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Pembrolizumab was administered by intravesical instillation once weekly for a total of six doses. Intra\u2010patient dose escalation was performed in three paired patient cohorts with doses starting at 50\u2009mg and increasing through 100\u2009mg to a maximum of 200\u2009mg. Adverse events (AEs) were assessed using Common Terminology Criteria for Adverse Events (CTCAE) v4.03 with dose limiting toxicity (DLT) defined as a clinically significant, drug\u2010related, Grade 4 haematological or Grade 3 or higher non\u2010haematological toxicity occurring within 7\u2009days of administration of the first treatment at a given dose for that patient.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Six patients were treated with no DLTs seen during dose escalation. Drug\u2010related AEs were of low grade and included dysuria and fatigue. All patients completed six doses of treatment as planned. Pharmacokinetic and pharmacodynamic assays did not detect any pembrolizumab in the serum following repeated intravesical administration, and no changes in peripheral immune cell populations were observed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Administration of intravesical pembrolizumab was well tolerated and did not raise any safety concerns in patients with NMIBC following TURBT. There was no evidence of systemic absorption or systemic immune effects following intravesical administration. Further studies are required to assess whether intravesical administration has anti\u2010tumour activity.<\/jats:p><\/jats:sec>","DOI":"10.1002\/bco2.220","type":"journal-article","created":{"date-parts":[[2023,1,13]],"date-time":"2023-01-13T04:02:07Z","timestamp":1673582527000},"page":"322-330","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["PemBla: A Phase 1 study of intravesical pembrolizumab in recurrent non\u2010muscle\u2010invasive bladder cancer"],"prefix":"10.1002","volume":"4","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7656-728X","authenticated-orcid":false,"given":"Victoria K.","family":"Woodcock","sequence":"first","affiliation":[{"name":"Department of Oncology Churchill Hospital, University of Oxford  Oxford UK"},{"name":"MRC Human Immunology Unit MRC Weatherall Institute of Molecular Medicine  Oxford 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