Condition

Advanced Melanoma

Purpose of the study

To evaluate the safety and tolerability, and determine the MTD and/or RPart2D of IOV-3001 in participants with advanced melanoma when administered prior to receiving the Lifileucel regimen. NCT06940739

Official Title

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 is eligible to participate?

Inclusion criteria

• Participant has unresectable or metastatic melanoma and experienced disease progression during systemic therapy 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 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 had another primary malignancy within the previous 3 years.
• Participants who require systemic steroid therapy 10 mg/day prednisone or another steroid equivalent dose.

Register your interest

To register your interest or find out more information about this clinical trial, please email: enquiries@gallipoliresearch.org.au. 

Study location

Gallipoli Medical Research, Greenslopes Private Hospital, Brisbane