What ongoing clinical trials are testing ivermectin with immunotherapy in cancer and when will results be reported?

1. What trials are actually running right now — the hard facts

The primary, actively reported clinical effort is a Phase I/II trial registered as NCT05318469 that tests oral ivermectin administered on a 3‑week schedule together with intravenous balstilimab (and in descriptions pembrolizumab in some parts of the protocol) for patients with metastatic triple‑negative breast cancer; this study is described on Gateway for Cancer Research and listed on ClinicalTrials.gov and was presented as an ASCO abstract in 2025 ^{[1] [5] [2]}.

2. Who is being enrolled, how the drugs are given, and follow‑up

Reported eligibility and dosing in public trial descriptions show adults with mTNBC, ECOG performance status 0–1, and ivermectin given orally on Days 1–3, 8–10, 15–17 of each 21‑day cycle while balstilimab (450 mg IV) or pembrolizumab (200 mg IV) is given on Day 1, with treatment continuing for up to 35 cycles (~2 years) or until progression or toxicity; patients are followed after treatment for at least 90 days and periodically thereafter ^{[6] [1] [7]}.

3. When will results be reported — timeline and what to expect

Multiple sources report that the Phase I/II study is expected to finish by 2026; as an early‑phase study this timeline refers to completion of planned enrollment and collection of key safety and preliminary efficacy endpoints, not definitive proof of clinical benefit — publication or abstract presentations should follow final data lock and peer review, but a Phase III, large randomized trial would still be required to establish efficacy for standard practice ^{[3] [4] [8] [2]}.

4. What those results would and would not prove

Even a favorable Phase I/II readout would primarily establish safety, recommended dosing and signals of activity (tumor shrinkage, progression‑free survival trends) in a small population; it would not substitute for large randomized controlled trials that are the accepted standard for demonstrating benefit and defining new standard‑of‑care therapies ^{[9] [4]}.

5. Scientific rationale and the evidence gap

Preclinical work shows ivermectin can inhibit cancer cell proliferation, induce apoptosis and may enhance antitumor immunity in models—findings that motivated the combination with immune checkpoint inhibitors—but clinical evidence in humans remains scarce and limited mostly to this and a few early registrations; reviews emphasize that cell‑line and animal signals frequently fail to translate to human benefit without rigorous trials ^{[10] [9] [11]}.

6. Competing narratives and potential agendas

Public interest in ivermectin after COVID‑19 has created an environment in which repurposing stories gain attention; some advocacy or integrative medicine outlets amplify preliminary positive anecdotes and case compilations, while oncologists and evidence‑based reviewers caution against extrapolating lab data and early cohort results to clinical recommendations — sources explicitly warn that misinformation could lead patients to forgo proven therapies and stress need for Phase III confirmation ^{[7] [12] [9] [4]}.

7. Bottom line for timing and certainty

At present, the only clearly documented, actively recruiting Phase I/II ivermectin + immunotherapy trial in cancer targets metastatic triple‑negative breast cancer and is projected to complete and report preliminary results in 2026; no large Phase III randomized trials or conclusive human efficacy data have been reported yet, so any efficacy claims remain provisional until larger, confirmatory trials appear ^{[1] [2] [3] [9]}.