Glioblastoma Multiforme of BrainPhase 2SEJNCT03047473
Avelumab in Patients With Newly Diagnosed Glioblastoma Multiforme
A Phase 2 study testing avelumab in people with Glioblastoma Multiforme of Brain, run by Clinique Neuro-Outaouais at 1 site in Canada.
Trial summary
This is a safety and tolerability study looking at the addition of avelumab, an immune checkpoint inhibitor, to standard therapy of temozolomide and radiotherapy in patients with newly diagnosed glioblastoma multiforme. All patients will be receiving active therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme of Brain
- What is being tested?
- avelumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteCanada
- Study dates
- 19 May 2017to 9 Aug 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent.
- Age ≥ 18 years.
- Present with newly diagnosed supratentorial Glioblastoma (GBM) with a tissue diagnosis that has been established following either a surgical resection or biopsy. This includes treatment-naïve -(chemotherapy and radiotherapy)- patients with prior diagnosis of a lower grade astrocytoma that has been upgraded to a histologically verified GBM.
- Karnofsky performance score of 70 or higher.
- Patients entering the study must be on a stable dose of up to 12 mg (maximum) of Dexamethasone (or equivalent) daily for symptoms related to cerebral edema. Following the first dose of avelumab, the duration of treatment with the current dose of dexamethasone (maximum 12 mg/day) or equivalent, should be no more than 7 consecutive days. The investigator(s) should make every effort to taper the dexamethasone as soon as symptom improvement allows to the lowest tolerable dose that controls the CNS symptoms.
- Will be or is undergoing or has received the standard therapy of chemo radiation therapy (60Gy in 30 fractions of 2Gy/day with concurrent temozolomide of 75mg/m2 per day PO) no more than 21 days ago.
Show all 18Show fewer
- Has not yet begun but will begin standard monthly temozolomide therapy.
- Patient must have at least 1 formalin fixed paraffin embedded tumor tissue block representative of glioblastoma available for biomarker analysis and determination of MGMT status (if not already done). If tumor block is not available or not of adequate quality, sufficient pathology material, representative of glioblastoma, must be available.
- Adequate hematological function defined by absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, and hemoglobin ≥ 9 g/dL (may have been transfused).
- Adequate hepatic function defined by a total bilirubin level ≤ 1.5 × the upper limit of normal (ULN) range and AST and ALT levels ≤ 2.5 × ULN for all subjects.
- Adequate renal function defined by an estimated creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method).
- Negative serum pregnancy test at screening for women of childbearing potential.
- Highly effective contraception for both male and female subjects if the risk of conception exists. (Note: The effects of the trial drug on the developing human fetus are unknown; thus, women of childbearing potential and men able to father a child must agree to use 2 highly effective contraception, defined as methods with a failure rate of less than 1 % per year. Highly effective contraception is required at least 28 days prior, throughout and for at least 60 days after avelumab treatment.
- International normalized ratio (INR) or PT (secs) and activated partial thromboplastin time (aPTT):
- in the absence of therapeutic intent to anticoagulate the subject: INR≤1.5 or PT ≤1.5 x ULN and aPTT ≤1.5 x ULN
- in the presence of therapeutic intent to anticoagulate the subject: INR or PT and aPTT within therapeutic limits (according to the medical standard in the institution).
- NOTE: Use of full-dose anticoagulants is permitted as long as the INR or aPTT is within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose of anticoagulants for at least two weeks prior to randomization.
- Willing and able to comply with the protocol as judged by the Investigator
Who cannot join
- Patients who have evidence of leptomeningeal disease.
- Known significant pulmonary, cardiovascular, hepatic disorders or any other disease that in the opinion of the investigator would be contraindicated to receive anti PD-L1 therapy such as avelumab.
- Prior treatment with bevacizumab or any checkpoint immune blockade thérapies.
- Any other concomitant immunosuppressant other than temozolamide and steroids or any recent (within 3 months) experimental therapy.
- Patients who have finished their radiotherapy course more than 3 weeks prior to Baseline.
- Prior organ transplantation, including allogeneic stem cell transplantation.
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- Significant acute or chronic infections including, among others:
- Known history of testing positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- Positive test for HBV surface antigen and / or confirmatory HCV RNA (if anti-HCV antibody tested positive).
- Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent:
- Subjects with diabetes type I, vitiligo, psoriasis, hypo or hyperthyroid disease or any other autoimmune disease not requiring immunosuppressive treatment are at the investigator's discretion eligible
- Subjects requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses ≤ 10 mg or 10 mg equivalent prednisone per day
- Administration of steroids through a route known to result in a minimal systemic exposure (topical, intranasal, intro-ocular, or inhalation) are acceptable.
- Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥ 3 NCI CTCAE v 4.03), any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma).
- Pregnancy or lactation.
- Known alcohol or drug abuse.
- Any psychiatric or cognitive condition that would prohibit the understanding or rendering of informed consent.
- Vaccination within 4 weeks of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines.
- Contraindication or intolerance to temozolomide.
- Any other malignancy within 5 years prior to randomization, except for adequately controlled limited basal cell carcinoma of the skin, squamous carcinoma of the skin or carcinoma in situ of the cervix.
- Evidence of any active infection requiring hospitalization or IV antibiotics within 2 weeks prior to randomization.
- Persisting toxicity related to prior therapy (NCI CTCAE v. 4.03 Grade > 1); however, alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable.
- Other severe acute or chronic medical conditions including colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Trial locations and contacts
1 site in 1 country.
About this study
This is a safety and tolerability study looking at the addition of avelumab, an immune checkpoint inhibitor, to standard therapy of temozolomide and radiotherapy in patients with newly diagnosed glioblastoma multiforme.
All patients will be receiving active therapy. Patients will begin the avelumab within 3 weeks of finishing their radiotherapy. Avelumab will be given at a dose of 10mg/kg IV every 2 weeks concomitantly with the monthly temozolomide. Avelumab will be continued for a total of 52 weeks.
Read the detailed description
Protocol Title: Avelumab in patients with newly diagnosed Glioblastoma Multiforme
Indication: Patients with newly diagnosed Glioblastoma Multiforme
Study Type: Single center, phase 2, open ended, open label addition of avelumab to standard therapy
Objectives
Primary Objectives:
To determine the safety and tolerability of avelumab administered as 10mg/kg IV q2weeks in patients receiving standard therapy for newly diagnosed GBM.
Secondary objectives:
To determine the impact of the addition of avelumab at a dose of 10mg/kg IV Q2weeks in patients receiving standard therapy for newly diagnosed GBM on overall survival (OS), progression free survival (PFS) and other antitumor activity parameters according to the immunotherapy Response Assessment for Neuro-Oncology (iRANO) (1) at 52 weeks.
Exploratory objectives:
To explore biomarkers that could predict treatment response to avelumab such as: the tumor immunoscore, presence and extent of PD-L1 expression on tumor cells and microglia/macrophages within the tumor
To correlate the OS and PFS in relation to the change between baseline and end of study neurocognitive function as measured by the evoked potential P300 (normal), the baseline corticosteroid dose, the average daily corticosteroid dose over the whole study duration, those who for tolerability reasons do not complete the temozolomide standard 6 monthly pulses of therapy and the presence and severity of immune related adverse events (irAE's).
To assess and compare above mentioned biomarkers in tissue samples from patients with second surgical resection ie treatment failures.
To assess in this GBM population the duration of pseudoprogression and the lagtime needed for immunotherapy to become effective.
Study Design: This is a single center, phase 2, open label, add-on, single dose study in patients receiving standard therapy for newly diagnosed GBM. In total 30 patients who meet the entry criteria will be entered into the study within 3 weeks of finishing their last day of combined radiotherapy/temozolamide. Avelumab will be initiated concurrently with the initiation of the first 5 day, monthly cycle of temozolamide and continued for a total of 260 weeks.
A local pathology report will constitute adequate documentation of histology for study inclusion.
The tumor block used for diagnosis of GBM must be collected for each patient and sent for MGMT assessment (if not already done), biomarker and immunoscore analysis. The availability of these samples is mandatory for randomization into the study, and they must be sent within 2 months after patient's entry into the study for analysis.
Paraffin embedded blocks containing formalin-fixed tumor tissue representative of the glioblastoma diagnosis is the preferred sample (if available, and of sufficient quality), otherwise, a partial tumor block, or pathology material should be sent. If surgery was not performed but biopsy was performed (or if it is not possible to send FFPE tumor tissue blocks) at least 10 unstained, uncovered slides must be sent.
The study will consist of 3 different phases: a Combination Phase, a Monotherapy Phase and an Extended Safety Follow-up Phase
Combination Phase: Upon completion of the standard combination therapy of radiotherapy (total dose 60 Gy, administered as daily 2Gy fractions, 5 days/week) and temozolomide (75 mg/m2/day p.o. qd) and a treatment break of no more than 21 days, the combination phase will start. Patients will receive temozolomide and avelumab for 6 cycles of 28 days each. During the 1st cycle Temozolomide will be given the first 5 days at a dose of 150mg/m2/day p.o. In the next cycle, the temozolomide dose should be escalated to 200/mg/m2 if permitted by the patient's hematological and non-hematological toxicity profile (as per NCI-CTC AE version 3). The temozolomide dose will be adjusted according to hematological and non-hematological toxicity as per temozolomide's product monograph (appendix 4). Avelumab will be administered on day 1 and day 15 of each cycle at a dose of 10mg/kg IV. Avelumab therapy will be withheld according to the occurrence and severity of avelumab related adverse events as per table 3. Patients will continue the combination of temozolomide (150-200mg/m2 per day PO X5 days Q28days) and avelumab (at 10mg/kg dose, IV on days 1 and 15 per cycle) until 6 cycles are completed or until confirmed disease progression or unacceptable (grade 3 or higher) avelumab related toxicity occurs.
Monotherapy Phase: Upon completion of the Combination Phase or upon stopping temozolomide because of temozolomide related toxicity the patient will continue into the avelumab Monotherapy Phase. Avelumab 10mg/kg IV Q2weeks will be continued as monotherapy until a total of 260 weeks of avelumab has been received or evidence of confirmed disease progression as per the iRANO definition or unacceptable (grade 3 or higher) avelumab related toxicity has occurred.
Patients who experience irAE's may according to table 3 directives have their avelumab therapy suspended.
The use of Bevacizumab, second surgical resection or re-irradiation will not be allowed in the study and will be considered as evidence of disease progression.
Patients will be promptly informed upon confirmation of disease progression as per the new iRANO criteria. They will be offered to pursue with the avelumab therapy as per protocol or to withdraw from therapy and enter the extended safety follow up phase.
Upon completion of the Monotherapy Phase at week 260 patients will be then be offered the option of being rolled over into an open label extension study or receive commercial avelumab via a special access program.
Extended Safety Follow-up Phase:
Patients who discontinue avelumab therapy for any reason at any point in the study will be entered into an extended safety follow-up period of 90 days. Treatment will then be at the investigator or local oncologist's discretion. All subjects will be observed for the possible occurrence of delayed irAE's. Survival data and information about subsequent therapies will be collected. Tissue samples in patients undergoing second surgical resections will be obtained for further biomarker analysis.
- Conditions
- Glioblastoma Multiforme of Brain
- Being tested
- avelumab
- Keywords
- newly diagnosed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
avelumabBiological
add on of avelumab 10mg/kg IV to standard therapy
| Study group | Role | What they receive |
|---|---|---|
| Newly diagnosed GBM | Experimental | single arm, open label Addition of Avelumab to standard treatment Receives: Biological: avelumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
The number of patients with an avelumab related adverse event leading to permanent or transient discontinuation of avelumab treatment.
Treatment related adverse events of special interest will include those of autoimmune origin (irAE).
The adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0
Measured: over the course of the 52 weeks stsudy
Secondary outcomes (1)
Safety and Tolerability
The number of Participants with an Emergent Adverse Event Leading to Avelumab Interruption or Termination
Measured: over the course of the 52 weeks study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start19 May 2017
- Primary completion9 Aug 2021
- Study completion9 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glioblastoma Multiforme of BrainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single center, add on, open label, single dose, single arm
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Neuro-Outaouais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Francois Jacques, Clinique Neuro-Outaouais
- Investigators
- François Jacques, MD, Principal investigator, Clinique Neuro-Outaouais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03047473
- Sponsor's protocol ID
- CNO-006
- Acronym
- SEJ
- Status last verified
- May 2025
- First submitted
- 31 Jan 2017
- Last updated
- 25 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Jacques FH, Nicholas G, Lorimer IAJ, Sikati Foko V, Prevost J, Dumais N, Milne K, Nelson BH, Woulfe J, Jansen G, Apedaile BE. Avelumab in newly diagnosed glioblastoma. Neurooncol Adv. 2021 Aug 25;3(1):vdab118. doi: 10.1093/noajnl/vdab118. eCollection 2021 Jan-Dec.
PubMed 34604752
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Avelumab in Patients With Newly Diagnosed Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT03047473
- Acronym / sponsor ID
- SEJ / CNO-006
- Conditions
- Glioblastoma Multiforme of Brain
- Keywords
- newly diagnosed
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Clinique Neuro-OutaouaisUniversity, hospital or other
- Study start
- 19 May 2017 (actual)
- Primary completion
- 9 Aug 2021 (actual)
- Study completion
- 9 Aug 2021 (actual)
- First posted
- 9 Feb 2017 (estimated)
- Results
- Posted 25 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a safety and tolerability study looking at the addition of avelumab, an immune checkpoint inhibitor, to standard therapy of temozolomide and radiotherapy in patients with newly diagnosed glioblastoma multiforme.
All patients will be receiving active therapy. Patients will begin the avelumab within 3 weeks of finishing their radiotherapy. Avelumab will be given at a dose of 10mg/kg IV every 2 weeks concomitantly with the monthly temozolomide. Avelumab will be continued for a total of 52 weeks.
Detailed description
Protocol Title: Avelumab in patients with newly diagnosed Glioblastoma Multiforme
Indication: Patients with newly diagnosed Glioblastoma Multiforme
Study Type: Single center, phase 2, open ended, open label addition of avelumab to standard therapy
Objectives
Primary Objectives:
To determine the safety and tolerability of avelumab administered as 10mg/kg IV q2weeks in patients receiving standard therapy for newly diagnosed GBM.
Secondary objectives:
To determine the impact of the addition of avelumab at a dose of 10mg/kg IV Q2weeks in patients receiving standard therapy for newly diagnosed GBM on overall survival (OS), progression free survival (PFS) and other antitumor activity parameters according to the immunotherapy Response Assessment for Neuro-Oncology (iRANO) (1) at 52 weeks.
Exploratory objectives:
To explore biomarkers that could predict treatment response to avelumab such as: the tumor immunoscore, presence and extent of PD-L1 expression on tumor cells and microglia/macrophages within the tumor
To correlate the OS and PFS in relation to the change between baseline and end of study neurocognitive function as measured by the evoked potential P300 (normal), the baseline corticosteroid dose, the average daily corticosteroid dose over the whole study duration, those who for tolerability reasons do not complete the temozolomide standard 6 monthly pulses of therapy and the presence and severity of immune related adverse events (irAE's).
To assess and compare above mentioned biomarkers in tissue samples from patients with second surgical resection ie treatment failures.
To assess in this GBM population the duration of pseudoprogression and the lagtime needed for immunotherapy to become effective.
Study Design: This is a single center, phase 2, open label, add-on, single dose study in patients receiving standard therapy for newly diagnosed GBM. In total 30 patients who meet the entry criteria will be entered into the study within 3 weeks of finishing their last day of combined radiotherapy/temozolamide. Avelumab will be initiated concurrently with the initiation of the first 5 day, monthly cycle of temozolamide and continued for a total of 260 weeks.
A local pathology report will constitute adequate documentation of histology for study inclusion.
The tumor block used for diagnosis of GBM must be collected for each patient and sent for MGMT assessment (if not already done), biomarker and immunoscore analysis. The availability of these samples is mandatory for randomization into the study, and they must be sent within 2 months after patient's entry into the study for analysis.
Paraffin embedded blocks containing formalin-fixed tumor tissue representative of the glioblastoma diagnosis is the preferred sample (if available, and of sufficient quality), otherwise, a partial tumor block, or pathology material should be sent. If surgery was not performed but biopsy was performed (or if it is not possible to send FFPE tumor tissue blocks) at least 10 unstained, uncovered slides must be sent.
The study will consist of 3 different phases: a Combination Phase, a Monotherapy Phase and an Extended Safety Follow-up Phase
Combination Phase: Upon completion of the standard combination therapy of radiotherapy (total dose 60 Gy, administered as daily 2Gy fractions, 5 days/week) and temozolomide (75 mg/m2/day p.o. qd) and a treatment break of no more than 21 days, the combination phase will start. Patients will receive temozolomide and avelumab for 6 cycles of 28 days each. During the 1st cycle Temozolomide will be given the first 5 days at a dose of 150mg/m2/day p.o. In the next cycle, the temozolomide dose should be escalated to 200/mg/m2 if permitted by the patient's hematological and non-hematological toxicity profile (as per NCI-CTC AE version 3). The temozolomide dose will be adjusted according to hematological and non-hematological toxicity as per temozolomide's product monograph (appendix 4). Avelumab will be administered on day 1 and day 15 of each cycle at a dose of 10mg/kg IV. Avelumab therapy will be withheld according to the occurrence and severity of avelumab related adverse events as per table 3. Patients will continue the combination of temozolomide (150-200mg/m2 per day PO X5 days Q28days) and avelumab (at 10mg/kg dose, IV on days 1 and 15 per cycle) until 6 cycles are completed or until confirmed disease progression or unacceptable (grade 3 or higher) avelumab related toxicity occurs.
Monotherapy Phase: Upon completion of the Combination Phase or upon stopping temozolomide because of temozolomide related toxicity the patient will continue into the avelumab Monotherapy Phase. Avelumab 10mg/kg IV Q2weeks will be continued as monotherapy until a total of 260 weeks of avelumab has been received or evidence of confirmed disease progression as per the iRANO definition or unacceptable (grade 3 or higher) avelumab related toxicity has occurred.
Patients who experience irAE's may according to table 3 directives have their avelumab therapy suspended.
The use of Bevacizumab, second surgical resection or re-irradiation will not be allowed in the study and will be considered as evidence of disease progression.
Patients will be promptly informed upon confirmation of disease progression as per the new iRANO criteria. They will be offered to pursue with the avelumab therapy as per protocol or to withdraw from therapy and enter the extended safety follow up phase.
Upon completion of the Monotherapy Phase at week 260 patients will be then be offered the option of being rolled over into an open label extension study or receive commercial avelumab via a special access program.
Extended Safety Follow-up Phase:
Patients who discontinue avelumab therapy for any reason at any point in the study will be entered into an extended safety follow-up period of 90 days. Treatment will then be at the investigator or local oncologist's discretion. All subjects will be observed for the possible occurrence of delayed irAE's. Survival data and information about subsequent therapies will be collected. Tissue samples in patients undergoing second surgical resections will be obtained for further biomarker analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single center, add on, open label, single dose, single arm
| Arm | Type | Receives |
|---|---|---|
| Newly diagnosed GBM | Experimental | Biological: avelumabsingle arm, open label Addition of Avelumab to standard treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Signed informed consent.
- Age ≥ 18 years.
- Present with newly diagnosed supratentorial Glioblastoma (GBM) with a tissue diagnosis that has been established following either a surgical resection or biopsy. This includes treatment-naïve -(chemotherapy and radiotherapy)- patients with prior diagnosis of a lower grade astrocytoma that has been upgraded to a histologically verified GBM.
- Karnofsky performance score of 70 or higher.
- Patients entering the study must be on a stable dose of up to 12 mg (maximum) of Dexamethasone (or equivalent) daily for symptoms related to cerebral edema. Following the first dose of avelumab, the duration of treatment with the current dose of dexamethasone (maximum 12 mg/day) or equivalent, should be no more than 7 consecutive days. The investigator(s) should make every effort to taper the dexamethasone as soon as symptom improvement allows to the lowest tolerable dose that controls the CNS symptoms.
Key exclusion criteria (23 listed)
- Patients who have evidence of leptomeningeal disease.
- Known significant pulmonary, cardiovascular, hepatic disorders or any other disease that in the opinion of the investigator would be contraindicated to receive anti PD-L1 therapy such as avelumab.
- Prior treatment with bevacizumab or any checkpoint immune blockade thérapies.
- Any other concomitant immunosuppressant other than temozolamide and steroids or any recent (within 3 months) experimental therapy.
- Patients who have finished their radiotherapy course more than 3 weeks prior to Baseline.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| avelumabadd on of avelumab 10mg/kg IV to standard therapy | Biological | Newly diagnosed GBM |
Primary outcome
Safety and Tolerability
Time frame: over the course of the 52 weeks stsudy
The number of patients with an avelumab related adverse event leading to permanent or transient discontinuation of avelumab treatment. Treatment related adverse events of special interest will include those of autoimmune origin (irAE). The adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0
1 secondary outcome
Safety and Tolerability
Time frame: over the course of the 52 weeks study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34604752Jacques FH, Nicholas G, Lorimer IAJ, Sikati Foko V, Prevost J, Dumais N, Milne K, Nelson BH, Woulfe J, Jansen G, Apedaile BE. Avelumab in newly diagnosed glioblastoma. Neurooncol Adv. 2021 Aug 25;3(1):vdab118. doi: 10.1093/noajnl/vdab118. eCollection 2021 Jan-Dec.
- GBM clinical trial websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François Jacques, MD principal investigator
Clinique Neuro-Outaouais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing avelumab in people with Glioblastoma Multiforme of Brain, run by Clinique Neuro-Outaouais at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: over the course of the 52 weeks stsudy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03047473, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.