NCT04562129

IL2 With Ipilimumab Followed by Nivolumab in Stage 3 or 4 Melanoma Patients

A Phase II Study of High Dose Bolus IL2 in Combination With Low Dose Ipilimumab Followed Sequentially by Nivolumab in Patients With Inoperable Stage III or Stage IV Melanoma Who Have Failed Prior Anti-PD1 Immunotherapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Melanoma Stage III
• Melanoma Stage IV
• Inoperable Disease

Interventions

Type	Name	Description
DRUG	Interleukin-2	High dose interleukin-2 (HD IL2) administered week 1 and 4 of each course (approximately 12 weeks)
DRUG	Ipilimumab	Low dose Ipilimumab given at time of HD IL2 administration on day 1 of the first 2 cycles of each course.
DRUG	Nivolumab	Nivolumab will be given at a dose of 480 mg IV week 7 of each course.

Timeline

• Start date: 2020-09-24
• Primary completion: 2026-07-01
• Completion: 2029-11-01
• First posted: 2020-09-24
• Last updated: 2026-04-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study