drugset / Trial / NCT02796352
A Phase II Study of High Dose Bolus IL2 in Patients With Inoperable Stage III or Stage IV Melanoma Who Have Failed Prior Anti-PD1 Immunotherapy: Efficacy and Biomarker Study
NaSingle-groupOpen-labelTreatment
Summary
This study is for patients with advanced stage III or stage IV melanoma not adequately treated by surgery who have progressed after treatment with nivolumab or pembrolizumab. The purpose of this study is to see if giving high dose interleukin-2 (IL-2) after progression on nivolumab or pembrolizumab is effective in treating metastatic melanoma. This study is also being done to look at the severity of side effects of IL-2 in patients. IL-2 is approved by the U.S. Food and Drug Administration (FDA) for the treatment of advanced melanoma.
Timeline
- Start
- 2016-09
- Primary completion
- 2017-02-16
- Completion
- 2017-04
Outcome
Outcome not reported
Stopped (Enrollment): “Slow accrual.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | aldesleukin | Protein / enzyme biologic | 600000 iu/kg | Intravenous |