Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001) - China Extension Study
Summary
The purpose of this study is to compare the efficacy of pembrolizumab + lenvatinib to chemotherapy in female participants with Stage III, IV, or recurrent endometrial carcinoma. It is hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for progression-free survival (PFS) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR). It is also hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for overall survival (OS). As of Amendment 7 eligible participants on study completion will be able to transition to an extension study, if available, in which they can continue to receive pembrolizumab monotherapy, lenvatinib monotherapy, or a combination of both pembrolizumab and lenvatinib as received in the parent study.
Timeline
- Start
- 2019-10-22
- Primary completion
- 2023-10-02
- Completion
- 2025-01-14
Outcome
Missed primary endpoint
registry analysis (non-inferiority test); Lenvatinib + Pembrolizumab vs Paclitaxel + Carboplatin; p = 0.5831415; Hazard Ratio (HR) 1.17 (95% CI 0.64 to 2.15); Log Rank NCT04865289 ↗
registry analysis (superiority test); Lenvatinib + Pembrolizumab vs Paclitaxel + Carboplatin; p = 0.6980186; Hazard Ratio (HR) 1.17 (95% CI 0.64 to 2.15); Log Rank NCT04865289 ↗
registry analysis (superiority test); Lenvatinib + Pembrolizumab vs Paclitaxel + Carboplatin; p = 0.52046; Hazard Ratio (HR) 1.01 (95% CI 0.57 to 1.80); Log Rank NCT04865289 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Carboplatin | Small molecule | 6 unknown | Intravenous |
| Subject | Lenvatinib | Small molecule | 20 mg | Oral |
| Comparator | Paclitaxel | Small molecule | 175 mg/m2 | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |