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ACTIVE NOT RECRUITING

NCT06190951

PHASE2

A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better Than Anti-PD1 Alone in Adult Participants With Resectable Stage 3 or 4 Melanoma

Sponsor: Regeneron Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called cemiplimab (each individually called a "study drug" or called "study drugs" when combined) compared with cemiplimab alone. These types of immunotherapy study drugs are collectively known as immune checkpoint inhibitors. Immunotherapies are treatments that use the immune system to recognize and kill cancer cells. The study is focused on participants with a type of skin cancer known as melanoma. The objective of this study is to see if the combination of fianlimab and cemiplimab is an effective treatment compared to cemiplimab in participants with high-risk, resectable melanoma. Participants will receive treatment before surgery, undergo resection, and then will have the option to continue treatment after resection. The study is looking at several other research questions, including: * What side effects may happen from receiving the study drug(s). * How much study drug(s) is in the blood at different times. * Whether the body makes antibodies against the study drug(s) (which could make the drug less effective or could lead to side effects). Antibodies are proteins that are naturally found in the blood stream that fight infections. * How administering the study drugs might improve quality of life.

Official title: A Phase 2 Peri-operative Trial of Fianlimab and Cemiplimab Compared With Anti-PD1 Alone in Patients With Resectable Stage III and IV Melanoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

151

Start Date

2024-09-18

Completion Date

2030-12-09

Last Updated

2026-02-10

Healthy Volunteers

Conditions

Melanoma

Interventions

DRUG

cemiplimab

Administered per the protocol

DRUG

Fixed Dose Combination (FDC) cemiplimab+fianlimab

Or coadministration, depending on availability.

DRUG

Placebo

Administered per the protocol

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

Locations (104)

UC San Diego

La Jolla, California, United States

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

Hoag Family Cancer Institute

Newport Beach, California, United States

California Pacific Medical Center Research Institute

San Francisco, California, United States

University of California San Francisco (UCSF)

San Francisco, California, United States

St John's Cancer Institute

Santa Monica, California, United States

University of Colorado Cancer Center

Aurora, Colorado, United States

Hartford Hospital

Hartford, Connecticut, United States

Yale University Cancer Center

New Haven, Connecticut, United States

Emory Healthcare, Emory Clinic

Atlanta, Georgia, United States

NorthShore University HealthSystem

Evanston, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute Brookline Avenue

Boston, Massachusetts, United States

University of Massachusetts Chan Medical School

Worcester, Massachusetts, United States

Washington University School of Medicine

St Louis, Missouri, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Northwell Health Cancer Institute

Lake Success, New York, United States

Duke Cancer Institute, University Hospital

Durham, North Carolina, United States

Seidman Cancer Center

Cleveland, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

The Ohio State University James Comprehensive Cancer Center

Columbus, Ohio, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

University of Tennessee Medical Center

Knoxville, Tennessee, United States

UT Southwestern/Simmons Comprehensive Cancer Center

Dallas, Texas, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

Inova Schar Cancer Institute

Fairfax, Virginia, United States

Lismore Base Hospital

Lismore, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Melanoma Institute of Australia

Wollstonecraft, New South Wales, Australia

The Townsville Hospital

Douglas, Queensland, Australia

Hervey Bay Hospital

Hervey Bay, Queensland, Australia

Flinders Medical Centre

Bedford Park, South Australia, Australia

The Queen Elizabeth Hospital

Woodville, South Australia, Australia

Icon Cancer Centre Hobart

Hobart, Tasmania, Australia

Eastern Health

Box Hill, Victoria, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

One Clinical Research at Hollywood Private Hospital

Nedlands, Western Australia, Australia

University Hospital Saint Poelten

Sankt Pölten, Lower Austria, Austria

Medical University of Graz

Graz, Styria, Austria

Medical University Innsbruck

Innsbruck, Tyrol, Austria

Medical University of Vienna

Vienna, Austria

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec, Canada

CHU de Quebec - Universite Laval

Québec, Canada

Hospices Civils de Lyon

Pierre-Bénite, Auvergne-Rhône-Alpes, France

Centre Georges Francois Leclerc

Dijon, Bourgogne-Franche-Comté, France

CHU-Dijon

Dijon, Burgundy, France

CHRU de Tours

Tours, Centre-Val de Loire, France

Chu De Bordeaux

Bordeaux, Gironde, France

Centre Hospitalier Universitaire Grenoble Alpes

La Tronche, Isere, France

Centre Francois Baclesse

Caen, Normandy, France

Centre Hospitalier Universitaire De Poitiers

Poitiers, Nouvelle-Aquitaine, France

Nantes University Hospital

Nantes, Pays de la Loire Region, France

Hopital Ambroise Pare

Boulogne, France

CHU Estaing

Clermont-Ferrand, France

Regional University Hospital of Lille 2208

Lille, France

Hopital Timone

Marseille, France

Centre Hospitalier Universitaire De Nice Hopital De L Archet

Nice, France

Saint Louis Hospital

Paris, Île-de-France Region, France

Gustave Roussy

Villejuif, Île-de-France Region, France

Universitatsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Universitatsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany

LMU Klinikum

Munich, Bavaria, Germany

University Hospital of Regensburg

Regensburg, Bavaria, Germany

Universitaetsklinikum Wuerzburg

Würzburg, Bavaria, Germany

University Hospital Giessen

Giessen, Hesse, Germany

Elbekliniken Stade Buxtehude

Buxtehude, Lower Saxony, Germany

Muhlenkreiskliniken Minden, Ruhr University Bochum

Bochum, North Rhine-Westphalia, Germany

University Hospital Essen

Essen, North Rhine-Westphalia, Germany

Hautklinik

Ludwigshafen am Rhein, Rhineland-Palatinate, Germany

University Hospital Dresden

Dresden, Saxony, Germany

Universitatsklinikum Leipzig, AoR

Leipzig, Saxony, Germany

Universitatsklinikum Schleswig Holstein Campus Luebeck

Lübeck, Schleswig-Holstein, Germany

Helios Klinikum Erfurt

Erfurt, Thuringia, Germany

SRH Wald- Klinikum Gera GmbH

Gera, Thuringia, Germany

Charite University Medicine

Berlin, Germany

Klinikum Bremen Ost

Bremen, Germany

Azienda Ospedaliera Santa Croce i Carle

Cuneo, Italy

Azienda Ospedaliero-Universitaria Ferrara

Ferrara, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori.

Milan, Italy

Istituto Europeo di Oncologia

Milan, Italy

Istituto Nazionale Tumori IRCCS Fondazione G Pascale

Naples, Italy

Universita della Campania Luigi Vanvitelli

Naples, Italy

Azienda Ospedaliero-Universitaria Maggiore della Carita - Oncology

Novara, Italy

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

Pisa, Italy

Campus Bio-Medico di Roma

Rome, Italy

Medical Oncology

Taormina, Italy

Azienda Sanitaria Universitaria del Friuli Centrale

Udine, Italy

Hospital Universitario Virgen de las Nieves

Granada, Andalusia, Spain

Hospital Universitario Virgen De La Victoria Malaga

Málaga, Andalusia, Spain

Hospital Universitari Son Espases

Palma, Balearic Islands, Spain

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Instituto Oncologico Dr Rosell

Barcelona, Catalonia, Spain

Hospital Clinico Universitario Virgen De La Arrixaca

El Palmar, Murcia, Spain

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Vall d'Hebron Hospital

Barcelona, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital Clinico Universitario San Cecilio

Granada, Spain

Hospital General Universitario Gregorio Maranon

Madrid, Spain

Hospital Clinico Universitario de Salamanca

Salamanca, Spain

Instituto Valenciano de Oncologia

Valencia, Spain

Clinical Research Directory

A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better Than Anti-PD1 Alone in Adult Participants With Resectable Stage 3 or 4 Melanoma

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (104)