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
Part of paid clinical trials in Cleveland, Ohio.
- Sponsor
- Hoffmann-La Roche
- Study ID
- NCT05645692
- Phase
- PHASE2
- Status
- Active Not Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Atezolizumab — DRUGParticipants will receive 1200 mg IV atezolizumab Q3W.
- Tobemstomig — DRUGParticipants will receive 600 mg IV tobemstomig Q3W.
- Tiragolumab — DRUGParticipants will receive 600 mg IV tiragolumab Q3W.
Study Details
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.
Key Dates
- Start date
- Apr 13, 2023
- Status verified
- Apr 2026
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 204 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Arm AParticipants will receive intravenous (IV) atezolizumab every 3 weeks (Q3W).
- Experimental: Arm BParticipants will receive IV tobemstomig Q3W.
- Experimental: Arm CParticipants will receive IV tobemstomig + IV tiragolumab Q3W.
Primary Outcome Measure
Incidence and Severity of Adverse Events [ Time Frame: Up to approximately 30 months ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44106 | - |
| MD Anderson Cancer Center | Houston | Texas | 77030 | - |
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