Actively Recruiting
The Assessment of Immune Response in Newly Diagnosed Glioblastoma Patients Treated With Pembrolizumab
Led by Medical University of Silesia · Updated on 2023-08-31
36
Participants Needed
1
Research Sites
221 weeks
Total Duration
On this page
Sponsors
M
Medical University of Silesia
Lead Sponsor
M
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice
Collaborating Sponsor
AI-Summary
What this Trial Is About
To evaluate the short-term and longer-term safety, tolerability, and effectiveness of neoadjuvant and adjuvant Pembrolizumab on top of standard therapy (Stupp protocol) in patients with Glioblastoma Multiforme (GBM). Randomized comparison of safety, tolerability, and clinical efficacy of (1) neoadjuvant and adjuvant Pembrolizumab (on top of Stupp protocol, n=12 patients), (2) neoadjuvant Pembrolizumab (on top of Stupp protocol, n=12 patients), and (3) standard of care (Stupp protocol only, n=12 patients). Immuno-PET examination will be performed before and after surgery in all patients.
CONDITIONS
Official Title
The Assessment of Immune Response in Newly Diagnosed Glioblastoma Patients Treated With Pembrolizumab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Age 18 to 70 years
- Able to follow the study protocol as judged by the investigator
- Confirmed diagnosis of Glioblastoma Multiforme (GBM) by clinical and radiological exams
- Tumor located outside critical brain areas and removable by surgery
- Karnofsky performance score of 80 or higher
- Life expectancy of at least 3 months
- Adequate organ function within 1 week before enrollment including:
- Hemoglobin ≥ 9 g/dL
- Absolute Neutrophil Count ≥ 1.5 x 10⁹/L
- White Blood Cell count ≥ 3 x 10⁹/L
- Platelets ≥ 100 x 10⁹/L
- AST/ALT ≤ 2.5 times upper limit of normal
- Serum creatinine within normal limits
- Glomerular Filtration Rate ≥ 50 mL/min
- Albumin above lower limit of normal
- Bilirubin ≤ 1.5 times upper limit of normal (except Gilbert's Syndrome with adequate direct bilirubin)
- INR and aPTT ≤ 1.5 times upper limit of normal (normal range required before surgery if on anticoagulants)
- Women of childbearing potential agree to abstain or use double barrier contraception during treatment and 120 days after last immuno-PET imaging
- Men agree to abstain or use double barrier contraception during treatment and 120 days after last immuno-PET imaging
You will not qualify if you...
- Any active cancer except certain treated or low-risk cancers such as basal or squamous cell carcinoma, cervical carcinoma in situ, breast cancer in situ, bladder cancer in situ, and low-grade prostate cancer under observation
- Previous systemic cancer treatments including radiotherapy, brachytherapy for brain tumor, chemotherapy, Carmustine wafer treatment, immune checkpoint inhibitors, or anticancer vaccination
- Allergy or hypersensitivity to Pembrolizumab, Atezolizumab, Temozolomide, monoclonal antibodies, or contrast agents
- Active systemic immunosuppressive therapy except corticosteroids under 12 mg
- Active autoimmune disease or treatment for autoimmune disease within 2 years
- History of immunodeficiency
- Active infection
- Significant cardiovascular disease such as advanced heart disease, recent heart attack, unstable arrhythmias, or unstable angina
- Active liver disease or hepatitis infections
- History of tuberculosis
- Mental disorders affecting participation
- Substance dependence
- Uncontrolled diseases affecting study compliance
- Use of other investigational agents or clinical trial participation within 28 days
- Major surgery within 4 weeks before enrollment or planned major surgery during study except diagnostic procedures
- Live vaccination within 30 days before enrollment
- Active immunosuppressive infection including HIV
- Body mass index 35 kg/m2 or higher
- Pregnancy, breastfeeding, or intention to become pregnant during the study without confirmed negative pregnancy test
- Any condition deemed harmful for participation by physician
- Inability to understand local language for quality-of-life questionnaires
- Tumors other than glioblastoma grade 4 IDH-wildtype or astrocytoma grade 3 or 4 IDH-mutant based on post-surgery pathology
- Presence of 1p19q codeletion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Wojciech Kaspera
Sosnowiec, Silesian, Poland, 41-200
Actively Recruiting
Research Team
W
Wojciech Kaspera, Md, Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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