What clinical trials are currently recruiting to test ivermectin in cancer patients and what endpoints do they use?

1. One trial, one cancer: the Cedars‑Sinai Phase I/II in metastatic TNBC

The only actively recruiting cancer trial repeatedly reported across clinical registries and institutional pages is NCT05318469, a Phase I/II investigator‑initiated study at Cedars‑Sinai evaluating ivermectin in combination with the PD‑1 inhibitor balstilimab (and in some descriptions pembrolizumab as comparator/combination) in patients with metastatic triple‑negative breast cancer; the protocol enrolls heavily pretreated mTNBC and includes an expansion cohort for PD‑L1 negative tumors ^{[7] [1] [2] [8]}.

2. What the trial is testing and how patients are treated

The Cedars‑Sinai protocol gives oral ivermectin on repeated days within 21‑day cycles alongside IV checkpoint inhibitor dosing every three weeks, with treatment permitted for many cycles (reports cite up to ~35 cycles) until progression, toxicity, or withdrawal, and patients followed at least 90 days post‑treatment per the trial description ^{[8] [2] [9]}. Eligibility rules published by the site include histologically confirmed mTNBC, stable treated brain metastases in some cases, and standard exclusions such as pregnancy and contraindicating comorbidities ^[1].

3. Endpoints: safety, dose finding and early efficacy signals — not definitive outcomes

Across the sources, the trial’s stated primary purposes are to assess safety, tolerability and to establish dosing (Phase I dose‑finding and recommended Phase II dose), with Phase II expansion evaluating early efficacy signals such as clinical benefit rates; conference reporting from ASCO has already highlighted a 4‑month clinical benefit rate metric and noted that overall survival data are still immature, illustrating the trial’s focus on early endpoints rather than phase‑3 style definitive endpoints ^{[2] [3] [8]}. Public summaries and institutional pages emphasize adverse event monitoring and dose‑limiting toxicities as core safety endpoints, and efficacy is reported through standard early‑phase measures (clinical benefit rate, objective responses and preliminary survival observations) in the available abstracts ^{[2] [3]}.

4. Context, caveats and the evidence gap

Multiple reviews and oncology commentators stress that ivermectin’s anticancer reputation is built predominantly on preclinical experiments (cell lines, animal models) and internet interest; comprehensive reviews found no large‑scale human RCT evidence and identified only this single active clinical trial in cancer as of the reporting dates, warning against extrapolating laboratory activity to patient benefit until robust human data arrive ^{[6] [4] [5]}. Clinical voices quoted in specialty coverage and institutional disclaimers underscore ethical concerns that enthusiasm or off‑label use could displace proven therapies, and they note that even promising Phase I/II results would still require randomized Phase III testing to change standards of care ^{[10] [11]}.

5. What reporting does not confirm

The assembled sources do not provide a complete, up‑to‑the‑minute recruitment status snapshot beyond the trial registration and institutional pages, nor do they provide final efficacy or survival results beyond early conference abstracts; therefore it cannot be asserted from these materials whether the trial remains open to enrollment at this exact moment or what the definitive efficacy outcomes will be—only that the trial’s endpoints prioritize safety/dose finding and early efficacy measures such as clinical benefit rate and immature survival signals ^{[7] [1] [3] [2]}.