Adding IL-2 to Tebentafusp to Eradicate Cancer Progression

NCT07063875 | Recruiting Phase 1 DMC

• 1 other identifier: SILVER Trial
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

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. 1.Can combining tebentafusp with IL-2 improve tumor response and overall survival?
2. 2.What are the benefits and side effects of this combination therapy?

Conditions

Uveal Melanoma; Metastatic Uveal Melanoma; Metastatic Uveal Melanoma in the Liver

Keywords

metastatic uveal melanoma; Immunotherapy; Treatment resistance; Combinational immunotherapy

Outcome Measures

Primary Outcomes (1)

• Safety of Combination therapy

  As assessed by CTCAE V5.0

  Through study completion, approx 1 year

Secondary Outcomes (2)

• Radiological progression free survival

  Through study completion, approx 1 year

• Overall Survival

  Through study completion, approx 1 year

Study Arms (1)

Treatment arm

EXPERIMENTAL

Single arm study -all enrolled participants will receive investigational products- IL-2 (Proleukin) and Tebetafusp

Drug: Aldesleukin

Interventions

Aldesleukin DRUG

IL-2 in combination with Tebentafusp

Also known as: Proleukin

Treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed metastatic UM or unresectable UM patients
• HLA-A\*02:01 positive
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• RECIST 1.1 defined progression on single-agent Tebentafusp, with no other intervening systemic therapies

You may not qualify if:

• 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)
• 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.
• 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.
• 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.

Sponsors & Collaborators

• St Vincent's Hospital, Sydney: lead

Study Sites (2)

Kinghorn Cancer Centre, St. Vincent's Hospital

Sydney, New South Wales, 2010, Australia

RECRUITING

Alfred Hospital

Melbourne, Victoria, 3004, Australia

NOT YET RECRUITING

MeSH Terms

Conditions

Uveal Melanoma

Interventions

aldesleukin

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases

Study Officials

• Anthony Joshua, FRACP

  St Vincent's Hospital, Sydney

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anthony Joshua, FRACP

CONTACT

61293555655; Anthony.Joshua@svha.org.au

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: July 14, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)