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

Eligibility 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.
• 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
• 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.