Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05318469 | Ivermectin in Combination With Balstilimab or Pembrolizumab in Patients With Metastatic Triple Negative Breast Cancer | PHASE1 | RECRUITING | 34 | — | — | Oct 13, 2023 | Oct 1, 2026 | May 6, 2026 | 1 | United States |
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...