{"commentary":{"count":20,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":15,"podcast":3,"youtube":2},"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\": \"NCT05327530\", \"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":"NCT05327530","nct_id":"NCT05327530","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct05327530. 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":1250,"size":"standard","size_rule":"Standard: 13–40 commentary sources"},"registry":{"acronym":null,"arms":[{"description":"Participants received intravenous infusion of Avelumab at a dose of 800 mg once every 2 weeks until unacceptable toxicity, withdraw consent or initiation of a new treatment.","label":"Avelumab","type":"EXPERIMENTAL"},{"description":"Participants received intravenous infusion of Avelumab at a dose of 800 milligrams (mg) once every 2 weeks in combination with intravenous infusion of SG at dose of 10 milligrams per kilogram (mg/kg) of bodyweight once a week on Day 1 and 8 of each 21-daytreatment cycles until unacceptable toxicity, withdraw consent or initiation of a new treatment.","label":"Avelumab + Sacituzumab Govitecan (SG)","type":"EXPERIMENTAL"},{"description":"Participants received intravenous infusion of Avelumab at a dose of 800 mg once every 2 weeks in combination with intravenous infusion of M6223 at dose of 1600 mg once every 2 weeks until unacceptable toxicity, withdraw consent or initiation of a new treatment.","label":"Avelumab + M6223","type":"EXPERIMENTAL"},{"description":"Participants received intravenous infusion of Avelumab at a dose of 800 mg once every 2 weeks in combination with intravenous infusion of NKTR-255 at a dose of 3 micrograms per kilogram (mcg/kg) of body weight once every 4 weeks until unacceptable toxicity, withdraw consent or initiation of a new treatment.","label":"Group D: Avelumab + NKTR-255","type":"EXPERIMENTAL"},{"description":"As per the Clinical Study Protocol, the control group (avelumab alone) was extended by data from an external control, i.e. the JAVELIN Bladder 100 study (JB100) (NCT02603432). Participants received an intravenous infusion of 10 mg/kg of Avelumab along with best supportive care (BSC), on Day 1 and 15 of each 28 days treatment cycle, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. BSC was administered asper the treating physician. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anticancer therapy.","label":"JB100 (NCT02603432)","type":"OTHER"}],"collaborators":["Merck KGaA, Darmstadt, Germany; Gilead Sciences; Nektar Therapeutics"],"completion_date":{"date":"2027-01-22","type":"ESTIMATED"},"conditions":["Locally Advanced or Metastatic Urothelial Carcinoma"],"enrollment":{"count":256,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Avelumab","type":"DRUG"},{"name":"Sacituzumab Govitecan (SG)","type":"DRUG"},{"name":"M6223","type":"DRUG"},{"name":"NKTR-255","type":"DRUG"},{"name":"JB100","type":"DRUG"}],"last_update":"2026-09-28","lead_sponsor":"EMD Serono Research & Development Institute, Inc.","official_title":"A Phase II, Multicenter, Randomized, Open Label, Parallel-Arm, Umbrella Study of Avelumab (MSB0010718C) in Combination With Other AntiTumor Agents as a Maintenance Treatment in Participants With Locally Advanced or Metastatic Urothelial Carcinoma Whose Disease Did Not Progress With First Line Platinum-Containing Chemotherapy (JAVELIN Bladder Medley)","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2025-06-20","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator - Avelumab + Sacituzumab Govitecan Versus Avelumab Monotherapy (Avelumab [Control Group] + JB 100 [External Control])","timeFrame":"Time from date of randomization to first documentation of progressive disease (PD) or death, assessed up to 32 months and 12 days (current study) and 41 months (JB100 extended control group)"},{"measure":"Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator - Avelumab + M6223 Versus Avelumab Monotherapy (Avelumab [Control Group] + JB 100 [External Control])","timeFrame":"Time from date of randomization to first documentation of progressive disease (PD) or death, assessed up to 32 months and 12 days (current study) and 41 months (JB100 extended control group)"},{"measure":"Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator - Avelumab + NKTR-255 Versus Avelumab Monotherapy (Avelumab [Control Group] + JB 100 [External Control])","timeFrame":"Time from date of randomization to first documentation of progressive disease (PD) or death, assessed up to 32 months and 12 days (current study) and 41 months (JB100 extended control group)"},{"measure":"Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events, and AEs of Special Interest (AESIs)","timeFrame":"Up to 32 months and 12 days (Current study) and 61 months and 11 days (JB100 extended control group)"}],"references":[{"citation":"Naing A, McKean M, Tolcher A, Victor A, Hu P, Gao W, Nogueira Filho MAF, Kitzing T, Gleicher S, Holland D, Richter E, Tadjalli-Mehr K, Siu LL. TIGIT inhibitor M6223 as monotherapy or in combination with bintrafusp alfa in patients with advanced solid tumors: a first-in-human, phase 1, dose-escalation trial. J Immunother Cancer. 2025 Feb 10;13(2):e010584. doi: 10.1136/jitc-2024-010584.","pmid":"39929671","type":"DERIVED"},{"citation":"Hoffman-Censits J, Grivas P, Powles T, Hawley J, Tyroller K, Seeberger S, Guenther S, Jacob N, Mehr KT, Hahn NM. The JAVELIN Bladder Medley trial: avelumab-based combinations as first-line maintenance in advanced urothelial carcinoma. Future Oncol. 2024 Feb;20(4):179-190. doi: 10.2217/fon-2023-0492. Epub 2023 Sep 6.","pmid":"37671748","type":"DERIVED"}],"start_date":{"date":"2022-08-17","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)","url":"https://clinicaltrials.gov/study/NCT05327530"},"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/nct05327530"}