RecruitingPhase 1Phase 2NCT07063875

Adding IL-2 to Tebentafusp to Eradicate Cancer Progression

Supplementing With IL-2 to Verifiably eRadicate Radiological Progression

Sponsor

St Vincent's Hospital, Sydney

Enrollment

8 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

Uveal Melanoma Metastatic Uveal Melanoma Metastatic Uveal Melanoma in the Liver

Summary

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding low-dose IL-2 (a natural immune-boosting protein) to tebentafusp — an approved immunotherapy for uveal melanoma (a rare eye cancer that has spread) — can help overcome cancer progression after tebentafusp alone stops working. **You may be eligible if...** - You have metastatic or unresectable uveal melanoma (eye cancer that has spread) - You carry a specific immune marker called HLA-A*02:01 - Your cancer progressed while on tebentafusp alone, with no other treatments in between - You are in good physical condition (ECOG performance status 0 or 1) **You may NOT be eligible if...** - You do not have the HLA-A*02:01 immune marker - You received other cancer treatments between stopping tebentafusp and enrolling - You have untreated or symptomatic brain metastases - You require steroids for neurological symptoms Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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