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

NCT06190951 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: R3767-ONC-22082022-502825-17-00
• Study Type: interventional
• Target: 151
• Locations: 7 countries
• Sites: 100

Brief 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.

Conditions

Melanoma

Keywords

Skin cancer; Fully resectable stage III melanoma; Fully resectable stage IV melanoma

Outcome Measures

Primary Outcomes (1)

• Pathological complete response (pCR) rate as assessed by Blinded Independent Pathological Review (BIPR)

  Up to 1 year

Secondary Outcomes (25)

• pCR rate as assessed by local pathologic review

  Up to 1 year

• Event-Free Survival (EFS)

  Up to 4 years

• Distant metastasis-free survival (DMFS)

  Up to 4 years

• Overall survival (OS)

  Up to 4 years

• Major pathological response (MPR) as assessed by BIPR

  Up to 4 years

Study Arms (3)

Arm A

ACTIVE COMPARATOR

As described in the protocol

Drug: cemiplimab; Drug: Placebo

Arm B

EXPERIMENTAL

As described in the protocol

Drug: Fixed Dose Combination (FDC) cemiplimab+fianlimab

Arm C

EXPERIMENTAL

As described in the protocol

Drug: Fixed Dose Combination (FDC) cemiplimab+fianlimab

Interventions

cemiplimab DRUG

Administered per the protocol

Also known as: REGN2810, Libtayo

Arm A

Fixed Dose Combination (FDC) cemiplimab+fianlimab DRUG

Or coadministration, depending on availability.

Also known as: REGN2810, Libtayo, REGN3767

Arm B; Arm C

Placebo DRUG

Administered per the protocol

Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.
• 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).
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

You may not qualify if:

• Medical conditions:
• Primary uveal melanoma
• 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.
• 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:
• 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.
• 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:
• Participants with a history of myocarditis.
• 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.

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (104)

UC San Diego

La Jolla, California, 92093, United States

Location

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90089, United States

Location

Hoag Family Cancer Institute

Newport Beach, California, 92663, United States

Location

California Pacific Medical Center Research Institute

San Francisco, California, 94115, United States

Location

University of California San Francisco (UCSF)

San Francisco, California, 94143, United States

Location

St John's Cancer Institute

Santa Monica, California, 90404, United States

Location

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Yale University Cancer Center

New Haven, Connecticut, 06510, United States

Location

Emory Healthcare, Emory Clinic

Atlanta, Georgia, 30322, United States

Location

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institute Brookline Avenue

Boston, Massachusetts, 02215, United States

Location

University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01655, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Northwell Health Cancer Institute

Lake Success, New York, 11042, United States

Location

Duke Cancer Institute, University Hospital

Durham, North Carolina, 27710, United States

Location

Seidman Cancer Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

The Ohio State University James Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15232, United States

Location

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Location

UT Southwestern/Simmons Comprehensive Cancer Center

Dallas, Texas, 75235, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

Location

Lismore Base Hospital

Lismore, New South Wales, 2480, Australia

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Melanoma Institute of Australia

Wollstonecraft, New South Wales, 2065, Australia

Location

The Townsville Hospital

Douglas, Queensland, 4814, Australia

Location

Hervey Bay Hospital

Hervey Bay, Queensland, 4655, Australia

Location

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

Location

The Queen Elizabeth Hospital

Woodville, South Australia, 5011, Australia

Location

Icon Cancer Centre Hobart

Hobart, Tasmania, 7000, Australia

Location

Eastern Health

Box Hill, Victoria, 3128, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3052, Australia

Location

One Clinical Research at Hollywood Private Hospital

Nedlands, Western Australia, 6009, Australia

Location

University Hospital Saint Poelten

Sankt Pölten, Lower Austria, 3100, Austria

Location

Medical University of Graz

Graz, Styria, 8036, Austria

Location

Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

Medical University of Vienna

Vienna, 1090, Austria

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec, H2X 0C1, Canada

Location

CHU de Quebec - Universite Laval

Québec, G1J 1Z4, Canada

Location

Hospices Civils de Lyon

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

Location

Centre Georges Francois Leclerc

Dijon, Bourgogne-Franche-Comté, 21000, France

Location

CHU-Dijon

Dijon, Burgundy, 21000, France

Location

CHRU de Tours

Tours, Centre-Val de Loire, 37044, France

Location

Chu De Bordeaux

Bordeaux, Gironde, 33075, France

Location

Centre Hospitalier Universitaire Grenoble Alpes

La Tronche, Isere, 38700, France

Location

Centre Francois Baclesse

Caen, Normandy, 14000, France

Location

Centre Hospitalier Universitaire De Poitiers

Poitiers, Nouvelle-Aquitaine, 86000, France

Location

Nantes University Hospital

Nantes, Pays de la Loire Region, 44093, France

Location

Hopital Ambroise Pare

Boulogne, 92104, France

Location

CHU Estaing

Clermont-Ferrand, 63003, France

Location

Regional University Hospital of Lille 2208

Lille, 59037, France

Location

Hopital Timone

Marseille, 13385, France

Location

Centre Hospitalier Universitaire De Nice Hopital De L Archet

Nice, 06202, France

Location

Saint Louis Hospital

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

Location

Gustave Roussy

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

Location

Universitatsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79104, Germany

Location

Universitatsklinikum Ulm

Ulm, Baden-Wurttemberg, 89081, Germany

Location

LMU Klinikum

Munich, Bavaria, 80337, Germany

Location

University Hospital of Regensburg

Regensburg, Bavaria, 93053, Germany

Location

Universitaetsklinikum Wuerzburg

Würzburg, Bavaria, 97080, Germany

Location

University Hospital Giessen

Giessen, Hesse, 35385, Germany

Location

Elbekliniken Stade Buxtehude

Buxtehude, Lower Saxony, 21614, Germany

Location

Muhlenkreiskliniken Minden, Ruhr University Bochum

Bochum, North Rhine-Westphalia, 44791, Germany

Location

University Hospital Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location

Hautklinik

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

Location

University Hospital Dresden

Dresden, Saxony, 01307, Germany

Location

Universitatsklinikum Leipzig, AoR

Leipzig, Saxony, 04103, Germany

Location

Universitatsklinikum Schleswig Holstein Campus Luebeck

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Helios Klinikum Erfurt

Erfurt, Thuringia, D-99089, Germany

Location

SRH Wald- Klinikum Gera GmbH

Gera, Thuringia, 07548, Germany

Location

Charite University Medicine

Berlin, 10117, Germany

Location

Klinikum Bremen Ost

Bremen, 28325, Germany

Location

Azienda Ospedaliera Santa Croce i Carle

Cuneo, 12100, Italy

Location

Azienda Ospedaliero-Universitaria Ferrara

Ferrara, 44124, Italy

Location

Fondazione IRCCS Istituto Nazionale dei Tumori.

Milan, 20133, Italy

Location

Istituto Europeo di Oncologia

Milan, 20141, Italy

Location

Istituto Nazionale Tumori IRCCS Fondazione G Pascale

Naples, 80131, Italy

Location

Universita della Campania Luigi Vanvitelli

Naples, 80131, Italy

Location

Azienda Ospedaliero-Universitaria Maggiore della Carita - Oncology

Novara, 28100, Italy

Location

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

Pisa, 56126, Italy

Location

Campus Bio-Medico di Roma

Rome, 00128, Italy

Location

Medical Oncology

Taormina, 98039, Italy

Location

Azienda Sanitaria Universitaria del Friuli Centrale

Udine, 33100, Italy

Location

Hospital Universitario Virgen de las Nieves

Granada, Andalusia, 18015, Spain

Location

Hospital Universitario Virgen De La Victoria Malaga

Málaga, Andalusia, 29010, Spain

Location

Hospital Universitari Son Espases

Palma, Balearic Islands, 07120, Spain

Location

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Instituto Oncologico Dr Rosell

Barcelona, Catalonia, 08028, Spain

Location

Hospital Clinico Universitario Virgen De La Arrixaca

El Palmar, Murcia, 30120, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

Location

Vall d'Hebron Hospital

Barcelona, 08029, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Clinico Universitario San Cecilio

Granada, 18016, Spain

Location

Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

Location

Hospital Clinico Universitario de Salamanca

Salamanca, 37007, Spain

Location

Instituto Valenciano de Oncologia

Valencia, 46009, Spain

Location

MeSH Terms

Conditions

Melanoma; Skin Neoplasms

Interventions

cemiplimab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: January 5, 2024
• Study Start: September 18, 2024
• Primary Completion (Estimated): November 2, 2026
• Study Completion (Estimated): December 9, 2030
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

CA (4); ES (13); FR (16); IT (11); US (28); DE (17); AU (11)