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

NCT03158935 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2020-08-14

No results posted yet for this study

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.

Conditions

  • Advanced Ovarian Cancer
  • Malignant Melanoma

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Marcus Butler, M.D. · Tumor Immunotherapy Program, Princess Margaret Cancer Centre

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-07
Primary Completion
2020-08-04
Completion
2020-08-04
FDA Drug
Yes

Countries

  • Canada

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03158935 on ClinicalTrials.gov