IOV-3001 for Advanced Melanoma with Lifileucel

This study is testing a new treatment called IOV-3001 in adults with advanced melanoma (a type of skin cancer that has spread or cannot be removed by surgery). IOV-3001 is given through an IV and is being studied to see how safe it is and what dose works best. You might be able to join if you are between 18 and 70 years old, have melanoma that is not in your eye, and your cancer has worsened after treatment with a PD-1/PD-L1 blocking antibody. This is the first time IOV-3001 is being given to people, and it will be given either before or after another treatment called lifileucel. The study aims to understand its safety within 30 days.

Study design
This is a Phase 1/2, open-label study, meaning both you and your doctors will know which treatment you are receiving. It plans to enroll 42 participants.
What's involved
You will receive IOV-3001 as a single IV infusion in a hospital setting. The study will assess safety and tolerability for up to 30 days.
Compensation
Not stated in the trial record.
Follow-up
The primary safety and tolerability endpoints are measured for up to 30 days after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06940739

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

Recruiting
PHASE1Ages 18–70Interventional
Iovance Biotherapeutics, Inc.
~42 participants
Updated 2026-06-15 on ClinicalTrials.gov
What's tested:IOV-3001

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Tolerability
Measured over Up to 30 days
+1 more outcome measured
Unresectable Melanoma
Metastatic Melanoma
Ocular Melanoma
5 sites across 5 states
Colorado1
North Carolina1
Tennessee1
Queensland1
Western Australia1
  • Iovance Biotherapeutics Study Team · STUDY_DIRECTOR · Iovance Biotherapeutics

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  • Safety and TolerabilityUp to 30 days

    The frequency and severity of treatment emergent adverse events and serious adverse events will be assessed when IOV-3001 administered

  • Recommended Dose for Phase 2Up to 30 days

    Determine the recommended dose for Phase 2