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).
Sequential
IOV-3001
Biological/VaccineIOV-3001 will be administered as a single dose by IV infusion, which will be administered in a hospital setting.
Safety and Tolerability
The frequency and severity of treatment emergent adverse events and serious adverse events will be assessed when IOV-3001 administered
Recommended Dose for Phase 2
Determine the recommended dose for Phase 2
Pharmacokinetics (PK) profile of IOV-3001
PK as measured by maximum observed drug concentration in plasma (Cmax) after single dose, and area under the concentration vs. time curve (AUC) after single dose.
Pharmacodynamic (PD) Profile of IOV-3001
The PD profile will be assessed by evaluating changes in the expression of phenotypic markers, serum cytokines and chemokines in blood.
Antidrug Antibody (ADA) Profile
ADAs to IOV-3001 will be measured in blood.
Overall Response Rate (ORR)
ORR is defined as the proportion of participants who have a confirmed CR or PR per RECIST v1.1 as assessed by the investigator from the date of lifileucel infusion until disease progression, start of a new anticancer therapy, or death due to any cause cause, whichever occurs first (up to a maximum of 5 years after the lifileucel infusion)
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