OncoMatch/Clinical Trials/NCT06336291
A Study With L19TNF in Combination With Lomustine in Patients With Glioblastoma at Progression or Recurrence
Is NCT06336291 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for glioblastoma.
Treatment: L19TNF · L19TNF · L19TNF · Lomustine · Lomustine — The trial aims to collect safety, efficacy, exposure, dose- response, pharmacokinetic and pharmacodynamic information of the combination of L19TNF and lomustine at different dose levels in patients with Glioblastoma at progression or recurrence
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: MGMT promoter status known
MGMT promotor status known
Prior therapy
Cannot have received: radiation therapy
Anti-cancer treatment with radiation therapy ... within 4 weeks prior to study treatment start
Cannot have received: chemotherapy
Anti-cancer treatment with ... chemotherapy ... within 4 weeks prior to study treatment start
Cannot have received: targeted therapy
Anti-cancer treatment with ... targeted therapies ... within 4 weeks prior to study treatment start
Cannot have received: immunotherapy
Anti-cancer treatment with ... immunotherapy ... within 4 weeks prior to study treatment start
Cannot have received: hormonal therapy
Anti-cancer treatment with ... hormones ... within 4 weeks prior to study treatment start
Cannot have received: tumor treating fields
Anti-cancer treatment with ... tumor treating fields ... within 4 weeks prior to study treatment start
Cannot have received: other antitumor therapies
Anti-cancer treatment with ... other antitumor therapies within 4 weeks prior to study treatment start
Cannot have received: investigational drug or device
Subjects who participated in an investigational drug or device study within 4 weeks prior to study treatment start
Cannot have received: alkylating agent (temozolomide, lomustine)
Exception: Grade ≥ 4 myelotoxicity with previous treatment
Grade ≥ 4 myelotoxicity with previous treatment of alkylating agents (e.g., TMZ, CCNU)
Cannot have received: VEGF inhibitor (bevacizumab)
Previous treatment with Bevacizumab
Cannot have received: L19TNF (L19TNF)
Previous treatment with L19TNF
Cannot have received: PH-L19TNFCCNU-02/20 study treatment
Previous treatment in the PH-L19TNFCCNU-02/20 study
Lab requirements
Blood counts
ANC < 1.5 x 10^9/L; platelets < 100 x 10^9/L; hemoglobin < 9.0 g/dl [excluded]
Kidney function
creatinine clearance < 60 mL/min/1.73m2 (or < 45 mL/min/1.73m2 for patients >65 years without albuminuria/proteinuria) [excluded]
Liver function
ALT, AST, ALP ≥ 2.5 x ULN or total bilirubin ≥ 1.5 x ULN [excluded]
Cardiac function
LVEF <55% or other clinically significant abnormalities on ECG/echo; NYHA > II heart failure; significant arrhythmias; QTc >470 ms
Absolute neutrophil count (ANC) < 1.5 x 10^9/L; platelets < 100 x 10^9/L or hemoglobin (Hb) < 9.0 g/dl. Chronically impaired renal function as indicated by creatinine clearance < 60 mL/min/1.73m2 or for patients older than 65 years without albuminuria or proteinuria, creatinine clearance < 45 mL/min/1.73m2. Inadequate liver function (ALT, AST, ALP ≥ 2.5 x ULN or total bilirubin ≥ 1.5 x ULN). LVEF <55% or any other abnormalities observed during baseline ECG and echocardiogram investigations that are considered as clinically significant by the investigator. Patients with a marked prolongation of QT/QTc interval (e.g., repeated demonstration of QTc >470 milliseconds using Fredricia's QT correction formula) are excluded.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Northwestern Memorial Hospital · Chicago, Illinois
- Massachusetts General Hospital (MGH) · Boston, Massachusetts
- Beth Israel Deaconess Medical Center (BIDMC) · Boston, Massachusetts
- Dana-Farber Cancer Institute (DFCI) · Boston, Massachusetts
- Memorial Sloan Kettering Cancer Center · New York, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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