[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657437":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":35,"studyPopulation":11,"armGroups":36,"interventions":51,"overallOfficials":175,"centralContacts":11,"locations":179,"responsibleParty":199,"collaborators":201,"id":205,"slug":206,"hasResults":207,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":11,"eligibilityCriteria":211,"healthyVolunteers":207,"sex":212,"minAge":213,"maxAge":11,"enrollmentInfo":214,"targetDuration":11,"studyType":217,"phases":218,"briefSummary":220,"conditions":221,"keywords":11,"overallStatus":223,"whyStopped":11,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":233},{"fullName":5,"class":6},"University of Southern California","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"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",null,"Up to 12 weeks",[14,17,21,25],{"measure":15,"description":16,"timeFrame":12},"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.",{"measure":18,"description":19,"timeFrame":20},"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.","Up to 2 years",{"measure":22,"description":23,"timeFrame":24},"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.","From first dose of treatment to death due to any cause, assessed up to 2 years",{"measure":26,"description":27,"timeFrame":28},"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.","From start of treatment to time of progression or death whichever comes first, assessed up to 2 years",{"allocation":30,"interventionModel":31,"interventionModelDescription":11,"primaryPurpose":32,"observationalModel":11,"timePerspective":11,"maskingInfo":33},"NA","SINGLE_GROUP","TREATMENT",{"masking":34,"maskingDescription":11,"whoMasked":11},"NONE","PRIMARY OBJECTIVES:\n\nI. 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.\n\nSECONDARY OBJECTIVES:\n\nI. To evaluate the safety of the combination based on Common Terminology Criteria for Adverse Events (CTCAE) version (v) 6.0.\n\nII. To evaluate the incidence of discontinuation of immune checkpoint inhibitor (ICI) therapy due to grade 3 or higher immune-related adverse events (irAEs).\n\nIII. To evaluate objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) (v1.1) by investigator assessment (objective response rate \\[ORR\\] will be reported separately for patients treated neoadjuvant therapy versus \\[vs.\\] others).\n\nIV. To evaluate overall survival (OS). V. To assess progression-free survival (PFS).\n\nEXPLORATORY OBJECTIVES:\n\nI. To evaluate change in serum cytokine\u002Fchemokine profile. II. To profile peripheral blood (PB) immune subsets.\n\nOUTLINE: This is a dose de-escalation study of anakinra in combination with tocilizumab, nivolumab, and ipilimumab.\n\nPatients receive anakinra subcutaneously (SC) once daily (QD) on days 1-21 of each cycle, once every other day of each cycle, or once every 3 days of each cycle. Patients also receive tocilizumab intravenously (IV), nivolumab IV, and ipilimumab IV on day 1 of each cycle. Cycles repeat every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo magnetic resonance imaging (MRI) and computed tomography (CT) or positron emission tomography (PET)\u002FCT during screening and as clinically indicated as well as blood sample collection throughout the study.\n\nAfter completion of study treatment, patients are followed up at 1 week and then every 6 months for up to 2 years.",[37],{"label":38,"type":39,"description":40,"interventionNames":41},"Treatment (anakinra, tocilizumab, nivolumab, ipilimumab)","EXPERIMENTAL","Patients receive anakinra SC QD on days 1-21 of each cycle, once every other day of each cycle, or once every 3 days of each cycle. Patients also receive tocilizumab IV, nivolumab IV, and ipilimumab IV on day 1 of each cycle. Cycles repeat every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo MRI and CT or PET\u002FCT during screening and as clinically indicated as well as blood sample collection throughout the study.",[42,43,44,45,46,47,48,49,50],"Biological: Anakinra","Procedure: Biospecimen Collection","Procedure: Computed Tomography","Other: Electronic Health Record Review","Biological: Ipilimumab","Procedure: Magnetic Resonance Imaging","Biological: Nivolumab","Procedure: Positron Emission Tomography","Biological: Tocilizumab",[52,62,72,89,93,108,128,149,161],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":57},"BIOLOGICAL","Anakinra","Given SC",[38],[58,59,60,61],"Kinaret","Kineret","rIL-1ra","rIL1RN",{"type":63,"name":64,"description":65,"armGroupLabels":66,"otherNames":67},"PROCEDURE","Biospecimen Collection","Undergo blood sample collection",[38],[68,69,70,71],"Biological Sample Collection","Biospecimen Collected","Sample Collection","Specimen Collection",{"type":63,"name":73,"description":74,"armGroupLabels":75,"otherNames":76},"Computed Tomography","Undergo CT or PET\u002FCT",[38],[77,78,79,80,81,82,83,84,85,86,87,88],"CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized axial tomography (procedure)","Computerized Tomography","Computerized Tomography (CT) scan","CT","CT Scan","Diagnostic CAT Scan","Diagnostic CAT Scan Service Type","tomography",{"type":6,"name":90,"description":91,"armGroupLabels":92,"otherNames":11},"Electronic Health Record Review","Ancillary studies",[38],{"type":53,"name":94,"description":95,"armGroupLabels":96,"otherNames":97},"Ipilimumab","Given IV",[38],[98,99,100,101,102,103,104,105,106,107],"Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody","BMS 734016","BMS-734016","BMS734016","Ipilimumab Biosimilar CS1002","MDX 010","MDX-010","MDX-CTLA4","MDX010","Yervoy",{"type":63,"name":109,"description":110,"armGroupLabels":111,"otherNames":112},"Magnetic Resonance Imaging","Undergo MRI",[38],[113,114,115,116,117,118,119,120,121,122,123,124,125,126,127],"Magnetic Resonance","Magnetic Resonance Imaging (MRI)","Magnetic resonance imaging (procedure)","Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance \u002F Nuclear Magnetic Resonance","MR","MR Imaging","MRI","MRI Scan","MRIs","NMR Imaging","NMRI","Nuclear Magnetic Resonance Imaging","sMRI","Structural MRI",{"type":53,"name":129,"description":95,"armGroupLabels":130,"otherNames":131},"Nivolumab",[38],[132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148],"ABP 206","BCD-263","BMS 936558","BMS-936558","BMS936558","CMAB819","MDX 1106","MDX-1106","MDX1106","NIVO","Nivolumab Biosimilar ABP 206","Nivolumab Biosimilar BCD-263","Nivolumab Biosimilar CMAB819","ONO 4538","ONO-4538","ONO4538","Opdivo",{"type":63,"name":150,"description":151,"armGroupLabels":152,"otherNames":153},"Positron Emission Tomography","Undergo PET\u002FCT",[38],[154,155,156,157,158,159,160],"Medical Imaging, Positron Emission Tomography","PET","PET Scan","Positron emission tomography (procedure)","Positron Emission Tomography Scan","Positron-Emission Tomography","PT",{"type":53,"name":162,"description":95,"armGroupLabels":163,"otherNames":164},"Tocilizumab",[38],[165,166,167,168,169,170,171,172,173,174],"Actemra","Avtozma","IL-6 receptor monoclonal antibodies: tocilizumab","Immunoglobulin G1, Anti-(Human Interleukin 6 Receptor) (Human-Mouse Monoclonal MRA Heavy Chain), Disulfide with Human-Mouse Monoclonal MRA Kappa-Chain, Dimer","MRA","R-1569","RoActemra","Tocilizumab-aazg","Tocilizumab-anoh","Tyenne",[176],{"name":177,"affiliation":5,"role":178},"Fumito Ito","PRINCIPAL_INVESTIGATOR",[180],{"facility":181,"status":11,"city":182,"state":183,"zip":184,"country":185,"countryCode":186,"cosmosGeoPoint":187,"geoPoint":192,"contacts":193},"USC \u002F Norris Comprehensive Cancer Center","Los Angeles","California","90033","United States","US",{"type":188,"coordinates":189},"Point",[190,191],-118.24368,34.05223,{"lat":191,"lon":190},[194,198],{"name":177,"role":195,"phone":196,"phoneExt":11,"email":197},"CONTACT","323-442-8140","Fumito.ito@med.usc.edu",{"name":177,"role":178,"phone":11,"phoneExt":11,"email":11},{"type":200,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[202],{"name":203,"class":204},"National Cancer Institute (NCI)","NIH","100657437","phase-1-adding-anakinra-and-tocilizumab-to-nivolumab-and-ipilimumab-for-the-treatment-of-melanoma-patients-50-years-of-age-or-older-100657437",false,"NCT07838974","Adding Anakinra and Tocilizumab to Nivolumab and Ipilimumab for the Treatment of Melanoma Patients 50 Years of Age or Older","Targeting Inflammaging-Associated Cytokine Signaling to Improve Efficacy and Reduce Immune-Related Toxicities of Anti-PD-1\u002FCTLA-4 Therapy","Inclusion Criteria:\n\n* Age ≥ 50 years old\n* Patients with melanoma, who are going to be treated with ipilimumab 1mg\u002FKg and nivolumab 3mg\u002FKg as a standard of care (SOC)\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n* Platelets ≥ 50 000\u002FµL\n* Hemoglobin ≥ 8.0 g\u002FdL\n* Absolute neutrophil count (ANC) ≥ 1500\u002FμL\n* Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) ≤ 3.0 X institutional ULN (up to 5 X institutional ULN if patient has liver metastases)\n* Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3.0 X institutional ULN (up to 5 X institutional ULN if patient has liver metastases)\n* Creatinine \\\u003C 2.0 ULN\n* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\n* Willingness to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol\n\nExclusion Criteria:\n\n* 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\n* Immunosuppressive systemic corticosteroids equivalent to prednisone 10 mg or greater in the 14 days prior to the first cycle\n* 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\n* 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 \u002F social situations that would limit compliance with study requirements\n* Positive pregnancy test, active pregnancy or nursing \u002F breast-feeding, due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants\n* History of solid organ or bone marrow transplantation\n* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug","ALL","50 Years",{"count":215,"type":216},40,"ESTIMATED","INTERVENTIONAL",[219],"PHASE1","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\u002For effective in treating melanoma patients who are 50 years of age or older.",[222],"Melanoma","NOT_YET_RECRUITING","2026-09-18",{"date":226,"type":227},"2026-09-24","ACTUAL",{"date":229,"type":216},"2026-11-01",{"date":231,"type":216},"2030-11-01",{"name":5,"class":6},1]