{"entity":{"id":"nct05243550","kind":"trial","name":"A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer","aka":["ENVISION"],"tldr":"A phase 3 trial of UGN-102 in bladder & urothelial cancer, run by UroGen Pharma Ltd., active and no longer recruiting.","summary":"A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer is a phase 3 interventional study registered as NCT05243550 by UroGen Pharma Ltd., with 240 participants enrolled, started 2022-03-01 and due to reach its primary completion in 2023-04-26. Interventions recorded: UGN-102. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05243550","url":"https://clinicaltrials.gov/study/NCT05243550"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["urogen-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05243550","phase":"3","setting":"A Phase 3, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-102 as Primary Chemoablative Therapy in Patients With Low-Grade (LG) Non-Muscle Invasive Bladder Cancer (NMIBC) at Intermediate Risk (IR) of Recurrence","sponsor":"UroGen Pharma Ltd.","started":"2022-03-01","startedType":"actual","yearReported":2024,"enrolled":240,"enrolledBasis":"registry","outcomes":[{"endpoint":"Complete Response Rate (CRR)","primary":true,"unit":"%","arms":[{"name":"UGN-102","n":240,"value":76.7,"note":"95% CI 70.8 to 81.9; Figures from the ClinicalTrials.gov results section (first posted 2024-11-04), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT05243550?tab=results"}]},"route":"/trials/nct05243550/","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/"}],"company":[{"id":"urogen-pharma","kind":"company","name":"UroGen Pharma","route":"/companies/urogen-pharma/"}]}}