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What are the current clinical trials for ivermectin in cancer treatment as of 2025?
Executive Summary
As of mid-2025, the clinical-trial landscape for ivermectin in oncology is limited but active, dominated by a phase I/II program testing ivermectin combined with immune checkpoint inhibitors in metastatic triple-negative breast cancer; no large-scale randomized phase III trials have been registered or reported. Multiple data points show an ongoing dose-finding and safety-focused effort—with early accrual and preliminary safety/clinical-benefit signals—but independent reviews warn that clinical evidence remains insufficient to support routine use outside trials and stress the need to counter misinformation [1] [2] [3] [4].
1. What advocates and registries claim — the active trials that catch attention
Clinical trial registries and abstract listings present a clear, focused program: a phase I/II trial testing ivermectin added to balstilimab or pembrolizumab for metastatic triple-negative breast cancer with primary aims of safety, dose-finding, and early efficacy signals. The trial listings explicitly describe objectives to determine the recommended phase 2 dose and to monitor adverse events while capturing secondary efficacy endpoints such as objective response rate, progression-free survival, and overall survival [1] [2]. Trial status information indicates active recruitment with estimated completion dates extending into late 2026, and an initial accrual of patients reported in early 2025, suggesting the program is in early human testing rather than broad efficacy validation [3] [1]. The registry language frames the effort as exploratory and combination-focused, not as definitive proof of benefit.
2. Early signals from investigators — safety and preliminary activity reported
Investigators presented interim findings that portray the ivermectin–balstilimab combination as generally safe and tolerable in the enrolled cohort and report encouraging clinical-benefit rates in a heavily pretreated metastatic triple-negative breast cancer population. Conference abstracts and single-center reports from mid-2025 emphasize manageable toxicity and instances of clinical activity, consistent with phase I/II expectations where safety leads the agenda and any efficacy observations are hypothesis-generating [3]. These early data are limited by small sample size, lack of randomized comparators, and short follow-up; therefore, while the safety profile supports continued study, it does not establish superiority, and reported benefit signals require confirmation in larger, controlled settings.
3. Broader investigational landscape — simulated trials and repurposing narratives
Beyond the breast cancer program, researchers have explored ivermectin in other contexts through hybrid methodologies; a 2025 simulated phase I/II study combined ivermectin with mebendazole in advanced solid tumors and reported a manageable safety profile with preliminary signals in select molecular subgroups such as KRAS G12C-mutated non-small cell lung cancer. This work is framed as exploratory and in silico-informed, not as clinical evidence ready for practice change, illustrating how repurposing research often advances via small trials and computational modeling before definitive trials are mounted [5]. These approaches broaden the hypothesis space but also underline that diverse preclinical and early-clinical signals do not equate to established clinical efficacy.
4. Independent appraisals and cautions — the scientific community urges restraint
Systematic reviews and commentary pieces published in mid-2025 emphasize that ivermectin has plausible anticancer mechanisms in preclinical models but that human clinical evidence remains limited and preliminary. These reviews caution clinicians and patients about misinformation and stress the ethical imperative to confine ivermectin use to registered trials until randomized data demonstrate benefit, noting the absence of large-scale RCTs or regulatory approvals for cancer indications [4]. The tone of these appraisals is precautionary: they validate continued research while warning against off-label adoption driven by non-peer-reviewed anecdotes or political narratives rather than rigorously controlled outcomes.
5. What to watch — timelines, endpoints, and potential biases to scrutinize
Key near-term milestones include the phase I/II trial’s completion of dose escalation, planned expansion cohorts, and updates on objective response and progression-free survival through 2026; these readouts will determine whether ivermectin combinations advance to randomized phase III evaluation [1]. Scrutinize endpoints and trial design—particularly randomization, control arms, and independent radiologic review—as early single-arm safety/efficacy reports are susceptible to selection bias and overinterpretation. Also monitor author affiliations and funding disclosures for potential agendas favoring repurposing claims, and expect independent reviewers to press for larger, confirmatory trials before clinical adoption [1] [3] [4].