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NCT05327530 · ClinicalTrials.gov registry record · Phase 2
A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)
A Phase 2 study of Locally Advanced or Metastatic Urothelial Carcinoma, sponsored by EMD Serono Research & Development Institute.
- Active
- Registry status
- Phase 2
- Development phase
- 256
- Enrollment target
- 20
- Study locations
NCT05327530: Active Phase 2 study of Locally Advanced or Metastatic Urothelial Carcinoma, sponsored by EMD Serono Research & Development Institute.
NCT05327530 is a Phase 2 study of Locally Advanced or Metastatic Urothelial Carcinoma that is active but no longer recruiting, run by EMD Serono Research & Development Institute. The registered enrollment target is 256 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05327530, a Phase 2 study of Locally Advanced or Metastatic Urothelial Carcinoma, is active but no longer recruiting, sponsored by EMD Serono Research & Development Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 256 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess the safety and efficacy of avelumab in combination with other anti-tumor agents as a maintenance treatment in participants with bladder cancer.
Primary Outcome
PFS:defined as time from date of randomization to first documentation of progressive disease (PD) or death, occurring within 2 scheduled tumor assessments after last evaluable assessment or randomization. PD:at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline/ appearance of 1/more new lesions. The propensity score (PS)-based weighted Kaplan-Meier estimated median PFS times. PS were used as weights to minimize im
Conditions Studied
Interventions
- DRUG Sacituzumab Govitecan
- DRUG Avelumab
- DRUG NKTR-255
- DRUG M6223
Study Locations (20)
Other
- Flinders Medical Centre - Bedford Park
- Sunshine Hospital - PARENT - Footscray
- Ashford Cancer Centre Research - Kurralta Park
- Liverpool Hospital - PARENT - Liverpool
- Calvary Mater Newcastle - PARENT - Newcastle
- Tasman Oncology Research Ltd - Oncology - Southport
- Macquarie University Hospital - PARENT - Sydney
- The Kinghorn Can Cen - Westmead
- ZNA Middelheim - Middelheim - account 2 - Antwerp
- AZ Klina - PARENT - Brasschaat
- Institut Jules Bordet - Medical Oncology - Brussels
- Universitair Ziekenhuis Gent - Medical Oncology - Ghent
Maryland
- Johns Hopkins University - Baltimore
- The Johns Hopkins Hospital - Baltimore
Washington
- Seattle Cancer Care Alliance - Seattle
- Multicare Health System Tacoma General Hospital - Tacoma
Idaho
- Beacon Cancer Care - Coeur d'Alene
Kansas
- University of Kansas Medical Center Research Institute, Inc. - 3901 Rainbow (MAIN) - Kansas City
Missouri
- AMR Kansas City, Formerly Center for Pharmaceutical Research, an AMR company - Kansas City, MO at St. Joseph Medical Center - Kansas City
Wisconsin
- University of Wisconsin Cancer Center - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 256 participants |
| Start Date | 2022-08-17 |
| Est. Completion | 2026-06-25 |
| Phase | Phase 2 |
What the registry record for NCT05327530 still lists
NCT05327530 is an interventional study that assigns participants to a tested intervention. The registered 256 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% higher).
The record links to 1 condition, with Locally Advanced or Metastatic Urothelial Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Sacituzumab Govitecan is the first listed.
NCT05327530 names 20 study sites across 7 states, led by Other, Maryland, Washington.
Frequently Asked Questions
What is clinical trial NCT05327530 about?
NCT05327530 is a clinical study titled "A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)". The purpose of this study is to assess the safety and efficacy of avelumab in combination with other anti-tumor agents as a maintenance treatment in participants with bladder cancer.
What is the current status of trial NCT05327530?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 256 participants. The study started on 2022-08-17. Estimated completion is 2026-06-25.
What conditions does trial NCT05327530 study?
This clinical trial studies the following conditions: Locally Advanced or Metastatic Urothelial Carcinoma.
What interventions are being tested in trial NCT05327530?
The interventions under investigation include: Sacituzumab Govitecan (DRUG), Avelumab (DRUG), NKTR-255 (DRUG), M6223 (DRUG).
Who is sponsoring clinical trial NCT05327530?
This trial is sponsored by EMD Serono Research & Development Institute, which has 81 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05327530 being conducted?
This trial has 20 study locations across Idaho, Kansas, Maryland, Missouri, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05327530's enrollment target sits among peer trials
256 215th of 2000 higher than 1,783 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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