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Adding Anakinra and Tocilizumab to Nivolumab and Ipilimumab for the Treatment of Melanoma Patients 50 Years of Age or Older
Sponsor: University of Southern California
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.
Official title: Targeting Inflammaging-Associated Cytokine Signaling to Improve Efficacy and Reduce Immune-Related Toxicities of Anti-PD-1/CTLA-4 Therapy
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-11-01
Completion Date
2030-11-01
Last Updated
2026-09-24
Healthy Volunteers
No
Conditions
Interventions
Anakinra
Given SC
Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo CT or PET/CT
Electronic Health Record Review
Ancillary studies
Ipilimumab
Given IV
Magnetic Resonance Imaging
Undergo MRI
Nivolumab
Given IV
Positron Emission Tomography
Undergo PET/CT
Tocilizumab
Given IV
Locations (1)
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States