Clinical Trial

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

Recruiting Phase 1/2
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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).
Protocol Amendment History 13 amendments
This ClinicalTrials.gov record has been amended 13 times since 2022-04-01; most recent amendment 2026-05-01.
Status change: Active, Not Recruiting → Recruiting 2025-05-06
Status change: Recruiting → Active, Not Recruiting 2025-01-15
Status change: Not Yet Recruiting → Recruiting 2023-10-09
Trial Details
NCT Number NCT05318469
Lead Sponsor Yuan Yuan
Collaborators: Agenus Inc., Gateway for Cancer Research
Conditions Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Triple-Negative Breast Carcinoma
Enrollment 34 participants
Start Date 2023-10-13
Primary Completion 2026-10 (estimated)
Study Completion 2026-10 (estimated)
Updated on ClinicalTrials.gov 2026-08-05