LN-145 in Advanced Cervical Carcinoma
Research type
Research Study
Full title
A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety Using Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients with Recurrent, Metastatic or Persistent Cervical Carcinoma
IRAS ID
229826
Contact name
Rebecca Kristeleit
Contact email
Sponsor organisation
Iovance Biotherapeutics, Inc.
Eudract number
2016-003447-11
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
16819, IND number
Duration of Study in the UK
5 years, 4 months, 22 days
Research summary
This is a phase 2, multicentre study to evaluate the efficacy and safety of a cell based therapy to treat advanced cervical cancer. Eligible participants are those for which surgical or radiation therapy is not amenable.
Cervical cancer is the leading cause of cancer-related deaths in women, with approx. 12, 800 new cases and 4210 deaths in the US alone in 2017. Early stage cancer is treatable, but advanced metastatic forms have poor outcomes due to ineffective current treatments. Recent research has demonstrated the power of the body’s own immune system to remove abnormal cancer cells and induce remission, enhancing survival rates. The cancer fighting cells are white blood cells, mainly those from the T-Lymphocytes family, and are referred to as Tumour Infiltrating Lymphocytes (TIL).
Approximately 59 female participants (18 years and older) will be infused with TIL. The length of the study including the pre-treatment (screening), treatment and follow-up is up to 5years.
The cell based therapy, called LN-145, used in this study is based on TIL therapy previously used to treat advanced metastatic melanoma in a phase 2 clinical study. Pre-treatment involves tumour resection (surgical removal), and TIL extraction. The number of TIL are then stimulated to multiply, and if successful participants begin lymphodepletion, whereby the lymphocytes in their body are destroyed, in order to condition their immune system and allow the infused TIL to more effectively target cancer cells. LN-145 is then infused into the participant, before starting successive IL-2 treatments. IL-2 encourages growth of the cancer attacking TIL. Participants will then be monitored for changes in their tumours.
Study procedures include: physical examination, blood/urine tests, quality of life questionnaires, heart function tests, review of mediations and side effects, tumour resection and radiographic assessments (CT, MRI and PET Scans).
REC name
London - West London & GTAC Research Ethics Committee
REC reference
17/LO/1472
Date of REC Opinion
25 Oct 2017
REC opinion
Further Information Favourable Opinion