LN-144 in Metastatic Melanoma
Research type
Research Study
Full title
A Phase 2, Multicenter Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-144) for Treatment of Patients with Metastatic Melanoma
IRAS ID
229812
Contact name
Heather Shaw
Contact email
Sponsor organisation
Iovance Biotherapeutics, Inc.
Eudract number
2017-000760-15
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
16317, IND number
Duration of Study in the UK
5 years, 2 months, 23 days
Research summary
This is a prospective, multicenter interventional study evaluating participants who receive Adoptive Cell Therapy (ACT) with LN-144 (autologous Tumour Infiltrating Lymphocyte (TIL)).
Approximately, 232,000 new cases of melanoma skin cancers occur globally each year, making it the fifth and sixth most common malignancy in men and women, respectively. Unlike other malignancies, the incidence of melanoma is increasing. One estimate predicts 112,000 new cases of invasive melanoma in 2030 if the current trend continues.
Recent research has demonstrated the power of the body’s own immune system to remove abnormal cancer cells. The cancer fighting cells are white blood cells, mainly those from the T-Lymphocytes family, and are referred to as TIL. Two therapies pembrolizumab and nivolumab which act to enhance the activity of the immune system to attack tumours have shown significant success at treating metastatic melanomas. However, they are associated with a spectrum of immune-related adverse events. A treatment to increase the number of TIL, which attack the patient’s specific cancer cells, could provide an effective treatment with less side-effects. LN-144 is composed of TIL extracted from the individuals’ own tumour (autologous), which are subsequently expanded (cell number increased) in a laboratory before injection back into the patient. This is called cell transfer therapy (CTT).
CTT with autologous TIL appears able to mediate robust remission in participants with metastatic melanoma and solid tumours, in which current standard-of-care has failed to treat. However, only a limited number of clinical centres can offer this treatment and there is no standardised procedure for TIL production. The Sponsor are developing a robust GMP process and, in parallel, are executing a clinical development program to evaluate the efficacy and safety of LN-144 in the treatment of melanoma.
Approximately 164 male and female participants aged between 18 and 70 years old will participate in this study.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
17/LO/1471
Date of REC Opinion
15 Nov 2017
REC opinion
Further Information Favourable Opinion