Safety and Efficacy of L19TNF Plus Temozolomide Chemoradiotherapy in Patients With Newly Diagnosed Glioblastoma

The purpose of this study is to explore the safety profile and establish a recommended dose (RD) for phase II of the antibody-cytokine fusion protein L19TNF plus standard TMZ chemoradiotherapy in patients with newly diagnosed glioblastoma. The study will be conducted in three consecutive parts: a dose finding part to determine the RD of L19TNF in combination with chemoradiotherapy, followed by a signal seeking part that investigates first signs of activity and then an activity evaluation part that studies the efficacy of L19TNF in combination with chemoradiotherapy against chemoradiotherapy alone.

NCT Number	NCT04443010
Lead Sponsor	Philogen S.p.A.
Conditions	Glioblastoma
Enrollment	226 participants
Start Date	2021-01-20
Primary Completion	2026-10 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2023-10-10