A Phase 1/2 interventional study of IOV-3001 in Unresectable Melanoma, Metastatic Melanoma and Ocular Melanoma, sponsored by Iovance Biotherapeutics, Inc.. Recruiting at 5 sites in 2 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by Iovance Biotherapeutics, Inc. · Phase 1/2, Interventional, and Other
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.
This study is the first-in-human (FIH) study of IOV-3001. IOV-3001 is an antibody interleukin-2 (IL-2) fusion protein in which a modified form of aldesleukin is incorporated into the antibody palivizumab.
The Phase 1 portion will include 2 parts. Participants will receive IOV-3001 either before the Lifileucel regimen (Part 1) or after Lifileucel instead of aldesleukin (Part 2).
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's planned enrollment of 42 is above the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →Iovance Biotherapeutics, Inc. is the lead sponsor of 16 studies on the registry; 8 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Dose escalation participants with unresectable or metastatic melanoma
Biological: IOV-3001
IOV-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
Time frame: Up to 30 days
Recommended Dose for Phase 2
Determine the recommended dose for Phase 2
Time frame: Up to 30 days
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.
Time frame: Up to 8 days
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.
Time frame: Up to 8 days
Antidrug Antibody (ADA) Profile
ADAs to IOV-3001 will be measured in blood.
Time frame: Up to 5 years
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)
Time frame: Up to 5 years
Complete Response (CR) rate
CR rate is defined as the proportion of participants who have a confirmed CR 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 (up to a maximum of 5 years after the lifileucel infusion)
Time frame: Up to 5 years
Duration of Response (DOR)
DOR is measured from the time that criteria are met for CR or PR per RECIST v1.1 as assessed by the investigator disease progression or death due to any cause (up to a maximum of 5 years after the lifileucel infusion)
Time frame: Up to 5 years
Disease Control Rate (DCR)
DCR is measured by the percentage of participants with a best overall confirmed response of CR or PR at any time participants with SD ≥ 4 weeks per RECIST v1.1 as assessed by the investigator from the date of lifileucel infusion disease progression, start of a new anticancer therapy, or death due to any cause (up to a maximum of 5 years after the lifileucel infusion)
Time frame: Up to 5 years
Progression-Free Survival (PFS)
PFS is defined as the time from the date of lifileucel infusion until disease progression per RECIST v1.1 as assessed by investigator or death due to any cause (up to a maximum of 5 years after the lifileucel infusion)
Time frame: Up to 5 years
Overall Survival (OS)
OS is the time from the date of lifileucel infusion to death due to any cause (up to a maximum of 5 years after the lifileucel infusion)
Time frame: Up to 5 years
In vivo persistence of Lifileucel
In vivo persistence of lifileucel products will be assessed in the blood.
Time frame: Up to 5 years
Plan to share: No
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Iovance Biotherapeutics, Inc.