{"entity":{"id":"nct05327530","kind":"trial","name":"A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)","aka":[],"tldr":"A phase 2 trial of Avelumab and Sacituzumab govitecan in bladder & urothelial cancer, run by EMD Serono Research & Development Institute, Inc., active and no longer recruiting.","summary":"A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley) is a phase 2 interventional study registered as NCT05327530 by EMD Serono Research & Development Institute, Inc., with 256 participants enrolled, started 2022-08-17 and due to reach its primary completion in 2025-06-20. Interventions recorded: Avelumab, Sacituzumab Govitecan (SG), M6223, NKTR-255 and JB100. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05327530","url":"https://clinicaltrials.gov/study/NCT05327530"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["avelumab","sacituzumab-govitecan"],"companies":["merck-kgaa"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05327530","phase":"2","setting":"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)","sponsor":"EMD Serono Research & Development Institute, Inc.","started":"2022-08-17","startedType":"actual","yearReported":2026,"enrolled":256,"enrolledBasis":"registry","outcomes":[{"endpoint":"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])","primary":true,"unit":"months","arms":[{"name":"Avelumab + Sacituzumab Govitecan (SG)","n":74,"value":11.17,"note":"95% CI 7.62 to 17.64; Figures from the ClinicalTrials.gov results section (first posted 2026-09-01), not from a publication"},{"name":"Avelumab + JB100 (NCT02603432)","n":74,"value":3.75,"note":"95% CI 3.32 to 5.65"}],"hr":0.54,"ci":[0.36,0.81],"source":"https://clinicaltrials.gov/study/NCT05327530?tab=results"},{"endpoint":"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])","primary":true,"unit":"months","arms":[{"name":"Avelumab + M6223","n":72,"value":5.42,"note":"95% CI 3.78 to 7.43; Figures from the ClinicalTrials.gov results section (first posted 2026-09-01), not from a publication"},{"name":"Avelumab + JB100 (NCT02603432)","n":74,"value":4.5,"note":"95% CI 3.45 to 7.20"}],"hr":0.95,"ci":[0.64,1.39],"source":"https://clinicaltrials.gov/study/NCT05327530?tab=results"},{"endpoint":"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])","primary":true,"unit":"months","arms":[{"name":"Avelumab + NKTR-255","n":73,"value":5.59,"note":"95% CI 3.75 to 12.91; Figures from the ClinicalTrials.gov results section (first posted 2026-09-01), not from a publication"},{"name":"Avelumab + JB100 (NCT02603432)","n":74,"value":4.5,"note":"95% CI 3.48 to 7.20"}],"hr":0.81,"ci":[0.55,1.21],"source":"https://clinicaltrials.gov/study/NCT05327530?tab=results"},{"endpoint":"Overall Survival (OS) -Avelumab + Sacituzumab Govitecan Versus Avelumab Monotherapy (Avelumab [Control Group] + JB 100 [External Control])","unit":"months","arms":[{"name":"Avelumab + Sacituzumab Govitecan (SG)","n":24,"note":"NA signifies median and upper limit of 95% CI could not be estimated due to small number of death events.; Figures from the ClinicalTrials.gov results section (first posted 2026-09-01), not from a publication"},{"name":"Avelumab + JB100 (NCT02603432)","n":40,"value":22.05,"note":"95% CI 16.92 to 28.78"}],"hr":0.69,"ci":[0.41,1.17],"source":"https://clinicaltrials.gov/study/NCT05327530?tab=results"}]},"route":"/trials/nct05327530/","neighbours":{"cancer":[{"id":"urothelial","kind":"cancer","name":"Bladder & urothelial cancer","route":"/cancers/urothelial/"},{"id":"muscle-invasive-bladder-cancer","kind":"cancer","name":"Muscle-invasive and advanced bladder cancer","route":"/cancers/muscle-invasive-bladder-cancer/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"drug":[{"id":"avelumab","kind":"drug","name":"Avelumab","route":"/drugs/avelumab/"},{"id":"sacituzumab-govitecan","kind":"drug","name":"Sacituzumab govitecan","route":"/drugs/sacituzumab-govitecan/"}],"company":[{"id":"merck-kgaa","kind":"company","name":"Merck KGaA (EMD Serono)","route":"/companies/merck-kgaa/"}]}}