# Study of Denileukin Diftitox in Participants With Stage IIIC and Stage IV Melanoma

Source: https://onco.cc/trials/nct01127451/  
OnCo record `nct01127451` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

Linked 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.

## Fields

- Kind: Trial
- Status: completed
- Last checked: 2026-09-24
- Tags: pipeline; ctgov-ingest
- Registry id: 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.
- Enrolled: 75
- Outcomes: Percentage of Participants With Immune-related Overall Response Rate (irORR): Denileukin Diftitox on Days 1 to 4 9.5% vs Denileukin Diftitox on Days 1, 8, and 15 3.1%; Overall Survival (OS): Denileukin Diftitox on Days 1 to 4 51.1 weeks vs Denileukin Diftitox on Days 1, 8, and 15 54.3 weeks; Progression Free Survival (PFS): Denileukin Diftitox on Days 1 to 4 12.1 weeks vs Denileukin Diftitox on Days 1, 8, and 15 12.1 weeks

## Sources

- ClinicalTrials.gov NCT01127451: https://clinicaltrials.gov/study/NCT01127451

## Connected records

- cancers: [Advanced melanoma (unresectable stage III and stage IV)](https://onco.cc/cancers/advanced-melanoma/), [Melanoma](https://onco.cc/cancers/melanoma/)
- drugs: [Denileukin diftitox](https://onco.cc/drugs/denileukin-diftitox/)
- companies: [Eisai](https://onco.cc/companies/eisai/)

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