drugset / Trial / NCT01258855

Aldesleukin With or Without Ziv-Aflibercept in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery

NCT01258855 ↗

Phase 2 Completed 84 enrolled National Cancer Institute (NCI)
RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized phase II trial studies how well aldesleukin with or without ziv-aflibercept works in treating patients with stage III-IV melanoma that cannot be removed by surgery. Aldesleukin may stimulate the white blood cells to kill cancer. Ziv-aflibercept may stop the growth of melanoma by blocking blood flow to the tumor. It is not yet known whether aldesleukin is more effective with or without ziv-aflibercept in treating melanoma.

Timeline

Start
2011-01-18
Primary completion
2018-03-29
Completion
2018-03-29

Outcome

Met primary endpoint

registry analysis (other test); Combination Arm (Ziv-Afilbercept+HD IL2) vs Mono-therapy Arm (HD IL2 Alone); p = 0.002; Log Rank NCT01258855 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Aflibercept Protein / enzyme biologic — Intravenous
Subject aldesleukin Protein / enzyme biologic — Intravenous