What is IOV-3001 studying for advanced melanoma?

IOV-3001 is being studied to evaluate its safety and appropriate dosing in adults with advanced melanoma who will receive lifileucel. Researchers want to understand how this modified interleukin-2 fusion protein works in patients whose melanoma has progressed after prior treatments. The study is sponsored by Iovance Biotherapeutics, Inc.

Who may be eligible for this advanced melanoma clinical trial?

Adults aged 18 to 70 with unresectable or metastatic melanoma that has progressed after PD-1 or PD-L1 antibody therapy may be eligible. Participants should have good overall health and no untreated brain metastases. Please review eligibility criteria for more details.

Is there any cost to participate in this advanced melanoma clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal expenses like travel may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years - 70Years

All Genders

ID06940739

Phase 12 Study of IOV-3001, a Modified Interleukin-2 Fusion Protein, in Adults With Advanced Unresectable or Metastatic Melanoma Receiving Lifileucel

Led by Iovance Biotherapeutics, Inc. · Updated on 2026-06-15

Participants Needed

Research Sites

4 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating a modified interleukin-2 fusion protein called IOV-3001 in adults with previously treated, unresectable or metastatic melanoma who will receive lifileucel. This Phase 12, open-label study aims to understand the safety, tolerability, and appropriate dosing of IOV-3001, which incorporates a modified form of aldesleukin into the antibody palivizumab. The trial includes participants with melanoma that has progressed after certain prior therapies and focuses on both cutaneous and uveal melanoma under specific conditions. Participants will receive IOV-3001 as a single intravenous infusion administered in a hospital setting. The Phase 1 portion has two parts in Part 1, IOV-3001 is given before the lifileucel treatment regimen in Part 2, it is given after lifileucel instead of aldesleukin. Dose escalation will occur in participants with unresectable or metastatic melanoma to determine the recommended dose for Phase 2. During the study, participants will be closely monitored for safety and pharmacokinetics up to 30 days after dosing, with longer-term follow-up to assess immune response, overall and progression-free survival, and response rates for up to 5 years. Researchers will evaluate treatment effects using radiographic assessments, immune profiles, and disease progression measures. Safety follow-up and data collection will continue after treatment to better understand the therapys impact and persistence.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 70Years

All Genders

Eligibility Criteria

You may qualify if you...

Participant must be 18 years of age or older at the time of signing the informed consent.
Participant has unresectable or metastatic melanoma.
Participant has melanoma not of uveal/ocular origin and experienced documented radiographic disease progression during systemic therapy with a PD-1/PD-L1 blocking antibody or within 12 weeks after the last dose of the PD-1/PD-L1 blocking antibody.
If the tumor is BRAF V600 mutation positive, participant also received or refused a BRAF inhibitor with or without a MEK inhibitor.
For Phase 1, Part 1 only: participants with uveal melanoma must have received or refused tebentafusp if available as standard of care and if HLA-A*02:01 positive.
Participant has an ECOG performance status of 0 or 1 and an estimated life expectancy of more than 6 months as determined by the investigator.
For Phase 1, Part 2 only: following tumor resection for lifileucel generation, participant must have at least one remaining measurable lesion.
Participant has recovered from all prior anticancer treatment-related adverse events.

You will not qualify if you...

Participant has symptomatic untreated brain metastases.
Participant is at increased risk for systemic infections, seizure disorders, coagulation disorders, or other active major medical illnesses of the cardiovascular, respiratory, or immune systems.
Participant has active uveitis requiring treatment.
Participant has any form of primary immunodeficiency such as severe combined immunodeficiency disease (SCID) or AIDS.
Participant has a history of hypersensitivity to any component of the study intervention.
Participant had another primary malignancy within the previous 3 years.
Participants requiring systemic steroid therapy of 10 mg/day prednisone or equivalent.
Participants with a history of allogeneic organ transplant or any form of cell therapy involving prior conditioning chemotherapy within the past 20 years.

Research Team

Iovance Biotherapeutics

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Phase 12 Study of IOV-3001, a Modified Interleukin-2 Fusion Protein, in Adults With Advanced Unresectable or Metastatic Melanoma Receiving Lifileucel

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria