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 an approved medication called pembrolizumab.
The objective of this study is to see if the combination of fianlimab and cemiplimab is an effective treatment compared to pembrolizumab in patients that have had 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) removal surgerytreatment involving removal of cancerous tissue and/or tumours and a margin of healthy tissue around it to reduce recurrence but are still at high riskthe possibility that something bad will happen for the recurrenceto occur or happen again of the disease. Pembrolizumab is an approved treatment in some countries in this clinical setting.
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 drug (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 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:
- All patients must be either stage IIB, IIC, III, or stage IV per American Joint Committee on Cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs (AJCC) 8th edition and have histologically confirmed melanoma that is completely surgically resected in order to be eligible as defined by the protocol
- Complete surgical resectionsurgical removal of tissue or part/all of an organ must be performed within 12 weeks prior to randomization, and enrollment may occur only after satisfactory wound healing from the surgery
- All patients must have disease-free status documented by a complete physical examinationan examination of your current symptoms, affected area(s) and overall medical history and imagingtests that create detailed images of areas inside the body studies within 4 weeks prior to randomization, as described in the protocol.