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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05645692




Registration number
NCT05645692
Ethics application status
Date submitted
28/11/2022
Date registered
9/12/2022

Titles & IDs
Public 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
Scientific title
A Phase II, Randomized, Multicenter, Open-Label, Controlled Study of Tobemstomig 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
Secondary ID [1] 0 0
BO44157
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urothelial Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Atezolizumab
Treatment: Drugs - Tobemstomig
Treatment: Drugs - Tiragolumab

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.


Treatment: Drugs: Atezolizumab
Participants will receive 1200 mg IV atezolizumab Q3W.

Treatment: Drugs: Tobemstomig
Participants will receive 600 mg IV tobemstomig Q3W.

Treatment: Drugs: Tiragolumab
Participants will receive 600 mg IV tiragolumab Q3W.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Confirmed Objective Response Rate (ORR)
Timepoint [1] 0 0
Up to approximately 30 months
Secondary outcome [1] 0 0
Progression-Free Survival (PFS)
Timepoint [1] 0 0
Up to approximately 30 months
Secondary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Up to approximately 30 months
Secondary outcome [3] 0 0
Duration of Response (DOR)
Timepoint [3] 0 0
Up to approximately 30 months
Secondary outcome [4] 0 0
PFS
Timepoint [4] 0 0
6 months and 12 months
Secondary outcome [5] 0 0
OS
Timepoint [5] 0 0
6 months, 12 months, and 18 months
Secondary outcome [6] 0 0
Disease Control Rate (DCR)
Timepoint [6] 0 0
Up to 12 weeks
Secondary outcome [7] 0 0
Time to Confirmed Deterioration (TTCD)
Timepoint [7] 0 0
Baseline up to 3 weeks
Secondary outcome [8] 0 0
Change from Baseline in European Organisation for Research and Cancer Treatment Item Library 187 (EORTC IL 187) Scores
Timepoint [8] 0 0
Up to approximately 30 months
Secondary outcome [9] 0 0
Maximum Concentration (Cmax) of Tobemstomig
Timepoint [9] 0 0
Up to approximately 30 months
Secondary outcome [10] 0 0
Time of Maximum Concentration (Tmax) of Tobemstomig
Timepoint [10] 0 0
Up to approximately 30 months
Secondary outcome [11] 0 0
Clearance (CL) of Tobemstomig
Timepoint [11] 0 0
Up to approximately 30 months
Secondary outcome [12] 0 0
Volume of Distribution at Steady State (Vss) of Tobemstomig
Timepoint [12] 0 0
Up to approximately 30 months
Secondary outcome [13] 0 0
Area Under the Curve (AUC) of Tobemstomig
Timepoint [13] 0 0
Up to approximately 30 months
Secondary outcome [14] 0 0
Half-Life (T1/2) of Tobemstomig
Timepoint [14] 0 0
Up to approximately 30 months
Secondary outcome [15] 0 0
Maximum serum concentration (Cmax) of tiragolumab
Timepoint [15] 0 0
Up to approximately 30 months
Secondary outcome [16] 0 0
Minimum serum concentration (Cmin) of tiragolumab
Timepoint [16] 0 0
Up to approximately 30 months
Secondary outcome [17] 0 0
Cmax of atezolizumab
Timepoint [17] 0 0
Up to approximately 30 months
Secondary outcome [18] 0 0
Cmin of atezolizumab
Timepoint [18] 0 0
Up to approximately 30 months
Secondary outcome [19] 0 0
Incidence of Anti-Drug Antibodies (ADAs)
Timepoint [19] 0 0
Up to approximately 30 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 tobemstomig, 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2026
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Macquarie University Hospital - Macquarie Park
Recruitment hospital [2] 0 0
Lyell McEwin Hospital - Adelaide
Recruitment hospital [3] 0 0
ICON Cancer Care Adelaide - Kurralta Park
Recruitment postcode(s) [1] 0 0
2113 - Macquarie Park
Recruitment postcode(s) [2] 0 0
5112 - Adelaide
Recruitment postcode(s) [3] 0 0
5037 - Kurralta Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Ohio
Country [4] 0 0
United States of America
State/province [4] 0 0
Tennessee
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
United States of America
State/province [6] 0 0
Washington
Country [7] 0 0
Brazil
State/province [7] 0 0
PR
Country [8] 0 0
Brazil
State/province [8] 0 0
RJ
Country [9] 0 0
Brazil
State/province [9] 0 0
RO
Country [10] 0 0
Brazil
State/province [10] 0 0
RS
Country [11] 0 0
Brazil
State/province [11] 0 0
SP
Country [12] 0 0
China
State/province [12] 0 0
Beijing City
Country [13] 0 0
China
State/province [13] 0 0
Beijing
Country [14] 0 0
China
State/province [14] 0 0
Chengdu City
Country [15] 0 0
China
State/province [15] 0 0
Guangzhou
Country [16] 0 0
China
State/province [16] 0 0
Shanghai City
Country [17] 0 0
China
State/province [17] 0 0
Shanghai
Country [18] 0 0
China
State/province [18] 0 0
Tianjin City
Country [19] 0 0
China
State/province [19] 0 0
Wuhan City
Country [20] 0 0
Denmark
State/province [20] 0 0
Aalborg
Country [21] 0 0
Denmark
State/province [21] 0 0
Aarhus N
Country [22] 0 0
Denmark
State/province [22] 0 0
Herlev
Country [23] 0 0
Denmark
State/province [23] 0 0
Odense C
Country [24] 0 0
France
State/province [24] 0 0
Besançon
Country [25] 0 0
France
State/province [25] 0 0
Bordeaux
Country [26] 0 0
France
State/province [26] 0 0
Lyon CEDEX 08
Country [27] 0 0
France
State/province [27] 0 0
Montpellier
Country [28] 0 0
France
State/province [28] 0 0
Rennes
Country [29] 0 0
France
State/province [29] 0 0
Villejuif
Country [30] 0 0
Germany
State/province [30] 0 0
Düsseldorf
Country [31] 0 0
Germany
State/province [31] 0 0
Halle (Saale)
Country [32] 0 0
Germany
State/province [32] 0 0
Hamburg
Country [33] 0 0
Germany
State/province [33] 0 0
Magdeburg
Country [34] 0 0
Germany
State/province [34] 0 0
Muenster
Country [35] 0 0
Germany
State/province [35] 0 0
Tübingen
Country [36] 0 0
Greece
State/province [36] 0 0
Athens
Country [37] 0 0
Greece
State/province [37] 0 0
Chaidari
Country [38] 0 0
Greece
State/province [38] 0 0
Thessaloniki
Country [39] 0 0
Italy
State/province [39] 0 0
Campania
Country [40] 0 0
Italy
State/province [40] 0 0
Emilia-Romagna
Country [41] 0 0
Italy
State/province [41] 0 0
Lazio
Country [42] 0 0
Italy
State/province [42] 0 0
Lombardia
Country [43] 0 0
Italy
State/province [43] 0 0
Puglia
Country [44] 0 0
Italy
State/province [44] 0 0
Umbria
Country [45] 0 0
Italy
State/province [45] 0 0
Veneto
Country [46] 0 0
Korea, Republic of
State/province [46] 0 0
Gyeonggi-do
Country [47] 0 0
Korea, Republic of
State/province [47] 0 0
Incheon
Country [48] 0 0
Korea, Republic of
State/province [48] 0 0
Seoul
Country [49] 0 0
Mexico
State/province [49] 0 0
Mexico CITY (federal District)
Country [50] 0 0
Poland
State/province [50] 0 0
Koszalin
Country [51] 0 0
Poland
State/province [51] 0 0
Kraków
Country [52] 0 0
Poland
State/province [52] 0 0
Olsztyn
Country [53] 0 0
Poland
State/province [53] 0 0
Skórzewo
Country [54] 0 0
Poland
State/province [54] 0 0
Warszawa
Country [55] 0 0
Spain
State/province [55] 0 0
Barcelona
Country [56] 0 0
Spain
State/province [56] 0 0
Madrid
Country [57] 0 0
Turkey
State/province [57] 0 0
Adana
Country [58] 0 0
Turkey
State/province [58] 0 0
Ankara
Country [59] 0 0
Turkey
State/province [59] 0 0
Edirne
Country [60] 0 0
Turkey
State/province [60] 0 0
Izmir
Country [61] 0 0
Turkey
State/province [61] 0 0
Kadiköy
Country [62] 0 0
United Kingdom
State/province [62] 0 0
Edinburgh
Country [63] 0 0
United Kingdom
State/province [63] 0 0
London
Country [64] 0 0
United Kingdom
State/province [64] 0 0
Preston
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Stevenage
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-LaRoche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: BO44157 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05645692