Study of Lenvatinib (MK-7902/E7080) in Combination With Pembrolizumab (MK-3475) Versus Standard of Care in Participants With Metastatic Colorectal Cancer (MK-7902-017/E7080-G000-325/LEAP-017)

Summary

The purpose of this study is to assess the safety and efficacy of lenvatinib (MK-7902/E7080) in combination with pembrolizumab (MK-3475) in participants with metastatic colorectal cancer. The study will also compare lenvatinib plus pembrolizumab with the standard of care treatment of regorafenib and TAS-102 (trifluridine and tipiracil hydrochloride). The primary study hypothesis is that lenvatinib plus pembrolizumab is superior to standard of care with respect to overall survival.

Timeline

Start

2021-03-29

Primary completion

2024-09-27

Completion

2024-09-27

Outcome

Missed primary endpoint

paper there was no statistically significant improvement in OS after lenvatinib plus pembrolizumab treatment versus SOC. PMID 38833658 ↗

paper P = .0379; prespecified threshold P = .0214. PMID 38833658 ↗

registry p = 0.3574; Hazard Ratio (HR) 0.92 (95% CI 0.60 to 1.42); Log Rank NCT04776148 ↗

release “The Phase 3 LEAP-017 trial evaluating KEYTRUDA plus LENVIMA did not meet its primary endpoint of OS” merck.com ↗

Publications

• Results Kawazoe A, Xu RH, Garcia-Alfonso P, Passhak M, Teng HW, Shergill A, Gumus M, Qvortrup C, Stintzing S, Towns K, Kim TW, Shiu KK, Cundom J, Ananda S, Lebedinets A, Fu R, Jain R, Adelberg D, Heinemann V, Yoshino T, Elez E; LEAP-017 Investigators. Lenvatinib Plus Pembrolizumab Versus Standard of Care for Previously Treated Metastatic Colorectal Cancer: Final Analysis of the Randomized, Open-Label, Phase III LEAP-017 Study. J Clin Oncol. 2024 Aug 20;42(24):2918-2927. doi: 10.1200/JCO.23.02736. Epub 2024 Jun 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lenvatinib	Small molecule	20 mg	Oral
Subject	Pembrolizumab	Monoclonal antibody	400 mg	Intravenous
Comparator	Regorafenib	Small molecule	160 mg	Oral
Comparator	TAS-102	Small molecule	35 mg/m2	—

Indications