Study of LN-144 in Patients with Advanced Melanoma
Research type
Research Study
Full title
A Phase 2, multicenter, open-label study of lifileucel (tumor-infiltrating lymphocytes [TIL]) in participants with previously treated advanced melanoma
IRAS ID
1012404
Contact name
Guy Ruble
Contact email
Sponsor organisation
Iovance Biotherapeutics Inc.
ISRCTN Number
N/A
Research summary
This study is being run to understand if lifileucel is safe and effective at treating advanced melanoma. Eligible participants will include adult patients with previously treated melanoma. Lifileucel is the test medication and will be given with other drugs known as ‘lifileucel regimen’. Lifileucel is a type of medicine that uses the body’s immune system to fight cancer. Specialised white blood cells that help the body fight against infections and diseases such as cancer will be obtained from tumour(s) to make Lifileucel. The lifileucel regimen includes 2 drugs (cyclophosphamide and fludarabine) to decrease lymphocytes (white blood cells) in the body, the lifileucel infusion, followed by aldesleukin to boost the activity of the lifileucel. Each eligible participant enrolled in the study, will have surgery to remove a piece of the tumour that will be used to make the lifileucel. If the study treatment is not available due to the tumour sample not growing sufficient cells to produce the test medication, the Study Doctor will discuss alternative options with the study participant. There will be multiple types of visits during the study. The length of participation in the Study will vary and can be up to approximately 5 years after receiving the study treatment. This study will consist of the following:
- Screening Period
- Tumour Resection visit
- Pre-treatment period
- Treatment Period
- Follow-Up and Assessment Period
This is a global trial which will recruit approximately 100 participants, and it is planned to run in 4 hospitals in the UK.REC name
Wales REC 5
REC reference
25/WA/0266
Date of REC Opinion
6 Oct 2025
REC opinion
Further Information Favourable Opinion