RecruitingPhase 1Phase 2NCT05318469

Ivermectin in Combination With Balstilimab or Pembrolizumab in Patients With Metastatic Triple Negative Breast Cancer

A Phase I/II Study Evaluating the Safety and Efficacy of Ivermectin in Combination With Immune Checkpoint Inhibitor in Patients With Metastatic Triple Negative Breast Cancer

Sponsor

Yuan Yuan

Enrollment

34 participants

Start Date

Oct 13, 2023

Study Type

INTERVENTIONAL

Conditions

Anatomic Stage IV Breast Cancer AJCC v8 Metastatic Triple-Negative Breast Carcinoma

Summary

This phase II trial studies the side effects and best dose of ivermectin in combination with balstilimab or pembrolizumab and to see how well they they work in shrinking tumors in patients with triple negative breast cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as balstilimab or pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ivermectin may help block the formation of growths that may become cancer. Giving ivermectin with balstilimab or pembrolizumab may increase the effect of balstilimab or pembrolizumab in shrinking tumors in patients with triple negative breast cancer. The secondary objectives of the study include evaluating the following efficacy outcomes: objective response rate (ORR), progression free survival (PFS), overall survival (OS), duration of response (DOR), clinical benefit rate (CBR), and patients' quality of life (QOL) by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests ivermectin (a common anti-parasite drug) combined with immune checkpoint drugs (balstilimab or pembrolizumab) in patients with metastatic triple-negative breast cancer — an aggressive form that has already spread and stopped responding to prior treatments. **You may be eligible if...** - You are 18 or older - You have metastatic triple-negative breast cancer (ER-, PR-, HER2-) - Your cancer has progressed after 1-2 prior treatment regimens - You are in reasonably good health (ECOG 0 or 1) - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - You have brain metastases that are untreated or unstable - You have an active autoimmune disease requiring treatment - You have had severe side effects from prior immunotherapy - You are pregnant or breastfeeding - You need systemic steroids 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

DRUGIvermectin

Ivermectin at the assigned dose administered PO on Days 1-3, 8-10, 15-17 of each 21 day cycle (Days1-3 of each week).

DRUGBalstilmab

Balstilimab 300 mg administered intravenously on Day 1 of each 21 day cycle.

DRUGPembrolizumab

Pembrolizumab 200 mg IV on Day 1 of each 21 day cycle

Locations(1)

Cedars-Sinai Medical Center

Los Angeles, California, United States

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NCT05318469

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