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

March 12, 2026 updated by: Hoffmann-La Roche

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1113AAE
        • Centro de Investigaciones Médicas y Desarrollo LC S.R.L
  • Australia
    • Victoria
      • St Albans, Victoria, Australia
        • Sunshine Hospital
  • Brazil
    • Goiás
      • Goiânia, Goiás, Brazil, 74605-070
        • Hospital Araujo Jorge
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50040-000
        • Hospital do Cancer de Pernambuco - HCP
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784-400
        • Hospital de Cancer de Barretos
      • São Paulo, São Paulo, Brazil, 01317-001
        • Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
  • Czechia
      • Praha 4 - Krc, Czechia, 140 59
        • Fakultni Thomayerova nemocnice
  • Germany
      • Essen, Germany, 45136
        • Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH
      • Langen, Germany, 63225
        • Dres. Andreas Köhler und Roswitha Fuchs
      • Ulm, Germany, 89075
        • Universitätsklinikum Ulm Am Michelsberg
  • Hungary
      • Tatabánya, Hungary, 2800
        • Komarom-Eszergom Varmegyei Szent Borbala Korhaz
  • Israel
      • Jerusaelm, Israel, 9112001
        • Hadassah University Hospital - Ein Kerem
      • Ramat Gan, Israel, 5262100
        • Sheba Medical Center
  • Italy
    • Emilia-Romagna
      • Ravenna, Emilia-Romagna, Italy, 48100
        • Ospedale Provinciale Santa Maria Delle Croci
    • Lombardy
      • Milan, Lombardy, Italy, 20132
        • Ospedale San Raffaele
  • Mexico
    • Mexico CITY (federal District)
      • Mexico City, Mexico CITY (federal District), Mexico, 03100
        • OncoMed
      • Mexico City, Mexico CITY (federal District), Mexico, 03100
        • Health Pharma Professional Research
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 66278
        • Centro Medico Zambrano Hellion
    • Oaxaca
      • Oaxaca City, Oaxaca, Mexico, 68020
        • Centro de Investigacion Clinica de Oaxaca
  • Peru
      • Arequipa, Peru, 04001
        • Centro Medico Monte Carmelo
      • Lima, Peru, Lima 34
        • Instituto Nacional de Enfermedades Neoplasicas
      • Lima, Peru, 41
        • Oncosalud Sac
      • Lima, Peru
        • Instituto Peruano de Oncología y Radioterapia
  • Poland
      • Kielce, Poland, 25-734
        • ?wi?tokrzyskie Centrum Onkologii
      • Krakow, Poland, 31-501
        • Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii
  • South Africa
      • Johannesburg, South Africa, 2196
        • Medical Oncology Centre of Rosebank
  • South Korea
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 05505
        • Asan Medical Center
      • Seoul, South Korea, 06351
        • Samsung Medical Center
      • Seoul, South Korea, 06273
        • Gangnam Severance Hospital, Yonsei University Health System
  • Spain
    • Madrid
      • Pozuelo de Alarcón, Madrid, Spain, 28223
        • Hospital Quiron de Madrid
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Hospital Universitario Virgen de La Arrixaca
  • Taiwan
      • Taipei, Taiwan, 100
        • National Taiwan Uni Hospital
  • United States
    • California
      • Los Alamitos, California, United States, 90720
        • Cancer Blood and Specialty Clinic
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Novant Health Presbyterain Medical Center
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: 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.
Other Names:
  • RO7247669
Drug: 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.
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.
Drug: 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.
Drug: Pembrolizumab
Participants will receive IV pembrolizumab Q3W until disease progression or until up to 24 months after the first treatment, whichever is sooner.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-Free Survival (PFS)
Time Frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 24 months)
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 24 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate (ORR)
Time Frame: Two consecutive occasions at least 4 weeks apart (up to approximately 24 months)
Two consecutive occasions at least 4 weeks apart (up to approximately 24 months)
Duration of Response (DOR)
Time Frame: 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)
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)
Overall Survival (OS)
Time Frame: From randomization to death from any cause (up to approximately 24 months)
From randomization to death from any cause (up to approximately 24 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2023

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

May 2, 2023

First Submitted That Met QC Criteria

May 2, 2023

First Posted (Actual)

May 10, 2023

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CO44194

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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