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 — DRUG
    Participants will receive 1200 mg IV atezolizumab Q3W.
  • Tobemstomig — DRUG
    Participants will receive 600 mg IV tobemstomig Q3W.
  • Tiragolumab — DRUG
    Participants 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 A
    Participants will receive intravenous (IV) atezolizumab every 3 weeks (Q3W).
  • Experimental: Arm B
    Participants will receive IV tobemstomig Q3W.
  • Experimental: Arm C
    Participants 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)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44106-
MD Anderson Cancer CenterHoustonTexas77030-

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