OncoMatch/Clinical Trials/NCT04443010
Safety and Efficacy of L19TNF Plus Temozolomide Chemoradiotherapy in Patients With Newly Diagnosed Glioblastoma
Is NCT04443010 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Onfekafusp alfa and Temozolomide for glioblastoma.
Treatment: Onfekafusp alfa · Temozolomide — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Prior therapy
Cannot have received: any treatment for glioma except surgery
Prior treatment for glioma, except surgery
Lab requirements
Blood counts
ANC < 1.5 x 10^9/L, platelets < 100 x 10^9/L or haemoglobin (Hb) < 9.0 g/dl [excluded]
Kidney function
creatinine clearance < 60 mL/min or serum creatinine > 1.5 ULN [excluded]
Liver function
ALT, AST, ALP ≥ 2.5 x ULN or total bilirubin ≥ 2.0 x ULN [excluded]
Cardiac function
Abnormal LVEF or any other abnormalities observed during baseline ECG and echocardiogram investigations that are considered as clinically significant by the investigator. Subjects with current or a history of QT/QTc prolongation are excluded. Heart insufficiency (> Grade II, NYHA criteria). Clinically significant cardiac arrhythmias or requiring permanent medication. INR > 1.5 ULN.
Absolute neutrophil count (ANC) < 1.5 x 10^9/L, platelets < 100 x 10^9/L or haemoglobin (Hb) < 9.0 g/dl. Chronically impaired renal function as indicated by creatinine clearance < 60 mL/min or serum creatinine > 1.5 ULN. Inadequate liver function (ALT, AST, ALP ≥ 2.5 x ULN or total bilirubin ≥ 2.0 x ULN). INR > 1.5 ULN. Heart insufficiency (> Grade II, NYHA criteria). Clinically significant cardiac arrhythmias or requiring permanent medication. Abnormal LVEF or any other abnormalities observed during baseline ECG and echocardiogram investigations that are considered as clinically significant by the investigator. Subjects with current or a history of QT/QTc prolongation are excluded.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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