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

Launched by IOVANCE BIOTHERAPEUTICS, INC. · Apr 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called IOV-3001 for adults with advanced melanoma, which is a serious type of skin cancer that can't be removed by surgery. The trial aims to understand how safe and effective this treatment is when given alongside another therapy called lifileucel. If you are at least 18 years old and have been diagnosed with metastatic melanoma that hasn't responded well to previous treatments, you might be eligible to participate. Key criteria for joining include having specific types of melanoma and being in good overall health, with a life expectancy of more than six months.

Participants in this trial will receive the study medication and will be closely monitored for any side effects and how well the treatment works. It's important to note that certain health conditions, such as untreated brain metastases or severe immune system disorders, may prevent someone from joining. The trial is currently recruiting, and being part of it could provide access to a new treatment option while contributing to important research for future melanoma patients.

Gender

ALL

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.