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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

Primary Purpose

Urothelial Cancer

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Atezolizumab
RO7247669
Tiragolumab
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urothelial Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Arm A

Arm B

Arm C

Arm Description

Participants will receive intravenous (IV) atezolizumab every 3 weeks (Q3W).

Participants will receive IV RO7247669 Q3W.

Participants will receive IV RO7247669 + IV tiragolumab Q3W.

Outcomes

Primary Outcome Measures

Confirmed Objective Response Rate (ORR)

Secondary Outcome Measures

Progression-Free Survival (PFS)
Overall Survival (OS)
Duration of Response (DOR)
PFS
OS
Disease Control Rate (DCR)
Time to Confirmed Deterioration (TTCD)
Change from Baseline in European Organisation for Research and Cancer Treatment Item Library 187 (EORTC IL 187) Scores
Maximum Concentration (Cmax) of RO7247669
Time of Maximum Concentration (Tmax) of RO7247669
Clearance (CL) of RO7247669
Volume of Distribution at Steady State (Vss) of RO7247669
Area Under the Curve (AUC) of RO7247669
Half-Life (T1/2) of RO7247669
Maximum serum concentration (Cmax) of tiragolumab
Minimum serum concentration (Cmin) of tiragolumab
Cmax of atezolizumab
Cmin of atezolizumab
Incidence of Anti-Drug Antibodies (ADAs)

Full Information

First Posted
November 28, 2022
Last Updated
October 9, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT05645692
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 13, 2023 (Actual)
Primary Completion Date
December 30, 2026 (Anticipated)
Study Completion Date
December 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urothelial Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Active Comparator
Arm Description
Participants will receive intravenous (IV) atezolizumab every 3 weeks (Q3W).
Arm Title
Arm B
Arm Type
Experimental
Arm Description
Participants will receive IV RO7247669 Q3W.
Arm Title
Arm C
Arm Type
Experimental
Arm Description
Participants will receive IV RO7247669 + IV tiragolumab Q3W.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Intervention Description
Participants will receive 1200 mg IV atezolizumab Q3W.
Intervention Type
Drug
Intervention Name(s)
RO7247669
Intervention Description
Participants will receive 600 mg IV RO7247669 Q3W.
Intervention Type
Drug
Intervention Name(s)
Tiragolumab
Intervention Description
Participants will receive 600 mg IV tiragolumab Q3W.
Primary Outcome Measure Information:
Title
Confirmed Objective Response Rate (ORR)
Time Frame
Up to approximately 30 months
Secondary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Time Frame
Up to approximately 30 months
Title
Overall Survival (OS)
Time Frame
Up to approximately 30 months
Title
Duration of Response (DOR)
Time Frame
Up to approximately 30 months
Title
PFS
Time Frame
6 months and 12 months
Title
OS
Time Frame
6 months, 12 months, and 18 months
Title
Disease Control Rate (DCR)
Time Frame
Up to 12 weeks
Title
Time to Confirmed Deterioration (TTCD)
Time Frame
Baseline up to 3 weeks
Title
Change from Baseline in European Organisation for Research and Cancer Treatment Item Library 187 (EORTC IL 187) Scores
Time Frame
Up to approximately 30 months
Title
Maximum Concentration (Cmax) of RO7247669
Time Frame
Up to approximately 30 months
Title
Time of Maximum Concentration (Tmax) of RO7247669
Time Frame
Up to approximately 30 months
Title
Clearance (CL) of RO7247669
Time Frame
Up to approximately 30 months
Title
Volume of Distribution at Steady State (Vss) of RO7247669
Time Frame
Up to approximately 30 months
Title
Area Under the Curve (AUC) of RO7247669
Time Frame
Up to approximately 30 months
Title
Half-Life (T1/2) of RO7247669
Time Frame
Up to approximately 30 months
Title
Maximum serum concentration (Cmax) of tiragolumab
Time Frame
Up to approximately 30 months
Title
Minimum serum concentration (Cmin) of tiragolumab
Time Frame
Up to approximately 30 months
Title
Cmax of atezolizumab
Time Frame
Up to approximately 30 months
Title
Cmin of atezolizumab
Time Frame
Up to approximately 30 months
Title
Incidence of Anti-Drug Antibodies (ADAs)
Time Frame
Up to approximately 30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: BO44157 https://forpatients.roche.com/
Phone
888-662-6728
Email
global-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-LaRoche
Official's Role
Study Director
Facility Information:
Facility Name
Advent Health Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Individual Site Status
Recruiting
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Name
SCRI Mark H. Zangmeister Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43219
Country
United States
Individual Site Status
Recruiting
Facility Name
SCRI Tennessee Oncology Chattanooga
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Individual Site Status
Recruiting
Facility Name
SCRI Tennessee Oncology Nashville
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
MD Anderson Cancer Center; Oncology
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Macquarie University Hospital
City
Macquarie Park
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Individual Site Status
Recruiting
Facility Name
Lyell McEwin Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5112
Country
Australia
Individual Site Status
Recruiting
Facility Name
ICON Cancer Care Adelaide
City
Kurralta Park
State/Province
South Australia
ZIP/Postal Code
5037
Country
Australia
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Evangelico De Curitiba
City
Curitiba
State/Province
PR
ZIP/Postal Code
80440-220
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Oncoclinicas Rio de Janeiro S.A.
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
22250-905
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital de Amor Amazônia
City
Porto Velho
State/Province
RO
ZIP/Postal Code
76834-899
Country
Brazil
Individual Site Status
Recruiting
Facility Name
*X*CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
City
Santo André
State/Province
SP
ZIP/Postal Code
09060-650
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Alemao Oswaldo Cruz
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01323-903
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Peking University First Hospital
City
Beijing City
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Cancer Hospital
City
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Name
West China Hospital - Sichuan University
City
Chengdu City
ZIP/Postal Code
610047
Country
China
Individual Site Status
Recruiting
Facility Name
Sun yat-sen University Cancer Center; Internal Medicine of Oncology
City
Guangzhou
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Name
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai City
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Name
Tianjin Cancer Hospital; urologic tumor
City
Tianjin City
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan City
ZIP/Postal Code
430023
Country
China
Individual Site Status
Recruiting
Facility Name
Aalborg Universitetshospital; Klinik Kirurgi-Kræft, Onkologisk afd.
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Aarhus Universitetshospital; Kræftafdelingen
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Herlev Hospital; Afdeling for Kræftbehandling
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Odense Universitetshospital, Onkologisk Afdeling, Klinisk Forsknings Enhed
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Name
CHRU Besançon
City
Besançon
ZIP/Postal Code
25030
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Leon Berard
City
Lyon CEDEX 08
ZIP/Postal Code
69373
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Régional du Cancer de Montpellier
City
Montpellier
ZIP/Postal Code
34298
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Eugène Marquis
City
Rennes
ZIP/Postal Code
35000
Country
France
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Düsseldorf; Urologische Klinik
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Alexandras General Hospital of Athens; Oncology Department
City
Athens
ZIP/Postal Code
115 28
Country
Greece
Individual Site Status
Recruiting
Facility Name
Athens Medical Center; Dept. of Oncology
City
Athens
ZIP/Postal Code
151 25
Country
Greece
Individual Site Status
Recruiting
Facility Name
Attikon University General Hospital
City
Chaidari
ZIP/Postal Code
124 62
Country
Greece
Individual Site Status
Recruiting
Facility Name
Theageneio Hospital
City
Thessaloniki
ZIP/Postal Code
546 39
Country
Greece
Individual Site Status
Recruiting
Facility Name
ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
City
Meldola
State/Province
Emilia-Romagna
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Recruiting
Facility Name
Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Name
Irccs Ospedale San Raffaele
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera S. Maria - Terni; Oncologia
City
Terni
State/Province
Umbria
ZIP/Postal Code
05100
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Seoul National University Bundang Hospital; Internal Medicine
City
Gyeonggi-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital, Yonsei University
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Szpital Wojewódzki im. Miko?aja Kopernika; Oddzia? Dzienny Chemioterapii
City
Koszalin
ZIP/Postal Code
75-581
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Szpital Uniwersytecki w Krakowie; Oddzial Kliniczny Onkologii i Poradnia Onkologiczna
City
Kraków
ZIP/Postal Code
31-501
Country
Poland
Individual Site Status
Recruiting
Facility Name
ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii;Wojska Polskiego 37
City
Olsztyn
ZIP/Postal Code
10-228
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne Pratia Poznan
City
Skórzewo
ZIP/Postal Code
60-185
Country
Poland
Individual Site Status
Recruiting
Facility Name
Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.
City
Warszawa
ZIP/Postal Code
04-073
Country
Poland
Individual Site Status
Recruiting
Facility Name
Hospital Univ Vall d'Hebron; Servicio de Oncologia
City
Sant Andreu de La Barca
State/Province
Barcelona
ZIP/Postal Code
08740
Country
Spain
Individual Site Status
Recruiting
Facility Name
Institut Catala d Oncologia Hospital Duran i Reynals
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Clínico San Carlos; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario La Paz; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Recruiting
Facility Name
Ankara City Hospital; Oncology
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Izmir Medical Point Hospital
City
Izmir
ZIP/Postal Code
35101
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology
City
Kadiköy
ZIP/Postal Code
34722
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Learn more about this trial

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

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