Status:
RECRUITING
The Assessment of Immune Response in Newly Diagnosed Glioblastoma Patients Treated With Pembrolizumab
Lead Sponsor:
Medical University of Silesia
Collaborating Sponsors:
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice
Conditions:
Newly Diagnosed Glioblastoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
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 M...
Detailed Description
This is an open-label, Phase IV study of Pembrolizumab employed in neoadjuvant and adjuvant setting on top of standard therapy to evaluate the short-term and long-term safety, tolerability and efficac...
Eligibility Criteria
Inclusion
- Signed Informed Consent Form
- Age ≥ 18 years
- Age ≤70 years
- Able to comply with the study protocol in the investigator's judgment
- Clinically and radiologically (contrast CT, full profile MRI - T1-weighted with or without contrast, T2-weighted, FLAIR, DWI, PWI, MR-spectroscopy) confirmed diagnosis of GBM, localized outside eloquent brain areas
- Resectable tumor
- Fully physically active ≥80 points in Karnofsky performance scale
- Life expectancy of at least 3 months
- Adequate organ function (confirmed within 1 weeks before enrollment):
- Hemoglobin ≥ 9g/dL
- Absolute Neutrophils Count (ANC) ≥1.5×109/L
- White Blood Cells (WBC) count ≥3×109/L
- Platelets (PTL) ≥ 100×109/L
- AST/ALT ≤2.5×ULN
- Serum creatinine (S-Cr) ≤ ULN
- Glomerular Filtration Rate (GFR) ≥50mL/min
- Albumin ≥ LLN
- Bilirubin ≤ 1.5 ULN (except patients with documented Gilbert's Syndrome, who must present adequate level of direct bilirubin)
- International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5×ULN. (Elevation of INR and aPTT due to administration of anticoagulation drugs is not a contraindication for the enrollment. However, it must return to normal range prior to surgery).
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use double barrier contraceptive methods that result in a failure rate of \< 1% per year during the treatment period and for at least 120 days after the last immuno-PET imaging.
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use double barrier contraceptive methods that result in a failure rate of \< 1% per year during the treatment period and for at least 120 days after the last immuno-PET imaging.
- Exclusion criteria:
- Patients who meet any of the following criteria will be excluded from study entry:
- Any active concomitant malignancy, except:
- Locally treated basal or squamous cell carcinoma
- Cervical carcinoma in situ
- Breast cancer in situ
- Bladder cancer in situ
- Low grade prostate cancer (under observation with PSA level in normal range)
- Any previous systemic cancer treatment, including, but not limited to:
- Radiotherapy
- Brachytherapy for brain tumor
- Chemotherapy
- Carmustine wafer treatment (Gliadel®)
- Any immune checkpoint inhibitor therapy or any anticancer vaccination
- Hypersensitivity or allergy to any substance with similar action mechanism to Pembrolizumab, Atezolizumab, Temozolomide, other monoclonal antibodies or contrast agents
- Any active immunosuppressive systemic therapy (except corticosteroids under 12mg)
- Any active autoimmune disease or systemic therapy for autoimmune disease within 2 years before enrollment
- History of any immunodeficiency
- Active infection
- Significant cardiovascular disease, such as New York Heart Association cardiac disease ≥ Class III, myocardial infarction within 3 months, coronary artery disease, unstable arrhythmias or unstable angina
- Active liver disease, hepatitis, HBV or HCV infection
- History of tuberculosis
- Any mental disorder that may affect patient's participation
- Any drug or psychoactive substance dependence
- Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol
- Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to study treatment initiation
- Major surgical procedure within 4 weeks prior to study enrollment or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis
- Any live vaccination within 30 days before enrollment
- Any active immunosuppressive systemic infection including history of human immunodeficiency virus (HIV) infection
- Body mass index (BMI) ≥ 35 kg/m2
- Pregnant or lactating or intending to become pregnant during the study - women who are not postmenopausal (postmenopausal defined as ≥ 12 months of non-drug-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 2 weeks prior to initiation of study treatment
- Any condition that the patient's physician determines to be detrimental to the patient participating in this study; including any clinically important deviations from normal clinical laboratory values or concurrent medical events.
- Inability to understand the local language for use of the patient QoL instruments.
- Tumor other than glioblastoma grade 4 IDH-wildtype, astrocytoma grade 3 or 4 IDH-mutant identified in post-surgery histopathology.
- Presence of 1p19q codeletion.
Exclusion
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05235737
Start Date
March 1 2022
End Date
May 30 2026
Last Update
August 31 2023
Active Locations (1)
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1
Wojciech Kaspera
Sosnowiec, Silesian, Poland, 41-200