{"entity":{"id":"nct05318469","kind":"trial","name":"Ivermectin with balstilimab or pembrolizumab in metastatic triple-negative breast cancer (Cedars-Sinai phase 1/2)","aka":[],"tldr":"A small single-centre trial in Los Angeles is testing whether adding a worm medicine to an immunotherapy antibody is safe, and then whether it shrinks triple-negative breast cancer that has spread. It opened in 2023 and has not reported.","summary":"The study opened on 13 October 2023, plans 34 patients and expects to reach its primary completion in October 2026 (ClinicalTrials.gov NCT05318469). Phase 1 finds the recommended phase 2 dose of ivermectin by counting adverse events, and phase 2 measures the objective response rate, with progression-free survival, overall survival and duration of response as secondary endpoints (ClinicalTrials.gov NCT05318469). No results have been posted and no publication is indexed on Europe PMC (ClinicalTrials.gov NCT05318469). The registry entry for the later ICONIC trial reports that among the first nine treated patients no treatment-related serious adverse events were observed (ClinicalTrials.gov NCT07487805).","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05318469","url":"https://clinicaltrials.gov/study/NCT05318469"},{"label":"ClinicalTrials.gov NCT07487805","url":"https://clinicaltrials.gov/study/NCT07487805"}],"tags":[],"related":[],"cancers":["tnbc"],"sections":[],"technologies":["checkpoint-inhibitor","drug-repurposing"],"targets":[],"drugs":["ivermectin","balstilimab","pembrolizumab"],"companies":["agenus","merck"],"institutions":["cedars-sinai-cancer"],"pathways":[],"terms":["rp2d","orr","single-arm"],"trials":[],"people":[],"bottlenecks":["b-generic-repurposing"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo agent (Claude Fable 5.1)","editedOn":"2026-09-24","note":"Written from cached ClinicalTrials.gov v2, Europe PMC, DailyMed, Drugs@FDA and WHO eEML responses; no figure appears without its source link."},"nct":"NCT05318469","phase":"1/2","setting":"Metastatic triple-negative breast cancer: single-arm phase 1 dose finding then phase 2, ivermectin by mouth on days 1 to 3 of each week with balstilimab or pembrolizumab intravenously on day 1 of each 21-day cycle","sponsor":"Yuan Yuan, sponsor-investigator at Cedars-Sinai Medical Center, with Agenus and Gateway for Cancer Research","result":"No results posted (ClinicalTrials.gov NCT05318469). The ICONIC registry entry reports no treatment-related serious adverse events among the first nine treated patients (ClinicalTrials.gov NCT07487805).","enrolled":34,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct05318469/","neighbours":{"cancer":[{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"},{"id":"drug-repurposing","kind":"technology","name":"Systematic drug repurposing","route":"/technologies/drug-repurposing/"}],"drug":[{"id":"balstilimab","kind":"drug","name":"Balstilimab","route":"/drugs/balstilimab/"},{"id":"ivermectin","kind":"drug","name":"Ivermectin","route":"/drugs/ivermectin/"},{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"}],"company":[{"id":"agenus","kind":"company","name":"Agenus","route":"/companies/agenus/"},{"id":"merck","kind":"company","name":"Merck & Co. (MSD)","route":"/companies/merck/"}],"institution":[{"id":"cedars-sinai-cancer","kind":"institution","name":"Cedars-Sinai Cancer","route":"/institutions/cedars-sinai-cancer/"}],"term":[{"id":"orr","kind":"term","name":"Objective response rate (ORR)","route":"/terms/orr/"},{"id":"rp2d","kind":"term","name":"Recommended phase 2 dose (RP2D)","route":"/terms/rp2d/"},{"id":"single-arm","kind":"term","name":"Single-arm trial","route":"/terms/single-arm/"}],"bottleneck":[{"id":"b-generic-repurposing","kind":"bottleneck","name":"No incentive to repurpose cheap drugs","route":"/bottlenecks/b-generic-repurposing/"}],"paper":[{"id":"paper-draganov-ivermectin-cold-tumours-npj-breast-cancer-2021","kind":"paper","name":"Ivermectin converts cold tumors hot and synergizes with immune checkpoint blockade for treatment of breast cancer (with 2026 expression of concern)","route":"/key-papers/paper-draganov-ivermectin-cold-tumours-npj-breast-cancer-2021/"}]}}