Actively Recruiting
Supplementing With IL-2 to Verifiably Eradicate Radiological Progression in Metastatic Uveal Melanoma
Led by St Vincent's Hospital, Sydney · Updated on 2025-07-14
8
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on metastatic uveal melanoma (mUM), a rare and aggressive eye cancer that often spreads to the liver and other organs. Patients with mUM generally have a poor outlook, with limited treatment options and no established standard care. Researchers aim to test whether adding interleukin-2 (IL-2) to the existing therapy tebentafusp can improve tumor response and survival by overcoming resistance to tebentafusp. All participants will receive both IL-2 and tebentafusp in a 28-day treatment cycle. During the first cycle, IL-2 is given on days 1 to 3, 10, 17, and 24, with tebentafusp administered on days 4, 11, 18, and 25. From the second cycle onward, IL-2 is given on days 1, 8, 15, and 22, while tebentafusp is given on days 2, 9, 16, and 23. This single-arm Phase Ib study evaluates this combination therapy's safety and effectiveness. Participants will be monitored through approximately one year of study completion, with researchers assessing safety, radiological progression-free survival, and overall survival. The study involves regular imaging and clinical evaluations to track tumor progression and participant health. This trial is sponsored by St Vincent's Hospital, Sydney, and aims to offer new options for patients with this serious illness.
CONDITIONS
Brief Title
Adding IL-2 to Tebentafusp to Eradicate Cancer Progression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed metastatic or unresectable uveal melanoma
- Positive for HLA-A*02:01
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Radiographic progression on single-agent tebentafusp with no other systemic therapies between
You will not qualify if you...
- Untreated or symptomatic central nervous system metastases, leptomeningeal disease, or spinal cord compression
- Treated CNS lesions must be stable for at least 4 weeks and neurologically stable off corticosteroids for 2 weeks
- Systemic steroid or immunosuppressive drug use within 2 weeks before first treatment, except limited adrenal insufficiency treatment or local steroids
- Any medical condition that prevents safe participation or compliance
- Chronic viral infections such as HIV, hepatitis B, or hepatitis C unless clinically indicated testing shows otherwise
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.
1 visit (in-person)
Duration - Approximately 1 year
Participants receive investigational drugs IL-2 and Tebentafusp to treat metastatic uveal melanoma.
Regular visits during treatment for drug administration and monitoring
Trial Site Locations
Total: 2 locations
1
Kinghorn Cancer Centre, St. Vincent's Hospital
Sydney, New South Wales, Australia, 2010
Actively Recruiting
2
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Not Yet Recruiting
Research Team
A
Anthony Joshua, FRACP
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here