NCT06940739

A Study to Investigate the Safety and Efficacy of IOV-3001 in Adults With Advanced Melanoma Who Will Receive Lifileucel

A Phase 1/2, Open-label Study of a Modified Interleukin-2 Fusion Protein (IOV-3001) in Participants With Previously Treated, Unresectable or Metastatic Melanoma Who Will Receive Lifileucel

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Iovance Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

A Phase 1/2, open-label study of a modified interleukin-2 fusion protein (IOV 3001) in participants with previously treated, unresectable or metastatic melanoma who will receive lifileucel.

Detailed description

This study is the first-in-human (FIH) study of IOV-3001. IOV-3001 is an antibody interleukin-2 (IL-2) fusion protein in which a modified form of aldesleukin is incorporated into the antibody palivizumab. The Phase 1 portion will include 2 parts. Participants will receive IOV-3001 either before the Lifileucel regimen (Part 1) or after Lifileucel instead of aldesleukin (Part 2).

Conditions

• Unresectable Melanoma
• Metastatic Melanoma
• Ocular Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	IOV-3001	IOV-3001 will be administered as a single dose by IV infusion, which will be administered in a hospital setting.

Timeline

• Start date: 2025-03-11
• Primary completion: 2032-06-01
• Completion: 2032-07-01
• First posted: 2025-04-23
• Last updated: 2025-12-03

Locations

4 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study