RecruitingPhase 1Phase 2NCT06940739

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


Sponsor

Iovance Biotherapeutics, Inc.

Enrollment

42 participants

Start Date

Mar 11, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing IOV-3001, an experimental drug, given alongside lifileucel (a type of cell therapy using your own immune cells) for patients with advanced melanoma (skin cancer) that has stopped responding to prior immunotherapy. **You may be eligible if...** - You are 18 or older - You have unresectable or metastatic melanoma (not from the eye) that progressed during or after PD-1/PD-L1 immunotherapy - If your melanoma has the BRAF V600 mutation, you have also received or declined BRAF-targeted therapy - You have good performance status (ECOG 0–1) and life expectancy over 6 months **You may NOT be eligible if...** - You have active autoimmune disease requiring systemic treatment - You have untreated brain metastases - Your organs are not functioning well enough - You have not progressed on prior immunotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALIOV-3001

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


Locations(4)

SCRI Oncology Partners- Denver

Denver, Colorado, United States

UNC Hospitals, The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Greenslopes Private Hospital

Greenslopes, Queensland, Australia

View Full Details on ClinicalTrials.gov

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NCT06940739


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