WO30070 Atezolizumab in advanced or metastatic urolthelial carcinoma

• Research type

  Research Study

• Full title

  A Phase III, Multicentre, Randomised, Placebo-controlled study of Atezolizumab (Anti-PD-L1 Antibody) as Monotherapy and in combination with Platinum-Based chemotherapy in patients with untreated locally advanced or metastatic urothelial carcinoma

• IRAS ID

  223878

• Contact name

  Rob Jones

• Sponsor organisation

  F Hoffmann-La Roche Ltd

• Eudract number

  2016-000250-35

• Clinicaltrials.gov Identifier

  NCT02807636

• Duration of Study in the UK

  1 years, 9 months, 15 days

• Research summary

  Research Summary - Urothelial carcinoma is the most common cancer of the urinary system worldwide with urothelial carcinoma of the bladder being the predominant histologic type and location. Data estimate that worldwide there were 123,000 deaths from bladder cancer in men and 42,000 in women in 2012.

  The overall 5-year survival rate for metastatic urothelial carcinoma is approximately 5.4%. A high unmet need exists for patients with metastatic urothelial carcinoma given the limited therapeutic advances that have been made over the past 30 years. In contrast to 5-year survival improvements observed in other advanced-stage diseases (approximately 20%−40% for breast, colon, melanoma, ovarian, and prostate cancer), there has been no improvement observed for metastatic urothelial carcinoma.

  Platinum-based combination chemotherapy is the preferred regimen in the first-line setting, and single agent chemotherapy is typically reserved for the second-line setting.
  Although there is an increasing understanding of the molecular biology and signaling pathways that underlie bladder cancer development and progression, no targeted agents currently have a role in the treatment of urothelial carcinoma. In bladder cancer, expression of PD-L1 has been associated with poor prognosis. Treatment with atezolizumab monotherapy in metastatic urothelial carcinoma has shown responses in patients with platinum-refractory cancer as well as in patients with 1L disease who are ineligible to receive cisplatin.

  The aim of this study is to evaluate the efficacy of blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin) (Arm A) with open-label atezolizumab monotherapy (Arm B) and blinded placebo in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin) (Arm C) as measured by investigator-assessed Progression Free Survival and Overall Survival.
  Patients will be treated in 21 day cycles and randomised (1:1:1). A planned 1200 patients will be enrolled globally with 17 patients in the UK across at least 4 UK sites.
  Lay Summary - : https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fforpatients.roche.com%252Fen%252Ftrials%252Fcancer%252Fbladder-cancer%252Fstudy-of-atezolizumab-as-monotherapy-and-in-combination-with-pla.html%2FNBTI%2F1IG3AQ%2FAQ%2Fc073e3f7-cbc0-4104-ae18-1d10a6c016ca%2F1%2Fq81X4lUvz2&data=05%7C02%7Cbrightonandsussex.rec%40hra.nhs.uk%7C777a12ca8a194806a34008dcc29993db%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638599212083000367%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=zWEhwDmQXSLdADVxY%2Bbjcvhy8mx5aUn1Fhgqjq9OK28%3D&reserved=0

  Has the registry been updated to include summary results?: Yes
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  If no – why not?:
  Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Yes
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  If pending, date when dissemination is expected:
  If no, explain why you didn't follow it:
  Have participants been informed of the results of the study?: Yes
  If yes, describe and/or provide URLs to materials shared and how they were shared: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fclinicaltrials.gov%252Fstudy%252FNCT02807636%253Fterm%253DWO30070%2526rank%253D1%2526tab%253Dresults%2FNBTI%2F1IG3AQ%2FAQ%2Fc073e3f7-cbc0-4104-ae18-1d10a6c016ca%2F2%2FhE9y_0kzds&data=05%7C02%7Cbrightonandsussex.rec%40hra.nhs.uk%7C777a12ca8a194806a34008dcc29993db%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638599212083046544%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=EzT6CDeF21lWUVz%2FUJYpI6v1QT3BsYYRdhyKcfrpEAk%3D&reserved=0

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  If pending, date when feedback is expected:
  If no, explain why they haven't:
  Have you enabled sharing of study data with others?: Yes
  If yes, describe or provide URLs to how it has been shared: Roche Global Policy on Sharing of Clinical Study Information - https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fa.storyblok.com%252Ff%252F126832%252Fx%252F091fe27314%252Froche-global-policy-on-sharing-of-clinical-study-informationv2-1-april2020-1.pdf%2FNBTI%2F1IG3AQ%2FAQ%2Fc073e3f7-cbc0-4104-ae18-1d10a6c016ca%2F3%2FdvMi7L_qkg&data=05%7C02%7Cbrightonandsussex.rec%40hra.nhs.uk%7C777a12ca8a194806a34008dcc29993db%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638599212083060412%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=2dSG5ozA5fkfhm6LdALetynejYkcCBH8HA3GcBoAQjs%3D&reserved=0
  If no, explain why sharing hasn't been enabled:
  Have you enabled sharing of tissue samples and associated data with others?: No
  If yes, describe or provide a URL:
  If no, explain why: Roche does not share samples with third parties; samples are collected in Roche sponsored clinical trials to support research conducted by Roche only. Roche may collaborate with 3rd parties though and samples would be made available to 3rd parties within the context of collaborations covered by collaboration contractual agreements, but samples are not shared with other parties for them to conduct their own research.

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  17/LO/0618

• Date of REC Opinion

  5 Jun 2017

• REC opinion

  Further Information Favourable Opinion