T cell therapy is an experimental personalized immunotherapy where tumor-infiltrating lymphocytes are isolated from the patient's own tumor tissue, expanded in vitro to billions of cells and then administered to the individual patient with the purpose of eliminating remaining cancer cells. In previous studies in malignant melanoma, the treatment has had a profound clinical effect in 50% of patients of which 20% seems to be long-time responders. Immune therapy in general has been spread from malignant melanoma to many other cancer forms and recent studies suggest that T cell therapy might also work in other types of cancer.
This study is a clinical protocol study that will include 25 patients with advanced metastatic cancer disease who have exhausted available therapeutic options. The primary objective is to evaluate the tolerability and safety of the treatment. The secondary objective is to characterize antitumor immune responses (immune monitoring) as well as to assess the clinical effect of the treatment by use of the objective response rate (using RECIST 1.1). In addition, overall survival (OS) and progression-free survival (PFS) will be described, but not included as endpoints.
The treatment regime involves the immunotherapeutic drugs ipilimumab and nivolumab, surgical removal of a tumor lesion, re-infusion of tumor-infiltrating lymphocytes (TILs) isolated from the tumor tissue, lymphodepleting chemotherapy and interleukin-2 (IL-2) treatment.
UPDATE NOVEMBER 2017: Patient inclusion has started october 2016.