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RecruitingLast updated: 21 April 2026

SILVER: This study is recruiting people with uveal melanoma to evaluate the combination of two targeted medicines (IL-2 and tebentafusp)Supplementing With IL-2 to Verifiably eRadicate Radiological Progression

Trial purpose

Medical clipboardCancer treatment

Tumor type

Skin Cancers Skin

Age

People18+

Trial acronym

SILVER

Clinical summary

Summary

This study aims to answer:

  • Can combining tebentafusp with IL-2 improve tumour response and overall survival?
  • 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.

 

 

Conditions

This trial is treating people with uveal melanoma (ocular melanoma) that is metastatic or unresectable, and is HLA-A*02:01 positive

Eligibility

Inclusion

  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

  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.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

St Vincent's Hospital, Sydney

Scientific Title

Supplementing With IL-2 to Verifiably eRadicate Radiological Progression

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