Investigating IOV-3001 for Advanced Melanoma Treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Hollywood Private Hospital Ramsay
  Nedlands, Western Australia, Australia Recruiting

Study contacts

• Study coordinator: Iovance Biotherapeutics
• Email: Clinical.Inquiries@iovance.com
• Phone: 1-844-845-4682

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.