NCT02501096

A Trial of Lenvatinib (E7080) Plus Pembrolizumab in Participants With Selected Solid Tumors

A Multicenter, Open-Label Phase 1b/2 Trial of Lenvatinib (E7080) Plus Pembrolizumab in Subjects With Selected Solid Tumors

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 357 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label Phase 1b/2 trial of lenvatinib (E7080) plus pembrolizumab in participants with selected solid tumors. Phase 1b will determine and confirm the maximum tolerated dose (MTD) for lenvatinib in combination with 200 milligrams (mg) (intravenous \[IV\], every 3 weeks \[Q3W\]) pembrolizumab in participants with selected solid tumors (i.e. non-small cell lung cancer, renal cell carcinoma, endometrial carcinoma, urothelial carcinoma, squamous cell carcinoma of the head and neck, melanoma or leiomyosarcoma). Phase 2 (Expansion) will evaluate the safety and efficacy of the combination in 7 cohorts at the MTD from Phase 1b (lenvatinib 20 mg/day orally + pembrolizumab 200 mg Q3W, IV).

Conditions

• Tumors

Interventions

Type	Name	Description
DRUG	Lenvatinib	Lenvatinib will be administered with water orally once a day (with or without food) continuously in 21-day treatment cycle.
DRUG	Pembrolizumab	Pembrolizumab will be administered as a dose of 200 mg Q3W, IV in 21-day treatment cycle.

Timeline

• Start date: 2015-07-22
• Primary completion: 2020-08-18
• Completion: 2022-07-11
• First posted: 2015-07-17
• Last updated: 2023-07-20
• Results posted: 2023-07-20

Locations

64 sites across 3 countries: United States, Norway, Spain

Regulatory

• FDA-regulated drug study