{"entity":{"id":"nct03473743","kind":"trial","name":"A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer","aka":[],"tldr":"A phase 1/2 trial of Erdafitinib, Cetrelimab, Cisplatin and Carboplatin in bladder & urothelial cancer, run by Janssen Research & Development, LLC, active and no longer recruiting.","summary":"A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer is a phase 1/2 interventional study registered as NCT03473743 by Janssen Research & Development, LLC, with 125 participants enrolled, started 2018-04-05 and due to reach its primary completion in 2022-09-30. Interventions recorded: Erdafitinib, Cetrelimab, Cisplatin and Carboplatin. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03473743","url":"https://clinicaltrials.gov/study/NCT03473743"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["erdafitinib","cetrelimab","cisplatin","carboplatin"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03473743","phase":"1/2","setting":"A Phase 1b-2 Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Various Regimens of Erdafitinib in Subjects With Metastatic or Locally Advanced Urothelial Cancer","sponsor":"Janssen Research & Development, LLC","started":"2018-04-05","startedType":"actual","yearReported":2023,"enrolled":125,"enrolledBasis":"registry","outcomes":[{"endpoint":"Phase 2: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator Assessment","primary":true,"unit":"%","arms":[{"name":"Arm A (Phase 2): Erdafitinib 8/9 mg Monotherapy","n":43,"value":44.2,"note":"Figures from the ClinicalTrials.gov results section (first posted 2023-10-25), not from a publication"},{"name":"Arm B (Phase 2): Erdafitinib 8 mg + Cetrelimab 240/480 mg","n":44,"value":54.5}],"source":"https://clinicaltrials.gov/study/NCT03473743?tab=results"}]},"route":"/trials/nct03473743/","neighbours":{"cancer":[{"id":"urothelial","kind":"cancer","name":"Bladder & urothelial cancer","route":"/cancers/urothelial/"},{"id":"muscle-invasive-bladder-cancer","kind":"cancer","name":"Muscle-invasive and advanced bladder cancer","route":"/cancers/muscle-invasive-bladder-cancer/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"drug":[{"id":"carboplatin","kind":"drug","name":"Carboplatin","route":"/drugs/carboplatin/"},{"id":"cetrelimab","kind":"drug","name":"Cetrelimab","route":"/drugs/cetrelimab/"},{"id":"cisplatin","kind":"drug","name":"Cisplatin","route":"/drugs/cisplatin/"},{"id":"erdafitinib","kind":"drug","name":"Erdafitinib","route":"/drugs/erdafitinib/"}],"company":[{"id":"johnson-johnson","kind":"company","name":"Johnson & Johnson","route":"/companies/johnson-johnson/"}]}}