Ivermectin + Immunotherapy in Metastatic TNBC (NCT05318469)
This actively recruiting clinical trial is evaluating ivermectin in combination with immune checkpoint inhibitors (balstilimab or pembrolizumab) in metastatic triple-negative breast cancer (mTNBC). Below is a clear, reader-friendly breakdown of what’s being tested — and what it actually means.
Key Takeaways
- This study tests ivermectin + immunotherapy in a monitored clinical setting.
- It’s a Phase I/II trial — mainly focused on safety, tolerability, and early signals.
- It does not prove ivermectin “treats cancer” — it shows researchers are evaluating a structured combination.
Quick Facts (At a Glance)
Why This Trial Matters
Metastatic triple-negative breast cancer is an aggressive subtype with fewer targeted treatment options. Even with checkpoint inhibitors like pembrolizumab, many patients progress after initial therapies. Researchers are exploring whether ivermectin could support immune response or alter tumor sensitivity to immunotherapy.
How the Treatment Schedule Works
The protocol is structured in 21-day cycles. Participants take ivermectin orally on scheduled days, and receive immunotherapy intravenously on Day 1 of each cycle.
| Component | Schedule | Notes |
|---|---|---|
| Ivermectin | Oral dosing on Days 1–3, 8–10, and 15–17 | Within each 21-day cycle |
| Immunotherapy | Balstilimab (450 mg IV) or Pembrolizumab (200 mg IV) | Infused on Day 1 of each cycle |
| Duration | Up to 35 cycles (~2 years) | Or until progression / toxicity / withdrawal |
What This Study Can (and Can’t) Prove
Because this is an early-phase trial and not a large randomized study, it is designed to answer specific questions — and it has limits.
What it CAN tell us
- Is the combination safe and tolerable?
- Are there early signals of activity worth studying further?
- Which patient profiles might benefit most?
What it CAN’T prove (yet)
- That ivermectin “cures cancer”.
- That the combination is better than standard therapy.
- Long-term outcomes across large populations.
Official Source
The official listing is the best place to track updates, recruitment status, and protocol changes:
ClinicalTrials.gov — NCT05318469 View the official trial listing →Protocol Stack (Quick Links)
Below are commonly referenced items mentioned in this article. Links are provided for convenience — always review the label and consult a professional before use.
6 / 12 / 18 mg - 100 tablets
