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Brief Title: RO7247669 Alone or in Combination With Tiragolumab vs Atezolizumab in Participants With Untreated Locally Advanced or Metastatic Urothelial Cancer

A Phase II, Randomized, Multicenter, Open-Label, Controlled Study of RO7247669 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

INTRODUCTION

  • Org Study ID: BO44157
  • Secondary ID: N/A
  • NTC ID: NCT05645692
  • Sponsor: Hoffmann-La Roche

BRIEF SUMMARY

This study will evaluate the efficacy, safety, and pharmacokinetics of RO7247669 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.

  • Overall Status
    Recruiting
  • Start Date
    April 13, 2023
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Confirmed Objective Response Rate (ORR)

Primary Outcome 1 - Timeframe: Up to approximately 30 months

CONDITION

  • Urothelial Cancer

ELIGIBILITY

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

- 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 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 5 years prior to Cycle 1, Day 1, 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 - 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 28 days 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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Clinical Trials

Role: Study Director

Affiliation: Hoffmann-LaRoche

Overall Contact

Name: Clinical Trials

Phone: 888-662-6728

Email: global-roche-genentech-trials@gene.com

LOCATION

Facility Status Contact
Facility: Advent Health Orlando
Orlando, Florida 32804
United States
Status: Recruiting Contact: N/A
Facility: SCRI Mark H. Zangmeister Center
Columbus, Ohio 43219
United States
Status: Recruiting Contact: N/A
Facility: SCRI Tennessee Oncology Chattanooga
Chattanooga, Tennessee 37404
United States
Status: Recruiting Contact: N/A
Facility: SCRI Tennessee Oncology Nashville
Nashville, Tennessee 37203
United States
Status: Recruiting Contact: N/A
Facility: Macquarie University Hospital
Macquarie Park, New South Wales 2109
Australia
Status: Recruiting Contact: N/A
Facility: Hospital Universitario Evangelico De Curitiba
Curitiba, PR 80440-220
Brazil
Status: Recruiting Contact: N/A
Facility: *X*CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
Santo André, SP 09060-650
Brazil
Status: Recruiting Contact: N/A
Facility: Hospital Alemao Oswaldo Cruz
Sao Paulo, SP 01323-903
Brazil
Status: Recruiting Contact: N/A
Facility: Peking University First Hospital
Beijing City, Campania 100034
China
Status: Recruiting Contact: N/A
Facility: Beijing Cancer Hospital
Beijing, Emilia-Romagna 100142
China
Status: Recruiting Contact: N/A
Facility: West China Hospital - Sichuan University
Chengdu City, Umbria 610047
China
Status: Recruiting Contact: N/A
Facility: Sun yat-sen University Cancer Center; Internal Medicine of Oncology
Guangzhou, 510060
China
Status: Recruiting Contact: N/A
Facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai City, 200025
China
Status: Recruiting Contact: N/A
Facility: Tianjin Cancer Hospital; urologic tumor
Tianjin City, 300060
China
Status: Recruiting Contact: N/A
Facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan City, 430022
China
Status: Recruiting Contact: N/A
Facility: Aarhus Universitetshospital; Kræftafdelingen
Aarhus N, 8200
Denmark
Status: Recruiting Contact: N/A
Facility: Odense Universitetshospital, Onkologisk Afdeling, Klinisk Forsknings Enhed
Odense C, 5000
Denmark
Status: Recruiting Contact: N/A
Facility: ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico
Napoli, 80131
Italy
Status: Recruiting Contact: N/A
Facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Meldola, 47014
Italy
Status: Recruiting Contact: N/A
Facility: Azienda Ospedaliera S. Maria - Terni; Oncologia
Terni, 05100
Italy
Status: Recruiting Contact: N/A
Facility: Seoul National University Bundang Hospital; Internal Medicine
Gyeonggi-do, 21565
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Gachon University Gil Medical Center
Incheon, 03080
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Seoul National University Hospital
Seoul, 03722
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Severance Hospital, Yonsei University
Seoul, 05505
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Asan Medical Center
Seoul, 135-710
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Samsung Medical Center
Seoul, 04-073
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.
Warszawa, 28040
Poland
Status: Recruiting Contact: N/A
Facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia
Madrid, 28041
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, 28046
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario La Paz; Servicio de Oncologia
Madrid, 28050
Spain
Status: Recruiting Contact: N/A
Facility: HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
Madrid,
Spain
Status: Recruiting Contact: N/A