TITAN
Research type
Research Study
Full title
A Phase I/II Study of the Safety and Efficacy of Talimogene Laherparepvec (T-VEC) Delivered by Intra-tumoural Injection in Combination with Isolated Limb Perfusion with Melphalan and Tumour Necrosis Factor-α in Patients with Advanced Extremity Tumours Including Metastatic Melanoma.
IRAS ID
220203
Contact name
Andrew Hayes
Contact email
Sponsor organisation
The Royal Marsden NHS Foundation Trust
Eudract number
2017-002861-22
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Isolated limb perfusion (ILP) is a specialised surgical technique used to treat patients with advanced cancers of the limbs, such as melanomas and sarcomas. ILP allows the targeted delivery of anti-cancer agents to the limb at higher doses that could be given to the general circulation. Although 60% of patients respond to ILP, this response is often short-lived and this treatment cannot prevent the cancer from spreading elsewhere in the body.\nTalimogene laherparepvec (also known as T-VEC) is a virus that has been engineered to specifically target cancer cells. When injected directly into a tumour, T-VEC has been shown to be effective and well-tolerated in patients with melanoma. T-VEC is able to stimulate an anti-tumour immune response and so cause tumours that have not been directly exposed to virus to shrink.\nThis study will investigate whether the combination of T-VEC with ILP is safe and effective in patients with melanoma and sarcoma of the limbs. This will be the first time these agents have been combined in patients. These treatments are being combined because there is good reason to suggest that this will improve the number of patients responding to ILP, the duration of that response and may cause tumours outside the limb to shrink.\nThis study will be conducted at a single site – The Royal Marsden Hospital. Patients with melanomas and sarcomas of the limbs that would be suitable for an ILP will be included. Patients will receive a total of 3 doses of T-VEC. The first 2 doses will be given prior to the ILP procedure, with the last dose given during the ILP procedure. The study treatment will be given over 6 weeks and patients will be part of the study for approximately 14 months.\n
REC name
South Central - Oxford A Research Ethics Committee
REC reference
18/SC/0041
Date of REC Opinion
16 Apr 2018
REC opinion
Further Information Favourable Opinion