Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001)

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

2019-04-11

Primary completion

2023-10-02

Completion

2025-02-05

Publications

• Results Marth C, Moore RG, Bidzinski M, Pignata S, Ayhan A, Rubio MJ, Beiner M, Hall M, Vulsteke C, Braicu EI, Sonoda K, Wu X, Frentzas S, Mattar A, Lheureux S, Chen X, Hasegawa K, Magallanes-Maciel M, Choi CH, Shalkova M, Kaen D, Wang PH, Berger R, Okpara CE, McKenzie J, Yao L, Orlowski R, Khemka V, Gilbert L, Makker V; ENGOT-en9/LEAP-001 Investigators. First-Line Lenvatinib Plus Pembrolizumab Versus Chemotherapy for Advanced Endometrial Cancer: A Randomized, Open-Label, Phase III Trial. J Clin Oncol. 2025 Mar 20;43(9):1083-1100. doi: 10.1200/JCO-24-01326. Epub 2024 Nov 26.
• Marth C, Lorusso D, Bidzinski M, Scollo P, Vardar MA, Oaknin A, Kaen DL, Nogueira-Rodrigues A, Miller DS, Hasegawa K, MacKay H, Moore RG, Santin AD, Yunokawa M, Romero I, Pignata S, Baron-Hay S, Kim YM, Amit A, Ghamande S, Danska-Bidzinska A, Tarnawski R, Wang PH, Yu Z, Slomovitz BM, Okpara CE, McKenzie J, Meng R, Orlowski R, Makker V. Lenvatinib plus pembrolizumab in participants with advanced or recurrent endometrial cancer: Study 309/KEYNOTE-775 and ENGOT-en9/LEAP-001 post-(neo)adjuvant therapy outcomes. Int J Gynecol Cancer. 2026 Apr 12;36(7):104693. doi: 10.1016/j.ijgc.2026.104693. Online ahead of print.
• Marth C, Moore RG, Bidzinski M, Salutari V, Altundag O, Rubio MJ, Levy T, Stillie A, Vulsteke C, Witteler R, Ariyoshi K, Wu X, Frentzas S, Mattar A, Slomovitz BM, Lheureux S, Chen X, Hasegawa K, Magallanes M, Choi CH, Shalkova M, Kaen DL, Cadoo K, Yao L, McKenzie J, Okpara CE, Meng R, Orlowski R, Gilbert L, Makker V. First-line lenvatinib plus pembrolizumab versus chemotherapy for advanced endometrial cancer: 1-Year follow-up after final analysis of the ENGOT-en9/LEAP-001 phase 3 trial. Int J Gynecol Cancer. 2026 Jan;36(1):102795. doi: 10.1016/j.ijgc.2025.102795. Epub 2025 Nov 11.
• Marth C, Tarnawski R, Tyulyandina A, Pignata S, Gilbert L, Kaen D, Rubio MJ, Frentzas S, Beiner M, Magallanes-Maciel M, Farrelly L, Choi CH, Berger R, Lee C, Vulsteke C, Hasegawa K, Braicu EI, Wu X, McKenzie J, Lee JJ, Makker V. Phase 3, randomized, open-label study of pembrolizumab plus lenvatinib versus chemotherapy for first-line treatment of advanced or recurrent endometrial cancer: ENGOT-en9/LEAP-001. Int J Gynecol Cancer. 2022 Jan;32(1):93-100. doi: 10.1136/ijgc-2021-003017. Epub 2021 Nov 19.

Drugs

Indications