Clinical Trial: NCT05852691
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
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 2| Lead Sponsor: | Hoffmann-La Roche |
| Information Provided By: | Hoffmann-La Roche |
| Last Update Posted: | 2026-09-10 |
Study Overview
Brief 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 (TNBC).
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
Conditions
Breast Cancer
Intervention / Treatment
- Drug: Tobemstomig
- Drug: Pembrolizumab
- Drug: Nab-Paclitaxel
Other Study ID Numbers
- CO44194
Start Date (Actual)
2023-07-18
Primary Completion Date (Estimated)
2026-10-19
Study Completion Date (Estimated)
2026-10-19
Enrollment (Actual)
83
Study Type
Interventional
Phase
Phase 2
| Lead Sponsor: | Hoffmann-La Roche |
| Information Provided By: | Hoffmann-La Roche |
| Last Update Posted: | 2026-09-10 |
Study Overview
Brief 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 (TNBC).
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
Conditions
Breast Cancer
Intervention / Treatment
- Drug: Tobemstomig
- Drug: Pembrolizumab
- Drug: Nab-Paclitaxel
Other Study ID Numbers
- CO44194
Start Date (Actual)
2023-07-18
Primary Completion Date (Estimated)
2026-10-19
Study Completion Date (Estimated)
2026-10-19
Enrollment (Actual)
83
Study Type
Interventional
Phase
Phase 2