{"entity":{"id":"keynote-057","kind":"trial","name":"KEYNOTE-057","aka":[],"tldr":"KEYNOTE-057 showed that pembrolizumab could clear bladder cancer confined to the lining in a substantial minority of people whose disease had stopped responding to BCG, giving the first drug alternative to removing the bladder.","summary":"After BCG fails in high-risk non-muscle-invasive bladder cancer the standard is radical cystectomy, which many patients decline or cannot have. KEYNOTE-057 was a single-arm phase 2 study of pembrolizumab in BCG-unresponsive disease. Cohort A enrolled patients with carcinoma in situ with or without papillary tumours, with complete response rate as the primary endpoint; cohort B enrolled papillary-only high-grade disease, with disease-free survival as the endpoint.\n\nIn cohort A a substantial minority achieved a complete response at three months and about half of those responses lasted a year or more, with a systemic immunotherapy toxicity profile. Pembrolizumab was approved in the United States in January 2020 for BCG-unresponsive carcinoma in situ, the first systemic drug for this setting, followed by nadofaragene firadenovec and nogapendekin alfa inbakicept as bladder-sparing alternatives.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02625961","url":"https://clinicaltrials.gov/study/NCT02625961"}],"tags":["subtype-trials"],"related":[],"cancers":["non-muscle-invasive-bladder-cancer","urothelial"],"sections":[],"technologies":[],"targets":[],"drugs":["pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["arjun-balar"],"bottlenecks":[],"keyPapers":["paper-keynote-057-lancet-oncol-2021"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02625961","phase":"2","setting":"High-risk non-muscle-invasive bladder cancer unresponsive to BCG in patients who decline or are unfit for cystectomy: single-arm pembrolizumab, with cohort A for carcinoma in situ and cohort B for papillary-only disease","sponsor":"Merck & Co. (MSD)","result":"Pembrolizumab produced complete responses in a substantial minority of patients with BCG-unresponsive carcinoma in situ, about half of them lasting a year or more; approved in January 2020.","yearReported":2020,"enrolled":296,"outcomes":[]},"route":"/trials/keynote-057/","neighbours":{"cancer":[{"id":"urothelial","kind":"cancer","name":"Bladder & urothelial cancer","route":"/cancers/urothelial/"},{"id":"non-muscle-invasive-bladder-cancer","kind":"cancer","name":"Non-muscle-invasive bladder cancer","route":"/cancers/non-muscle-invasive-bladder-cancer/"}],"drug":[{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"}],"company":[{"id":"merck","kind":"company","name":"Merck & Co. (MSD)","route":"/companies/merck/"}],"person":[{"id":"arjun-balar","kind":"person","name":"Arjun V. Balar","route":"/people/arjun-balar/"}],"paper":[{"id":"paper-keynote-057-lancet-oncol-2021","kind":"paper","name":"KEYNOTE-057: pembrolizumab for BCG-unresponsive non-muscle-invasive bladder cancer with carcinoma in situ","route":"/key-papers/paper-keynote-057-lancet-oncol-2021/"}]}}