The Assessment of Immune Response in Newly Diagnosed Glioblastoma Patients Treated With Pembrolizumab
NCT ID: NCT05235737
Last Updated: 2023-08-31
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE4
Total Enrollment
36 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-03-01
Study Completion Date
2026-05-30
Brief Summary
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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.
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.
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Detailed Description
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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 efficacy in disease control in Glioblastoma Multiforme (GBM) patients. The control arm will be a group of patients treated in accordance with Standard of Care (SoC).
The study will include 3 treatment arms (up to n=12 evaluable patients per arm) and will be conducted at single site in Poland.
Patients with GBM will be randomly assigned in 1:1:1 ratio into one of 3 treatment arms:
* 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 BSA daily during radiotherapy and six cycles post-radiotherapy of 150-200mg/m2 BSA for 5 days in each 28-day cycle)
* 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 BSA for 5 days in each 28-day cycle)
* 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 BSA for 5 days in each 28-day cycle) A pre-screening period will identify potential candidates for enrollment. Once qualified to the study patients will be randomized to one of the treatment arms. Then patients randomized to treatment arm 1 and 2 will receive first dose of neoadjuvant Pembrolizumab on day 4 and day 18 (200mg each). An immuno-PET scan for these arm 1 and 2 patients will be performed on day 29 and 30. Up to 72 hours after last immuno-PET scan all patients will undergo tumor resection. After surgery all patients will be treated in accordance with standard of care (Stupp protocol) with combined radio- and chemotherapy. Radiotherapy will consist of 60Gy over 6 weeks in daily fraction of 2Gy in Mo-Fri setting and parallel chemotherapy with Temozolomide of 75mg/m2 of BSA on a daily basis. After completion of radiotherapy the chemotherapy will continue for six cycles of 28 days with 150-200mg/m2 Temozolomide on days 1-5 of each cycle. In addition, patients randomized to arm 1 will receive 16 cycles of 21 days with Pembrolizumab treatment in adjuvant setting of 200mg/cycle.
During treatment period all patients will be assessed every three months and MRI will be performed in order to evaluate disease status/response.
After EOT patient's follow up period will continue for up to 3 years from initial resection with MRI assessment every 3 months.
If progression/relapse is identified, patients will undergo a tumor resection or biopsy within 48 hours thereafter.
All patients will then stay in follow up until the end of three years follow up period or death from any cause.
The evaluation of safety, tolerability, and quality-of-life (QoL) will be based on adverse event reporting criteria (Common Terminology Criteria for Adverse Events - CTCAE/WHO Classification of Diseases - ICD10), ECOG status assessment, KPS assessment, EORTC - QLQ-C30 and EORTC-QLQ-BN20 scale.
Clinical assessment will be based on Response Assessment in Neuro-Oncology (RANO). For patients treated with immunotherapy beyond onset of objective disease progression, the iRANO scale will be used within first 6 months of immunotherapy.
Due to a significant risk of identifying other pathology than GBM (i.e. metastasic tumor) in post-surgery histopathology it is anticipated that up to additional 6 patients may be recruited in order to achieve planned number of evaluable patients.
The study will include 3 treatment arms (up to n=12 evaluable patients per arm) and will be conducted at single site in Poland.
Patients with GBM will be randomly assigned in 1:1:1 ratio into one of 3 treatment arms:
* 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 BSA daily during radiotherapy and six cycles post-radiotherapy of 150-200mg/m2 BSA for 5 days in each 28-day cycle)
* 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 BSA for 5 days in each 28-day cycle)
* 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 BSA for 5 days in each 28-day cycle) A pre-screening period will identify potential candidates for enrollment. Once qualified to the study patients will be randomized to one of the treatment arms. Then patients randomized to treatment arm 1 and 2 will receive first dose of neoadjuvant Pembrolizumab on day 4 and day 18 (200mg each). An immuno-PET scan for these arm 1 and 2 patients will be performed on day 29 and 30. Up to 72 hours after last immuno-PET scan all patients will undergo tumor resection. After surgery all patients will be treated in accordance with standard of care (Stupp protocol) with combined radio- and chemotherapy. Radiotherapy will consist of 60Gy over 6 weeks in daily fraction of 2Gy in Mo-Fri setting and parallel chemotherapy with Temozolomide of 75mg/m2 of BSA on a daily basis. After completion of radiotherapy the chemotherapy will continue for six cycles of 28 days with 150-200mg/m2 Temozolomide on days 1-5 of each cycle. In addition, patients randomized to arm 1 will receive 16 cycles of 21 days with Pembrolizumab treatment in adjuvant setting of 200mg/cycle.
During treatment period all patients will be assessed every three months and MRI will be performed in order to evaluate disease status/response.
After EOT patient's follow up period will continue for up to 3 years from initial resection with MRI assessment every 3 months.
If progression/relapse is identified, patients will undergo a tumor resection or biopsy within 48 hours thereafter.
All patients will then stay in follow up until the end of three years follow up period or death from any cause.
The evaluation of safety, tolerability, and quality-of-life (QoL) will be based on adverse event reporting criteria (Common Terminology Criteria for Adverse Events - CTCAE/WHO Classification of Diseases - ICD10), ECOG status assessment, KPS assessment, EORTC - QLQ-C30 and EORTC-QLQ-BN20 scale.
Clinical assessment will be based on Response Assessment in Neuro-Oncology (RANO). For patients treated with immunotherapy beyond onset of objective disease progression, the iRANO scale will be used within first 6 months of immunotherapy.
Due to a significant risk of identifying other pathology than GBM (i.e. metastasic tumor) in post-surgery histopathology it is anticipated that up to additional 6 patients may be recruited in order to achieve planned number of evaluable patients.
Conditions
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Newly Diagnosed Glioblastoma
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Open Label
Study Groups
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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)
Group Type
ACTIVE_COMPARATOR
Pembrolizumab
Intervention Type
DRUG
Adding Pembrolizumab as a neoadjuvant and adjuvant therapy to the standard of care protocol
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)
Group Type
ACTIVE_COMPARATOR
Pembrolizumab
Intervention Type
DRUG
Adding Pembrolizumab as a neoadjuvant therapy to the standard of care protocol
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)
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Pembrolizumab
Adding Pembrolizumab as a neoadjuvant and adjuvant therapy to the standard of care protocol
Intervention Type
DRUG
Pembrolizumab
Adding Pembrolizumab as a neoadjuvant therapy to the standard of care protocol
Intervention Type
DRUG
Eligibility Criteria
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Exclusion Criteria
Patients who meet any of the following criteria will be excluded from study entry:
1. Any active concomitant malignancy, except:
1. Locally treated basal or squamous cell carcinoma
2. Cervical carcinoma in situ
3. Breast cancer in situ
4. Bladder cancer in situ
5. Low grade prostate cancer (under observation with PSA level in normal range)
2. Any previous systemic cancer treatment, including, but not limited to:
1. Radiotherapy
2. Brachytherapy for brain tumor
3. Chemotherapy
4. Carmustine wafer treatment (Gliadel®)
5. Any immune checkpoint inhibitor therapy or any anticancer vaccination
3. Hypersensitivity or allergy to any substance with similar action mechanism to Pembrolizumab, Atezolizumab, Temozolomide, other monoclonal antibodies or contrast agents
4. Any active immunosuppressive systemic therapy (except corticosteroids under 12mg)
5. Any active autoimmune disease or systemic therapy for autoimmune disease within 2 years before enrollment
6. History of any immunodeficiency
7. Active infection
8. 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
9. Active liver disease, hepatitis, HBV or HCV infection
10. History of tuberculosis
11. Any mental disorder that may affect patient's participation
12. Any drug or psychoactive substance dependence
13. Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol
14. Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to study treatment initiation
15. 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
16. Any live vaccination within 30 days before enrollment
17. Any active immunosuppressive systemic infection including history of human immunodeficiency virus (HIV) infection
18. Body mass index (BMI) ≥ 35 kg/m2
19. 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
20. 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.
21. Inability to understand the local language for use of the patient QoL instruments.
22. Tumor other than glioblastoma grade 4 IDH-wildtype, astrocytoma grade 3 or 4 IDH-mutant identified in post-surgery histopathology.
23. Presence of 1p19q codeletion.
1. Any active concomitant malignancy, except:
1. Locally treated basal or squamous cell carcinoma
2. Cervical carcinoma in situ
3. Breast cancer in situ
4. Bladder cancer in situ
5. Low grade prostate cancer (under observation with PSA level in normal range)
2. Any previous systemic cancer treatment, including, but not limited to:
1. Radiotherapy
2. Brachytherapy for brain tumor
3. Chemotherapy
4. Carmustine wafer treatment (Gliadel®)
5. Any immune checkpoint inhibitor therapy or any anticancer vaccination
3. Hypersensitivity or allergy to any substance with similar action mechanism to Pembrolizumab, Atezolizumab, Temozolomide, other monoclonal antibodies or contrast agents
4. Any active immunosuppressive systemic therapy (except corticosteroids under 12mg)
5. Any active autoimmune disease or systemic therapy for autoimmune disease within 2 years before enrollment
6. History of any immunodeficiency
7. Active infection
8. 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
9. Active liver disease, hepatitis, HBV or HCV infection
10. History of tuberculosis
11. Any mental disorder that may affect patient's participation
12. Any drug or psychoactive substance dependence
13. Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol
14. Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to study treatment initiation
15. 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
16. Any live vaccination within 30 days before enrollment
17. Any active immunosuppressive systemic infection including history of human immunodeficiency virus (HIV) infection
18. Body mass index (BMI) ≥ 35 kg/m2
19. 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
20. 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.
21. Inability to understand the local language for use of the patient QoL instruments.
22. Tumor other than glioblastoma grade 4 IDH-wildtype, astrocytoma grade 3 or 4 IDH-mutant identified in post-surgery histopathology.
23. Presence of 1p19q codeletion.
Minimum Eligible Age
18 Years
Maximum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice
OTHER
Sponsor Role
collaborator
Medical University of Silesia
OTHER
Sponsor Role
lead
Responsible Party
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Wojciech Kaspera
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Wojciech Kaspera
Sosnowiec, Silesian, Poland
Site Status
RECRUITING
Countries
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Poland
Central Contacts
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Facility Contacts
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References
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Reference Type
BACKGROUND
Other Identifiers
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2019/ABM/01/00062
Identifier Type: -
Identifier Source: org_study_id
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Post Marketing Surveillance: Newly Diagnosed Glioblastoma Multiforme Treated With Radiotherapy/Temozolomide and Adjuvant Temozolomide (Study P04739)
NCT00704808
COMPLETED
Mycophenolate Mofetil in Combination With Standard of Care for the Treatment of Glioblastoma
NCT05236036
ACTIVE_NOT_RECRUITING
PHASE1
Treatment of Recurrent Glioblastoma With Fractionated Radiotherapy Combined With Cadonilimab
NCT05737368
UNKNOWN
PHASE1
Enhanced Adjuvant Therapy for Newly Diagnosed GBM With Partial Surgical Resection or Short-term Progression
NCT06936046
RECRUITING
PHASE2
In Situ Immune Parameters and Their Prognostic Role on the Survival of Patients With Glioblastoma
NCT03481231
COMPLETED
Biological Therapy and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
NCT00052715
TERMINATED
PHASE2
Lapatinib With Temozolomide and Regional Radiation Therapy for Patients With Newly-Diagnosed Glioblastoma Multiforme
NCT01591577
COMPLETED
PHASE2
Dose-Escalated Photon IMRT or Proton Beam Radiation Therapy Versus Standard-Dose Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma
NCT02179086
ACTIVE_NOT_RECRUITING
PHASE2
Glioblastoma Treatment With Irradiation and Olaptesed Pegol (NOX-A12) in MGMT Unmethylated Patients
NCT04121455
ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
Nimotuzumab in Adults With Glioblastoma Multiforma
NCT00753246
COMPLETED
PHASE3
Addition of Anlotinib Hydrochloride to the Stupp Regimen Versus the Stupp Regimen Alone for Newly Diagnosed Glioblastoma
NCT04157478
UNKNOWN
PHASE2
Nivolumab, Ipilimumab, and Short-course Radiotherapy in Adults With Newly Diagnosed, MGMT Unmethylated Glioblastoma
NCT03367715
COMPLETED
PHASE2
Safety and Tolerability of CVGBM in Adults with Newly Diagnosed MGMT-Unmethylated Glioblastoma or Astrocytoma
NCT05938387
ACTIVE_NOT_RECRUITING
PHASE1
Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma
NCT05879367
RECRUITING
PHASE1
Pre-operative RT and TMZ in Patients With Newly Diagnosed GBM Diagnosed Glioblastoma. A Phase I Study. (PARADIGMA)
NCT03480867
WITHDRAWN
PHASE1