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Which cancer types, if any, have ongoing registered human trials of ivermectin (clinicaltrials.gov) and what are their status?
Executive Summary
ClinicalTrials.gov records show at least one ongoing registered human trial testing ivermectin in cancer patients—a phase I/II combination study in metastatic triple‑negative breast cancer (NCT05318469) that is active and recruiting, evaluating ivermectin with balstilimab or pembrolizumab and reporting early safety and efficacy signals [1] [2] [3]. Broader claims that ivermectin has multiple ongoing cancer trials (lung, colorectal, gynecologic) are inconsistent in the reviewed material and rest mostly on preclinical literature and reviews cautioning that human evidence remains limited [4] [5] [6].
1. A clear lead trial — why the triple‑negative breast cancer study matters
ClinicalTrials.gov lists a phase I/II study investigating ivermectin plus balstilimab or pembrolizumab in metastatic triple‑negative breast cancer, started in October 2023 with an estimated completion in October 2026; the record describes dosing every 21 days for 34 participants and lists objectives including safety, objective response rate, progression‑free survival and overall survival [1] [2]. Interim clinical reports published in mid‑2025 indicate the trial is ongoing and actively recruiting, with at least nine patients accrued and dose levels 1 and 2 completed; investigators reported one serious adverse event, a clinical benefit rate around 37.5%, and a median progression‑free survival of 2.5 months so far, with dose level 3 enrollment continuing [3]. These entries show the trial is the principal registered human study of ivermectin in cancer with concrete enrollment and early outcome data.
2. What reviewers and recent papers say — enthusiasm tempered by evidence gaps
Recent reviews and articles characterize ivermectin as having preclinical anticancer activity across cell lines — breast, gastric, glioblastoma and gynecologic cancer models — but they emphasize the absence of robust clinical proof of benefit and limited in vivo human data [5] [7] [6]. A 2024 Cureus review summarized multiple in vitro findings and urged that extensive animal and clinical work is required before clinical adoption [5]. A 2025 gynecologic oncology review warned that clinical evidence is lacking for gynecologic cancers and cautioned against clinical use outside trials [6]. These reviews corroborate that while laboratory signals exist, clinical confirmation is preliminary, and investigators and clinicians are advising restraint pending larger, controlled studies.
3. Conflicting or overstated claims — where messages diverge
Several summaries and secondary sources in the provided material assert that additional ivermectin cancer trials exist for lung and colorectal cancers or suggest widespread clinical investigation [4] [5]. Those claims are less well supported by the detailed trial records and peer‑reviewed reviews in the dataset, which consistently point to the metastatic triple‑negative breast cancer trial as the primary registered human study with available enrollment and outcome information [1] [3]. One source notes that searches of ClinicalTrials.gov are necessary to confirm trial listings, reflecting that some published commentary infers broader activity without presenting direct registry citations [4]. Readers should treat broader lists of cancer types under investigation as provisional unless verified on the registry.
4. Safety signals, early outcomes, and what they actually indicate
The phase I/II breast cancer trial’s interim update reporting one serious adverse event, completion of two dose levels, a clinical benefit rate of 37.5%, and median progression‑free survival of 2.5 months provides early safety and activity signals but not definitive evidence of efficacy [3]. Phase I/II designs primarily assess tolerability and dose‑finding; small patient numbers and short follow‑up limit interpretation of response rates and survival metrics. Reviews emphasize that existing human data are small and uncontrolled, underscoring that promising early signals must be validated in larger randomized trials before any change in clinical practice [5] [7]. The trial remains important as a proof‑of‑concept but is not confirmatory.
5. What to watch next — registry updates, peer‑reviewed results, and potential agendas
Follow‑up on ClinicalTrials.gov and peer‑reviewed publications from the NCT05318469 study will be decisive: registry updates through 2026 should report accrual, completed dose escalation, and expanded cohort results; peer‑reviewed manuscripts will be necessary to evaluate methodology and robustness [1] [2]. Be alert to agenda signals: preclinical enthusiasm and advocacy pieces can overstate applicability, while conservatively framed reviews urge caution; industry or investigator press releases may highlight interim benefits before confirmatory data arrive [5] [6]. For accurate status and recruitment details, the trial record and subsequent peer‑reviewed reports are the authoritative sources; broader claims about multiple ivermectin cancer trials require direct registry citations to be accepted.