Study on SV-BR-1-GM and Retifanlimab Combination for Advanced Breast Cancer

Sponsor: BriaCell Therapeutics Corporation

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03328026

Provider View

This clinical trial is testing a new combination treatment using SV-BR-1-GM and retifanlimab for patients with advanced breast cancer that has returned or spread after standard treatments. The study aims to determine if this combination is safe and effective.

Patient Parameters

Program Overview

This study is exploring a new treatment for patients with advanced breast cancer that has either come back or spread after standard treatments. The treatment combines SV-BR-1-GM with retifanlimab, an immunotherapy drug. The study will first test the safety of this combination in a small group of patients. If it is found to be safe, more patients will be treated to further evaluate its effectiveness. Participants will receive the treatment every three weeks and will be monitored closely for any side effects and how well the cancer responds.

Description

This clinical trial is designed to test a new combination treatment for patients with advanced breast cancer that has returned or spread after standard treatments. The treatment involves using SV-BR-1-GM along with retifanlimab, an immunotherapy drug. The study is divided into two phases: Phase I will focus on ensuring the treatment is safe, while Phase II will evaluate its effectiveness in controlling the cancer.

Participants will receive the treatment every three weeks. The initial group of patients will help determine if the combination is safe. If successful, more patients will be included to further assess the treatment's effectiveness. The study will also explore different schedules for administering retifanlimab to see if timing affects the treatment's success.

Patients will undergo regular evaluations, including imaging studies and safety assessments, to monitor their response to the treatment. The study will also include a sub-study involving a special type of scan to evaluate immune response in a small group of patients.

Participants will be followed closely throughout the study, and those who benefit from the treatment may continue receiving it as long as it is effective and safe. After completing the treatment, patients will be monitored for long-term outcomes and survival.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of breast cancer that has returned or spread and has not responded to previous treatments.
  • For patients with metastatic disease:
    • HER2 positive and hormone receptor positive tumors must have failed hormonal therapy and at least two anti-HER2 treatments.
    • HER2 negative and hormone receptor positive tumors must have failed hormonal therapy and at least two chemotherapy regimens.
    • HER2 positive and hormone receptor negative tumors must have failed at least two anti-HER2 treatments.
    • Triple Negative tumors must have exhausted available therapies, including taxane and carboplatin.
  • Patients with stable brain metastases may be eligible if they meet specific conditions, such as no need for steroids and prior radiation therapy.
  • Be 18 years or older and female.
  • Have an expected survival of at least 4 months.
  • Have a good performance status (ECOG 0-1), with some exceptions for ECOG 2 with approval.
  • Provide written informed consent.

Exclusion Criteria

  • Recent chemotherapy, immunotherapy, or major surgery within 21 days before starting the study.
  • Recent radiotherapy within specific timeframes before starting the study.
  • Unresolved side effects from previous treatments that have not returned to baseline levels.
  • Allergies or hypersensitivity to the study drugs or their components.
  • Significant kidney or liver function abnormalities.
  • Blood clotting issues unless controlled with medication.
  • Heart conditions or abnormal ECG results.
  • Women who are pregnant or nursing.
  • Men and women of childbearing potential must use effective contraception.
  • History of other cancers within the past 3 years, with some exceptions.
  • Active infections or history of tuberculosis.
  • Severe psychiatric disorders unless approved by the investigator.
  • Recent live vaccinations.
  • Participation in another clinical trial without approval.

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