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Brief Title The Effect of Atezolizumab in Combination With Gemcitabine/Carboplatin and Gemcitabine/Carboplatin Alone in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma Who Are Ineligible for Cisplatin-based Therapy
Official Title A Phase III, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of Atezolizumab (Anti PD-L1 Antibody) in Combination With Gemcitabine/Carboplatin Versus Gemcitabine/Carboplatin Alone in Patients With Untreated Locally Advanced or Metastatic Urothelial Carcinoma Who Are Ineligible For Cisplatin-Based Therapy
Principal Investigator O'Donnell, Peter
Brief Summary This is a Phase III, multicenter, randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of atezolizumab (anti programmed death-ligand 1 [PD-L1] antibody) in combination with gemcitabine/carboplatin versus placebo plus gemcitabine/carboplatin in participants with locally advanced or metastatic urothelial carcinoma (UC) who have not received prior systemic therapy and who are ineligible to receive cisplatin-based therapy. Participants will be randomized in a 2:1 ratio (experimental to control arm) to receive either atezolizumab in combination with gemcitabine/carboplatin or to placebo in combination with gemcitabine/carboplatin.
Gender Both
Ages 18 Years
Enrollment 435
Accepts Healthy Volunteers No
Lead Sponsor Hoffmann-La RocheIndustry
Collaborator
Study Design Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Study Phase Phase 3
Study Type Interventional
Contact Name
Contact Phone 1-855-702-8222 (adult trials) or 1-773-702-6808 (pediatric trials)
Condition Urothelial Carcinoma
Detail for Health Professional (on clinicaltrials.gov)
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