drugset / Trial / NCT07838974

Adding Anakinra and Tocilizumab to Nivolumab and Ipilimumab for the Treatment of Melanoma Patients 50 Years of Age or Older

NCT07838974 ↗

NaSingle-groupOpen-labelTreatment

Summary

This phase I trial studies the side effects of adding anakinra and tocilizumab to standard treatment with nivolumab and ipilimumab and to see how well it works in treating melanoma patients who are 50 years of age or older. Anakinra and tocilizumab are used to decrease the body's immune response and lower side effects. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Researchers think that anakinra and tocilizumab may reduce the side effects experienced from standard treatment with nivolumab and ipilimumab while also preserving their anti-cancer effects. Adding anakinra and tocilizumab to standard treatment with nivolumab and ipilimumab may be safe, tolerable, and/or effective in treating melanoma patients who are 50 years of age or older.

Timeline

Start
2026-11-01
Primary completion
2029-11-01
Completion
2030-11-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Anakinra Protein / enzyme biologic — Subcutaneous
Subject Tocilizumab Monoclonal antibody — Intravenous
Background Ipilimumab Monoclonal antibody — Intravenous
Background Nivolumab Monoclonal antibody — Intravenous

Indications