The ACTIVATE (Adoptive Cell Therapy InVigorated to Augment Tumour Eradication) 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 Tumour Eradication) Trial

Summary:

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, tumour-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 tumour cells and enters them, thereby causing tumour 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.

Trial Description

Primary Outcome:

  • Monitoring of serious adverse events to determine the safety of initiating pembrolizumab following lymphodepleting chemotherapy, TIL administration, and low dose IL-2 injections within 35 days of TIL infusion.
Secondary Outcome:
  • Overall Response Rate
  • Overall and Progression Free Survival
  • Safety profile of pembrolizumab therapy given after or in combination with ACT in patients with advanced melanoma and ovarian cancer using CTCAE v4.0
This study will involve treatment with chemotherapy, TILs, IL-2, pembrolizumab, tests and procedures done for safety, and the collection of archival tumour tissue, fresh tumour biopsies, and blood samples for biomarker research.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society