Investigating IOV-3001 for Advanced Melanoma Treatment

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

This study is testing a new treatment called IOV-3001 to see if it can help adults with advanced melanoma who haven't been able to have surgery.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Iovance Biotherapeutics, Inc. (industry)
• Drugs / interventions: chemotherapy, prednisone, palivizumab
• Locations: 4 sites (Denver, Colorado and 3 other locations)
• Trial ID: NCT06940739 on ClinicalTrials.gov

What this trial studies

This is a Phase 1/2 open-label study evaluating the safety and efficacy of IOV-3001, a modified interleukin-2 fusion protein, in adults with unresectable or metastatic melanoma. Participants will receive IOV-3001 either before or after treatment with Lifileucel, depending on the study phase. The study aims to assess the potential benefits of this novel therapy in patients who have previously undergone systemic therapy. It is the first-in-human study of this treatment approach.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with unresectable or metastatic melanoma who have experienced disease progression after prior systemic therapy.

Not a fit: Patients with melanoma of uveal/ocular origin who have not received standard care options may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced melanoma who have limited treatment alternatives.

How similar studies have performed: Other studies involving interleukin-2 therapies have shown promise, but this specific approach with IOV-3001 is novel.

Eligibility criteria

Inclusion Criteria:

1. Participant must be ≥ 18 years of age at the time of signing the informed consent.
2. Participant has unresectable or metastatic melanoma.
3. 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, the participant also received or refused a BRAF inhibitor with or without a MEK inhibitor.

   OR Phase 1, Part 1 only: For participants with uveal melanoma, tebentafusp must have been received if available as standard of care (human leukocyte antigen \[HLA\]-A\*02:01 positive participant and approved by local authorities for uveal melanoma) or refused.
4. Participant has an ECOG performance status of 0 or 1 and, in the investigator's opinion, an estimated life expectancy of \> 6 months.
5. Phase 1, Part 2 only: Following tumor resection for lifileucel generation, the participant will have at least one remaining measurable lesion, as defined by RECIST v1.1.
6. Participant has recovered from all prior anticancer treatment-related AEs

Exclusion Criteria:

1. Participant has symptomatic untreated brain metastases.
2. Participant is at an increased risk for systemic infections; seizure disorders; coagulation disorders; or other active major medical illnesses of the cardiovascular, respiratory, or immune systems.
3. Participant has active uveitis that requires active treatment.
4. Participant has any form of primary immunodeficiency (e.g., severe combined immunodeficiency disease \[SCID\] or AIDS).
5. Participant has a history of hypersensitivity to any component of the study intervention.
6. Participant had another primary malignancy within the previous 3 years.
7. Participants who require systemic steroid therapy 10 mg/day prednisone or another steroid equivalent dose.
8. Participants who have had a history of allogeneic organ transplant or any form of cell therapy involving prior conditioning chemotherapy within the past 20 years.

Where this trial is running

Denver, Colorado and 3 other locations

• SCRI Oncology Partners- Denver — Denver, Colorado, United States (RECRUITING)
• UNC Hospitals, The University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (RECRUITING)
• Sarah Cannon Research Institute — Nashville, Tennessee, United States (RECRUITING)
• Greenslopes Private Hospital — Greenslopes, Queensland, Australia (RECRUITING)

Study contacts

• Study coordinator: Iovance Biotherapeutics

Conditions: Unresectable Melanoma, Metastatic Melanoma, Ocular Melanoma, Tumor Infiltrating Lymphocytes, TIL, Cell Therapy, Autologous Adoptive Cell Therapy, Cellular Immuno-therapy