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NOT YET RECRUITING
NCT07838974
PHASE1

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

View on ClinicalTrials.gov

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

BIOLOGICAL

Anakinra

Given SC

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Computed Tomography

Undergo CT or PET/CT

OTHER

Electronic Health Record Review

Ancillary studies

BIOLOGICAL

Ipilimumab

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

BIOLOGICAL

Nivolumab

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

BIOLOGICAL

Tocilizumab

Given IV

Locations (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States