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
Urothelial Cancer
About this trial
This is an interventional treatment trial for Urothelial Cancer
Eligibility Criteria
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 symptomatic hypercalcemia Active or history of autoimmune disease or immune deficiency History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan Active tuberculosis (TB) or acute Epstein-Barr virus (EBV) Significant cardiovascular/cerebrovascular disease within 3 months prior to initiation of study treatment Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study History of another primary malignancy other than urothelial carcinoma within 2 years prior to initiation of study treatment, with the exception of malignancies with a negligible risk of metastasis or death Severe infection within 4 weeks prior to initiation of study treatment Treatment with therapeutic oral or intravenous antibiotics within 2 weeks prior to initiation of study treatment. Participants receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease [COPD] exacerbation), or who are receiving oral antibiotics to treat a urinary tract infection are eligible for the study Prior allogeneic stem cell or solid organ transplantation Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during treatment or within 5 months after the final dose of atezolizumab, 4 months after the final dose of RO7247669, or 90 days after the final dose of tiragolumab Current treatment with anti-viral therapy for HBV Treatment with any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment Treatment with investigational therapy within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-TIGIT and anti-LAG3 therapeutic antibodies or pathways targeting agents Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives prior to initiation of study treatment Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
Sites / Locations
- Advent Health OrlandoRecruiting
- Cleveland ClinicRecruiting
- SCRI Mark H. Zangmeister CenterRecruiting
- SCRI Tennessee Oncology ChattanoogaRecruiting
- SCRI Tennessee Oncology NashvilleRecruiting
- MD Anderson Cancer Center; OncologyRecruiting
- Macquarie University HospitalRecruiting
- Lyell McEwin HospitalRecruiting
- ICON Cancer Care AdelaideRecruiting
- Hospital Universitario Evangelico De CuritibaRecruiting
- Oncoclinicas Rio de Janeiro S.A.Recruiting
- Hospital de Amor AmazôniaRecruiting
- *X*CEPHO - Centro de Estudos e Pesquisas em Hematologia e OncologiaRecruiting
- Hospital Alemao Oswaldo Cruz
- Peking University First HospitalRecruiting
- Beijing Cancer HospitalRecruiting
- West China Hospital - Sichuan UniversityRecruiting
- Sun yat-sen University Cancer Center; Internal Medicine of OncologyRecruiting
- Ruijin Hospital, Shanghai Jiaotong University School of MedicineRecruiting
- Tianjin Cancer Hospital; urologic tumorRecruiting
- Union Hospital Tongji Medical College Huazhong University of Science and TechnologyRecruiting
- Aalborg Universitetshospital; Klinik Kirurgi-Kræft, Onkologisk afd.Recruiting
- Aarhus Universitetshospital; KræftafdelingenRecruiting
- Herlev Hospital; Afdeling for KræftbehandlingRecruiting
- Odense Universitetshospital, Onkologisk Afdeling, Klinisk Forsknings EnhedRecruiting
- CHRU BesançonRecruiting
- CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-AndreRecruiting
- Centre Leon BerardRecruiting
- Institut Régional du Cancer de MontpellierRecruiting
- Centre Eugène MarquisRecruiting
- Universitätsklinikum Düsseldorf; Urologische Klinik
- Alexandras General Hospital of Athens; Oncology DepartmentRecruiting
- Athens Medical Center; Dept. of OncologyRecruiting
- Attikon University General HospitalRecruiting
- Theageneio HospitalRecruiting
- ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-GinecologicoRecruiting
- Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia MedicaRecruiting
- IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia MedicaRecruiting
- Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia MedicaRecruiting
- Irccs Ospedale San RaffaeleRecruiting
- Azienda Ospedaliera S. Maria - Terni; OncologiaRecruiting
- IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda
- Seoul National University Bundang Hospital; Internal MedicineRecruiting
- Gachon University Gil Medical CenterRecruiting
- Seoul National University HospitalRecruiting
- Severance Hospital, Yonsei UniversityRecruiting
- Asan Medical CenterRecruiting
- Samsung Medical CenterRecruiting
- Szpital Wojewódzki im. Miko?aja Kopernika; Oddzia? Dzienny Chemioterapii
- Szpital Uniwersytecki w Krakowie; Oddzial Kliniczny Onkologii i Poradnia OnkologicznaRecruiting
- ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii;Wojska Polskiego 37Recruiting
- Centrum Medyczne Pratia PoznanRecruiting
- Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.Recruiting
- Hospital Univ Vall d'Hebron; Servicio de OncologiaRecruiting
- Institut Catala d Oncologia Hospital Duran i ReynalsRecruiting
- Hospital Universitario Clínico San Carlos; Servicio de OncologiaRecruiting
- Hospital Universitario 12 de Octubre; Servicio de OncologiaRecruiting
- Hospital Universitario La Paz; Servicio de OncologiaRecruiting
- HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de OncologiaRecruiting
- Ankara City Hospital; OncologyRecruiting
- Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan YerleskesiRecruiting
- Izmir Medical Point HospitalRecruiting
- Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical OncologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Arm A
Arm B
Arm C
Participants will receive intravenous (IV) atezolizumab every 3 weeks (Q3W).
Participants will receive IV RO7247669 Q3W.
Participants will receive IV RO7247669 + IV tiragolumab Q3W.