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A phase 2 trial of Denileukin diftitox in Melanoma and Advanced melanoma, run by Eisai Inc., completed.
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.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
75 enrolled.
90% CI 3.3 to 20.4; Figures from the ClinicalTrials.gov results section (first posted 2022-04-13), not from a publication · 90% CI 0.1 to 13.9
Source90% CI 37.1 to 113.6; Figures from the ClinicalTrials.gov results section (first posted 2022-04-13), not from a publication · 90% CI 30.7 to 77.1
Source90% CI 11.6 to 14.0; Figures from the ClinicalTrials.gov results section (first posted 2022-04-13), not from a publication · 90% CI 11.6 to 13.0
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Percentage of Participants With Immune-related Overall Response Rate (irORR)primary | Denileukin Diftitox on Days 1 to 4 | 42 | 9.5% | - | - | link |
| Denileukin Diftitox on Days 1, 8, and 15 | 32 | 3.1% | ||||
| Overall Survival (OS) | Denileukin Diftitox on Days 1 to 4 | 42 | 51.1 weeks | - | - | link |
| Denileukin Diftitox on Days 1, 8, and 15 | 32 | 54.3 weeks | ||||
| Progression Free Survival (PFS) | Denileukin Diftitox on Days 1 to 4 | 42 | 12.1 weeks | - | - | link |
| Denileukin Diftitox on Days 1, 8, and 15 | 32 | 12.1 weeks |
Shares Denileukin diftitox, Advanced melanoma (unresectable stage III and stage IV), Melanoma and the tag pipeline.
Shares Denileukin diftitox and the tag pipeline.
Shares Advanced melanoma (unresectable stage III and stage IV), Melanoma and the tag pipeline.
Shares Advanced melanoma (unresectable stage III and stage IV), Melanoma and the tag pipeline.
Shares Advanced melanoma (unresectable stage III and stage IV), Melanoma and the tag pipeline.
Shares Advanced melanoma (unresectable stage III and stage IV), Melanoma and the tag pipeline.
Shares Advanced melanoma (unresectable stage III and stage IV), Melanoma and the tag pipeline.
Shares Advanced melanoma (unresectable stage III and stage IV), Melanoma and the tag pipeline.