Actively Recruiting
Adding IL-2 to Tebentafusp to Eradicate Cancer Progression
Led by St Vincent's Hospital, Sydney · Updated on 2025-07-14
8
Participants Needed
2
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A recent clinical trial found that after 36 months, patients taking tebentafusp had a median survival of 21.6 months, compared to 16.9 months for those in the control group. Since recruitment for tebentafusp in metastatic uveal melanoma (mUM) has ended, a new trial is starting to test whether adding IL-2 can help overcome resistance to tebentafusp and improve its effectiveness. This study aims to answer: 1. Can combining tebentafusp with IL-2 improve tumor response and overall survival? 2. What are the benefits and side effects of this combination therapy? All participants will receive both IL-2 and tebentafusp in a 28-day treatment cycle. The dosing schedule is as follows: Cycle1: Day1-3 IL-2 Day4 Tebentafusp Day 10 IL-2 Day 11 Tebentafusp Day 17 IL-2 Day 18 Tebentafusp Day 24 IL-2 Day 25 Tebentafusp Cycle 2 \& thereafter Day 1 IL-2 Day 2 Tebentafusp Day 8 IL-2 Day 9 Tebentafusp Day 15 IL-2 Day 16 Tebentafusp Day 22 IL-2 Day 23 Tebentafusp
CONDITIONS
Official 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
- Disease progression defined by RECIST 1.1 while on single-agent tebentafusp with no other systemic therapies in between
You will not qualify if you...
- Untreated or symptomatic central nervous system metastases, leptomeningeal disease, or spinal cord compression
- Presence of treated CNS lesions not stable for at least 4 weeks after surgery or radiation
- Neurological instability or use of systemic corticosteroids within 2 weeks prior to trial entry
- Use of systemic steroids or other immunosuppressive drugs within 2 weeks before first dose, except for controlled adrenal insufficiency with prednisone ≤10 mg daily or equivalent, and local steroid treatments
- Medical conditions that may prevent safe participation or compliance as judged by the physician
- Chronic viral infections such as HIV, hepatitis B, or hepatitis C unless clinically indicated to test
AI-Screening
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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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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