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.
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
Patients must not be receiving other concomitant biologic therapy, targeted therapy, chemotherapy, other anti-cancer therapy or any other investigational agents while on this protocol
Immunosuppressive systemic corticosteroids equivalent to prednisone 10 mg or greater in the 14 days prior to the first cycle
Active autoimmune disease requiring systemic treatment in the past 2 years (i.e. use of disease modifying agents or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc) is not considered a form of systemic treatment
Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness / social situations that would limit compliance with study requirements
Single group
Anakinra
Biological/VaccineGiven SC
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Computed Tomography
Procedure/SurgeryUndergo CT or PET/CT
Electronic Health Record Review
Other interventionAncillary studies
Ipilimumab
Biological/VaccineGiven IV
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Nivolumab
Biological/VaccineGiven IV
Positron Emission Tomography
Procedure/SurgeryUndergo PET/CT
Tocilizumab
Biological/VaccineGiven IV
Tolerated dose of the combination of anakinra and tocilizumab that can be used in conjunction with nivolumab and ipilimumab in patients 50 years or older
Incidence of discontinuation of immune checkpoint inhibitor therapy due to grade 3 or higher immune-related adverse events
This analysis will be conducted for each dose level examined separately. The estimand for this objective will be the number of patients with the objective's outcome measure coded as yes divided by the number of patients evaluable for this objective. Exact confidence interval of this proportion will also be calculated.
Objective response rate
Will evaluate objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) by investigator assessment. This analysis will be conducted for each dose level examined separately. The estimand for this objective will be the number of patients demonstrating each RECIST category divided by the number of patients evaluable for this objective. The best response rate will be estimated by the number of patients who demonstrate partial response or complete response divided by the number of patients evaluable for this objective.
Overall survival
The probability of remaining alive as a function of time since enrollment will be calculated by the method of Kaplan and Meier (Kaplan EL and Meier P. Nonparametric estimation from incomplete observations. J Amer Statist Assoc, 457-481, 1958). The one year and two-year estimates will be reported for each dose group separately and for the aggregated evaluable population. There is no plan to conduct statistical comparisons between the dose groups.
Progression free survival (PFS)
The probability of remaining PFS-event free as a function of time since enrollment will be calculated by the method of Kaplan and Meier (Kaplan EL and Meier P. Nonparametric estimation from incomplete observations. J Amer Statist Assoc, 457-481, 1958). The one year and two-year estimates will be reported for each dose group separately and for the aggregated evaluable population. There is no plan to conduct statistical comparisons between the dose groups.
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University of Southern California
Lead sponsor
National Cancer Institute (NCI)
Collaborator
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