Data from Clinicaltrials.gov - Curated by EPG Health - Last updated 02 July 2018

A Phase III, randomised study of atezolizumab alone and in combination with chemotherapy versus chemotherapy alone in participants with untreated advanced urothelial cancer.

purpose

A Phase III, randomised study of atezolizumab alone and in combination with chemotherapy versus chemotherapy alone in participants with untreated advanced urothelial cancer.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Multicenter, Randomized, 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
Actual Study Start Date: June 30, 2016
Estimated Primary Completion Date: November 17, 2020
Estimated Study Completion Date: November 17, 2020

Arm:
- Experimental:
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
- Placebo Comparator: Placebo+Gemcitabine+Carboplatin/Cisplatin
- Experimental: Atezolizumab Monotherapy

Category Value
Date last updated at source 25-Jun-18
Study type(s) Interventional
Expected enrolment 1200
Study start date 30-Jun-16
Estimated primary completion date 17-Nov-20

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