NCT05645692

A Study Evaluating Different Immunotherapies (LAG-3 and PD-1 With or Without TIGIT, Compared to PD-L1 Alone) in Participants With Untreated Locally Advanced Metastatic Urothelial Cancer

A Phase II, Randomized, Multicenter, Open-Label, Controlled Study of Tobemstomig Alone or in Combination With Tiragolumab Versus Atezolizumab in Patients With Previously Untreated Locally Advanced or Metastatic Urothelial Cancer Who Are Ineligible for Platinum-Containing Chemotherapy

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety of tobemstomig alone or in combination with tiragolumab compared with atezolizumab in participants with previously untreated, locally advanced or metastatic urothelial cancer (mUC) who are ineligible to receive a platinum containing chemotherapy.

Conditions

• Urothelial Cancer

Interventions

Type	Name	Description
DRUG	Atezolizumab	Participants will receive 1200 mg IV atezolizumab Q3W.
DRUG	Tobemstomig	Participants will receive 600 mg IV tobemstomig Q3W.
DRUG	Tiragolumab	Participants will receive 600 mg IV tiragolumab Q3W.

Timeline

• Start date: 2023-04-13
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2022-12-09
• Last updated: 2026-01-30

Locations

56 sites across 15 countries: United States, Australia, Brazil, China, Denmark, France, Germany, Greece, Italy, Mexico, Poland, South Korea, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study