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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

Next steps

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
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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (23)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Fakultni Thomayerova nemocnicePrague 4CzechiaCompleted
KEM I Evang. Kliniken Essen-Mitte gGmbHEssenGermanyCompleted
Gemeinschaftspraxis Fuer Haematologie Und OnkologieLangen (Hessen)GermanyCompleted
Universitaetsklinikum Ulm AoRUlmGermanyCompleted
Aalborg University HospitalAalborgDenmarkCompleted
RigshospitaletCopenhagen OeDenmarkCompleted
Odense University HospitalOdense CDenmarkCompleted
Vejle HospitalVejleDenmarkCompleted
University Clinical Hospital Virgen De La ArrixacaMurciaSpainCompleted
Hospital Universitario Quironsalud MadridPozuelo de AlarcónSpainCompleted
Somogy Vármegyei Kaposi Mór Oktató KórházKaposvárHungaryCompleted
Bacs-Kiskun Varmegyei OktatokorhazKecskemétHungaryCompleted
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi OktatokorhazMiskolcHungaryCompleted
Komarom-Esztergom Varmegyei Szent Borbala KorhazTatabányaHungaryCompleted
Azienda USL Toscana CentroEmpoliItalyCompleted
Ospedale San Raffaele S.r.l.MilanItalyCompleted
Azienda Unità Sanitaria Locale della RomagnaRavennaItalyCompleted
Stichting Ziekenhuis Gelderse ValleiEde GldNetherlandsCompleted
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W BydgoszczyBydgoszczPolandCompleted
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W KrakowieCracowPolandCompleted
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut BadawczyGliwicePolandCompleted
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w KielcachKielcePolandCompleted
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyWarsawPolandCompleted

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This page is information, not medical advice. Discuss any trial with your doctor.