A Phase 3 Trial of Fianlimab (REGN3767, Anti-LAG-3) + Cemiplimab Versus Pembrolizumab in Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma
A Phase 3 Trial of Fianlimab (REGN3767, Anti-LAG-3) + Cemiplimab Versus Pembrolizumab in Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma
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:
Key Inclusion Criteria:
Age ≥12 years on the date of providing informed consent
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
Measurable disease per RECIST v1.1
Performance status:
Anticipated life expectancy of at least 3 months
Key Exclusion Criteria:
Uveal melanoma
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.
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
Unknown BRAF V600 mutation status as described in the protocol
Systemic immune suppression:
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.
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.
Active or untreated brain metastases or spinal cord compression. Patients with leptomeningeal disease are excluded. Patients with known brain metastases are eligible if they:
Participants with a history of myocarditis.
Note: Other protocol-defined Inclusion/ Exclusion criteria apply
Ciudad Autonoma de Buenos Aires, Buenos Aires 1061, Argentina
Ciudad Autonoma de Buenos Aires, Buenos Aires 1408, Argentina
Buenos Aires, 1125, Argentina
Namur, B5000, Belgium
Belo Horizonte, Minas Gerais 30130-090, Brazil
Passo Fundo, Rio Grande do Sul 99010-090, Brazil
São José do Rio Preto, São Paulo 15090-000, Brazil
Vinohrady, Prague 10034, Czechia
Saint Priest En Jarez, Pays de la Loire Region 42270, France
Tbilisi, 0144, Georgia
Nuremberg, Bavaria 90408, Germany
Mainz, Rhineland-Palatinate 55131, Germany
Kiel, Schleswig-Holstein 24105, Germany
Nyíregyháza, Szabolcs-Szatmár-Bereg 4400, Hungary
Naples, Campania 80121, Italy
Monza, 20052, Italy
Concepción, Departamento de Junín 12125, Peru
Lima, Provincia Constitucional del Callao 07016, Peru
Słupsk, Pomeranian 76-200, Poland
Barcelona, Catalonia 08028, Spain
Istanbul, 81450, Turkey (Türkiye)