Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Date last updated
18/06/2024
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
Query!
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
Query!
Secondary ID [1]
0
0
CO44194
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Breast
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Progression-Free Survival (PFS)
Query!
Assessment method [1]
0
0
Query!
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)
Query!
Secondary outcome [1]
0
0
Objective Response Rate (ORR)
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Two consecutive occasions at least 4 weeks apart (up to approximately 24 months)
Query!
Secondary outcome [2]
0
0
Duration of Response (DOR)
Query!
Assessment method [2]
0
0
Query!
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)
Query!
Secondary outcome [3]
0
0
Overall Survival (OS)
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
From randomization to death from any cause (up to approximately 24 months)
Query!
Secondary outcome [4]
0
0
PFS rate at 12 months
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
12 months after randomization
Query!
Secondary outcome [5]
0
0
OS rate at 12 months
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
12 months after randomization
Query!
Secondary outcome [6]
0
0
Serum Concentration of Tobemstomig
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
Up to approximately 24 months
Query!
Secondary outcome [7]
0
0
Incidence of Anti-Drug Antibodies (ADAs) to Tobemstomig
Query!
Assessment method [7]
0
0
Query!
Timepoint [7]
0
0
Up to approximately 24 months
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
18/07/2023
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
27/02/2026
Query!
Actual
Query!
Sample size
Target
160
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
ICON Cancer Care Adelaide - Kurralta Park
Query!
Recruitment hospital [2]
0
0
Sunshine Hospital; Oncology Research - St Albans
Query!
Recruitment hospital [3]
0
0
Fiona Stanley Hospital; FSH Cancer Centre Clinical Trials Unit - Bull Creek
Query!
Recruitment postcode(s) [1]
0
0
5037 - Kurralta Park
Query!
Recruitment postcode(s) [2]
0
0
- St Albans
Query!
Recruitment postcode(s) [3]
0
0
6149 - Bull Creek
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Colorado
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Maryland
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Missouri
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
New York
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
North Carolina
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Oregon
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
South Dakota
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Washington
Query!
Country [10]
0
0
Argentina
Query!
State/province [10]
0
0
Buenos Aires
Query!
Country [11]
0
0
Argentina
Query!
State/province [11]
0
0
Caba
Query!
Country [12]
0
0
Argentina
Query!
State/province [12]
0
0
La Rioja
Query!
Country [13]
0
0
Argentina
Query!
State/province [13]
0
0
Rosario
Query!
Country [14]
0
0
Brazil
Query!
State/province [14]
0
0
BA
Query!
Country [15]
0
0
Brazil
Query!
State/province [15]
0
0
GO
Query!
Country [16]
0
0
Brazil
Query!
State/province [16]
0
0
PE
Query!
Country [17]
0
0
Brazil
Query!
State/province [17]
0
0
RO
Query!
Country [18]
0
0
Brazil
Query!
State/province [18]
0
0
RS
Query!
Country [19]
0
0
Brazil
Query!
State/province [19]
0
0
SP
Query!
Country [20]
0
0
Czechia
Query!
State/province [20]
0
0
Novy Jicin
Query!
Country [21]
0
0
Czechia
Query!
State/province [21]
0
0
Olomouc
Query!
Country [22]
0
0
Czechia
Query!
State/province [22]
0
0
Praha 4 - Krc
Query!
Country [23]
0
0
Czechia
Query!
State/province [23]
0
0
Praha 5
Query!
Country [24]
0
0
Denmark
Query!
State/province [24]
0
0
Aalborg
Query!
Country [25]
0
0
Denmark
Query!
State/province [25]
0
0
København Ø
Query!
Country [26]
0
0
Denmark
Query!
State/province [26]
0
0
Odense C
Query!
Country [27]
0
0
Denmark
Query!
State/province [27]
0
0
Vejle
Query!
Country [28]
0
0
Germany
Query!
State/province [28]
0
0
Dortmund
Query!
Country [29]
0
0
Germany
Query!
State/province [29]
0
0
Essen
Query!
Country [30]
0
0
Germany
Query!
State/province [30]
0
0
Esslingen
Query!
Country [31]
0
0
Germany
Query!
State/province [31]
0
0
Freiburg
Query!
Country [32]
0
0
Germany
Query!
State/province [32]
0
0
Hannover
Query!
Country [33]
0
0
Germany
Query!
State/province [33]
0
0
Heidelberg
Query!
Country [34]
0
0
Germany
Query!
State/province [34]
0
0
Koblenz
Query!
Country [35]
0
0
Germany
Query!
State/province [35]
0
0
Langen
Query!
Country [36]
0
0
Germany
Query!
State/province [36]
0
0
Lübeck
Query!
Country [37]
0
0
Germany
Query!
State/province [37]
0
0
Mainz
Query!
Country [38]
0
0
Germany
Query!
State/province [38]
0
0
Münster
Query!
Country [39]
0
0
Germany
Query!
State/province [39]
0
0
Schwerin
Query!
Country [40]
0
0
Germany
Query!
State/province [40]
0
0
Ulm
Query!
Country [41]
0
0
Hungary
Query!
State/province [41]
0
0
Kaposvár
Query!
Country [42]
0
0
Hungary
Query!
State/province [42]
0
0
Kecskemét
Query!
Country [43]
0
0
Hungary
Query!
State/province [43]
0
0
Miskolc
Query!
Country [44]
0
0
Israel
Query!
State/province [44]
0
0
Jerusalem
Query!
Country [45]
0
0
Israel
Query!
State/province [45]
0
0
Ramat Gan
Query!
Country [46]
0
0
Israel
Query!
State/province [46]
0
0
Tel Aviv
Query!
Country [47]
0
0
Italy
Query!
State/province [47]
0
0
Emilia-Romagna
Query!
Country [48]
0
0
Italy
Query!
State/province [48]
0
0
Friuli-Venezia Giulia
Query!
Country [49]
0
0
Italy
Query!
State/province [49]
0
0
Lombardia
Query!
Country [50]
0
0
Italy
Query!
State/province [50]
0
0
Toscana
Query!
Country [51]
0
0
Korea, Republic of
Query!
State/province [51]
0
0
Seoul
Query!
Country [52]
0
0
Mexico
Query!
State/province [52]
0
0
Mexico CITY (federal District)
Query!
Country [53]
0
0
Mexico
Query!
State/province [53]
0
0
Nuevo LEON
Query!
Country [54]
0
0
Mexico
Query!
State/province [54]
0
0
Oaxaca
Query!
Country [55]
0
0
Netherlands
Query!
State/province [55]
0
0
EDE
Query!
Country [56]
0
0
Peru
Query!
State/province [56]
0
0
Arequipa
Query!
Country [57]
0
0
Peru
Query!
State/province [57]
0
0
Lima
Query!
Country [58]
0
0
Poland
Query!
State/province [58]
0
0
Bydgoszcz
Query!
Country [59]
0
0
Poland
Query!
State/province [59]
0
0
Gliwice
Query!
Country [60]
0
0
Poland
Query!
State/province [60]
0
0
Kielce
Query!
Country [61]
0
0
Poland
Query!
State/province [61]
0
0
Koszalin
Query!
Country [62]
0
0
Poland
Query!
State/province [62]
0
0
Kraków
Query!
Country [63]
0
0
Poland
Query!
State/province [63]
0
0
Warszawa
Query!
Country [64]
0
0
South Africa
Query!
State/province [64]
0
0
Johannesburg
Query!
Country [65]
0
0
South Africa
Query!
State/province [65]
0
0
Port Elizabeth
Query!
Country [66]
0
0
Spain
Query!
State/province [66]
0
0
LA Coruña
Query!
Country [67]
0
0
Spain
Query!
State/province [67]
0
0
Madrid
Query!
Country [68]
0
0
Spain
Query!
State/province [68]
0
0
Murcia
Query!
Country [69]
0
0
Spain
Query!
State/province [69]
0
0
Navarra
Query!
Country [70]
0
0
Spain
Query!
State/province [70]
0
0
Malaga
Query!
Country [71]
0
0
Spain
Query!
State/province [71]
0
0
Sevilla
Query!
Country [72]
0
0
Spain
Query!
State/province [72]
0
0
Valencia
Query!
Country [73]
0
0
Taiwan
Query!
State/province [73]
0
0
Taipei City
Query!
Country [74]
0
0
Taiwan
Query!
State/province [74]
0
0
Taipei
Query!
Country [75]
0
0
Taiwan
Query!
State/province [75]
0
0
Taoyuan City
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Hoffmann-La Roche
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study is to assess the efficacy and safety of a novel immunotherapy candidate, tobemstomig, in combination with nab-paclitaxel, for patients with previously untreated, locally advanced, unresectable or metastatic (Stage IV) programmed death-ligand 1 (PD-L1)-positive triple-negative breast cancer (TNBC).
Query!
Trial website
https://clinicaltrials.gov/study/NCT05852691
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Clinical Trials
Query!
Address
0
0
Hoffmann-La Roche
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Reference Study ID Number: CO44194 https://forpatients.roche.com/
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
888-662-6728
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/study/NCT05852691
Download to PDF