| Protocol No: | ECCT/24/04/04 | Date of Protocol: | 13-09-2023 |
| Study Title: |
A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND STUDY OF TOBEMSTOMIG/RO7247669 COMBINED WITH NAB-PACLITAXEL COMPARED WITH
PEMBROLIZUMAB COMBINED WITH NABPACLITAXEL IN PARTICIPANTS WITH PREVIOUSLY UNTREATED, PD-L1-POSITIVE, LOCALLY-ADVANCED UNRESECTABLE OR METASTATIC TRIPLE-NEGATIVE BREAST CANCER
|
| Study Objectives: | Breast cancer is the most frequently diagnosed cancer among women, and the leading cause of cancer-related deaths in women worldwide. TNBC accounts for 12% - 20% of newly diagnosed breast cancer cases. TNBC is characterized immunohistologically by the lack of expression of hormonal estrogen receptor (ER) and progesterone receptor (PgR), and lack of overexpression and/or amplification of the human epidermal growth factor receptor 2 (HER2)/neuraminidase (NEU) gene. Compared with other breast cancer subtypes, TNBC tumors are generally larger in size, more poorly differentiated, have more extensive lymph node involvement at diagnosis, and exhibit an invasive phenotype. Patients with TNBC have a higher risk of both local and distant recurrence, and metastases are more likely to occur in visceral organs and the brain, rather than bone, when compared with patients with other breast cancers. Patients with metastatic TNBC have relatively poorer outcomes. 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). |
| Laymans Summary: | 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 |
| Abstract of Study: | Protocol Number: CO44194 Study Name: TNBC Version Number: 4 Test Compound: Tobemstomig (RO7247669) STUDY RATIONALE 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). Breast cancer is the most frequently diagnosed cancer among women, and the leading cause of cancer-related deaths in women worldwide. TNBC accounts for 12%-20% of newly diagnosed breast cancer cases.
This study will randomize in a 1:1 ratio to one of two treatment arms:
The first approximately 12 participants will be included in a safety run-in period in which participants will be randomized equally to tobemstomig plus nab-paclitaxel or pembrolizumab plus nab-paclitaxel (targeting 6 participants on each combination). The remaining participants will continue to be randomized in a 1:1 ratio to receive TOBEMSTOMIG plus nab-paclitaxel or pembrolizumab plus nab-paclitaxel
Number of patients
Approximately 160 patients (1:1 ratio in arm A and B)
End of Study:
A participant is considered to have completed the study if he or she has completed all phases of the study including the last visit/last scheduled procedure shown in the schedule of activities (see Section 1.3 of protocol). The end of this study is defined as the date of the last visit of the last participant in the study or the date at which the last data point required for statistical analysis or safety follow-up is received from the last participant, whichever occurs later. In addition, the Sponsor may decide to terminate the study at any time
Study Duration
The total duration of study participation for each individual is expected to range from 1 day to more than 30 months.
|