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Clinical Trial Summary

The purpose of this study is to find out if the administration of Interleukin-2 concurrently with ipilimumab followed by Nivolumab will result in improved anti-cancer activity and if it is effective for advanced melanoma.


Clinical Trial Description

This is a Phase II study of high dose bolus interleukin-2 (HD IL2) in combination with low dose ipilimumab followed sequentially by nivolumab in patients with advanced inoperable stage III or stage IV melanoma who have failed prior anti-PD1 immunotherapy. The planned treatment consists of up to 3 courses (One cycle is 21 days and one course is 4 cycles). HD IL2 will be given during week 1 of the 2 initial cycles or each course. Ipilimumab will be given concurrently at the low dose of 1 mg/kg on Day 1 of the 2 initial cycles of each course for up to 2 doses, total. Nivolumab will be given on Day 1 of the 3rd cycle of each course. No systemic treatment will be administered during the 4th cycle. Response assessment will occur at the end of the 4th cycle. Patients without evidence of disease progression (RECIST v.1.1) or limiting toxicities will be offered additional courses of treatment for up to a maximum of 3 courses, total ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04562129
Study type Interventional
Source H. Lee Moffitt Cancer Center and Research Institute
Contact Leticia Tetth
Phone 813-745-4617
Email Leticia.Tetteh@moffitt.org
Status Recruiting
Phase Phase 2
Start date September 24, 2020
Completion date September 2029

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