Actively Recruiting
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
Led by Iovance Biotherapeutics, Inc. · Updated on 2025-12-03
42
Participants Needed
4
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating a new modified interleukin-2 fusion protein called IOV-3001 in adults with advanced melanoma that cannot be removed by surgery or has spread to other parts of the body. This study is the first time IOV-3001 is being tested in humans. It focuses on participants who have previously received treatment and will receive a cell therapy called lifileucel. The study includes both Phase 1 and Phase 2 parts to evaluate safety and dosing. Participants will receive IOV-3001 through a single intravenous infusion in a hospital setting. In the Phase 1 portion, the treatment is given either before lifileucel (Part 1) or after lifileucel instead of another drug called aldesleukin (Part 2). The study aims to find the recommended dose for Phase 2 and to monitor safety and tolerability within 30 days after treatment. During the study, participants will be closely monitored with evaluations of drug levels in the body, immune response, and the presence of anti-drug antibodies for up to 5 years. Researchers will also measure tumor response, disease control, progression-free survival, overall survival, and the persistence of lifileucel. Participants will undergo various assessments, and safety will be followed up to ensure proper monitoring throughout the study period, which lasts several years.
CONDITIONS
Brief 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 signing informed consent
- Participant has unresectable or metastatic melanoma
- Participant has melanoma not of uveal/ocular origin and experienced 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: Participants with uveal melanoma must have received or refused tebentafusp if available and approved
- Participant has an ECOG performance status of 0 or 1 with estimated life expectancy over 6 months
- For Phase 1, Part 2: Participant has at least one measurable lesion following 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, seizures, coagulation disorders, or major cardiovascular, respiratory, or immune illnesses
- Participant has active uveitis requiring treatment
- Participant has any primary immunodeficiency such as severe combined immunodeficiency or AIDS
- Participant has history of hypersensitivity to any study intervention component
- Participant had another primary malignancy within the previous 3 years
- Participant requires systemic steroid therapy equivalent to prednisone 10 mg/day or more
- Participant has history of allogeneic organ transplant or cell therapy involving conditioning chemotherapy within past 20 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 30 days
Participants receive the investigational drug IOV-3001 as a single intravenous infusion in a hospital setting, either before or after receiving Lifileucel.
1 to 2 visits depending on treatment sequence (before or after Lifileucel)
Duration - Up to 5 years
Participants are monitored for safety, pharmacokinetics, pharmacodynamics, and long-term treatment outcomes including response rates and survival for up to 5 years after treatment.
Periodic visits over 5 years for assessments and monitoring
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
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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