What ongoing clinical trials are registered testing ivermectin in cancer and what doses do they list?
Executive summary
There are very few registered clinical trials testing ivermectin in cancer: the clearest active, publicly listed study is NCT05318469 (a phase I/II trial combining oral ivermectin with anti‑PD‑1 immunotherapy in metastatic triple‑negative breast cancer) and at least one other registry entry or investigator‑initiated record exists but provides limited dosing detail in public summaries (ClinicalTrials.gov; Gateway for Cancer Research; ASCO) [1] [2] [3]. Public materials describe schedules for oral ivermectin administration in the TNBC trial but do not publish a consistent mg/kg or absolute milligram dose in the documents provided here, and other registered trials named in secondary sources either list ivermectin as one of multiple repurposed agents or lack publicly posted dose details [4] [5] [6] [7].
1. The registered trials landscape: almost a single, focused effort
Most peer‑reviewed reporting and trial registries reviewed converge on one clear active oncology trial testing ivermectin clinically: a phase I/II combination study of ivermectin with balstilimab or pembrolizumab for metastatic triple‑negative breast cancer, registered as NCT05318469 and presented in an ASCO abstract (ClinicalTrials.gov; Gateway for Cancer Research; ASCO) [1] [2] [3]. Secondary searches and review articles identify an additional investigator‑level interest set and a small “atavistic chemotherapy” program that includes ivermectin among several repurposed agents, but these are described in broader programmatic terms rather than as standalone, dose‑specified ivermectin trials in the public records provided [5].
2. What the TNBC trial (NCT05318469) says about dosing and schedule
Public descriptions of the TNBC phase I/II protocol indicate oral ivermectin is administered on a three‑week cycle with dosing days specified as Days 1–3, 8–10 and 15–17 of each 21‑day cycle, given alongside intravenous balstilimab or pembrolizumab on Day 1, and continued for up to 35 cycles (approximately two years) or until progression or toxicity (OncoDaily; Integrative Cancer Care; Gateway for Cancer Research) [4] [5] [2]. Those summaries specify the timing and combination but do not publish a single, explicit milligram or mg/kg number in the documents provided here; the ClinicalTrials.gov summary referenced by multiple outlets is cited as the trial identifier but the public snippet available in this dataset does not display the numeric ivermectin dose [1] [4].
3. Other registered or reported studies and gaps in dose reporting
At least one other ClinicalTrials.gov identifier appeared in the search results (NCT04447235) and the National Cancer Institute lists a related protocol entry (NCI‑2022‑02421), but the short registry snippets provided do not include human ivermectin dose information, and secondary summaries describe these more as exploratory or programmatic efforts that include ivermectin among multiple agents rather than detailed single‑agent dose‑finding trials (ClinicalTrials.gov; NCI) [6] [7] [5]. Integrative Cancer Care’s reporting asserted two registered U.S. studies were found in a ClinicalTrials.gov search, but the publicly quoted materials again focus on schedules and trial aims rather than precise mg dosing [5].
4. Why dose transparency matters and what preclinical data imply
Preclinical work showing anticancer activity used concentrations and animal models that often require exposure levels not easily or safely achieved in humans, and clinicians warn that efficacious doses in mice may be toxic if translated directly to people—an explicit concern cited by oncology experts and review literature (PubMed review; Oncology News Central) [8] [9]. Systematic reviews and mechanistic papers also emphasize that human clinical trial literature for anticancer uses of ivermectin is scarce, reinforcing the need for carefully reported dose‑finding in early trials (PMC review; ScienceDirect) [10] [11].
5. Bottom line: registered trials exist, schedules available, numeric doses not consistently public
The public record in these sources confirms an active, internationally reported phase I/II trial (NCT05318469) testing oral ivermectin on a repeated‑three‑day schedule within 21‑day cycles combined with checkpoint inhibitors for metastatic TNBC, and mentions of other registry entries or programs that include ivermectin; however, the exact milligram or mg/kg doses for ivermectin are not consistently published in the excerpts available here and other registry entries lack clear dosing detail in public summaries [1] [4] [2] [5]. Given preclinical‑to‑clinical translation concerns and the historic public controversy over off‑label ivermectin use, transparent dose‑finding and peer‑reviewed reporting from these trials will be essential before any clinical conclusions can be drawn [8] [9].