Brief Summary
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 cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs known as melanomaa type of cancer that develops from melanocytes, which are the cells that produce pigment generally in the skin (but can develop in other areas of the body). 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 bloodthe red bodily fluid that transports oxygen and other nutrients around the body 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 lifethe overall well-being of a person diagnosed with cancer, encompassing both physical and emotional aspects of health
Intervention / Treatment
- Drug: Fianlimab
- Drug: Cemiplimab
- Drug: Pembrolizumab
- Drug: Placebo
Key Inclusion Criteria:
- Age ≥12 years on the date of providing informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment.
- Patients with histologically confirmed unresectable Stage III and Stage IV (metastatic) melanoma (AJCC, 8th revised edition) who have not received prior systemic therapy for advancedat a late stage, far along unresectable disease
- Patients who received adjuvant and/or neoadjuvant systemic therapies are eligible if they did not have evidence of progression or recurrenceto occur or happen again of disease and/or discontinued due to occurrence of unmanageable imAEs ≥ gradea description of how abnormal cancer cells and tissue look under a microscope when compared to healthy cells 3 (with the exclusion of endocrinopathies which are fully controlled by hormonea chemical substance produced by glands in the endocrine system that regulates various functions in the body replacement) while on such therapies. Also, patients must have had a treatment-free and disease-free interval of >6 months. Accrual of these patients is limited to approximately 10% of the total population enrolled.
- Patients with acral and mucosal melanomas are eligible. Accrual will be limited to 10% of the total population.
- Measurable disease per RECIST v1.1
- Previously irradiated lesions can only be counted as target lesions if they have been demonstrated to progress and no other target lesion is available
- Cutaneous lesions should be evaluated as non-target lesions
- Performance status:
- For adult patients: Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status (PS) 0 or 1
- For pediatric patients: Karnofsky performance status ≥70 (patients ≥16 years) or Lansky performance status ≥70 (patients ≤16 years)
- Anticipated life expectancy of at least 3 months.