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
Key facts
- Where
- Kaposvár, Kecskemét, Miskolc és Tatabánya, MagyarországSee the 4 sites
- Phase
- 2. fázis
Where in Magyarország
- Somogy Vármegyei Kaposi Mór Oktató KórházKaposvár, MagyarországNo longer taking part
- Bacs-Kiskun Varmegyei OktatokorhazKecskemét, MagyarországNo longer taking part
- Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi OktatokorhazMiskolc, MagyarországNo longer taking part
- Komarom-Esztergom Varmegyei Szent Borbala KorhazTatabánya, MagyarországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- F. Hoffmann-La Roche AG
- Trial code
- EU 2022-502457-34-00
- Record updated
- 2026. március 31.
- Original description
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)Read full original descriptionShow less
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
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)
Inclusion: 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.
Exclusion: Major surgical procedure within 4 weeks prior to initiation of study treatment; History of malignancy within 5 years prior to consent; History of leptomeningeal disease; 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; Poor venous access; Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.