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.
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.
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).