drugset / Trial / NCT03374839

Combined Therapy of Nivolumab and Adoptive T Cell Therapy in Metastatic Melanoma Patients

NCT03374839

NaSingle-groupOpen-labelTreatment

Summary

To improve the efficacy of immunotherapy for cancer, recent studies focused on specific targets to redirect the immune network toward eradicating a variety of tumors and ameliorating the self-destructive process. A clinically relevant immune escape mechanism in melanoma is the activation of the Programmed cell Death-1 (PD-1) receptor on infiltrating T cells. By blocking PD-1 receptors with anti-PD-1 monoclonal antibodies (mAbs), T-cells are unaffected by the PD-L1 expressed on tumor cells and the patients T cells are free to respond to melanoma antigens and attack tumor cells. So the objective of this trial is to evaluate the safety and the efficacy of a combined therapy Nivolumab and adoptive T cell therapy in metastatic melanoma patients.

Timeline

Start
2018-02-12
Primary completion
2024-01
Completion
2024-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Nivolumab Monoclonal antibody 3 mg/kg
Subject Tumor Infiltrating Lymphocytes Cell therapy 5e+08 cells
Subject Tumor Infiltrating Lymphocytes Cell therapy 1e+09 cells
Subject Tumor Infiltrating Lymphocytes Cell therapy 2e+10 cells
Background aldesleukin Protein / enzyme biologic 6e+06 iu Subcutaneous

Indications