NCT05973903

Lenvatinib, Pembrolizumab, and Tumor Treating Fields (TTFields) for Second-line Treatment of Glioblastoma

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Tel Aviv Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This will be a prospective, open label, single center, phase I lead-in study of 10 patients to a single arm phase-II study of 37 additional patients to assess the effectiveness of pembrolizumab and lenvatinib combination therapy for recurrent glioblastoma (rGBM) patients wearing TTFields electrodes.

Detailed description

Male and female patients, 18 years of age or older, with confirmed GBM progressed after first-line treatment. Patients either with or without first-line TTFields alternating field therapy - will be eligible to enroll in the study.

Conditions

• GBM

Interventions

Type	Name	Description
DRUG	Lenvatinib	Oral Lenvatinib 20 mg once daily
DRUG	Pembrolizumab	intravenous pembrolizumab 200 mg every three weeks
DEVICE	Tumor Treating Fields (TTFields)	TTF extra-dermal scalp electrodes

Timeline

• Start date: 2024-06-01
• Primary completion: 2026-10-01
• Completion: 2027-10-01
• First posted: 2023-08-03
• Last updated: 2024-12-04