RecruitingPhase 3NCT06072612

Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer.

Randomized, Open-Label Study of the Bria-IMT Regimen and Check Point Inhibitor vs Physicians' Choice in Advanced Metastatic Breast Cancer.

Sponsor

BriaCell Therapeutics Corporation

Enrollment

404 participants

Start Date

Dec 5, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Breast Cancer Metastatic Metastatic Breast Cancer Breast Neoplasm End Stage Cancer

Summary

This is a multicenter randomized, open label study to evaluate overall survival with the Bria-IMT regimen in combination with Checkpoint Inhibitor \[Retifanlimab\], versus Treatment of Patients'/Physicians' Choice (TPC) in advanced metastatic or locally recurrent breast cancer (aMBC) patients with no approved alternative therapies available.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests Bria-IMT — a type of immune cell therapy — combined with an immune checkpoint drug, compared to a doctor's chosen standard treatment, for people with advanced metastatic breast cancer who have already tried multiple prior therapies. It aims to see whether this novel immune approach can extend survival. **You may be eligible if...** - You are 18 or older - You have advanced or metastatic breast cancer that cannot be surgically removed - You have received standard prior therapies specific to your breast cancer type (e.g., at least 3 HER2-targeted regimens if HER2+, or prior CDK4/6 inhibitor therapy if hormone receptor+) - You are in reasonable health with adequate organ function **You may NOT be eligible if...** - You have active autoimmune disease or are on immune-suppressing drugs - You have serious uncontrolled infections - You have brain metastases that are not stable - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALSV-BR-1-GM

SV-BR-1-GM is an experimental, allogeneic, whole cell breast tumor cell line stably transfected with the CSF2 gene (encoding GM-CSF) to secrete GM-CSF in vivo to consequently augment dendritic cell activity

DRUGCyclophosphamide

Cyclophosphamide is an alkylating agent with indications for treatment of malignant diseases including breast cancer. Cyclophosphamide (Cytoxan) 300 mg/m2 I.V., single dose, will be given to patients assigned to the SV-BR-1-GM. Cyclophosphamide will be administered 2-3 days prior to SV-BR-1-GM inoculations.

DRUGInterferon infiltration of the inoculation site

Interferon is a cytokine released by cells to regulate immune responses to viral infections. For this study, 0.1 mcg Pegasys per injection site (x 4 injection sites) will be administered.

DRUGRetifanlimab

Retifanlimab is a checkpoint inhibitor. A total dose of 375mg will be administered at first cycle on or about day +2 (+/-1d). In all other cycles, Retifanlimab is permitted to be administered between Day -2/-3 to Day 2±1 of the cycle based on the convenience of the patients and the clinical sites. However once the timing of the CPI is chosen for C1, it must be given on the same day thereafter throughout the trial.

DRUGTreatment of Physician's Choice

Patients in the TPC arm of the study will be treated with one or a combination of the following: carboplatin, taxanes, capecitabine, gemcitabine, vinorelbine or eribulin in accordance with the investigators and institutional standard of care. For HER2+ patients, a HER2-targeted agent of the physician's choice can be part of TPC.

Locations(79)

Mayo Clinic-Comprehensive Cancer Center-Breast Clinic

Phoenix, Arizona, United States

University of Arizona-Cancer Center

Tucson, Arizona, United States

Los Angeles cancer Network_Anaheim

Anaheim, California, United States

Comprehensive Blood and Cancer Center

Bakersfield, California, United States

Cedars-Sinai Cancer Beverly Hills

Beverly Hills, California, United States

Los Angeles Cancer Network_Corona

Corona, California, United States

Los Angeles cancer Network_Fountain Vallley

Fountain Valley, California, United States

Los Angeles Cancer Network_Glendale

Glendale, California, United States

Hoag Hospital Center

Irvine, California, United States

Hoag Hospital Irvine

Irvine, California, United States

Los Angeles Cancer Network