Actively Recruiting
A Study to Investigate the Safety and Efficacy of IOV-3001 in Adults With Advanced Melanoma Who Will Receive Lifileucel
Led by Iovance Biotherapeutics, Inc. · Updated on 2025-12-03
42
Participants Needed
4
Research Sites
381 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Investigate the Safety and Efficacy of IOV-3001 in Adults With Advanced Melanoma Who Will Receive Lifileucel
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be 18 years of age or older at the time of consent
- Participant has unresectable or metastatic melanoma
- Participant has melanoma not of uveal/ocular origin with documented disease progression during or within 12 weeks after PD-1/PD-L1 antibody therapy; if BRAF V600 mutation positive, participant also received or refused BRAF inhibitor with or without MEK inhibitor
- For Phase 1 Part 1 only: participants with uveal melanoma must have received or refused tebentafusp if available and approved
- Participant has an ECOG performance status of 0 or 1 and an estimated life expectancy over 6 months
- For Phase 1 Part 2 only: participant will have at least one measurable lesion post tumor resection for lifileucel generation
- Participant has recovered from all prior anticancer treatment-related adverse events
You will not qualify if you...
- Participant has symptomatic untreated brain metastases
- Participant is at increased risk for systemic infections, seizure disorders, coagulation disorders, or major cardiovascular, respiratory, or immune illnesses
- Participant has active uveitis requiring treatment
- Participant has any primary immunodeficiency such as SCID or AIDS
- Participant has a history of hypersensitivity to any study intervention component
- Participant had another primary malignancy within the past 3 years
- Participant requires systemic steroid therapy equivalent to 10 mg/day prednisone or more
- Participant has had allogeneic organ transplant or cell therapy with conditioning chemotherapy within the past 20 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
SCRI Oncology Partners- Denver
Denver, Colorado, United States, 80218
Actively Recruiting
2
UNC Hospitals, The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
3
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
4
Greenslopes Private Hospital
Greenslopes, Queensland, Australia, 4120
Actively Recruiting
Research Team
I
Iovance Biotherapeutics
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
OTHER
Number of Arms
1
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