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:
- Can combining tebentafusp with IL-2 improve tumor 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. 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
Intervention / Treatment
- Drug: Aldesleukin
Inclusion Criteria:
- 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