Supplementing With IL-2 to Verifiably eRadicate Radiological Progression

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Australia
Alfred Hospital
NOT_YET_RECRUITING
Melbourne
Kinghorn Cancer Centre, St. Vincent's Hospital
RECRUITING
Sydney
Contact Information
Primary
Anthony Joshua, FRACP
Anthony.Joshua@svha.org.au
61293555655
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2027-09
Participants
Target number of participants: 8
Treatments
Experimental: Treatment arm
Single arm study -all enrolled participants will receive investigational products- IL-2 (Proleukin) and Tebetafusp
Sponsors
Leads: St Vincent's Hospital, Sydney

This content was sourced from clinicaltrials.gov