A Multi-centre, Two-arm, Randomized, Open, Phase II Study Investigating SentoClone® Compared to Reference Treatment in Advanced Malignant Melanoma
Malignant melanoma is one of the most common cancer forms worldwide and WHO estimates
132,000 new cases each year. The incidence rate vary up to 150-fold between different
regions and ethnicities, the highest rates are found in emigrated Caucasian populations
(e.g. Australia and New Zealand).
There are few therapy alternatives for advanced malignant melanomas. At present, dacarbazine
(Dacarbazine Medac®) is the most commonly used therapy. Immunotherapy with IL-2 and IFN is
an alternative, but it is associated with multiple side effects. Hence, there remains a
considerable need for alternative treatments.
By using SentoClone®, autologous tumour-reactive lymphocytes are expanded and infused to the
patient, where they have the opportunity to seek out and attack the primary tumour and
metastases. The first step is to identify the tumour draining lymph node(s), which is done
in parallel to surgical resection of the primary tumour or metastasis. The sentinel and/or
metinel node(s), the initial meeting place between tumour antigen and the immune system, are
further dissected and collected during the surgery.
In this study SentoClone® will be compared with Dacarbazine Medac® and Temodal® which are
currently regarded as standard first-line therapies in advanced malignant melanoma.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Tumour response rate, defined as complete response (CR) or partial response (PR) (i.e. at least partial response) measured using the RECIST (Response Evaluation Criteria in Solid Tumours) criteria.
At baseline and 18, 26 and 34 weeks after treatment
Christian Ingvar, MD
Lund University Hospital
Sweden: Medical Products Agency