Study on Ivermectin and Balstilimab for Treating Metastatic Triple Negative Breast Cancer

Sponsor: Yuan Yuan

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05318469

Provider View

This clinical trial is testing a combination of ivermectin and balstilimab to see if it can help shrink tumors in patients with triple negative breast cancer that has spread to other parts of the body. The study aims to find the best dose and evaluate the treatment's effectiveness and impact on patients' quality of life.

Patient Parameters

Program Overview

This phase II study is exploring the use of ivermectin and balstilimab to treat metastatic triple negative breast cancer. Balstilimab is an immunotherapy drug that may help the immune system attack cancer cells, while ivermectin might block the growth of cancerous tumors. The study will assess how well this combination works in shrinking tumors and improving patients' quality of life. Researchers will also look at various outcomes, such as how long patients live without the cancer getting worse and their overall survival rates.

Description

Participants in this study will take ivermectin by mouth once daily on specific days of a 21-day cycle. They will also receive balstilimab through an IV on the first day of each cycle. This treatment will continue for up to 35 cycles unless the cancer progresses or side effects become too severe. After completing the treatment, patients will be monitored for 90 days and then periodically to check their health and any long-term effects.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of metastatic triple negative breast cancer.
  • Cancer must have progressed after 1-2 previous treatments in the metastatic setting.
  • Have measurable or evaluable disease.
  • Must be in good overall health with a performance status of 0 or 1.
  • Must have adequate organ function based on specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 120 days after the last dose.
  • Men must agree to use contraception and not donate sperm during the study and for 120 days after the last dose.
  • Must provide written informed consent to participate in the study.

Exclusion Criteria

  • Have an immune system deficiency or are taking high doses of steroids or other immunosuppressive drugs.
  • Have received chemotherapy, radiation, or other cancer treatments recently.
  • Have had a live vaccine within 30 days before starting the study.
  • Are taking warfarin or have difficulty swallowing pills.
  • Are pregnant, breastfeeding, or planning to become pregnant.
  • Have allergies to the study drugs.
  • Have other active cancers or untreated brain metastases.
  • Have a history of lung inflammation or active infections.
  • Have a history of HIV, Hepatitis B, or Hepatitis C.
  • Have a history of tuberculosis or other serious medical conditions.
  • Have psychiatric or substance abuse issues that could interfere with the study.
  • Have had a recent organ transplant or significant heart problems.
  • Have active autoimmune diseases requiring treatment in the past two years.

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