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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Ahmad Tarhini · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a phase II study of high dose bolus interleukin-2 (HD IL2) in patients with advanced inoperable stage III or stage IV melanoma who have prior anti-PD1 immunotherapy. Each course consists of 2 cycles of HD IL2 as follows: high-dose IL2 at 600,000 IU/kg is given intravenously (IV) every 8 hours for up to 14 doses (one cycle), followed by a rest period of 1-2 weeks and readmission for a second HD IL2 cycle for up to 14 doses (second cycle). The planned treatment consists of 3 courses (6 cycles) of HD IL-2. Response assessment will occur at the end of each course of therapy and patients without evidence of disease progression (Response Evaluation Criteria in Solid Tumors, RECIST, version 1.1) or limiting toxicities will be offered additional courses of treatment of HD IL2 for a maximum of 3 courses.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	High dose bolus interleukin-2 (HD IL2)	Each course consists of 2 cycles of HD IL2 as follows: high-dose IL2 at 600,000 IU/kg is given intravenously (IV) every 8 hours for up to 14 doses (one cycle), followed by a rest period of 1-2 weeks and readmission for a second HD IL2 cycle for up to 14 doses (second cycle). The planned treatment consists of 3 courses (6 cycles) of HD IL-2.

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-02-16
• Completion: 2017-04-01
• First posted: 2016-06-10
• Last updated: 2018-04-20
• Results posted: 2018-04-20

Locations

1 site across 1 country: United States