Bladder Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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, any other antibody or drug specifically targeting T cell costimulation or immune checkpoint pathways, 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) and replication-deficient coronavirus vaccines approved or authorized by local Health Authorities
Other protocol defined exclusion criteria could apply

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Estimated Enrollment:

252

Study ID:

NCT05327530

Recruitment Status:

Recruiting

Sponsor:

EMD Serono Research & Development Institute, Inc.

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There are 8 Locations for this study

See Locations Near You

Beacon Cancer Care
Coeur d'Alene Idaho, 83814, United States
Rush University Medical Center
Chicago Illinois, 60612, United States
The Johns Hopkins Hospital
Baltimore Maryland, 21287, United States
Washington University
Saint Louis Missouri, 63110, United States
Inova Schar Cancer Institute
Falls Church Virginia, 22042, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
Multicare Health System Tacoma General Hospital
Tacoma Washington, 98405, United States
University of Wisconsin Cancer Center
Madison Wisconsin, 53706, United States
Calvary Mater Newcastle - PARENT
Newcastle , , Australia
Tasman Oncology Research Ltd - Oncology
Southport , , Australia
AZ Groeninge - Campus Kennedylaan - account 2
Kortrijk , , Belgium
Centre Hospitalier de l'Ardenne - PARENT
Libramont-Chevigny , , Belgium
Seoul National University Bundang Hospital
Seongnam-si , , Korea, Republic of
Samsung Medical Center
Seoul , , Korea, Republic of
Seoul National University Hospital
Seoul , , Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , , Korea, Republic of
Hospital Clinic de Barcelona - Servicio de Oncologia
Barcelona , , Spain
Hospital de la Santa Creu i Sant Pau - Dept of Oncology
Barcelona , , Spain
Hospital General Universitario de Elche - Servicio de Oncologia
Elche , , Spain
ALTHAIA, Xarxa assistencial Universitaria de Manresa - Oncology Dept
Manresa , , Spain

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Estimated Enrollment:

252

Study ID:

NCT05327530

Recruitment Status:

Recruiting

Sponsor:


EMD Serono Research & Development Institute, Inc.

How clear is this clinincal trial information?

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