Malignant Melanoma Clinical Trial
Official title:
Phase Ib Trial of Pembrolizumab Administered in Combination With or Following Adoptive Cell Therapy- A Multiple Cohort Study; The ACTIVATE (Adoptive Cell Therapy InVigorated to Augment Tumor Eradication) Trial
This is a phase 1b study for patients with metastatic (cancer has spread to various parts of
the body) melanoma and ovarian cancer. The main purpose is to examine the safety and efficacy
of administering pembrolizumab after receiving chemotherapy, tumor-infiltrating lymphocytes
(TIL) and low dose interleukin 2 (IL-2).
Patients will first receive either cyclophosphamide, or cyclophosphamide and fludarabine.
These are chemotherapy agents that prepare the body to receive TILs.
Patients are then infused with autologous TILs, a type of white blood cell that recognizes
tumor cells and enters them, thereby causing tumor cells to break down.
Following TILs infusion, patients will receive low-dose IL-2 therapy. This is a type of
protein that is intended to activate and stimulate the growth of cells in the patient's
immune system.
If the patient meets the required criteria, they will be given pembrolizumab, a monoclonal
antibody (drug made up of cloned immune cells) that is designed to block a protein called
programed cell death ligand 1 (PD-L1) which will allow the body's immune system to kill the
cancer cells.
This study will involve treatment with chemotherapy, TILs, IL-2, pembrolizumab, tests and procedures done for safety, and the collection of archival tumor tissue, fresh tumor biopsies, and blood samples for biomarker research. ;
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