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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05852691




Registration number
NCT05852691
Ethics application status
Date submitted
2/05/2023
Date registered
10/05/2023

Titles & IDs
Public title
A Study of Tobemstomig + Nab-Paclitaxel Compared With Pembrolizumab + Nab-Paclitaxel in Participants With Previously Untreated, PD-L1-Positive, Locally-Advanced Unresectable or Metastatic Triple-Negative Breast Cancer
Scientific title
A Phase II, Multicenter, Randomized, Double-Blind Study of Tobemstomig/RO7247669 Combined With Nab-Paclitaxel Compared With Pembrolizumab Combined With Nab-Paclitaxel in Participants With Previously Untreated, PD-L1-Positive, Locally-Advanced Unresectable or Metastatic Triple-Negative Breast Cancer
Secondary ID [1] 0 0
CO44194
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tobemstomig
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Nab-Paclitaxel

Experimental: Arm A - Participants will receive tobemstomig every 3 weeks, plus nab-paclitaxel administered on a repeating schedule of 3 weeks on, 1 week off, until disease progression or until up to 24 months after the first treatment, whichever is sooner.

Active comparator: Arm B - Participants will receive pembrolizumab every 3 weeks, plus nab-paclitaxel administered on a repeating schedule of 3 weeks on, 1 week off, until disease progression or until up to 24 months after the first treatment, whichever is sooner.


Treatment: Drugs: Tobemstomig
Participants will receive intravenous (IV) tobemstomig every 3 weeks (Q3W) until disease progression or until up to 24 months after the first treatment, whichever is sooner.

Treatment: Drugs: Pembrolizumab
Participants will receive IV pembrolizumab Q3W until disease progression or until up to 24 months after the first treatment, whichever is sooner.

Treatment: Drugs: Nab-Paclitaxel
Participants will receive IV nab-paclitaxel weekly for 3 weeks, followed by 1 week off, until disease progression or until up to 24 months after the first treatment, whichever is sooner.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS)
Timepoint [1] 0 0
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 24 months)
Secondary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
Two consecutive occasions at least 4 weeks apart (up to approximately 24 months)
Secondary outcome [2] 0 0
Duration of Response (DOR)
Timepoint [2] 0 0
From the first occurrence of a confirmed objective response to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 24 months)
Secondary outcome [3] 0 0
Overall Survival (OS)
Timepoint [3] 0 0
From randomization to death from any cause (up to approximately 24 months)
Secondary outcome [4] 0 0
PFS rate at 12 months
Timepoint [4] 0 0
12 months after randomization
Secondary outcome [5] 0 0
OS rate at 12 months
Timepoint [5] 0 0
12 months after randomization
Secondary outcome [6] 0 0
Serum Concentration of Tobemstomig
Timepoint [6] 0 0
Up to approximately 24 months
Secondary outcome [7] 0 0
Incidence of Anti-Drug Antibodies (ADAs) to Tobemstomig
Timepoint [7] 0 0
Up to approximately 24 months

Eligibility
Key inclusion criteria
* Metastatic or locally advanced unresectable, histologically documented triple-negative breast cancer (TNBC) (absence of HER2-over-expression, ER, and PgR expression by local assessment)
* HER2-low-status
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
* If metastatic disease (Stage IV), measurable disease outside of the bone
* No prior systemic therapy for metastatic or locally advanced unresectable TNBC
* Tumor PD-L1 expression as documented through central testing of a representative tumor tissue specimen
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Adequate hematologic and end-organ function
* Negative HIV test at screening, with the following exception: individuals with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count = 200/uL, and have an undetectable viral load
* Negative hepatitis B surface antigen (HBsAg) test at screening
* Positive hepatitis B surface antibody (HBsAb) test at screening, or a negative HBsAb at screening accompanied by either of the following: negative hepatitis B core antibody (HBcAb); positive HBcAb test followed by quantitative hepatitis B virus (HBV) DNA < 500 IU/mL
* Negative hepatitis C virus (HCV) antibody test at screening, or a positive HCV antibody test followed by a negative HCV RNA test at screening
* 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, or intention of becoming pregnant during the study or within 4 months after the final dose of tobemstomig or pembrolizumab, and 6 months after the final dose of nab-paclitaxel
* Poor venous access
* History of malignancy within 5 years prior to consent, except for the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate >90%), such as adequately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer
* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
* History of leptomeningeal disease
* Pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
* Hypercalcemia or hypercalcemia that is symptomatic
* Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis (granulomatosis with polyangiitis), Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis
* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
* Active tuberculosis (TB)
* Significant cardiovascular/cerebrovascular disease within 3 months prior to consent
* History or presence of an abnormal ECG that is deemed clinically significant
* History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias such as structural heart disease (e.g., severe left ventricular systolic dysfunction, left ventricular hypertrophy), coronary heart disease (symptomatic or with ischemia demonstrated by diagnostic testing), clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia), or family history of sudden unexplained death or long QT syndrome
* Major surgical procedure within 4 weeks prior to initiation of study treatment
* Treatment with therapeutic oral or IV antimicrobials (anti-bacterial, anti-fungal, antiviral, anti-parasitic) within 1 week prior to initiation of study treatment
* Prior allogeneic stem cell or solid organ transplantation
* Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the participant at high risk from treatment complications
* Treatment with a live, attenuated vaccine within 28 days 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 anti-CTLA therapeutic antibodies or an anti-LAG3 agent
* Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and IL-2) within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment
* Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including, but not limited to, prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF agents) within 2 weeks prior to initiation of study treatment
* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
* Known hypersensitivity to Chinese hamster ovary cell products or to any component of the tobemstomig or pembrolizumab formulation
* Known allergy or hypersensitivity to any component of the to nab-paclitaxel formulation

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
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
18/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/02/2026
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Recruitment hospital [1] 0 0
ICON Cancer Care Adelaide - Kurralta Park
Recruitment hospital [2] 0 0
Sunshine Hospital; Oncology Research - St Albans
Recruitment hospital [3] 0 0
Fiona Stanley Hospital; FSH Cancer Centre Clinical Trials Unit - Bull Creek
Recruitment postcode(s) [1] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [2] 0 0
- St Albans
Recruitment postcode(s) [3] 0 0
6149 - Bull Creek
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Oregon
Country [8] 0 0
United States of America
State/province [8] 0 0
South Dakota
Country [9] 0 0
United States of America
State/province [9] 0 0
Virginia
Country [10] 0 0
United States of America
State/province [10] 0 0
Washington
Country [11] 0 0
Argentina
State/province [11] 0 0
Buenos Aires
Country [12] 0 0
Argentina
State/province [12] 0 0
Caba
Country [13] 0 0
Argentina
State/province [13] 0 0
La Rioja
Country [14] 0 0
Argentina
State/province [14] 0 0
Rosario
Country [15] 0 0
Brazil
State/province [15] 0 0
BA
Country [16] 0 0
Brazil
State/province [16] 0 0
GO
Country [17] 0 0
Brazil
State/province [17] 0 0
PE
Country [18] 0 0
Brazil
State/province [18] 0 0
RO
Country [19] 0 0
Brazil
State/province [19] 0 0
RS
Country [20] 0 0
Brazil
State/province [20] 0 0
SP
Country [21] 0 0
Czechia
State/province [21] 0 0
Novy Jicin
Country [22] 0 0
Czechia
State/province [22] 0 0
Olomouc
Country [23] 0 0
Czechia
State/province [23] 0 0
Praha 4 - Krc
Country [24] 0 0
Czechia
State/province [24] 0 0
Praha 5
Country [25] 0 0
Denmark
State/province [25] 0 0
Aalborg
Country [26] 0 0
Denmark
State/province [26] 0 0
København Ø
Country [27] 0 0
Denmark
State/province [27] 0 0
Odense C
Country [28] 0 0
Denmark
State/province [28] 0 0
Vejle
Country [29] 0 0
Germany
State/province [29] 0 0
Berlin
Country [30] 0 0
Germany
State/province [30] 0 0
Dortmund
Country [31] 0 0
Germany
State/province [31] 0 0
Essen
Country [32] 0 0
Germany
State/province [32] 0 0
Esslingen
Country [33] 0 0
Germany
State/province [33] 0 0
Freiburg
Country [34] 0 0
Germany
State/province [34] 0 0
Hannover
Country [35] 0 0
Germany
State/province [35] 0 0
Heidelberg
Country [36] 0 0
Germany
State/province [36] 0 0
Koblenz
Country [37] 0 0
Germany
State/province [37] 0 0
Langen
Country [38] 0 0
Germany
State/province [38] 0 0
Lübeck
Country [39] 0 0
Germany
State/province [39] 0 0
Mainz
Country [40] 0 0
Germany
State/province [40] 0 0
Münster
Country [41] 0 0
Germany
State/province [41] 0 0
Schwerin
Country [42] 0 0
Germany
State/province [42] 0 0
Ulm
Country [43] 0 0
Hungary
State/province [43] 0 0
Kaposvár
Country [44] 0 0
Hungary
State/province [44] 0 0
Kecskemét
Country [45] 0 0
Hungary
State/province [45] 0 0
Miskolc
Country [46] 0 0
Hungary
State/province [46] 0 0
Tatabanya
Country [47] 0 0
Israel
State/province [47] 0 0
Jerusalem
Country [48] 0 0
Israel
State/province [48] 0 0
Ramat Gan
Country [49] 0 0
Israel
State/province [49] 0 0
Tel Aviv
Country [50] 0 0
Italy
State/province [50] 0 0
Emilia-Romagna
Country [51] 0 0
Italy
State/province [51] 0 0
Friuli-Venezia Giulia
Country [52] 0 0
Italy
State/province [52] 0 0
Lombardia
Country [53] 0 0
Italy
State/province [53] 0 0
Toscana
Country [54] 0 0
Korea, Republic of
State/province [54] 0 0
Seoul
Country [55] 0 0
Mexico
State/province [55] 0 0
Mexico CITY (federal District)
Country [56] 0 0
Mexico
State/province [56] 0 0
Nuevo LEON
Country [57] 0 0
Mexico
State/province [57] 0 0
Oaxaca
Country [58] 0 0
Netherlands
State/province [58] 0 0
EDE
Country [59] 0 0
Peru
State/province [59] 0 0
Arequipa
Country [60] 0 0
Peru
State/province [60] 0 0
Lima
Country [61] 0 0
Poland
State/province [61] 0 0
Bydgoszcz
Country [62] 0 0
Poland
State/province [62] 0 0
Gliwice
Country [63] 0 0
Poland
State/province [63] 0 0
Kielce
Country [64] 0 0
Poland
State/province [64] 0 0
Koszalin
Country [65] 0 0
Poland
State/province [65] 0 0
Kraków
Country [66] 0 0
Poland
State/province [66] 0 0
Warszawa
Country [67] 0 0
South Africa
State/province [67] 0 0
Johannesburg
Country [68] 0 0
South Africa
State/province [68] 0 0
Port Elizabeth
Country [69] 0 0
South Africa
State/province [69] 0 0
Pretoria
Country [70] 0 0
Spain
State/province [70] 0 0
LA Coruña
Country [71] 0 0
Spain
State/province [71] 0 0
Madrid
Country [72] 0 0
Spain
State/province [72] 0 0
Murcia
Country [73] 0 0
Spain
State/province [73] 0 0
Navarra
Country [74] 0 0
Spain
State/province [74] 0 0
Malaga
Country [75] 0 0
Spain
State/province [75] 0 0
Sevilla
Country [76] 0 0
Spain
State/province [76] 0 0
Valencia
Country [77] 0 0
Taiwan
State/province [77] 0 0
Taipei City
Country [78] 0 0
Taiwan
State/province [78] 0 0
Taipei
Country [79] 0 0
Taiwan
State/province [79] 0 0
Taoyuan City

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-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: CO44194 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/NCT05852691