2022-502457-34-00CompletedPhase 2
A 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
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 31 Mar 2026
Brief summary (registry, in English)
To evaluate the efficacy of tobemstomig plus nab-paclitaxel compared with pembrolizumab plus nab-paclitaxel in the full analysis set (FAS) based on progression-free survival (PFS)
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 71 (actual)
- First submitted
- 24 Apr 2023
- Start date
- 13 Mar 2024
- Lead sponsor
- F. Hoffmann-La Roche AG
- Diseases
- Triple-negative breast cancer
- EU CT number
- 2022-502457-34-00
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 71
- 23 sites in 8 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Major surgical procedure within 4 weeks prior to initiation of study treatment
Other illness
- History of malignancy within 5 years prior to consent
- History of leptomeningeal disease
Lab values
- Prior treatment with CD137 agonists or anti-cytotoxic T-lymphocyte-associated protein (CTLA) therapeutic antibodies or an anti-lymphocyte-activation gene 3 protein (LAG-3) agent
Other
- Poor venous access
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
Who the study is looking for
- Metastatic or locally advanced unresectable, histologically documented TNBC [absence of human epidermal growth factor receptor 2 (HER2)-over-expression, estrogen receptor (ER), and progesterone receptor (PgR) expression by local assessment]
- Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (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 programmed death-ligand 1 (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, defined by protocol-specified laboratory test results, obtained within 14 days prior to initiation of study treatment
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (23)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fakultni Thomayerova nemocnice | Prague 4 | Czechia | Completed |
| KEM I Evang. Kliniken Essen-Mitte gGmbH | Essen | Germany | Completed |
| Gemeinschaftspraxis Fuer Haematologie Und Onkologie | Langen (Hessen) | Germany | Completed |
| Universitaetsklinikum Ulm AoR | Ulm | Germany | Completed |
| Aalborg University Hospital | Aalborg | Denmark | Completed |
| Rigshospitalet | Copenhagen Oe | Denmark | Completed |
| Odense University Hospital | Odense C | Denmark | Completed |
| Vejle Hospital | Vejle | Denmark | Completed |
| University Clinical Hospital Virgen De La Arrixaca | Murcia | Spain | Completed |
| Hospital Universitario Quironsalud Madrid | Pozuelo de Alarcón | Spain | Completed |
| Somogy Vármegyei Kaposi Mór Oktató Kórház | Kaposvár | Hungary | Completed |
| Bacs-Kiskun Varmegyei Oktatokorhaz | Kecskemét | Hungary | Completed |
| Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz | Miskolc | Hungary | Completed |
| Komarom-Esztergom Varmegyei Szent Borbala Korhaz | Tatabánya | Hungary | Completed |
| Azienda USL Toscana Centro | Empoli | Italy | Completed |
| Ospedale San Raffaele S.r.l. | Milan | Italy | Completed |
| Azienda Unità Sanitaria Locale della Romagna | Ravenna | Italy | Completed |
| Stichting Ziekenhuis Gelderse Vallei | Ede Gld | Netherlands | Completed |
| Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy | Bydgoszcz | Poland | Completed |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie | Cracow | Poland | Completed |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy | Gliwice | Poland | Completed |
| Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Kielcach | Kielce | Poland | Completed |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy | Warsaw | Poland | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.