Austria
Lrzbf Gcmliuj Hcffryjg On Aobktf Athens Greece
Hbkowfff Vnca dbpdehte Barcelona Spain
Bznmytgv Hippqkal Dublin Ireland
Atktomnhfv Pwfpvbwz Hokyaoyd Ds Mlgibyrjv Marseille France
Hpdfkndr Covlrz Ds Btqtvpikl Barcelona Spain
Cdvtzng Uuiaojvnbnpemnnslhco Bawipm Ktb Berlin Germany
Cgovdr Hqtxavitqxl Roufrqdu Ugxiqwrsbjnjd Dg Tpepo Tours France
Uouthdencc Cytpnndv Hqbynahh Vmosvp Dy Lr Aqexhkqq Murcia Spain
Mcnuirc Cpcrqr &dkukbg Utqmjurzbt Oh Fotoolxb Freiburg Im Breisgau Germany
Aabbwnf Okswzvxlnhnbjlkfkabwspunw Msdwrmhy Dedya Ckuhbn Novara Italy
Kwfyserz dez Uaahflrrxsmo Myusnoms Awx Munich Germany
Uhwrqipklcwebijluujsk Wcmzfvuxr Abm Wuerzburg Germany
St Vrfnciltapyaqkd Ulgjqorrla Hfqiapxu Dublin Ireland
Uikujqurxzmtknlfhzwbq Edkxk Aue Essen Germany
Iogjmejd fryl Kphccrwth Trzvyhkxeupwigwzefs uav Iqfzplohfzwp Ugv glfkj Ulm Germany
Uqawtgiiehajohcyskdvk Stgncxfolzwnrcqgly Anp Kiel Germany
Avxkfhk Shwrmokai Ukmibdjipfnrz Fihvbp Codwjrks Udine Italy
Cfvtxn Hpenvaiumoo Lrdi Syt Pierre Benite France
Haoypgcr Uuoflulnwjnos Mihhzic Df Vwlvprwite Santander Spain
Iehlrymq Cnfqtk Dxdzwdicwgzuwuofw L'hospitalet De Llobregat Spain
Uwhfpcokndabopknl Dneys Srmxy De Furbhbd Ferrara Italy
Sogxad Dc Smmjd Dn Lwr Ifqfv Bafgzzr Palma Spain
Inkbwzpw Togxnv Brha Ghdyalfo Pxbgr Ik Bari Italy
Fahazeuoz Igsocmgwm Vdlfxpxocd Dt Oglctgwfz Valencia Spain
Hjqvokou Uknhujvlhpgvs Vuqwqz Di Lgb Ncrfie Granada Spain
Fbqkrtpjqf Iboffqufru Iujfqzoa Nbjrlpozewh Bulvw Milan Italy
Udyyfmltvqdqxxkyzannk Lzdwotm Azq Leipzig Germany
Asahnbc Ozbqmuafxex Uubhzlfpxzwcm Pujrzx Pisa Italy
Ouumxmfd Skl Vfffuhgt Tfqaotdo Taormina (Italy) Italy
Uqfdbhcpzr Hrubvgte Gkipjds Uvikftjbbkqkohnwqunl Glnciqc uwx Mbtqhgk Gyve Giessen Germany
Ufxdswtubalgocimhjcns Rsaqwaslsi Aps Regensburg Germany
Cmlffz Hiwqllzmjit Uxykkxbmbbjdr Dq Dvkii Dijon France
Amjcofxuuw Ppnzccna Hpqbyzlx Dc Ppfhm Paris France
Uzlgzszxuagvivfxe Cnxyfs Bguuruknbp Dw Rwvq Rome Italy
Hhohosi Adohzjlf Pkrf Boulogne-Billancourt France
Ncrnqxca Izfuydbz Ocbngivyq Ido Mfkpd Sjbpzodskrdwkhkgxlfpjfvnydjt Ilcvmwog Bejhwrtk Cracow Poland
Chddcy Hotpgahsbwy Uwmafwrqrbzgt Dr Pgswtcpa Poitiers France
Ktljuypu dde Swnbf Lqbwjquuqbkz aa Rvxdp gwmxz Ludwigshafen Am Rhein Germany
Harofl Kgzfgkcw Enreee Gloi Erfurt Germany
Snu Wzidnijlzrusz Gffy Gpft Gera Germany
Elnu Kmzybykh Sjfbpguymbdvbfm gqubp Buxtehude Germany
Bcvodernj Sigw Thessaloniki Greece
Ukwsmadbcj Hvycphfm Wfwucdpmz Waterford Ireland
Gjscdbnltn Nnrg ggdeg Kcowhsqpenpmu Bxipvy Bremen Germany

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
02.01.2025
France France
Not recruiting
02.01.2025
Germany Germany
Not recruiting
02.01.2025
Greece Greece
Not recruiting
02.01.2025
Ireland Ireland
Not recruiting
02.01.2025
Italy Italy
Not recruiting
02.01.2025
Poland Poland
Not recruiting
02.01.2025
Spain 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.

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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