A Phase II Study of the Interleukin-6 Receptor Inhibitor Sarilumab in Combination with Ipilimumab Nivolumab and Relatlimab in Patients with Unresectable Stage III or Stage IV Melanoma

Brief description of study

This study is looking at a treatment for advanced melanoma, a type of skin cancer. The study has two parts. First, patients will get a combination of four drugs, Ipilimumab, Nivolumab and Relatlimab and the main one Sarilumab, in a trial where everyone knows what treatment they're getting. In the second part, patients will be randomly chosen to receive three drugs with or without sarilumab for about 24 weeks. The study team wants to see how safe and effective this combination is for treating melanoma. The treatment plan involves two phases: a starting phase for the treatment and the second phase being ongoing treatment. Patients will be watched for up to two years. This study will help us understand if the treatment combinations are worth studying more. The study team will also look at how the drugs work in the body and if there are few side effects. We'll compare the groups that got different treatments to see which one is better. The study has specific plans for how much of each drug patients will get, and we'll adjust the dose if needed. This study is making sure the treatment has few side effects and is helpful in treatment advanced melanoma.

Clinical Study Identifier: s22-00325
ClinicalTrials.gov Identifier: NCT05428007
Principal Investigator: Jeffrey S. Weber.

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