{"entity":{"id":"nct01127451","kind":"trial","name":"Study of Denileukin Diftitox in Participants With Stage IIIC and Stage IV Melanoma","aka":[],"tldr":"A phase 2 trial of Denileukin diftitox in Melanoma and Advanced melanoma, run by Eisai Inc., completed.","summary":"Study of Denileukin Diftitox in Participants With Stage IIIC and Stage IV Melanoma is a phase 2 interventional study registered as NCT01127451 by Eisai Inc., with 75 participants recorded, started 2010-06-22 and reaching its primary completion in 2015-04-07. Interventions recorded: Denileukin diftitox. Conditions recorded: Stage IIIC Melanoma, Stage IV Melanoma.\n\nLinked to the drug Denileukin diftitox because the registry names it among its interventions and Melanoma and Advanced melanoma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01127451","url":"https://clinicaltrials.gov/study/NCT01127451"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["denileukin-diftitox"],"companies":["eisai"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01127451","phase":"2","setting":"A Phase II Open-Label, Multicenter Study of Denileukin Diftitox in Patients With Stage IIIC and Stage IV Melanoma","sponsor":"Eisai Inc.","started":"2010-06-22","startedType":"actual","yearReported":2022,"enrolled":75,"enrolledBasis":"registry","outcomes":[{"endpoint":"Percentage of Participants With Immune-related Overall Response Rate (irORR)","primary":true,"unit":"%","arms":[{"name":"Denileukin Diftitox on Days 1 to 4","n":42,"value":9.5,"note":"90% CI 3.3 to 20.4; Figures from the ClinicalTrials.gov results section (first posted 2022-04-13), not from a publication"},{"name":"Denileukin Diftitox on Days 1, 8, and 15","n":32,"value":3.1,"note":"90% CI 0.1 to 13.9"}],"source":"https://clinicaltrials.gov/study/NCT01127451?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"weeks","arms":[{"name":"Denileukin Diftitox on Days 1 to 4","n":42,"value":51.1,"note":"90% CI 37.1 to 113.6; Figures from the ClinicalTrials.gov results section (first posted 2022-04-13), not from a publication"},{"name":"Denileukin Diftitox on Days 1, 8, and 15","n":32,"value":54.3,"note":"90% CI 30.7 to 77.1"}],"source":"https://clinicaltrials.gov/study/NCT01127451?tab=results"},{"endpoint":"Progression Free Survival (PFS)","unit":"weeks","arms":[{"name":"Denileukin Diftitox on Days 1 to 4","n":42,"value":12.1,"note":"90% CI 11.6 to 14.0; Figures from the ClinicalTrials.gov results section (first posted 2022-04-13), not from a publication"},{"name":"Denileukin Diftitox on Days 1, 8, and 15","n":32,"value":12.1,"note":"90% CI 11.6 to 13.0"}],"source":"https://clinicaltrials.gov/study/NCT01127451?tab=results"}]},"route":"/trials/nct01127451/","neighbours":{"cancer":[{"id":"advanced-melanoma","kind":"cancer","name":"Advanced melanoma (unresectable stage III and stage IV)","route":"/cancers/advanced-melanoma/"},{"id":"melanoma","kind":"cancer","name":"Melanoma","route":"/cancers/melanoma/"}],"drug":[{"id":"denileukin-diftitox","kind":"drug","name":"Denileukin diftitox","route":"/drugs/denileukin-diftitox/"}],"company":[{"id":"eisai","kind":"company","name":"Eisai","route":"/companies/eisai/"}]}}