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 melanomaa type of cancer that develops from melanocytes, which are the cells that produce pigment generally in the skin (but can develop in other areas of the body) (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 Oncologythe study, diagnosis and treatment of cancer Group (ECOG) Performance Status of 0 or 1
- RECIST 1.1 defined progression on single-agent Tebentafusp, with no other intervening systemic therapies