Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma (IMvigor130)

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