{"preliminary_commentary":{"by_channel":{"x_thread":6},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":[["pembrolizumab"]],"indication":"metastatic urothelial cancer after first-line chemotherapy","name":"HCRN GU14-182","nct_id":"NCT02500121","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=hcrn-gu14-182-nct02500121. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Commercially available normal saline will be used as the placebo. No active placebo drug will be mixed with the normal saline. Treatment will continue, in the absence of prohibitive toxicities or disease progression, for up to 24 months.","label":"Control Arm A","type":"PLACEBO_COMPARATOR"},{"description":"Pembrolizumab, 200mg IV every 3 weeks. Treatment will continue, in the absence of prohibitive toxicities or disease progression, for up to 24 months.","label":"Experimental Arm B","type":"EXPERIMENTAL"}],"collaborators":["Hoosier Cancer Research Network","Merck Sharp & Dohme LLC"],"completion_date":{"date":"2021-01-01","type":"ACTUAL"},"conditions":["Urothelial Carcinoma","Bladder Cancer"],"enrollment":{"count":108,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Placebo","otherNames":[],"type":"OTHER"},{"name":"Pembrolizumab","otherNames":[],"type":"DRUG"}],"last_update":"2022-09-30","lead_sponsor":"Matthew Galsky","official_title":"A Randomized, Double-blinded, Phase II Study of Maintenance Pembrolizumab Versus Placebo After First-Line Chemotherapy in Patients With Metastatic Urothelial Cancer: Hoosier Cancer Research Network GU14-182","overall_status":"COMPLETED","phases":["PHASE2"],"primary_completion_date":{"date":"2019-07-01","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression-free Survival (PFS)","timeFrame":"Calculated after a median follow-up time of 12.9 months"}],"references":[{"citation":"Galsky MD, Mortazavi A, Milowsky MI, George S, Gupta S, Fleming MT, Dang LH, Geynisman DM, Walling R, Alter RS, Kassar M, Wang J, Gupta S, Davis N, Picus J, Philips G, Quinn DI, Haines GK 3rd, Hahn NM, Zhao Q, Yu M, Pal SK. Randomized Double-Blind Phase II Study of Maintenance Pembrolizumab Versus Placebo After First-Line Chemotherapy in Patients With Metastatic Urothelial Cancer. J Clin Oncol. 2020 Jun 1;38(16):1797-1806. doi: 10.1200/JCO.19.03091. Epub 2020 Apr 9.","pmid":"32271672","type":"DERIVED"}],"start_date":{"date":"2015-11-11","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Testing the PD-1 Inhibitor Pembrolizumab as Maintenance Therapy After Initial Chemotherapy in Metastatic Bladder Cancer","url":"https://clinicaltrials.gov/study/NCT02500121"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/hcrn-gu14-182-nct02500121"}