# A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)

Source: https://onco.cc/trials/nct05327530/  
OnCo record `nct05327530` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-22
- Tags: pipeline; ctgov-ingest
- Registry id: 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.
- Enrolled: 256
- Outcomes: 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]): Avelumab + Sacituzumab Govitecan (SG) 11.17 months vs Avelumab + JB100 (NCT02603432) 3.75 months, HR 0.54; 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]): Avelumab + M6223 5.42 months vs Avelumab + JB100 (NCT02603432) 4.5 months, HR 0.95; 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]): Avelumab + NKTR-255 5.59 months vs Avelumab + JB100 (NCT02603432) 4.5 months, HR 0.81; Overall Survival (OS) -Avelumab + Sacituzumab Govitecan Versus Avelumab Monotherapy (Avelumab [Control Group] + JB 100 [External Control]): Avelumab + Sacituzumab Govitecan (SG) vs Avelumab + JB100 (NCT02603432) 22.05 months, HR 0.69

## Sources

- ClinicalTrials.gov NCT05327530: https://clinicaltrials.gov/study/NCT05327530

## Connected records

- cancers: [Bladder & urothelial cancer](https://onco.cc/cancers/urothelial/), [Muscle-invasive and advanced bladder cancer](https://onco.cc/cancers/muscle-invasive-bladder-cancer/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- drugs: [Avelumab](https://onco.cc/drugs/avelumab/), [Sacituzumab govitecan](https://onco.cc/drugs/sacituzumab-govitecan/)
- companies: [Merck KGaA (EMD Serono)](https://onco.cc/companies/merck-kgaa/)

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