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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06190951
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Regeneron Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Clinical Trial Management
Principal Investigator Affiliation Regeneron Pharmaceuticals
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Canada, France, Germany, Italy, Spain, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Melanoma
Arms & Interventions

Arms

Active Comparator: Arm A

As described in the protocol

Experimental: Arm B

As described in the protocol

Experimental: Arm C

As described in the protocol

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UC San Diego, La Jolla, California

Status

Recruiting

Address

UC San Diego

La Jolla, California, 92093

USC Norris Comprehensive Cancer Center, Los Angeles, California

Status

Recruiting

Address

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033

Hoag Family Cancer Institute, Newport Beach, California

Status

Recruiting

Address

Hoag Family Cancer Institute

Newport Beach, California, 92663

San Francisco, California

Status

Recruiting

Address

California Pacific Medical Center Research Institute

San Francisco, California, 94115

San Francisco, California

Status

Recruiting

Address

University of California San Francisco (UCSF)

San Francisco, California, 94143

St John's Cancer Institute, Santa Monica, California

Status

Recruiting

Address

St John's Cancer Institute

Santa Monica, California, 90404

Hartford Hospital, Hartford, Connecticut

Status

Recruiting

Address

Hartford Hospital

Hartford, Connecticut, 06102

Emory Healthcare, Emory Clinic, Atlanta, Georgia

Status

Recruiting

Address

Emory Healthcare, Emory Clinic

Atlanta, Georgia, 30322

NorthShore University HealthSystem, Evanston, Illinois

Status

Recruiting

Address

NorthShore University HealthSystem

Evanston, Illinois, 60201

Worcester, Massachusetts

Status

Recruiting

Address

University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01655

Washington University School of Medicine, Saint Louis, Missouri

Status

Recruiting

Address

Washington University School of Medicine

Saint Louis, Missouri, 63110

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey

Status

Recruiting

Address

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901

Northwell Health Cancer Institute, Lake Success, New York

Status

Recruiting

Address

Northwell Health Cancer Institute

Lake Success, New York, 11040

Durham, North Carolina

Status

Recruiting

Address

Duke Cancer Institute, University Hospital

Durham, North Carolina, 27710

Seidman Cancer Center, Cleveland, Ohio

Status

Recruiting

Address

Seidman Cancer Center

Cleveland, Ohio, 44106

Cleveland Clinic Foundation, Cleveland, Ohio

Status

Recruiting

Address

Cleveland Clinic Foundation

Cleveland, Ohio, 44195

Thomas Jefferson University Hospital, Philadelphia, Pennsylvania

Status

Recruiting

Address

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107

University of Tennessee Medical Center, Knoxville, Tennessee

Status

Recruiting

Address

University of Tennessee Medical Center

Knoxville, Tennessee, 37920

Houston, Texas

Status

Recruiting

Address

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

University of Virginia, Charlottesville, Virginia

Status

Recruiting

Address

University of Virginia

Charlottesville, Virginia, 22908

International Sites

Westmead Hospital, Westmead, New South Wales, Australia

Status

Recruiting

Address

Westmead Hospital

Westmead, New South Wales, 2145

Melanoma Institute of Australia, Wollstonecraft, New South Wales, Australia

Status

Recruiting

Address

Melanoma Institute of Australia

Wollstonecraft, New South Wales, 2065

The Queen Elizabeth Hospital, Woodville, South Australia, Australia

Status

Recruiting

Address

The Queen Elizabeth Hospital

Woodville, South Australia, 5011

Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

Status

Recruiting

Address

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3052

Nedlands, Western Australia, Australia

Status

Recruiting

Address

One Clinical Research at Hollywood Private Hospital

Nedlands, Western Australia, 6009

Montreal, Quebec, Canada

Status

Recruiting

Address

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec, H2X 0C1

CHU de Quebec - Universite Laval, Quebec City, Quebec, Canada

Status

Recruiting

Address

CHU de Quebec - Universite Laval

Quebec City, Quebec, G1J1Z4

CHU-Dijon, Dijon, Burgundy, France

Status

Recruiting

Address

CHU-Dijon

Dijon, Burgundy, 21000

Chu De Bordeaux, Bordeaux, Gironde, France

Status

Recruiting

Address

Chu De Bordeaux

Bordeaux, Gironde, 33075

Saint Louis Hospital, Paris, Ile De France, France

Status

Recruiting

Address

Saint Louis Hospital

Paris, Ile De France, 75010

Gustave Roussy, Villejuif, Ile De France, France

Status

Recruiting

Address

Gustave Roussy

Villejuif, Ile De France, 94800

Centre Francois Baclesse, Caen, Normandy, France

Status

Recruiting

Address

Centre Francois Baclesse

Caen, Normandy, 14000

Hopital Ambroise Pare, Boulogne, France

Status

Recruiting

Address

Hopital Ambroise Pare

Boulogne, , 92104

CHU Estaing, Clermont Ferrand, France

Status

Recruiting

Address

CHU Estaing

Clermont Ferrand, , 63003

Lille, France

Status

Recruiting

Address

Regional University Hospital of Lille 2208

Lille, , 59037

Hopital Timone, Marseille, France

Status

Recruiting

Address

Hopital Timone

Marseille, , 13385

Nice, France

Status

Recruiting

Address

Centre Hospitalier Universitaire De Nice Hopital De L Archet

Nice, , 06202

University Hospital Giessen, Giessen, Hessen, Germany

Status

Recruiting

Address

University Hospital Giessen

Giessen, Hessen, 35385

Universitatsklinikum Leipzig, AoR, Leipzig, Saxony, Germany

Status

Recruiting

Address

Universitatsklinikum Leipzig, AoR

Leipzig, Saxony, 04103

Charite University Medicine, Berlin, Germany

Status

Recruiting

Address

Charite University Medicine

Berlin, , 10117

Cona, Ferrara, Italy

Status

Recruiting

Address

Azienda Ospedaliero-Universitaria Ferrara

Cona, Ferrara, 44124

Pisa, Italy

Status

Recruiting

Address

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

Pisa, , 56126

Vall d'Hebron Hospital, Barcelona, Spain

Status

Recruiting

Address

Vall d'Hebron Hospital

Barcelona, , 08029

Hospital Clinic de Barcelona, Barcelona, Spain

Status

Recruiting

Address

Hospital Clinic de Barcelona

Barcelona, , 08036

Salamanca, Spain

Status

Recruiting

Address

Hospital Clinico Universitario de Salamanca

Salamanca, , 37007

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