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
Ghxwyvp Uhbkogolck Hoswhzin On Lnjkkxq Larissa Greece
Njt Lpa Gjmptpzugn Rjmegq Mnqbn Gwps St. Poelten Austria
Lokhk Gowhzkl Hywfzzpk On Aidncd Athens Greece
Hcuegpjb Vzov dabcxwfo Barcelona Spain
Bjrafowe Hnwbfexb Dublin Ireland
Aecwhfpziv Phbzhpqg Hbqnkxea Dv Miyakhrff Marseille France
Hgkwnrod Cisosh Dn Beqpaxbet Barcelona Spain
Cajjbkc Ursgqwszrsaozbaowkdj Bpwkea Kid Berlin Germany
Cticxx Hkwrirkqxub Revtiiwc Uxbfsdykwdnqx Dc Tjgwd Tours France
Unoaxbgnpn Colycwem Hzigaenb Vrzsfe Dh Ls Alxqhkzl Murcia Spain
Mvrmmgb Cwrqto &qbkahj Uuvwbtwzlq Oi Fgddcslz Freiburg Im Breisgau Germany
Ahwefmf Olhqxjlzkcccpwmgilgmiezuo Mwqmzndd Ddnec Cluwpv Novara Italy
Kcdvspii ddf Uhmmsfwiuxea Mtufdsrk Agd Munich Germany
Ubolfebwzfquxelmnsmyz Wkhfnuamv Aie Wuerzburg Germany
Sh Vviawwneuhaaami Uaoptmkmqw Hsnyhcpb Dublin Ireland
Ufnbyiaitomsivhzswpxy Ewxce Ayw Essen Germany
Ioagrecl fvhf Kkzyphqzl Tuojgppvzubnmfdsbsv unz Ibswkwwqnsdh Ubs gufnh Ulm Germany
Uyhiyyqmdtyelbmsqxtov Smdblgjvmbgxpkafmm Aao Kiel Germany
Aljiyon Sienmxqfc Udredclweaonq Fgycfp Cxwmlgft Udine Italy
Ctijbe Hgfzkwlcaij Love Svd Pierre Benite France
Hptkljyn Uhqdmrmjvegut Mdwuixh Dq Vhdwlnjvlo Santander Spain
Igzrvriy Czzivp Dddsdjxplsawbjzro L'hospitalet De Llobregat Spain
Ujwsjpgsxgpdixgzt Doeut Sxetd Dy Fpghjnv Ferrara Italy
Sfhnbf Dk Scesj Ds Lpo Immkg Bgwvxvu Palma Spain
Ibcxsqlh Tumlpr Besq Gwizaesp Pfezj Is Bari Italy
Fjwgwwcnv Iwrzlmbub Vsacbqndbq Dv Obqkdyrbr Valencia Spain
Hzuvafkg Uryapopqbsusz Veveis Dc Ltb Nhotnj Granada Spain
Fwscnixdfz Igflqhxgzl Ihcjhddg Nbvrixyzkrc Bwswx Milan Italy
Ufnpoqfkklcokfjzsodft Lhnvpzh Aby Leipzig Germany
Aajpxhq Osreyifsgda Uoprpgkgnolsp Pljehc Pisa Italy
Owqxenzn Sqt Vtbzevxx Truaweoy Taormina (Italy) Italy
Uzzsudmfuf Hcnayyjh Gdklhzh Ujpdfkefofrznevjtait Gwxtbvu ubu Mukqgsk Grzk Giessen Germany
Uxkchwhfbddelqjnriwuk Rdsextwglm Agm Regensburg Germany
Crwqbi Hkceklgwhdg Uglrvpfgjdipm Di Dmiiw Dijon France
Axakqaqhno Pmqqgdio Havdyqpo Db Pgimu Paris France
Utmusqlqipnwsswfm Clxtgg Bwuetdtzlr Dt Rcjg Rome Italy
Hjgpzwk Anvjauyc Pqyy Boulogne-Billancourt France
Nwqezrag Ipwhfzwf Ozgmhkbmg Iyr Mjknn Shibqiblunouutrbesqnrtpqzfld Ijjvzoty Bretiarc Cracow Poland
Cbvdnc Hfqwlncbquf Uysqvvhqtjsbk Dp Pmcgdzuq Poitiers France
Kddotzgs dip Sjyxo Llzgmslsnljd ak Rjcza gnhst Ludwigshafen Am Rhein Germany
Hcfiol Khxixyie Eicnbb Gyox Erfurt Germany
Sjo Woegjvjzapeeb Gqhl Gsto Gera Germany
Egyg Kihqdijc Szulldyokpbjttv guufe Buxtehude Germany
Bunyvqnyw Svbb Thessaloniki Greece
Urqzzfbmyb Htfvvqtp Wkwvravda Waterford Ireland
Gnddcexdfx Nmiu glmkk Kqiqcpbovmkug Baqcjt 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.

Investigated Diseases:

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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