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Are there ongoing clinical trials (ClinicalTrials.gov) testing ivermectin for cancer and what are their statuses and start dates?
Executive Summary
Two registered clinical trials on ClinicalTrials.gov testing ivermectin as a cancer treatment are actively described in the supplied analyses: a Phase I/II study combining ivermectin with the PD‑1 pathway agent balstilimab for metastatic triple‑negative breast cancer (TNBC) and additional registry entries showing multiple ivermectin‑cancer studies with varied statuses and start dates. The balstilimab combination trial (NCT05318469) is specifically reported as accruing patients and reporting early signals of clinical benefit in a heavily pretreated population, while broader ClinicalTrials.gov searches identify trials with start dates spanning 2015–2023 and statuses including Recruiting, Active, not recruiting, and Completed [1] [2] [3].
1. Why this matters: clinical trials are the only path from lab to clinic
Clinical development is the mechanism that translates preclinical anticancer signals into clinical practice, and the presence of registered trials indicates investigators are testing ivermectin beyond its antiparasitic use. Peer‑reviewed reviews emphasize promising mechanistic and preclinical data but stress that randomized trials are required before therapeutic claims; several reviews recommend caution pending large, controlled studies [4] [5]. The supplied analyses identify at least one multi‑center Phase I/II trial combining ivermectin with an immune checkpoint agent, signaling a translational effort to exploit putative synergistic mechanisms. These registered trials on ClinicalTrials.gov provide protocol details, endpoints, and timelines necessary for clinicians and patients to assess when and how evidence might mature [1] [2].
2. What the registries show: trial counts, statuses, and start dates
ClinicalTrials.gov searches reported in the analyses reveal multiple entries testing ivermectin in oncology with a mix of statuses: Recruiting, Active, not recruiting, and Completed, and start dates ranging from 2015 through 2023. The summary provided notes that some trials remain in recruitment while others have completed, indicating a heterogeneous and ongoing research landscape rather than a single, definitive study [2]. The Phase I/II ivermectin-plus‑balstilimab trial is explicitly registered and active, reflecting ongoing patient accrual and dose‑finding objectives typical of early‑phase cancer trials [1]. These registry records are the primary source for up‑to‑date trial status and start dates and should be consulted directly for protocol‑level details [2].
3. The headline trial: ivermectin plus balstilimab in metastatic TNBC
The most detailed study identified is a Phase I/II trial (NCT05318469) evaluating ivermectin in combination with balstilimab in metastatic triple‑negative breast cancer, reported to have accrued nine patients to date and to have shown encouraging clinical benefit rates in a heavily pretreated cohort. The trial’s primary objectives include establishing a recommended Phase II dose and measuring objective response rate, reflecting standard early‑phase endpoints for safety and preliminary efficacy [1]. Gateway For Cancer Research and clinical oncology abstracts referenced this trial, indicating institutional engagement and preliminary outcome reporting; however, full peer‑reviewed results and larger confirmatory studies remain necessary before any clinical practice changes [6] [1].
4. Conflicting tones in the literature: cautious reviewers versus hopeful integrative reports
The published literature and commentary show a split in tone: systematic and PubMed‑indexed reviews urge caution and call for randomized controlled trials to confirm anticancer effects, highlighting that most evidence remains preclinical or early‑phase [4] [5]. Conversely, integrative‑care summaries and some trial reports present encouraging early signals and advocate further exploration, sometimes emphasizing translational enthusiasm [3]. These differing emphases reflect distinct agendas: conservative academic appraisal prioritizes robust randomized evidence and safety, whereas integrative or translational outlets may accentuate mechanistic promise and preliminary clinical benefit. Readers should weigh both perspectives and prioritize registry entries and peer‑reviewed trial results for definitive guidance [4] [3].
5. Bottom line and where to check next for real‑time updates
As of the supplied analyses, there are ongoing registered clinical trials testing ivermectin for cancer, notably a Phase I/II combination with balstilimab in metastatic TNBC that is actively accruing and reporting preliminary benefit signals; broader registry searches show trials with start dates from 2015–2023 and mixed statuses including recruiting and completed [1] [2]. For the most current, authoritative trial statuses, start dates, and protocol documents, consult ClinicalTrials.gov directly and review published abstracts or full manuscripts associated with specific NCT numbers. Researchers, clinicians, and patients should rely on completed, peer‑reviewed results and randomized data before considering ivermectin as an oncologic therapy [2] [4].