A Single Center, Open-Label, Randomized Study to Evaluate the Safety and Efficacy of Neoadjuvant and Adjuvant Pembrolizumab on Top of Standard Chemo-Radiotherapy (Stupp Protocol) in Treatment of Patients With Newly Diagnosed Glioblastoma Multiforme (GBM).

Who is this study for? Patients with newly diagnosed glioblastoma multiforme
What treatments are being studied? Pembrolizumab
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Signed Informed Consent Form

• Age ≥ 18 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.

Locations
Other Locations
Poland
Wojciech Kaspera
RECRUITING
Sosnowiec
Contact Information
Primary
Wojciech Kaspera, Md, Phd
wkaspera@sum.edu.pl
+48-32-3682551
Time Frame
Start Date: 2022-03-01
Estimated Completion Date: 2026-05-30
Participants
Target number of participants: 36
Treatments
Active_comparator: Treatment arm 1
n=12 evaluable patients - neoadjuvant Pembrolizumab (2 doses, 200mg each) plus adjuvant Pembrolizumab (16 cycles q3w, 200mg each) on top of standard chemo-radiotherapy (Stupp protocol: radiotherapy 60Gy over 6 weeks, 2 Gy per daily fraction Mo-Fri setting plus Temozolomide 75mg/m2 of body surface area (BSA) daily during radiotherapy and six cycles post-radiotherapy of 150-200mg/m2 for 5 days in each 28-day cycle)
Active_comparator: Treatment arm 2
n=12 evaluable patients - neoadjuvant Pembrolizumab (2 doses, 200mg each) on top of standard chemo-radiotherapy (Stupp protocol: radiotherapy 60Gy over 6 weeks, 2 Gy per daily fraction Mo-Fri setting plus Temozolomide 75mg/m2 BSA daily during radiotherapy and six cycles post-radiotherapy of 150-200mg/m2 for 5 days in each 28-day cycle)
No_intervention: Treatment arm 3
n=12 evaluable patients - standard chemo-radiotherapy (Stupp protocol: radiotherapy 60Gy over 6 weeks, 2 Gy per daily fraction Mo-Fri setting plus Temozolomide 75mg/m2 BSA daily during radiotherapy and six cycles post-radiotherapy of 150-200mg/m2 for 5 days in each 28-day cycle)
Sponsors
Leads: Medical University of Silesia
Collaborators: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice

This content was sourced from clinicaltrials.gov