Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma

Study Purpose

This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called REGN2810, also known as cemiplimab (each individually called a "study drug" or called "study drugs" when combined). The study is focused on patients with a type of skin cancer known as melanoma. The aims of the study are to see how effective the combination of fianlimab and cemiplimab are in treating the melanoma skin cancer, in comparison with a medication, pembrolizumab, approved for the treatment of melanoma skin cancer in adults, and to observe any similarities, or differences, in how the study drugs work in adolescent participants compared with adult participants. The study is looking at several other research questions, including:

- What side effects may happen from receiving the study drugs.

- How much study drug is in the blood at different times.

- Whether the body makes antibodies against the study drugs (which could make the drugs 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	12 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Key

Inclusion Criteria:

1. Age ≥12 years on the date of providing informed consent. 2. Patients with histologically confirmed unresectable Stage III and Stage IV (metastatic) melanoma (AJCC, 8th revised edition) who have not received prior systemic therapy for advanced unresectable disease. 1. Patients who received adjuvant and/or neoadjuvant systemic therapies are eligible if they did not have evidence of progression or recurrence of disease and/or discontinued due to occurrence of unmanageable irAEs ≥ grade 3 (with the exclusion of endocrinopathies which are fully controlled by hormone replacement) while on such therapies. Also, patients must have had a treatment-free and disease-free interval of >6 months. 2. Patients with acral and mucosal melanomas are eligible. Accrual will be limited to 10% of the total population. 3. Measurable disease per RECIST v1.1. 1. Previously irradiated lesions can only be counted as target lesions if they have been demonstrated to progress and no other target lesion is available. 2. Cutaneous lesions should be evaluated as non-target lesions. 4. Performance status: 1. For adult patients: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. 2. For pediatric patients: Karnofsky performance status ≥70 (patients ≥16 years) or Lansky performance status ≥70 (patients ≤16 years) 5. Anticipated life expectancy of at least 3 months. Key

Exclusion Criteria:

1. 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. 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. 4. Unknown BRAF V600 mutation status as described in the protocol. 5. Systemic immune suppression: 1. Use of immunosuppressive doses of corticosteroids (≤10mg of prednisone per day or equivalent) within 14 days of the first dose of study medication. Physiologic replacement doses are allowed up to and including 10mg of prednisone/day or equivalent. Inhaled or topical steroids are permitted, if they are not for treatment of an autoimmune disorder. 2. Other clinically relevant forms of systemic immune suppression. 6. Treatment with other anti-cancer therapy including immuno- therapy, chemotherapy, major surgery or biological therapy within 21 days prior to the first dose of trial treatment. Adjuvant hormonotherapy used for breast cancer or other hormone-sensitive cancers in long term remission is allowed. 7. History or current evidence of significant (CTCAE Grade ≥2) local or systemic infection (e. g., cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 14 days prior to the first dose of trial medication. 8. Active or untreated brain metastases or spinal cord compression. Patients with leptomeningeal disease are excluded. Patients with known brain metastases are eligible if they: 1. Received radiotherapy or another appropriate standard therapy for the brain metastases, 2. Have neurologically returned to baseline (except for residual signs and symptoms related to the CNS treatment) for at least 14 days prior to enrollment. 3. Did not require immunosuppressive doses of corticosteroids therapy (>10mg of prednisone per day or equivalent) in the 14 days prior to enrollment. 4. Are asymptomatic with a single untreated brain metastasis <10 mm in size. 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.	NCT05352672
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 3
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	Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Czechia, France, Georgia, Germany, Hungary, Ireland, Italy, Mexico, Netherlands, Peru, Poland, Romania, South Africa, Spain, Turkey, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Melanoma
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: A: fianlimab+cemiplimab dose 1

Protocol Amendment 1: 40 participants randomized 2:1:1 (Futility Analysis) Protocol Amendment 3: 140 participants randomized 2:2:2:1 Protocol Amendment 3: 1050 participants randomized 2:2:2:1 ((PFS population) Protocol Amendment 3: 360 participants randomized 1:1:1 (OS Analysis)

Experimental: A1: fianlimab+cemiplimab dose 2

Protocol Amendment 3: 140 participants randomized 2:2:2:1 Protocol Amendment 3: 1050 participants randomized 2:2:2:1 ((PFS population) Protocol Amendment 3: 360 participants randomized 1:1:1 (OS Analysis)

Experimental: B: pembrolizumab+placebo

Experimental: C: cemiplimab+placebo

Interventions

Drug: - Fianlimab

Intravenous (IV) infusion

Drug: - Cemiplimab

IV infusion

Drug: - Pembrolizumab

IV infusion

Drug: - Placebo

IV infusion

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.

University of California San Diego, La Jolla, California

Status

Recruiting

Address

University of California San Diego

La Jolla, California, 92093

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