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Brief Title: Vemurafenib and TIL Therapy for Metastatic Melanoma
Official Title: T-cell Therapy in Combination With Vemurafenib for Patients With BRAF Mutated Metastatic Melanoma
Study ID: NCT02354690
Brief Summary: Background: Adoptive T cell therapy with tumor infiltrating lymphocytes (TILs) has been reported to induce durable clinical responses in patients with metastatic melanoma. From patients own tumor material T cells are extracted, expanded and activated in vitro in a 4-6 weeks culture period. Before TIL infusion patients are preconditioned with a lymphodepleting chemotherapeutic regimen. After TIL infusion, patients are treated with IL-2 to support T cell activation and expansion in vivo. The BRAF inhibitor is an approved treatment of metastatic melanoma and functions by selectively inhibiting the BRAF mutated enzyme, consequently halting the proliferation of tumor cells. Furthermore, in vitro tests have shown that vemurafenib has immunomodulatory effects that are hypothesized to synergize with TIL therapy, which has been confirmed in animal studies. Objectives: * To evaluate safety and feasibility when combining vemurafenib and ACT with TILs. * To evaluate treatment related immune responses * To evaluate clinical efficacy Design: * Patients will be screened with a physical exam, medical history, blood samples and ECG. * Patients will start vemurafenib 960 mg BID and will continue during TIL preparation. * 7 days after start of vemurafenib, patients will undergo surgery to harvest tumor material for TIL production. * Patient stops vemurafenib and is admitted day -8 in order to undergo lymphodepleting chemotherapy with cyclophosphamide and fludara starting day -7. * On day 0 patients receive TIL infusion and shortly after starts IL-2 infusion continually following the decrescendo regimen. * The patients will followed until progression or up to 5 years.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Center for Cancer Immune Therapy, Dept. of Haematology/Oncology, Copenhagen, Herlev, Denmark
Name: Inge Marie Svane, Prof., MD
Affiliation: Department of Oncology, Copenhagen University Hospital, Herlev, Herlev Ringvej 75, DK-2730 Herlev, Denmark
Role: STUDY_DIRECTOR
Name: Troels Holz Borch, MD
Affiliation: Department of Oncology, Copenhagen University Hospital, Herlev, Herlev Ringvej 75, DK-2730 Herlev, Denmark
Role: PRINCIPAL_INVESTIGATOR