Clinical Trial Spotlight

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)

ConditionMetastatic TNBC
PhaseI / II
StatusRecruiting
LocationCedars-Sinai (Los Angeles)

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.

Context
The most important part is that this is being tested in a controlled clinical environment. That is very different from anecdotal use.

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.
Important
A clinical trial listing is the most reliable way to track what’s being tested, how, and in whom — but results will only become clear after completion and publication.

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 →
Disclaimer: This content is for informational purposes only and does not constitute medical advice. Do not self-prescribe. Always consult a qualified healthcare provider before considering any treatment approach.

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.

Ivermectin
6 / 12 / 18 mg - 100 tablets
Buy Ivermectin →
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