Metastatic Melanoma Clinical Trial
Official title:
T-cell Therapy in Combination With Vemurafenib for Patients With BRAF Mutated Metastatic Melanoma
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.
n/a
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