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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03158935
Other study ID # ACTIVATE
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date July 7, 2017
Est. completion date August 4, 2020

Study information

Verified date August 2020
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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, 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.


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.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Cyclophosphamide
Cohort 1: i.v., 60mg/kg per day for 2 days Cohort 2: i.v., 30mg/kg per day for 2 days
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
Interleukin-2 (IL-2)
Cohort 1 and 2: i.v., 125,000 IU/kg subcutaneous per day

Locations

Country Name City State
Canada Princess Margaret Cancer Centre Toronto Ontario

Sponsors (2)

Lead Sponsor Collaborator
University Health Network, Toronto Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Toxicities will be monitored on an ongoing basis. Severe adverse events will be reviewed for attribution to the study drug and whether they resolve to an acceptable grade within 35 days of TIL infusion. This information will be used to determine if the patient will go on to receive pembrolizumab. The regimen will be deemed feasible if at least 80% of patients enrolled go on to receive pembrolizumab. 2 years
Secondary Overall Response Rate To evaluate the response rate of pembrolizumab following or in combination with ACT using measurable disease by RECIST v1.1. 2 years
Secondary Overall and Progression Free Survival To evaluate the survival outcomes of overall and progression free survival per tumour type 2 years
Secondary Safety profile of pembrolizumab therapy given after or in combination with ACT in patients with advanced melanoma and ovarian cancer using CTCAE v4.0 Events that are both unrelated and related to treatment will be captured using CTCAE v4.0. The total number of episodes for each event will be reported, as well as the severity and attribution to study therapy. 2 years
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