Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug duo takes on tough melanoma before surgery

NCT ID NCT06190951

Disease control Sponsor: Regeneron Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding fianlimab to the immunotherapy cemiplimab works better than cemiplimab alone for people with high-risk, removable melanoma. About 151 participants will receive the drugs before surgery, then continue after. The goal is to see if the combination destroys more cancer cells and improves long-term outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

151 people

The number who actually took part.

Started

Sep 2024

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1. All patients must be either stage III (IIIB, IIIC, IIID) or stage IV (M1a, M1b, M1c) per American Joint Committee on Cancer (AJCC) 8th edition (Amin 2017) and have histologically confirmed cutaneous melanoma that is deemed completely surgically resectable in order to be eligible as described in the protocol. 2. Patients with stage III melanoma must have clinically detectable disease that is confirmed as malignant on the pathology report. The pathology report must be reviewed, signed and dated by the investigator; this process will be confirmed during the interactive voice response system (IVRS) process as described in the protocol. 3. Patients must be candidates for full resection with curative intent and must be able to be surgically rendered free of disease with negative margins on resected specimens at surgery. The treatment plan including date of surgery must be documented by the investigator prior to randomization. 4. All patients must undergo full disease staging through a complete physical examination and imaging studies within 4 weeks prior to randomization. Imaging must include a computer tomography (CT) scan of the chest, abdomen, pelvis (if the primary tumor is on the head/neck then include a CT scan of head/neck), and all known sites of previously resected disease (if applicable) and brain magnetic resonance imaging (MRI) (or brain CT with contrast allowed if MRI is contraindicated). 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 Key Exclusion Criteria: Medical conditions: 1. Primary uveal melanoma 2. Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents. The following are non-exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement, psoriasis not requiring systemic treatment. 3. Patients must not have received any prior systemic anti-cancer therapy for melanoma. Prior radiotherapy for melanoma is allowed if not given to a target lesion or, if given to a target lesion, there is pathological evidence of disease progression in the same lesion. 4. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C virus (HCV) infection; or diagnosis of immunodeficiency that is related to or results in chronic infection as described in the protocol. Prior/concomitant therapy: 5. Use of immunosuppressive doses of corticosteroids (≥10mg of prednisone per day or equivalent) within 14 days of the first dose of study medication as described in the protocol. 6. Treatment with any anti-cancer therapy for malignancies other than melanoma, including immuno- therapy, chemotherapy, radiotherapy, or biological therapy in the 5 years prior to randomization as described in the protocol. Other comorbidities: 7. Participants with a history of myocarditis. 8. History or current evidence of significant (CTCAE grade ≥2) local or systemic infection (e. g., cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 2 weeks prior to the first dose of trial medication. Note: Other protocol-defined inclusion/ exclusion criteria apply

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Melanoma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

melanoma skin neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Melanoma

Contacts and locations

Locations

  • Azienda Ospedaliera Santa Croce i Carle

    Cuneo, 12100, Italy

  • Azienda Ospedaliero-Universitaria Ferrara

    Ferrara, 44124, Italy

  • Azienda Ospedaliero-Universitaria Maggiore della Carita - Oncology

    Novara, 28100, Italy

  • Azienda Sanitaria Universitaria del Friuli Centrale

    Udine, 33100, Italy

  • CHRU de Tours

    Tours, Centre-Val de Loire, 37044, France

  • CHU Estaing

    Clermont-Ferrand, 63003, France

  • CHU de Quebec - Universite Laval

    Québec, G1J 1Z4, Canada

  • CHU-Dijon

    Dijon, Burgundy, 21000, France

  • California Pacific Medical Center Research Institute

    San Francisco, California, 94115, United States

  • Campus Bio-Medico di Roma

    Rome, 00128, Italy

  • Centre Francois Baclesse

    Caen, Normandy, 14000, France

  • Centre Georges Francois Leclerc

    Dijon, Bourgogne-Franche-Comté, 21000, France

  • Centre Hospitalier Universitaire De Nice Hopital De L Archet

    Nice, 06202, France

  • Centre Hospitalier Universitaire De Poitiers

    Poitiers, New Aquitaine, 86000, France

  • Centre Hospitalier Universitaire Grenoble Alpes

    La Tronche, Isere, 38700, France

  • Centre Hospitalier de l'Universite de Montreal (CHUM)

    Montreal, Quebec, H2X 0C1, Canada

  • Charite University Medicine

    Berlin, 10117, Germany

  • Chu De Bordeaux

    Bordeaux, Gironde, 33075, France

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Dana Farber Cancer Institute Brookline Avenue

    Boston, Massachusetts, 02215, United States

  • Duke Cancer Institute, University Hospital

    Durham, North Carolina, 27710, United States

  • Eastern Health

    Box Hill, Victoria, 3128, Australia

  • Elbekliniken Stade Buxtehude

    Buxtehude, Lower Saxony, 21614, Germany

  • Emory Healthcare, Emory Clinic

    Atlanta, Georgia, 30322, United States

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042, Australia

  • Fondazione IRCCS Istituto Nazionale dei Tumori.

    Milan, 20133, Italy

  • Gustave Roussy

    Villejuif, Île-de-France Region, 94800, France

  • Hartford Hospital

    Hartford, Connecticut, 06102, United States

  • Hautklinik

    Ludwigshafen am Rhein, Rhineland-Palatinate, D-67063, Germany

  • Helios Klinikum Erfurt

    Erfurt, Thuringia, D-99089, Germany

  • Hervey Bay Hospital

    Hervey Bay, Queensland, 4655, Australia

  • Hoag Family Cancer Institute

    Newport Beach, California, 92663, United States

  • Hopital Ambroise Pare

    Boulogne, 92104, France

  • Hopital Timone

    Marseille, 13385, France

  • Hospices Civils de Lyon

    Pierre-Bénite, Auvergne-Rhône-Alpes, 69495, France

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Clinico Universitario San Cecilio

    Granada, 18016, Spain

  • Hospital Clinico Universitario Virgen De La Arrixaca

    El Palmar, Murcia, 30120, Spain

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007, Spain

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007, Spain

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916, Spain

  • Hospital Universitari Son Espases

    Palma, Balearic Islands, 07120, Spain

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011, Spain

  • Hospital Universitario Virgen De La Victoria Malaga

    Málaga, Andalusia, 29010, Spain

  • Hospital Universitario Virgen de las Nieves

    Granada, Andalusia, 18015, Spain

  • Icon Cancer Centre Hobart

    Hobart, Tasmania, 7000, Australia

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031, United States

  • Instituto Oncologico Dr Rosell

    Barcelona, Catalonia, 08028, Spain

  • Instituto Valenciano de Oncologia

    Valencia, 46009, Spain

  • Istituto Europeo di Oncologia

    Milan, 20141, Italy

  • Istituto Nazionale Tumori IRCCS Fondazione G Pascale

    Naples, 80131, Italy

  • Klinikum Bremen Ost

    Bremen, 28325, Germany

  • LMU Klinikum

    Munich, Bavaria, 80337, Germany

  • Lismore Base Hospital

    Lismore, New South Wales, 2480, Australia

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Medical Oncology

    Taormina, 98039, Italy

  • Medical University Innsbruck

    Innsbruck, Tyrol, 6020, Austria

  • Medical University of Graz

    Graz, Styria, 8036, Austria

  • Medical University of Vienna

    Vienna, 1090, Austria

  • Melanoma Institute of Australia

    Wollstonecraft, New South Wales, 2065, Australia

  • Muhlenkreiskliniken Minden, Ruhr University Bochum

    Bochum, North Rhine-Westphalia, 44791, Germany

  • Nantes University Hospital

    Nantes, Pays de la Loire Region, 44093, France

  • NorthShore University HealthSystem

    Evanston, Illinois, 60201, United States

  • Northwell Health Cancer Institute

    Lake Success, New York, 11042, United States

  • One Clinical Research at Hollywood Private Hospital

    Nedlands, Western Australia, 6009, Australia

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3052, Australia

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

  • Regional University Hospital of Lille 2208

    Lille, 59037, France

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901, United States

  • SRH Wald- Klinikum Gera GmbH

    Gera, Thuringia, 07548, Germany

  • Saint Louis Hospital

    Paris, Île-de-France Region, 75010, France

  • Seidman Cancer Center

    Cleveland, Ohio, 44106, United States

  • St John's Cancer Institute

    Santa Monica, California, 90404, United States

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5, Canada

  • The Ohio State University James Comprehensive Cancer Center

    Columbus, Ohio, 43210, United States

  • The Queen Elizabeth Hospital

    Woodville, South Australia, 5011, Australia

  • The Townsville Hospital

    Douglas, Queensland, 4814, Australia

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107, United States

  • U.O. Oncologia Medica 2 Universitaria, Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126, Italy

  • UC San Diego

    La Jolla, California, 92093, United States

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90089, United States

  • UT Southwestern/Simmons Comprehensive Cancer Center

    Dallas, Texas, 75235, United States

  • Universita della Campania Luigi Vanvitelli

    Naples, 80131, Italy

  • Universitaetsklinikum Wuerzburg

    Würzburg, Bavaria, 97080, Germany

  • Universitatsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79104, Germany

  • Universitatsklinikum Leipzig, AoR

    Leipzig, Saxony, 04103, Germany

  • Universitatsklinikum Schleswig Holstein Campus Luebeck

    Lübeck, Schleswig-Holstein, 23538, Germany

  • Universitatsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89081, Germany

  • University Hospital Dresden

    Dresden, Saxony, 01307, Germany

  • University Hospital Essen

    Essen, North Rhine-Westphalia, 45147, Germany

  • University Hospital Giessen

    Giessen, Hesse, 35385, Germany

  • University Hospital Saint Poelten

    Sankt Pölten, Lower Austria, 3100, Austria

  • University Hospital of Regensburg

    Regensburg, Bavaria, 93053, Germany

  • University of California San Francisco (UCSF)

    San Francisco, California, 94143, United States

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045, United States

  • University of Massachusetts Chan Medical School

    Worcester, Massachusetts, 01655, United States

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920, United States

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • University of Virginia

    Charlottesville, Virginia, 22908, United States

  • Vall d'Hebron Hospital

    Barcelona, 08029, Spain

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Westmead Hospital

    Westmead, New South Wales, 2145, Australia

  • Yale University Cancer Center

    New Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.