{"entity":{"id":"nct06331299","kind":"trial","name":"A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer","aka":["UTOPIA"],"tldr":"A phase 3 trial testing UGN-103 in bladder & urothelial cancer, active and no longer recruiting.","summary":"A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer is a phase 3 interventional study registered as NCT06331299, led by UroGen Pharma, and active but no longer recruiting on the registry. Official title: A Phase 3, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-103, a Novel Formulation of UGN-102, for the Treatment of Patients With Low-grade (LG) Non-muscle Invasive Bladder Cancer (NMIBC) at Intermediate-risk (IR) of Recurrence. Planned enrolment is 99 participants (actual). The study started in 2024-08-29 and primary completion is expected in 2025-09-11. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06331299","url":"https://clinicaltrials.gov/study/NCT06331299"}],"tags":["ctgov-ingest"],"related":[],"cancers":["urothelial","non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["ugn-103"],"companies":["urogen-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06331299","phase":"3","setting":"A Phase 3, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-103, a Novel Formulation of UGN-102, for the Treatment of Patients With Low-grade (LG) Non-muscle Invasive Bladder Cancer (NMIBC) at Intermediate-risk (IR) of Recurrence","sponsor":"UroGen Pharma","started":"2024-08-29","startedType":"actual","enrolled":99,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct06331299/","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":"ugn-103","kind":"drug","name":"UGN-103","route":"/drugs/ugn-103/"}],"company":[{"id":"urogen-pharma","kind":"company","name":"UroGen Pharma","route":"/companies/urogen-pharma/"}]}}