Adding IL-2 to tebentafusp to overcome resistance in uveal melanoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1/2 open‑label trial gives all participants combination therapy with IL‑2 and tebentafusp in repeating 28‑day cycles to see if IL‑2 can boost anti‑tumor activity and overcome resistance. Eligible patients are HLA‑A*02:01 positive adults with unresectable or metastatic uveal melanoma and RECIST‑documented progression on single‑agent tebentafusp. The regimen uses short pulses of IL‑2 timed around scheduled tebentafusp doses, with close safety monitoring and predefined criteria for dose modifications. Key endpoints include safety and response rates, with overall survival and progression‑free survival as important secondary measures.

Why it matters

Who can join: the full rules

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.

Where it's running

• Kinghorn Cancer Centre, St. Vincent's Hospital
  Sydney, New South Wales, Australia Recruiting
• Alfred Hospital
  Melbourne, Victoria, Australia Not yet recruiting

Study contacts

• Principal investigator: Anthony Joshua, FRACP — St Vincent's Hospital, Sydney
• Study coordinator: Anthony Joshua, FRACP
• Email: Anthony.Joshua@svha.org.au
• Phone: 61293555655

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Dual-target CSPG4/GD2 CAR-NK Cells for Advanced Melanoma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.