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

Running, not enrolling · Phase 2

Conditions studied: Locally Advanced or Metastatic Urothelial Carcinoma

In brief

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.

Key facts

Study ID

NCT05327530

Run by

EMD Serono Research & Development Institute, Inc.

People needed

256

Starts

2022-08-17

Expected to finish

2026-06-25

Last updated by the study team

2026-04-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants with histologically confirmed, unresectable locally advanced or metastatic urothelial carcinoma. Both transitional cell and mixed transitional/non- transitional cell histologies are allowed, but transitional cell carcinoma must be the predominant histology
• Participants has documented Stage IIIA/IIIB with N1-N3, or Stage IV disease (per American Joint Committee on Cancer/International Union for Cancer Control Tumor Node Metastasis system, 8th edition) at the start of first line chemotherapy.
• The last dose of first line chemotherapy must have been received no less than 4 weeks, and no more than 10 weeks, prior to randomization in the present study
• Estimated life expectancy of at least 3 months
• Participants without progressive disease as per RECIST v1.1 guidelines following completion of 4 to 6 cycles of 1L chemotherapy. Eligibility based on this criterion will be determined by Investigator review of pre chemotherapy and post chemotherapy radiological assessments (CT/MRI scans).
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
• Adequate hematological, hepatic, and renal function as defined in the protocol
• Other protocol defined inclusion criteria could apply

You may not qualify if…

• Participants with prior immunotherapy with Interleukin-2 (IL-2), IL-15, interferon alfa (IFN-α), or an anti programmed death receptor-1 (PD-1), anti programmed death-ligand 1 (PD-L1), anti PD-L2, anti CD137, or cytotoxic T cell lymphocyte-4 (CTLA-4) antibody (including ipilimumab), anti TROP2, anti-T-cell-immuno-receptor with Ig and ITM domains (anti-TIGIT) any other antibody or drug specifically targeting T cell costimulation or immune checkpoint pathways, agents targeting Nectin-4, or any of the investigational drugs used in combination with avelumab.
• Participants with active infection 48 hours before randomization requiring systemic therapy
• Participants with known prior or suspected hypersensitivity to study drugs or any component in their formulations
• Participants with prior adjuvant or neoadjuvant systemic therapy within 12 months of randomization
• Participants with vaccination within 4 weeks of the first dose of study treatment and while on trial is prohibited except for administration of inactivated vaccines (for example, inactivated influenza vaccines) administered >= 2 weeks prior first dose of study treatment. All severe acute respiratory syndrome coronavirus (SARS-CoV-2) vaccines approved or authorized by local Health Authorities are allowed
• Other protocol defined exclusion criteria could apply

Where it is running

• University of Kansas Medical Center Research Institute, Inc. - 3901 Rainbow (MAIN) — Kansas City, Kansas, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• The Johns Hopkins Hospital — Baltimore, Maryland, United States
• AMR Kansas City, Formerly Center for Pharmaceutical Research, an AMR company - Kansas City, MO at St. Joseph Medical Center — Kansas City, Missouri, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States
• Multicare Health System Tacoma General Hospital — Tacoma, Washington, United States
• University of Wisconsin Cancer Center — Madison, Wisconsin, United States
• Flinders Medical Centre — Bedford Park, Australia
• Sunshine Hospital - PARENT — Footscray, Australia
• Ashford Cancer Centre Research — Kurralta Park, Australia
• Liverpool Hospital - PARENT — Liverpool, Australia
• Calvary Mater Newcastle - PARENT — Newcastle, Australia
• Tasman Oncology Research Ltd - Oncology — Southport, Australia
• Macquarie University Hospital - PARENT — Sydney, Australia
• The Kinghorn Can Cen — Westmead, Australia
• ZNA Middelheim - Middelheim - account 2 — Antwerp, Belgium
• AZ Klina - PARENT — Brasschaat, Belgium
• Institut Jules Bordet - Medical Oncology — Brussels, Belgium
• Universitair Ziekenhuis Gent - Medical Oncology — Ghent, Belgium
• AZ Groeninge - Campus Kennedylaan - account 2 — Kortrijk, Belgium
• Centre Hospitalier de l'Ardenne - PARENT — Libramont, Belgium
• CHU de Liège - PARENT — Liège, Belgium
• Universitaetsklinikum Wuerzburg - Klinik u. Poliklinik f. Urologie u. Kinderurologie — Wuerzburg, Belgium
• William Osler Health System - Brampton Civic Hospital — Brampton, Canada
• Beacon Cancer Care — Coeur d'Alene, Idaho, United States

Full record on ClinicalTrials.gov

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