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Ivermectin · 1 trial · 2 indications
Phase 1: To determine the recommended phase 2 dose of ivermectin in combination with balstilimab or pembrolizumab using NCI-CTCAE v5.0
Phase 2: To determine the efficacy of ivermectin in combination with balstilimab or pembrolizumab in mTNBC using the objective response rate (ORR)
| Arm | Type | Description |
|---|---|---|
| Treatment (ivermectin, balstilimab) | EXPERIMENTAL | Patients will receive balstilimab 450 mg or pembrolizumab 200 mg, IV, on Day 1 of each 3 week cycle and ivermectin at the assigned dose (see Section 5.1, Table 5.1.2), PO, Days 1-3, 8-10, 15-17 of each cycle (Days 1-3 of each week) until disease progression, intolerable toxicities, withdrawal of consent, or up to 35 treatments or 2 years of balstilimab or pembrolizumab, whichever comes first |
| Name | Type | Description |
|---|---|---|
| Ivermectin | DRUG | 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). |
| Balstilmab | DRUG | Balstilimab 300 mg administered intravenously on Day 1 of each 21 day cycle. |
| Pembrolizumab | DRUG | Pembrolizumab 200 mg IV on Day 1 of each 21 day cycle |
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 neg...
Ivermectin is being studied as a Phase 1 investigational small molecule for the treatment of Anatomic Stage IV Breast Cancer AJCC v8, specifically in patients with metastatic triple-negative breast carcinoma. It is being evaluated in combination with balstilimab or pembrolizumab in an ongoing clinical trial in the United States.
Ivermectin is being developed by Agenus Inc., a biopharmaceutical company traded on NASDAQ under the ticker AGEN. The company is sponsoring a Phase 1 clinical trial of the drug in combination with other agents for metastatic triple-negative breast cancer.
Ivermectin is in Phase 1 clinical development for Anatomic Stage IV Breast Cancer AJCC v8. It is an investigational drug and has not been approved by the FDA for this indication. The ongoing trial is currently recruiting participants in the United States.
Ivermectin is being studied in clinical trial NCT05318469, titled "Ivermectin in Combination With Balstilimab or Pembrolizumab in Patients With Metastatic Triple Negative Breast Cancer." This Phase 1, uncontrolled, open-label trial is recruiting 34 participants in the United States and is not randomized or double-blinded.
No, Ivermectin is a distinct investigational small molecule being studied in combination with balstilimab or pembrolizumab in a Phase 1 trial for metastatic triple-negative breast cancer. Balstilimab and pembrolizumab are separate drugs used as combination partners in the trial, not alternative names for Ivermectin.