Ivermectin and Balstilimab in Metastatic Triple Negative Breast Cancer

Summary

The purpose of this study is to evaluate whether concurrent use of oral ivermectin and intravenous (IV) balstilimab is safe and effective in treating patients with triple negative breast cancer. Researchers want to know the most effective dosage of ivermectin when combined with balstilimab and whether patients will experience increased length of time during treatment that the cancer does not worsen. The study will also evaluate how well the body responds to the treatment. Researchers also aim to learn more about immune cells and tumor biomarkers from blood, tissue, and stool collected from the study. A biomarker is a biological molecule found in blood, other body fluids or tissues that may be a sign of a condition or disease and can be used to predict someone’s response to a specific treatment. Balstilimab is an investigational drug; ivermectin is approved for other conditions, but its use in this study is considered experimental.


Inclusion Criteria

  • Age: ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) ≤ 1
  • Life expectancy > 3 months
  • Histologically confirmed metastatic triple negative breast cancer. Triple negative status will be defined as estrogen receptor (ER) and progesterone receptor (PR) ≤ 10% and HER2 negative (by immunohistochemistry [IHC] or fluorescence in situ hybridization [FISH]), per American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
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Study Location(s)

  • Cedars-Sinai Cancer at Beverly Hills (THO) : Amy Oppenheim
  • Cedars-Sinai Cancer at SOCC : Amy Oppenheim


More about this Clinical Trial

Full Title

IIT2022-07-YUAN-IB-TNBC: A Phase I/II Study Evaluating the Safety and Efficacy of Ivermectin in Combination with Balstilimab in Patients with Metastatic Triple Negative Breast Cancer with expansion cohort in PD-L1 Negative TNBC

Details
Disease Type/Condition

Breast

Principal Investigator

Yuan, Yuan

Co-Investigators

Dorothy Park, Jin Sun Bitar, Maryliza El-Masry, Monica Mita, Philomena McAndrew, Stephen Shiao

Age Group

Adult

Phase

I/II

IRB Number

STUDY00002505

ClinicalTrials.gov ID

NCT05318469

Key Eligibility
ClinicalTrials.gov

Contact
Name

Amy Oppenheim

Phone
+1 310-423-3713
Email
amy.oppenheim@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Breast

Principal Investigator

Yuan, Yuan

Age Group

Adult

Phase

I/II

IRB Number

IIT2022-07-YUAN-IB-TNBC

ClinicalTrials.gov ID

NCT05318469

Key Eligibility
ClinicalTrials.gov

Contact
Name

Amy Oppenheim

Phone
+1 310-423-3713
Email
amy.oppenheim@cshs.org
Want to join the study or
learn more?