What clinical trials registered in ClinicalTrials.gov are testing ivermectin for cancer as of 2025?

1. The lone registered ivermectin–cancer trial: identifier and basic record

The ClinicalTrials.gov record for NCT05318469 corresponds to a Phase I/II study evaluating ivermectin in combination with balstilimab (a PD‑1/PD‑L1 axis immune checkpoint agent) in patients with metastatic triple‑negative breast cancer, and this identifier is cited in multiple trial announcements and meeting abstracts ^{[1] [6] [2]}. Journal and conference materials list NCT05318469 as the formal registry number for the study under discussion at ASCO and in Gateway for Cancer Research communications ^{[2] [6]}.

2. What the trial tests and how it’s being run

The trial pairs oral ivermectin with an immune checkpoint inhibitor (balstilimab or pembrolizumab in related descriptions) to test whether ivermectin’s immunomodulatory effects convert “cold” tumors to “hot,” improving responses to checkpoint blockade in mTNBC; trial materials and institutional summaries describe evaluating safety, tumor response, progression‑free and overall survival as endpoints ^{[6] [7]}. Dosing schedules reported in secondary coverage describe intermittent oral ivermectin on specific days of a 21‑day cycle alongside IV balstilimab or pembrolizumab, with treatment continuing for up to 35 cycles or until progression/toxicity — details drawn from trial overviews and clinical‑trial summaries ^{[7] [6]}.

3. How authoritative sources and reviews position this effort

Major reviews in oncology and systematic summaries emphasize that clinical data in humans are minimal and that large randomized controlled trials confirming anticancer benefit do not exist; contemporary reviews explicitly note a dearth of human clinical evidence and call for rigorous trials to follow preclinical signals ^{[3] [8] [5]}. A 2025 Annals of Oncology effort that surveyed trials and media reported only one active clinical trial involving ivermectin and cancer, matching the ClinicalTrials.gov listing ^[4].

4. Preclinical rationale that prompted the trial

Preclinical laboratory work shows ivermectin can induce immunogenic cancer cell death, modulate the ATP/P2X4/P2X7 axis, reduce immunosuppressive cells, and synergize with checkpoint blockade in breast‑cancer models — mechanistic and animal data that underpin the combination strategy being tested in NCT05318469 ^[9]. Numerous in vitro and animal studies (and at least dozens of preclinical publications) are cited across reviews as the basis for repurposing interest, but authors repeatedly stress that preclinical promise is not proof of clinical benefit ^{[8] [10]}.

5. Conflicting counts, media claims, and reporting limitations

Some non‑peer‑reviewed outlets have reported two registered trials or suggested more rapid expansion of ivermectin oncology trials, but authoritative surveys of ClinicalTrials.gov and oncology reviews around 2025 report a single active trial; the discrepancy highlights how secondary outlets can overcount or misread registry entries and underscores the need to consult ClinicalTrials.gov directly for real‑time status ^{[11] [4]}. The ClinicalTrials.gov entry itself is the definitive registry record cited by ASCO and trial sponsor materials ^{[1] [2]}.

6. Bottom line and what the registry data cannot tell readers

Registry data confirm there is one identifiable interventional trial of ivermectin for cancer on ClinicalTrials.gov as of 2025 (NCT05318469) and that the wider evidence base in humans remains very limited, with no large RCTs demonstrating clinical benefit to date ^{[1] [3] [4]}. ClinicalTrials.gov entries provide protocol and status but do not substitute for peer‑reviewed trial results; until trial outcomes are reported and replicated, preclinical promise should not be conflated with effective treatment ^{[3] [8]}.