Actively Recruiting
Safety and Efficacy of L19TNF Plus Temozolomide Chemoradiotherapy in Patients With Newly Diagnosed Glioblastoma
Led by Philogen S.p.A. · Updated on 2023-10-10
226
Participants Needed
1
Research Sites
305 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy of L19TNF Plus Temozolomide Chemoradiotherapy in Patients With Newly Diagnosed Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Histologically confirmed newly diagnosed glioblastoma
- Karnofsky Performance Score of 70% or higher
- Documented negative tests for HIV, HBV, and HCV infection
- For women of childbearing potential, negative pregnancy test within 14 days before treatment and agreement to use effective contraception during the study and for 6 months after
- Male participants able to father children must agree to use two acceptable methods of contraception during the study
- Signed informed consent form indicating understanding of the study
- Willingness and ability to follow the scheduled visits, treatment plan, and study procedures
You will not qualify if you...
- Prior treatment for glioma except surgery
- Unable to undergo contrast-enhanced MRI
- Planned treatment with tumor-treating fields before disease progression
- Known allergy to TNF, temozolomide, any study medication components, or similar proteins
- Low blood counts: neutrophils below 1.5 x 10^9/L, platelets below 100 x 10^9/L, or hemoglobin below 9.0 g/dL
- Chronic kidney impairment or creatinine clearance below 60 mL/min
- Poor liver function with elevated enzymes or bilirubin
- Elevated INR above 1.5 times normal
- Any serious medical condition or inability to comply with the study
- Active or history of autoimmune disease that could worsen with immune stimulation
- Recent serious heart or cerebrovascular diseases
- Heart failure above Grade II or significant heart rhythm problems
- Abnormal heart function or prolonged QT interval on ECG
- Uncontrolled high blood pressure
- High-risk arterial aneurysm
- Severe peripheral vascular disease
- Recent major trauma or surgery within 3 weeks
- History of tuberculosis
- Pregnancy or breastfeeding
- Need for high-dose corticosteroids or immunosuppressants
- Active infections or other severe diseases posing risk
- Other cancers unless disease-free for at least 2 years
- Use of growth factors or immunomodulators within 7 days before treatment
- Serious non-healing wounds or fractures
- Need for therapeutic dose anticoagulants
- Concurrent anti-cancer treatments besides study medication
- Recent live vaccination within 4 weeks before or planned during the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
UniversitatSpital USZ
Zurich, Switzerland
Actively Recruiting
Research Team
T
Teresa Hemmerle, PhD
CONTACT
S
Serena Bettarini, Pharmacist
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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