NCT03158935

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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, 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.

Detailed description

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.

Conditions

• Advanced Ovarian Cancer
• Malignant Melanoma

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Cohort 1: i.v., 60mg/kg per day for 2 days Cohort 2: i.v., 30mg/kg per day for 2 days
DRUG	Fludarabine	Cohort 1: i.v., 25mg/m2 per day for 5 days
PROCEDURE	Pembrolizumab	Cohort 1 and 2: i.v., 200mg every 3 weeks
BIOLOGICAL	Tumor-Infiltrating Lymphocytes (TILs)	Cohort 1 and 2: i.v., 1x10\^10 - 1.6x10\^11 cells
BIOLOGICAL	Interleukin-2 (IL-2)	Cohort 1 and 2: i.v., 125,000 IU/kg subcutaneous per day

Timeline

• Start date: 2017-07-07
• Primary completion: 2020-08-04
• Completion: 2020-08-04
• First posted: 2017-05-18
• Last updated: 2020-08-14

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study