Breast CancerPhase 2NCT05852691
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
A Phase 2 study testing Tobemstomig, Pembrolizumab and Nab-Paclitaxel in people with Breast Cancer, run by Hoffmann-La Roche at 36 sites in 16 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Tobemstomig, Pembrolizumab and Nab-Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 36 sitesin 16 countries
- Study dates
- 18 Jul 2023to 15 Oct 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
36 sites in 16 countries.
36 sites in 16 countries
United States4 sites
Novant Health Presbyterain Medical Center
Charlotte, North Carolina, 28204
Cancer Blood and Specialty Clinic
Los Alamitos, California, 90720
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
Brazil4 sites
Hospital de Cancer de Barretos
Barretos, São Paulo, 14784-400
Hospital Araujo Jorge
Goiânia, Goiás, 74605-070
Hospital do Cancer de Pernambuco - HCP
Recife, Pernambuco, 50040-000
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
São Paulo, São Paulo, 01317-001
Peru4 sites
Centro Medico Monte Carmelo
Arequipa, 04001
Oncosalud Sac
Lima, 41
Instituto Nacional de Enfermedades Neoplasicas
Lima, Lima 34
Instituto Peruano de Oncología y Radioterapia
Lima
South Korea4 sites
Seoul National University Hospital
Seoul, 03080
Asan Medical Center
Seoul, 05505
Gangnam Severance Hospital, Yonsei University Health System
Seoul, 06273
Samsung Medical Center
Seoul, 06351
Germany3 sites
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH
Essen, 45136
Dres. Andreas Köhler und Roswitha Fuchs
Langen, 63225
Universitätsklinikum Ulm Am Michelsberg
Ulm, 89075
Mexico3 sites
Health Pharma Professional Research
Mexico City, Mexico CITY (federal District), 03100
OncoMed
Mexico City, Mexico CITY (federal District), 03100
Centro Médico Zambrano Hellion
Monterrey, Nuevo León, 66278
Israel2 sites
Hadassah University Hospital - Ein Kerem
Jerusaelm, 9112001
Sheba Medical Center
Ramat Gan, 5262100
Italy2 sites
Ospedale San Raffaele
Milan, Lombardy, 20132
Ospedale Provinciale Santa Maria Delle Croci
Ravenna, Emilia-Romagna, 48100
Poland2 sites
?wi?tokrzyskie Centrum Onkologii
Kielce, 25-734
Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii
Krakow, 31-501
Spain2 sites
Hospital Universitario Virgen de La Arrixaca
El Palmar, Murcia, 30120
Hospital Quiron de Madrid
Pozuelo de Alarcón, Madrid, 28223
Argentina1 site
Centro de Investigaciones Médicas y Desarrollo LC S.R.L
Buenos Aires, C1113AAE
South Africa1 site
Medical Oncology Centre of Rosebank
Johannesburg, 2196
About this study
Official 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
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).
- Conditions
- Breast Cancer
- Being tested
- Tobemstomig, Pembrolizumab, Nab-Paclitaxel
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TobemstomigDrug
Also called RO7247669
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.
PembrolizumabDrug
Participants will receive IV pembrolizumab Q3W until disease progression or until up to 24 months after the first treatment, whichever is sooner.
Nab-PaclitaxelDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | 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. Receives: Drug: Tobemstomig; Drug: Nab-Paclitaxel |
| Arm B | Active comparator | 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. Receives: Drug: Pembrolizumab; Drug: Nab-Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Measured: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 24 months)
Secondary outcomes (3)
Objective Response Rate (ORR)
Measured: Two consecutive occasions at least 4 weeks apart (up to approximately 24 months)
Duration of Response (DOR)
Measured: 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)
Measured: From randomization to death from any cause (up to approximately 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start18 Jul 2023
- Primary completion15 Oct 2026
- Study completion15 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05852691
- Sponsor's protocol ID
- CO44194
- Status last verified
- Oct 2026
- First submitted
- 2 May 2023
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05852691
- Acronym / sponsor ID
- CO44194
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2023 (actual)
- Primary completion
- 15 Oct 2026 (actual)
- Study completion
- 15 Oct 2026 (actual)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Tobemstomig, Drug: Nab-PaclitaxelParticipants 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. |
| Arm B | Active comparator | Drug: Pembrolizumab, Drug: Nab-PaclitaxelParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TobemstomigAlso: RO7247669Participants 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. | Drug | Arm A |
| PembrolizumabParticipants will receive IV pembrolizumab Q3W until disease progression or until up to 24 months after the first treatment, whichever is sooner. | Drug | Arm B |
| Nab-PaclitaxelParticipants 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 | Arm A, Arm B |
Primary outcome
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)
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: 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)
Overall Survival (OS)
Time frame: From randomization to death from any cause (up to approximately 24 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
36 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tobemstomig, Pembrolizumab and Nab-Paclitaxel in people with Breast Cancer, run by Hoffmann-La Roche at 36 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Brazil, Peru, South Korea, Germany and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.