University of Southern California
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.
PRIMARY OBJECTIVES: I. To establish the tolerated dose of the combination of anakinra and tocilizumab that can be used in conjunction with nivolumab and ipilimumab for further evaluation in patients 50 years of age or older at the start of treatment. SECONDARY OBJECTIVES: I. To evaluate the safety of the combination based on Common Terminology Criteria for Adverse Events (CTCAE) version (v) 6.0. II. To evaluate the incidence of discontinuation of immune checkpoint inhibitor (ICI) therapy due to grade 3 or higher immune-related adverse events (irAEs). III. To evaluate objective response ra…
Inclusion Criteria: * Age ≥ 50 years old * Patients with melanoma, who are going to be treated with ipilimumab 1mg/Kg and nivolumab 3mg/Kg as a standard of care (SOC) * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 * Platelets ≥ 50 000/µL * Hemoglobin ≥ 8.0 g/dL * Absolute neutrophil count (ANC) ≥ 1500/μL * Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) ≤ 3.0 X institutional ULN (up to 5 X institutional ULN if patient has liver metastases) * Alanine aminotransf…
Given SC
Undergo blood sample collection
Undergo CT or PET/CT
Ancillary studies
Given IV
Undergo MRI
Given IV
Undergo PET/CT
Given IV
Arctuva estimate
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