NCT07063875 Adding IL-2 to Tebentafusp to Eradicate Cancer Progression
| NCT ID | NCT07063875 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | St Vincent's Hospital, Sydney |
| Condition | Uveal Melanoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 8 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 8 participants in total. It began in 2025-06-01 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Anthony Joshua, FRACP
PRINCIPAL INVESTIGATOR
St Vincent's Hospital, Sydney
Frequently Asked Questions
Who can join the NCT07063875 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Uveal Melanoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07063875 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07063875 currently recruiting?
Yes, NCT07063875 is actively recruiting participants. Contact the research team at Anthony.Joshua@svha.org.au for enrollment information.
Where is the NCT07063875 trial being conducted?
This trial is being conducted at Sydney, Australia, Melbourne, Australia.
Who is sponsoring the NCT07063875 clinical trial?
NCT07063875 is sponsored by St Vincent's Hospital, Sydney. The principal investigator is Anthony Joshua, FRACP at St Vincent's Hospital, Sydney. The trial plans to enroll 8 participants.
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