NCT04447755

A Study of Lenvatinib (MK-7902) in Pediatric Participants With Relapsed or Refractory Solid Malignancies (MK-7902-013/E7080)

An Open-Label, Multicenter Phase 2 Basket Study to Evaluate the Antitumor Activity and Safety of Lenvatinib in Children, Adolescents, and Young Adults With Relapsed or Refractory Solid Malignancies

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 2 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to evaluate the antitumor activity and safety of lenvatinib (MK-7902/E7080) in children, adolescents, and young adults with relapsed or refractory solid malignancies after administration. Participants were enrolled into Ewing sarcoma (EWS), rhabdomyosarcoma (RMS), high-grade glioma (HGG), diffuse midline glioma, medulloblastoma, ependymoma, and Other Solid Tumors Excluding Osteosarcoma, diffuse midline glioma, medulloblastoma, and ependymoma cohorts.

Conditions

• Relapsed or Refractory Solid Tumors

Interventions

Type	Name	Description
DRUG	Lenvatinib	Lenvatinib capsules administered orally at 14 mg/m\^2 QD

Timeline

• Start date: 2020-07-30
• Primary completion: 2022-09-16
• Completion: 2025-02-13
• First posted: 2020-06-25
• Last updated: 2025-10-03
• Results posted: 2023-10-04

Locations

49 sites across 20 countries: United States, Argentina, Australia, Belgium, Croatia, Czechia, France, Guatemala, Hungary, Israel, Italy, New Zealand, Peru, Russia, Serbia, South Africa, South Korea, Spain, Sweden, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study