Adding IL-2 to Tebentafusp to Eradicate Cancer Progression

Launched by ST VINCENT'S HOSPITAL, SYDNEY · Jul 2, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for people with metastatic uveal melanoma, a type of eye cancer that has spread, often to the liver. Researchers want to see if adding a medication called IL-2 to an existing drug called tebentafusp can help the treatment work better by shrinking tumors and improving how long patients live. Tebentafusp alone has already shown some benefit, but this study aims to find out if the combination can overcome resistance and provide even better results.

People eligible for this trial are adults aged 65 to 74 who have confirmed metastatic uveal melanoma, are positive for a specific genetic marker (called HLA-A*02:01), and have previously shown cancer progression while on tebentafusp alone. Participants should be in good general health and able to carry out daily activities. In this study, all patients will receive both IL-2 and tebentafusp in cycles over 28 days, with a carefully planned schedule of doses. The trial is currently recruiting, and patients will be closely monitored for benefits and possible side effects to understand how safe and effective the combination treatment is.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Histologically or cytologically confirmed metastatic UM or unresectable UM patients
• • 2. HLA-A\*02:01 positive
• • 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• • 4. RECIST 1.1 defined progression on single-agent Tebentafusp, with no other intervening systemic therapies
• Exclusion Criteria:
• • 1. Presence of untreated or symptomatic central nervous system (CNS) metastases, leptomeningeal disease, or cord compression. (NOTE: Participants with treated CNS lesions may enroll provided all of the following apply: Treated CNS lesions must be radiographically stable for ≥ 4 weeks after intervention (surgery and/or radiation). Participants must be neurologically stable off systemic corticosteroids for at least 2 weeks prior to trial entry, AND Greater than 14 days elapsed between the last dose of previous Tebentafusp and first dose of IL-2 on trial)
• • 2. Systemic treatment with steroids or any other immunosuppressive drug use within 2 weeks of the planned first dose of program intervention, with the following exceptions: Treatment for well-controlled and asymptomatic adrenal insufficiency is permitted, but replacement dosing is limited to prednisone ≤ 10 mg daily or the equivalent; Local steroid therapies (eg, optic, ophthalmic, intra- articular, or inhaled medications) are acceptable.
• • 3. Any relevant medical condition, which in the opinion of the treating physician, would prevent the participant enrolling into the Program due to concerns related to safety, compliance with procedures, or interpretation of program results.
• • 4. Chronic viral infections as indicated below. NOTE: Testing for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) status prior to enrollment is not necessary unless clinically indicated.