NCT03202446

Randomized Clinical Trial Evaluating the Use of the Laser-Assisted Immunotherapy (LIT/inCVAX) in Advanced Breast Cancer

Phase 3 Randomized Clinical Trial Evaluating the Use of the Laser-Assisted Immunotherapy (LIT) System in Advanced Breast Cancer

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Eske Corporation S.A.C · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Our study evaluates the use of Laser-Assisted Immunotherapy (LIT) plus placebo and LIT plus low-dose cyclophosphamide versus that of Standard of Care in patients presenting with Stage IIIA, IIIB or IV breast cancer. One-third of enrolled patients will receive LIT plus placebo, one-third will receive LIT plus low-dose cyclophosphamide, and one-third will be assigned to a control group that receives Standard of Care.

Detailed description

Laser-Assisted Immunotherapy (LIT) is intended to a systemic anti-tumor immune response by priming a tumor with laser energy to liberate an array of tumor antigens from whole cells, immediately followed by administration of the immune stimulant Glycated Chitosan (GC), which is designed to activate antigen presenting cells and facilitate the uptake of tumor antigens. In turn, the antigen presenting cells activate the patient's immune system, resulting in an immune response towards the remaining tumor(s). In this study it is investigated if the addition of low-dose cyclophosphamide increases the anti-tumor immune response of LIT, as well as comparing the effect of LIT plus Placebo or LIT plus low-dose cyclophosphamide to a control arm of patients receiving Standard of Care therapy.

Conditions

• Breast Cancer Stage IIIA
• Breast Cancer, Stage IIIB
• Breast Cancer Stage IV

Interventions

Type	Name	Description
DRUG	1% Glycated Chitosan
DEVICE	Photothermal Laser
DRUG	Placebo
DRUG	Cyclophosphamide
DRUG	Standard of Care

Timeline

• Start date: 2016-06-13
• Primary completion: 2018-01-01
• Completion: 2018-01-01
• First posted: 2017-06-28
• Last updated: 2018-02-23

Locations

4 sites across 1 country: Peru