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.
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, 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
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There are 10 Locations for this study
Coeur d'Alene Idaho, 83814, United States
Chicago Illinois, 60612, United States
Kansas City Kansas, 66205, United States More Info
Principal Investigator
Baltimore Maryland, 21287, United States
Kansas City Missouri, 66204, United States More Info
Principal Investigator
Saint Louis Missouri, 63110, United States
Falls Church Virginia, 22042, United States
Seattle Washington, 98109, United States More Info
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Tacoma Washington, 98405, United States More Info
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Madison Wisconsin, 53706, United States More Info
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Bedford Park , , Australia More Info
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Clayton , , Australia More Info
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Kurralta Park , , Australia More Info
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Newcastle , , Australia More Info
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Southport , , Australia More Info
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St Leonards , , Australia More Info
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Sydney , , Australia More Info
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Westmead , , Australia More Info
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Antwerpen , , Belgium More Info
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Bruxelles , , Belgium More Info
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Gent , , Belgium More Info
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Kortrijk , , Belgium More Info
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Libramont-Chevigny , , Belgium More Info
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Wuerzburg , , Belgium More Info
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Brampton , , Canada More Info
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Greenfield Park , , Canada More Info
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Ottawa , , Canada More Info
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Naestved , , Denmark More Info
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Åalborg , , Denmark More Info
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Angers cedex 2 , , France More Info
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Bordeaux Cedex , , France More Info
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Caen Decex , , France More Info
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Creteil , , France More Info
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Le Mans , , France More Info
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Lyon , , France More Info
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Marseille Cedex 5 , , France More Info
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Nîmes , , France More Info
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Paris , , France More Info
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Poitiers Cedex , , France More Info
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Rennes cedex , , France More Info
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SAINT-HERBLAIN Cedex , , France More Info
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Strasbourg , , France More Info
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Strasbourg , , France More Info
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Essen , , Germany More Info
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Frankfurt , , Germany More Info
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Halle , , Germany More Info
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Muenster , , Germany More Info
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Mönchengladbach , , Germany More Info
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Stuttgart , , Germany More Info
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Athens , , Greece More Info
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Haidari , , Greece More Info
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Thessaloniki , , Greece More Info
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Bologna , , Italy More Info
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Firenze , , Italy More Info
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Forli - Cesena , , Italy More Info
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Milano , , Italy More Info
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Milano , , Italy More Info
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Misterbianco , , Italy More Info
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Napoli , , Italy More Info
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Padova , , Italy More Info
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Pisa , , Italy More Info
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Ravenna , , Italy More Info
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Roma , , Italy More Info
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Rome , , Italy More Info
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San Giovanni Rotondo , , Italy More Info
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Terni , , Italy More Info
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Daejeon , , Korea, Republic of More Info
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Gyeonggi-do , , Korea, Republic of More Info
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Seongnam-si , , Korea, Republic of More Info
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Seoul , , Korea, Republic of More Info
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Seoul , , Korea, Republic of More Info
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Seoul , , Korea, Republic of More Info
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Badajoz , , Spain More Info
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Barcelona , , Spain More Info
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Barcelona , , Spain More Info
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Barcelona , , Spain More Info
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Barcelona , , Spain More Info
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Cordoba , , Spain More Info
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Elche , , Spain More Info
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Lugo , , Spain More Info
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Madrid , , Spain More Info
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Manresa , , Spain More Info
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Valencia , , Spain More Info
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Kaohsiung , , Taiwan More Info
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Kaohsiung , , Taiwan More Info
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Taipei City , , Taiwan More Info
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Taipei , , Taiwan More Info
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London , , United Kingdom More Info
Principal Investigator
Manchester , , United Kingdom More Info
Principal Investigator
Preston , , United Kingdom More Info
Principal Investigator
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