What are the published results (if any) from NCT05318469 and related ivermectin–immunotherapy TNBC trials after 2025?
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Executive summary
The only published outcome from the ivermectin + immunotherapy TNBC effort tied to ClinicalTrials.gov identifier NCT05318469 through the end of 2025 is an ASCO 2025 meeting abstract reporting safety and an “encouraging” clinical benefit rate (CBR) for the ivermectin + balstilimab combination, prompting calls for further study [1] [2] [3]. There are no complete peer‑reviewed full‑text trial results or posted results on ClinicalTrials.gov for NCT05318469 available in the provided reporting beyond that 2025 abstract and registry entries/announcements [4] [5] [6] [7].
1. What was actually reported at ASCO 2025 and in accompanying abstracts
Investigators presented a phase I/II dataset at the 2025 ASCO Annual Meeting (abstract e13146) describing NCT05318469, and concluded that the ivermectin + balstilimab combination “is safe and well tolerated” and that an “encouraging CBR was observed in this heavily pretreated population,” language that the abstract and ASCO program repeat verbatim [1] [2] [3]. The ASCO abstract situates the work as early‑phase: the trial’s design, eligibility and endpoints were summarized and the finding was framed as hypothesis‑generating rather than definitive efficacy proof [2] [3].
2. What public trial records and registries say (or do not say)
ClinicalTrials.gov and related registry pages for NCT05318469 exist and describe the phase I/II study of ivermectin combined with balstilimab or pembrolizumab in metastatic triple‑negative breast cancer (mTNBC), but the provided ClinicalTrials.gov entries do not include posted final results or a full results dataset accessible in the sources [4] [5] [6] [8]. Other registries and institutional pages (Gateway for Cancer Research, ICH GCP, Cedars‑Sinai notices) list the protocol, rationale and expansion cohorts (including PD‑L1–negative TNBC) and echo preclinical rationale that ivermectin may “turn cold tumors hot” via T‑cell infiltration, but these are protocol and promotional descriptions rather than outcome reports [9] [10] [11].
3. What is missing: no peer‑reviewed full publication or posted results after 2025
Across the assembled reporting, there is no indication that a full peer‑reviewed manuscript with complete safety tables, objective response rates, progression‑free survival or overall survival data for NCT05318469 was published by the end of 2025; only the ASCO abstract is cited as a public disclosure of study data to date [1] [2] [7]. ClinicalTrials.gov and other registry snapshots in the sources do not show uploaded results or a final study report accessible in these materials, so detailed numerical outcomes and longer‑term follow‑up remain unpublished in the provided record [4] [5] [6].
4. Related trials and the broader context: early signals, not practice‑changing evidence
Media and specialty outlets repeating trial rationale and institutional activity (Cedars‑Sinai coverage, OncLive, trial listings) emphasize the scientific logic — preclinical models showing T‑cell infiltration with ivermectin and the intent to make immune‑cold TNBC “hot” — but these are context pieces and trial announcements rather than independent efficacy evidence [9] [12] [11]. The ASCO abstract’s framing — safety established in early phase and “encouraging CBR” — is consistent with an early signal that justifies continued investigation, not a confirmation that ivermectin plus PD‑1 blockade is effective in routine care [1] [2].
5. Caveats, alternative viewpoints and possible agendas in reporting
Reporting outlets and trial promoters highlight ivermectin’s low cost and biological plausibility, which can feed enthusiasm among clinicians and patients; however, the materials do not provide the complete data needed to evaluate magnitude of benefit, durability, subgroup effects, or safety signal details required for regulatory or guideline change [9] [11]. Given ivermectin’s public profile outside oncology, it is important to separate early clinical signals from broader claims about efficacy; the ASCO abstract itself calls for continued investigation rather than immediate adoption [1] [2].
6. Bottom line: what a careful reader should conclude after 2025
As of the end of 2025, the only published outcome for NCT05318469 in the provided sources is an ASCO 2025 abstract reporting tolerability and an encouraging clinical benefit rate for ivermectin + balstilimab, with no full peer‑reviewed results or ClinicalTrials.gov results posted in the supplied reporting; further, the registries and institutional pages document the trial design and rationale but not comprehensive outcome data, leaving definitive judgments on efficacy and safety incomplete [1] [2] [4] [5].