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A Phase II Study of the Interleukin-6 Receptor Inhibitor Sarilumab in Combination With Ipilimumab, Nivolumab and Relatlimab in Patients With Unresectable Stage III or Stage IV Melanoma

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Record identity and dates

Source
ClinicalTrials.gov
Source record ID
NCT05428007
Title field or adapter rule
{'original_value': 'A Phase II Study of the Interleukin-6 Receptor Inhibitor Sarilumab in Combination With Ipilimumab, Nivolumab and Relatlimab in Patients With Unresectable Stage III or Stage IV Melanoma', 'source_field': 'protocolSection.identificationModule.officialTitle'}
Ingested At
2026-10-31T23:27:29.705862+00:00
Published At
2026-10-28T00:00:00+00:00
Record Updated At
2026-10-28
Source Retrieved At
2026-10-31T22:18:13.198083+00:00
Timestamp Basis
ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter
Date limitation
ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Fields recorded by this source

protocolSection.conditionsModule.conditions
["Melanoma", "Unresectable Melanoma"]
protocolSection.statusModule.lastUpdatePostDateStruct
{"date": "2026-10-28", "type": "ACTUAL"}
protocolSection.identificationModule.nctId
"NCT05428007"
protocolSection.identificationModule.officialTitle
"A Phase II Study of the Interleukin-6 Receptor Inhibitor Sarilumab in Combination With Ipilimumab, Nivolumab and Relatlimab in Patients With Unresectable Stage III or Stage IV Melanoma"
protocolSection.statusModule.overallStatus
"RECRUITING"
protocolSection.designModule.phases
["PHASE2"]
protocolSection.statusModule.resultsFirstPostDateStruct
null

Study condition terms

  • Melanoma (protocolSection.conditionsModule.conditions)
  • Unresectable Melanoma (protocolSection.conditionsModule.conditions)

Interventions recorded in this study

  • {'armGroupLabels': ['Stage I: sarilumab, ipilimumab, nivolumab and relatlimab', 'Stage II: sarilumab, ipilimumab, nivolumab and relatlimab'], 'description': 'Injectable solutions of sarilumab are formulated in 2 mL of aqueous solution in a 5 mL vial containing 175 mg/ml of sarilumab arginine (8.94 mg), histidine (3.71 mg), polysorbate 20 (2.28 mg), sucrose (57 mg) and Water for Injection USP.Patients will be administered sarilumab at a dose of 150 mg subcutaneously in combination with ipilimumab, nivolumab and relatlimab given intravenously, with nivolumab/relatlimab given intravenously, or sarilumab at a dose of 150 mg subcutaneously given alone.', 'name': 'Sarilumab', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
  • {'armGroupLabels': ['Stage I: sarilumab, ipilimumab, nivolumab and relatlimab', 'Stage II: ipilimumab, nivolumab and relatlimab', 'Stage II: sarilumab, ipilimumab, nivolumab and relatlimab'], 'description': 'Ipilimumab injection is a sterile, nonpyrogenic, clear to slightly opalescent, colorless to pale yellow solution, single-use, preservative-free, isotonic aqueous solution that may contain particles. It is formulated at a concentration of 5 mg/mL ipilimumab in TRIS hydrochloride (also known as 2-amino-2-hydroxymethyl-1,3-propanediol hydrochloride), sodium chloride, mannitol, pentetic acid (also known as diethylenetriaminepentaacetic acid or DTPA), polysorbate 80, and water at pH 7.0. Sodium hydroxide and/or hydrochloric acid may be used to adjust the pH of the solution. Ipilimumab Injection 200 mg/40 mL (5 mg/mL) is packaged in a 50-cc Type I flint molded glass vials.', 'name': 'Ipilimumab Injection', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
  • {'armGroupLabels': ['Stage I: sarilumab, ipilimumab, nivolumab and relatlimab', 'Stage II: ipilimumab, nivolumab and relatlimab', 'Stage II: sarilumab, ipilimumab, nivolumab and relatlimab'], 'description': 'The FDC drug product, referred to as nivolumab/relatlimab, contains relatlimab and nivolumab in a single vial in a kit of 2 vials. The product is a sterile, non-pyrogenic, single-use, isotonic aqueous solution for IV infusion. It is formulated at a total protein concentration of 16 mg/mL (4 mg/mL relatlimab and 12 mg/mL nivolumab) and is packaged in a 20-cc glass vial in a kit of two vials. Each vial contains 80 mg of relatlimab and 240 mg of nivolumab.', 'name': 'Nivolumab/Relatlimab', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])

An intervention appearing in a study record does not establish an effect or an approved use.

Drug names recorded in this source

  • Sarilumab (protocolSection.armsInterventionsModule.interventions[].name)
  • Ipilimumab Injection (protocolSection.armsInterventionsModule.interventions[].name)
  • Nivolumab/Relatlimab (protocolSection.armsInterventionsModule.interventions[].name)

A recorded drug name is not by itself an indication or a condition-specific relationship.

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