A Study Evaluating Different Immunotherapies (LAG-3 and PD-1 With or Without TIGIT, Compared to P… (NCT05645692) | Clinical Trial Compass
Active — Not RecruitingPhase 2
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
United States, Australia204 participantsStarted 2023-04-13
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
* Histologically or cytologically documented locally advanced or metastatic transitional cell carcinoma (TCC) of the urothelium. Participants with squamous, sarcomatoid, micropapillary, and glandular variant histologies are eligible for inclusion in the study, provided that a urothelial component is present in the tumor specimen. Participants with other variant histologies or pure variant histologies are not eligible for inclusion in this study
* Ineligible ("unfit") to receive platinum-based chemotherapy
* No prior chemotherapy for inoperable locally advanced or metastatic or recurrent urothelial carcinoma (UC)
* Measurable disease; at least one measurable lesion as defined by response evaluation criteria in solid tumors, version 1.1 (RECIST v1.1)
* Availability of a representative leftover tumor specimen that is suitable for determination of PD-L1 status as assessed by a central laboratory
* Adequate hematologic and end organ function
* Negative for hepatitis B and hepatitis C virus (HCV)
* Adequate cardiovascular function
Exclusion Criteria:
* Pregnancy or breastfeeding
* GFR \<15 mL/min/1.73 m2
* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
* History of leptomeningeal disease
* Uncontrolled tumor-related pain
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
* Uncontrolled or symptom…