MO29983 - Atezolizumab in patients with Urinary Tract Carcinoma

• Research type

  Research Study

• Full title

  An open label, single arm, multicenter, safety study of atezolizumab in locally advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract

• IRAS ID

  213099

• Contact name

  Robert Huddart

• Contact email

  robert.huddart@icr.ac.uk

• Sponsor organisation

  F Hoffmann-La Roche Ltd

• Eudract number

  2016-002625-11

• Duration of Study in the UK

  6 years, 0 months, 1 days

• Research summary

  Bladder cancer is the ninth most common cancer in the world.In 2012, an estimated 14.1 million people worldwide had bladder cancer;in the same year 123,051 deaths were attributable to the disease.
  Urothelial carcinoma of the urinary tract(UC),also termed transitional cell carcinoma,is the most common cancer of the urinary system,responsible for more than 90% of diagnosed cases in the industrialized world.The bladder is the predominant location for UC,but tumours can also originate in the renal pelvis,urethra,or ureter,which are also lined by urothelial cells.

  Despite the efficacy of first-line regimens for patients with advanced UC,nearly all patients experience disease progression and require second-line therapy.There are currently no approved second-line therapies for UC in the United States and only one approved agent,vinflunine,in the EU.

  Several non-urothelial subtypes of bladder cancer are also observed,including squamous cell carcinoma(SCC),adenocarcinoma,small cell carcinoma,and other rarer forms.Non-urothelial bladder cancer is more common in non-Western areas of the world.The prognosis for most forms of advanced non-urothelial bladder cancer is poor.

  Atezolizumab is a humanized immunoglobulin G monoclonal antibody.Clinical trials have shown positive clinical responses in multiple cancer types treated with atezolizumab.

  Given the high unmet need for new therapies for advanced bladder cancer,it is of considerable interest to evaluate atezolizumab in a population of bladder cancer patients that mimics more closely a standard clinical population.As a first step in this process,the primary objective of Study MO29983 will be to analyze the safety of atezolizumab in a population of bladder cancer patients that includes patients who would have been screened out of many of the previous studies.
  A total of approximately 1000 participants will be recruited into this study globally.In the UK it is expected that 35 participants will be enrolled across 8 participating study centres.
  Patients will be treated in 3 weekly(21 day) cycles.
  Lay summary of study results: Should be be published on the Roche forpatients website by the end of Q1 2024
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• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  16/LO/1940

• Date of REC Opinion

  7 Dec 2016

• REC opinion

  Further Information Favourable Opinion