{"entity":{"id":"nct04165317","kind":"trial","name":"A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer","aka":["CREST"],"tldr":"A phase 3 trial testing Sasanlimab in bladder & urothelial cancer, active and no longer recruiting.","summary":"A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer is a phase 3 interventional study registered as NCT04165317, led by Pfizer, and active but no longer recruiting on the registry. Official title: A Phase 3, Multinational, Randomised, Open-Label, Three Parallel-Arm Study of PF-06801591, an Anti-PD-1 Antibody, in Combination With Bacillus Calmette-Guerin (BCG Induction With or Without BCG Maintenance) Versus BCG (Induction and Maintenance) in Participants With High-Risk, BCG-Naïve Non-Muscle Invasive Bladder Cancer or PF-06801591 as a Single Agent in Participants With BCG-Unresponsive NMIBC. Planned enrolment is 1068 participants (actual). The study started in 2019-12-30 and primary completion is expected in 2024-12-02. Results have been posted on ClinicalTrials.gov; they are not yet summarised here.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT04165317","url":"https://clinicaltrials.gov/study/NCT04165317"}],"tags":["ctgov-ingest"],"related":[],"cancers":["urothelial","non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["sasanlimab"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04165317","phase":"3","setting":"A Phase 3, Multinational, Randomized, Open-Label, Three Parallel-Arm Study of PF-06801591, an Anti-PD-1 Antibody, in Combination With Bacillus Calmette-Guerin (BCG Induction With or Without BCG Maintenance) Versus BCG (Induction and Maintenance) in Participants With High-Risk, BCG-Naïve Non-Muscle Invasive Bladder Cancer or PF-06801591 as a Single Agent in Participants With BCG-Unresponsive NMIBC","sponsor":"Pfizer","participation":[{"nct":"NCT04165317","source":"https://clinicaltrials.gov/study/NCT04165317","fetchedAt":"2026-10-07T16:53:15.464Z","studySha256":"8138354d00a95cd7ed292cd47eaedc921d2d30902e0832aed6feefad5021676b","overallStatus":"ACTIVE_NOT_RECRUITING","lastUpdatePosted":"2026-01-22","leadSponsor":"Pfizer","collaboratorCount":0,"minimumAge":"18 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":1068,"enrolmentType":"ACTUAL","siteCount":194,"recruitingSiteCount":0,"countries":["Australia","Belgium","Canada","China","France","Germany","Italy","Japan","Poland","Russia","South Korea","Spain","United Kingdom","United States"]}],"started":"2019-12-30","startedType":"actual","enrolled":1068,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct04165317/","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":"sasanlimab","kind":"drug","name":"Sasanlimab","route":"/drugs/sasanlimab/"}],"company":[{"id":"pfizer","kind":"company","name":"Pfizer (incl. Seagen)","route":"/companies/pfizer/"}]}}