Study on Using Sarilumab with Ipilimumab, Nivolumab, and Relatlimab for Advanced Melanoma That Cannot Be Surgically Removed
Sponsor: NYU Langone Health
ClinicalTrials ID:NCT05428007
This clinical trial is testing a new combination of drugs, including sarilumab, ipilimumab, nivolumab, and relatlimab, to see if they are safe and effective in treating advanced melanoma that cannot be removed by surgery.
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Program Overview
The purpose of this study is to evaluate the safety and effectiveness of a new drug combination for treating advanced melanoma that cannot be surgically removed. The drugs being tested include sarilumab, which is approved for rheumatoid arthritis but not for melanoma, and a combination of ipilimumab, nivolumab, and relatlimab, which are used for advanced melanoma. The study aims to see if this combination can reduce side effects and improve treatment outcomes for patients with stage III or IV melanoma.
Description
This study is divided into two phases: an induction phase and a maintenance phase. During the induction phase, which lasts 8 weeks, patients will receive a combination of drugs including ipilimumab, nivolumab, relatlimab, and sarilumab. Ipilimumab is given intravenously on the first day, while nivolumab and relatlimab are given together every 4 weeks. Sarilumab is administered under the skin every 2 weeks. After the induction phase, patients enter the maintenance phase, which can last up to 2 years. During this phase, the same combination of drugs is given every 8 weeks, with sarilumab only given during the first 24 weeks. The study will monitor how well patients tolerate the treatment and how their cancer responds.
Eligibility Criteria
Inclusion Criteria
- Must sign a consent form agreeing to participate in the study.
- Must be willing to attend scheduled visits and follow the treatment plan.
- Must have stage IIIb/c/d or stage IV melanoma that cannot be removed by surgery.
- All types of melanoma except for eye melanoma are allowed.
- Must not have received previous treatment for metastatic melanoma, except for certain surgeries or radiation.
- Must have a complete physical exam and imaging tests within 4 weeks before starting the study.
- Disease must be measurable by specific criteria.
- Must provide baseline imaging before starting treatment.
Exclusion Criteria
- Cannot have untreated brain metastases or eye melanoma.
- Cannot have had another type of cancer unless it was completely removed or in remission for at least 2 years.
- Cannot have active autoimmune diseases, except for certain conditions like type I diabetes or skin disorders that don't need systemic treatment.
- Cannot be on systemic steroids or immunosuppressive medications within 14 days before starting the study, except for inhaled or topical steroids.
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