A Study to Investigate the Safety and Efficacy of IOV-3001 in Adults With Advanced Melanoma Who W… (NCT06940739) | Clinical Trial Compass
RecruitingPhase 1/2
A Study to Investigate the Safety and Efficacy of IOV-3001 in Adults With Advanced Melanoma Who Will Receive Lifileucel
United States, Australia42 participantsStarted 2025-03-11
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Participant must be ≥ 18 years of age 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, the participant also received or refused a BRAF inhibitor with or without a MEK inhibitor.
✓. Participant has an ECOG performance status of 0 or 1 and, in the investigator's opinion, an estimated life expectancy of \> 6 months.
✓. 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.
✓. Participant has recovered from all prior anticancer treatment-related AEs
Exclusion criteria
✕. Participant has symptomatic untreated brain metastases.
✕. 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.
✕. Participant has active uveitis that requires active treatment.
✕. Participant has any form of primary immunodeficiency (e.g., 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 who require systemic steroid therapy 10 mg/day prednisone or another steroid equivalent dose.
✕. 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.