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
NCT ID: NCT05852691
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
83 participants
INTERVENTIONAL
2023-07-18
2026-12-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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.
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.
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.
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.
Pembrolizumab
Participants will receive IV pembrolizumab Q3W until disease progression or until up to 24 months after the first treatment, whichever is sooner.
Interventions
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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.
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.
Pembrolizumab
Participants will receive IV pembrolizumab Q3W until disease progression or until up to 24 months after the first treatment, whichever is sooner.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Cancer Blood and Specialty Clinic
Los Alamitos, California, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Novant Health Presbyterain Medical Center
Charlotte, North Carolina, United States
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Centro de Investigaciones Médicas y Desarrollo LC S.R.L
Buenos Aires, , Argentina
Sunshine Hospital
St Albans, Victoria, Australia
Hospital Araujo Jorge
Goiânia, Goiás, Brazil
Hospital do Cancer de Pernambuco - HCP
Recife, Pernambuco, Brazil
Hospital de Cancer de Barretos
Barretos, São Paulo, Brazil
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
São Paulo, São Paulo, Brazil
Fakultni Thomayerova nemocnice
Praha 4 - Krc, , Czechia
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH
Essen, , Germany
Dres. Andreas Köhler und Roswitha Fuchs
Langen, , Germany
Universitätsklinikum Ulm Am Michelsberg
Ulm, , Germany
Komarom-Eszergom Varmegyei Szent Borbala Korhaz
Tatabánya, , Hungary
Hadassah University Hospital - Ein Kerem
Jerusaelm, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Ospedale Provinciale Santa Maria Delle Croci
Ravenna, Emilia-Romagna, Italy
Ospedale San Raffaele
Milan, Lombardy, Italy
Health Pharma Professional Research
Mexico City, Mexico CITY (federal District), Mexico
OncoMed
Mexico City, Mexico CITY (federal District), Mexico
Centro Médico Zambrano Hellion
Monterrey, Nuevo León, Mexico
Centro de Investigacion Clinica de Oaxaca
Oaxaca City, Oaxaca, Mexico
Centro Medico Monte Carmelo
Arequipa, , Peru
Oncosalud Sac
Lima, , Peru
Instituto Nacional de Enfermedades Neoplasicas
Lima, , Peru
Instituto Peruano de Oncología y Radioterapia
Lima, , Peru
?wi?tokrzyskie Centrum Onkologii
Kielce, , Poland
Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii
Krakow, , Poland
Medical Oncology Centre of Rosebank
Johannesburg, , South Africa
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Quiron de Madrid
Pozuelo de Alarcón, Madrid, Spain
Hospital Universitario Virgen de La Arrixaca
El Palmar, Murcia, Spain
National Taiwan Uni Hospital
Taipei, , Taiwan
Countries
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Other Identifiers
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CO44194
Identifier Type: -
Identifier Source: org_study_id