Efficacy and Safety of Pembrolizumab Plus Investigational Agents in Combination With Chemotherapy as First-Line Treatment in Extensive-Stage Small Cell Lung Cancer (ES-SCLC) (MK-3475-B99/ KEYNOTE-B99)
Фаза 2
Завершено
NCT04924101
| Заболевание | Small Cell Lung Cancer |
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| Фаза | Фаза 2 |
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| Спонсор | Merck Sharp & Dohme LLC |
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| Статус | Завершено |
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| Участники | 126 участн. |
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| Вмешательство | Pembrolizumab, MK-4830, Boserolimab, Lenvatinib, Etoposide |
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| Дата начала | 15.07.2021 |
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| Дата завершения | 23.06.2025 |
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| Публикация результатов | 1.07.2026 |
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Кратко
The purpose of this study is to evaluate the use of investigational agents (MK-4830, boserolimab (MK-5890) and lenvatinib (MK-7902)) in combination with pembrolizumab (MK-3475) and etoposide/platinum chemotherapy for the first-line treatment of participants with extensive-stage small cell Lung Cancer (ES-SCLC). No formal hypothesis testing will be performed for this study.
Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Up to approximately 43 months · Percentage of participants
| Pembrolizumab + MK-4830 + Chemotherapy | 65.1 Percentage of participants |
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| Pembrolizumab + Boserolimab + Chemotherapy | 73.2 Percentage of participants |
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| Pembrolizumab + Lenvatinib + Chemotherapy | 73.7 Percentage of participants |
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Six-Month Progression-Free Survival (PFS) Rate as Assessed by BICR Per RECIST 1.1
At 6 months · Percentage of Participants
| Pembrolizumab + MK-4830 + Chemotherapy | 45.2 Percentage of Participants |
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| Pembrolizumab + Boserolimab + Chemotherapy | 40.4 Percentage of Participants |
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| Pembrolizumab + Lenvatinib + Chemotherapy | 55.9 Percentage of Participants |
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