A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100)

Official Title

A Phase 3, Multicentre, Multinational, Randomized, Open-label, Parallel-arm Study Of Avelumab (msb0010718c) Plus Best Supportive Care Versus Best Supportive Care Alone As A Maintenance Treatment In Patients With Locally Advanced Or Metastatic Urothelial Cancer Whose Disease Did Not Progress After Completion Of First-line Platinum-containing Chemotherapy

Summary:

The main purpose of this study is to compare maintenance treatment with avelumab plus best supportive care (BSC) with BSC alone, to determine if avelumab has an effect on survival in patients with locally advanced or metastatic urothelial cancer that did not worsen during or following completion of first-line chemotherapy.

Trial Description

Primary Outcome:

  • Overall Survival
Secondary Outcome:
  • Progression-Free Survival
  • Objective Response
  • Duration of Response
  • Disease Control
  • Cmax
  • Ctrough
  • Incidence of Anti-Drug Antibody
  • Tumour Tissue Biomarkers
  • Functional Assessment of Cancer Therapy - Bladder Cancer
  • EuroQoL EQ-5D

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society