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The Selected Tumor-infiltrating Lymphocyte Against Refractory Melanoma-01 Trial (STAR-M01)


Key Information

Who may qualify?

  • Patients with advancedmelanoma progressing onnivolumab or pembrolizumab(anti-PD-1) therapy. Patientwith BRAF mutated tumormust also have progressedon vemurafenib (anti-BRAF)therapy
  • Bearing a melanoma deposit(metastasis) that can beremoved surgically for TILproduction
  • Good performance status, nomajor organ dysfunction, noimmune dysfunction

Recruitment status

  • Not yet recruiting

Key words

  • Melanoma, T cell, transfusion,PD-1, cell sorting, tumourinfiltrating lymphocytes (TILs)
Therapy Type:
Adoptive Therapy

About the Trial

A small number of anti-tumour immune cells, called T cells, can naturally infiltrate tumours in most patients, but they fail to control cancer growth. Current antibody-based immunotherapy designed to boost these anti-tumour T cells only works in a minority of patients.


Another way to therapeutically harness anti-tumor T cells consists of producing them in large numbers outside the body and transfusing them into patients. In this project, the researchers propose to make a T cell transfusion product highly enriched in tumor-reactive T cells using patients’ own tumor as source material.


This is achieved by sorting T cells from a surgically removed tumor. Cell sorting is based on the expression by T cells of a cell surface marker called PD-1, which acts as a “tag” for tumor-reactivity. The researchers have optimized the parameters of a sophisticated cell sorter, and the cell culture conditions to expand the sorted T cells to large numbers for infusion into patients.


The main goal of this project is to test the feasibility, the safety, and the potential efficacy of this T cell immunothera-py in 24 patients with metastatic melanoma resistant to standard treatment. To guide the design of subsequent trials, this team will characterize the biologic features of the starting tumors and the T cell products for their association with treatment efficacy and side effects.


Enrolled patients will be able to participate in a patient-led support group to help them understand and communicate to others what to expect from anti-tumor T cell transfusion immunotherapy.


Clinical Trial #: TBD