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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502457-34-00

Acronym

CO44194

Enrollment

Registered

2023-08-18

Start date

2024-03-13

Completion date

2025-12-03

Last updated

2025-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Triple-Negative Breast Cancer (TNBC)

Brief summary

Progression-free survival (FAS)

Detailed description

Objective response rate (ORR), Duration of response (DOR), Overall survival (OS), Incidence and severity of adverse events, with severity determined according to national cancer institute common terminology criteria for adverse events, version 5.0 (NCI CTCAE v5.0), Change from baseline in targeted clinical laboratory test results, Change from baseline in targeted vital signs

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-free survival (FAS)	—

Secondary

Measure	Time frame
Objective response rate (ORR), Duration of response (DOR), Overall survival (OS), Incidence and severity of adverse events, with severity determined according to national cancer institute common terminology criteria for adverse events, version 5.0 (NCI CTCAE v5.0), Change from baseline in targeted clinical laboratory test results, Change from baseline in targeted vital signs	—

Countries

Czechia, Denmark, Germany, Hungary, Italy, Netherlands, Poland, Spain

Outcome results