{"commentary":{"count":108,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":90,"podcast":12,"youtube":6},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT02807636\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"IMvigor130","nct_id":"NCT02807636","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=imvigor130-nct02807636. The price is fixed at order. We build the report after the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1950,"size":"deep","size_rule":"Deep: 41+ commentary sources"},"registry":{"acronym":"IMvigor130","arms":[{"description":"Participants will receive blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).","label":"Atezolizumab+Gemcitabine+Carboplatin/Cisplatin","type":"EXPERIMENTAL"},{"description":"Participants will receive blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).","label":"Placebo+Gemcitabine+Carboplatin/Cisplatin","type":"PLACEBO_COMPARATOR"},{"description":"Eligible participants will receive open-label atezolizumab as monotherapy.","label":"Atezolizumab Monotherapy","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2024-02-12","type":"ACTUAL"},"conditions":["Urothelial Carcinoma"],"enrollment":{"count":1213,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Atezolizumab","type":"DRUG"},{"name":"Carboplatin","type":"DRUG"},{"name":"Gemcitabine","type":"DRUG"},{"name":"Placebo","type":"OTHER"},{"name":"Cisplatin","type":"DRUG"}],"last_update":"2025-02-24","lead_sponsor":"Hoffmann-La Roche","official_title":"A Phase III, Multicenter, Randomized, Placebo-Controlled Study of Atezolizumab (Anti-PD-L1 Antibody) as Monotherapy and in Combination With Platinum-Based Chemotherapy in Patients With Untreated Locally Advanced or Metastatic Urothelial Carcinoma","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2022-08-31","type":"ACTUAL"},"primary_outcomes":[{"measure":"Investigator Assessed Progression-Free Survival (PFS) in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm","timeFrame":"Baseline up to first documented disease progression or death, whichever occurs first (up to approximately 35 months)"},{"measure":"Overall Survival (OS) in Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm","timeFrame":"Baseline until death due to any cause (up to approximately 73 months)"},{"measure":"Overall Survival (OS) in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm","timeFrame":"Baseline until death due to any cause (up to approximately 73 months)"}],"references":[{"citation":"Galsky MD, Guan X, Rishipathak D, Rapaport AS, Shehata HM, Banchereau R, Yuen K, Varfolomeev E, Hu R, Han CJ, Li H, Liang Y, Vucic D, Wang L, Zhu J, Yu H, Herbst RH, Hajaj E, Kiner E, Bamias A, De Santis M, Davis ID, Arranz JA, Kikuchi E, Bernhard S, Williams P, Lee C, Mellman I, Sanjabi S, Johnston R, Black PC, Grande E, Mariathasan S. Immunomodulatory effects and improved outcomes with cisplatin- versus carboplatin-based chemotherapy plus atezolizumab in urothelial cancer. Cell Rep Med. 2024 Feb 20;5(2):101393. doi: 10.1016/j.xcrm.2024.101393. Epub 2024 Jan 26.","pmid":"38280376","type":"DERIVED"},{"citation":"Grande E, Arranz JA, De Santis M, Bamias A, Kikuchi E, Del Muro XG, Park SH, De Giorgi U, Alekseev B, Mencinger M, Izumi K, Schutz FA, Puente J, Li JR, O'Donnell PH, Kalebasty AR, Ye D, Mariathasan S, Bene-Tchaleu F, Bernhard S, Lee C, Davis ID, Galsky MD. Atezolizumab plus chemotherapy versus placebo plus chemotherapy in untreated locally advanced or metastatic urothelial carcinoma (IMvigor130): final overall survival analysis results from a randomised, controlled, phase 3 study. Lancet Oncol. 2024 Jan;25(1):29-45. doi: 10.1016/S1470-2045(23)00540-5. Epub 2023 Dec 12.","pmid":"38101433","type":"DERIVED"},{"citation":"Bamias A, Davis ID, Galsky MD, Arranz JA, Kikuchi E, Grande E, Del Muro XG, Park SH, De Giorgi U, Alekseev B, Mencinger M, Izumi K, Schutz FA, Puente J, Li JR, Panni S, Gumus M, Ozguroglu M, Mariathasan S, Poloz Y, Bene-Tchaleu F, Lee C, Bernhard S, De Santis M. Atezolizumab monotherapy versus chemotherapy in untreated locally advanced or metastatic urothelial carcinoma (IMvigor130): final overall survival analysis from a randomised, controlled, phase 3 study. Lancet Oncol. 2024 Jan;25(1):46-61. doi: 10.1016/S1470-2045(23)00539-9. Epub 2023 Dec 12.","pmid":"38101431","type":"DERIVED"},{"citation":"Grande E, Bamias A, Galsky MD, Kikuchi E, Davis ID, Arranz JA, Rezazadeh Kalebasty A, Garcia Del Muro X, Park SH, De Giorgi U, Alekseev B, Mencinger M, Izumi K, Puente J, Li JR, Bernhard S, Nicholas A, Telliez J, De Santis M. Overall Survival by Response to First-line Induction Treatment with Atezolizumab plus Platinum-based Chemotherapy or Placebo plus Platinum-based Chemotherapy for Metastatic Urothelial Carcinoma. Eur Urol Open Sci. 2023 Nov 4;58:28-36. doi: 10.1016/j.euros.2023.10.002. eCollection 2023 Dec.","pmid":"37954037","type":"DERIVED"},{"citation":"Galsky MD, Arija JAA, Bamias A, Davis ID, De Santis M, Kikuchi E, Garcia-Del-Muro X, De Giorgi U, Mencinger M, Izumi K, Panni S, Gumus M, Ozguroglu M, Kalebasty AR, Park SH, Alekseev B, Schutz FA, Li JR, Ye D, Vogelzang NJ, Bernhard S, Tayama D, Mariathasan S, Mecke A, Thastrom A, Grande E; IMvigor130 Study Group. Atezolizumab with or without chemotherapy in metastatic urothelial cancer (IMvigor130): a multicentre, randomised, placebo-controlled phase 3 trial. Lancet. 2020 May 16;395(10236):1547-1557. doi: 10.1016/S0140-6736(20)30230-0.","pmid":"32416780","type":"DERIVED"},{"citation":"Balar AV, Galsky MD, Rosenberg JE, Powles T, Petrylak DP, Bellmunt J, Loriot Y, Necchi A, Hoffman-Censits J, Perez-Gracia JL, Dawson NA, van der Heijden MS, Dreicer R, Srinivas S, Retz MM, Joseph RW, Drakaki A, Vaishampayan UN, Sridhar SS, Quinn DI, Duran I, Shaffer DR, Eigl BJ, Grivas PD, Yu EY, Li S, Kadel EE 3rd, Boyd Z, Bourgon R, Hegde PS, Mariathasan S, Thastrom A, Abidoye OO, Fine GD, Bajorin DF; IMvigor210 Study Group. Atezolizumab as first-line treatment in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm, multicentre, phase 2 trial. Lancet. 2017 Jan 7;389(10064):67-76. doi: 10.1016/S0140-6736(16)32455-2. Epub 2016 Dec 8.","pmid":"27939400","type":"DERIVED"}],"start_date":{"date":"2016-06-30","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma","url":"https://clinicaltrials.gov/study/NCT02807636"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/imvigor130-nct02807636"}