Trial Outcomes & Findings for Avelumab in Patients With Newly Diagnosed Glioblastoma Multiforme (NCT NCT03047473)

NCT ID: NCT03047473

Last Updated: 2025-05-25

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 38 participants
• Primary outcome timeframe: over the course of the 52 weeks stsudy
• Results posted on: 2025-05-25

Participant Flow

Enrolment began 19 May 2017 and ended 04 August 2021 Enrollmenet was conducted at the study site : Clinique Neuro-Outaouais

430 candidates were prescreened 38 were screened with 30 randomized The reasons for screen failure included: blood abnormality (n=3) withdrawal of consent (n=4) and low Karnofsky score (n=1)

Participant milestones

Measure	Newly Diagnosed GBM single arm, open label Addition of Avelumab to standard treatment avelumab: add on of avelumab 10mg/kg IV to standard therapy
Overall Study STARTED	30
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Newly Diagnosed GBM single arm, open label Addition of Avelumab to standard treatment avelumab: add on of avelumab 10mg/kg IV to standard therapy
Overall Study Lost to Follow-up	2

Baseline Characteristics

Avelumab in Patients With Newly Diagnosed Glioblastoma Multiforme

Baseline characteristics by cohort

Measure	Newly Diagnosed GBM n=30 Participants single arm, open label Addition of Avelumab to standard treatment avelumab: add on of avelumab 10mg/kg IV to standard therapy
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Canada	30 participants n=5 Participants
MGMT methylation status MGMT methylated	10 Participants n=5 Participants
MGMT methylation status MGMT unmethylated	16 Participants n=5 Participants
MGMT methylation status MGMT status unknown	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Newly Diagnosed GBM n=30 Participants single arm, open label Addition of Avelumab to standard treatment avelumab: add on of avelumab 10mg/kg IV to standard therapy
Safety and Tolerability tumor progression	19 participants
Safety and Tolerability radiation necrosis	2 participants
Safety and Tolerability seizure	2 participants
Safety and Tolerability thrombotic event	2 participants
Safety and Tolerability liver enzymes elevation	3 participants
Safety and Tolerability other	12 participants

SECONDARY outcome

Timeframe: over the course of the 52 weeks study

The number of Participants with an Emergent Adverse Event Leading to Avelumab Interruption or Termination

Outcome measures

Measure	Newly Diagnosed GBM n=30 Participants single arm, open label Addition of Avelumab to standard treatment avelumab: add on of avelumab 10mg/kg IV to standard therapy
Safety and Tolerability	3 Participants

Adverse Events

Newly Diagnosed GBM

Serious events: 27 serious events

Other events: 5 other events

Deaths: 26 deaths

Serious adverse events

Measure	Newly Diagnosed GBM n=30 participants at risk single arm, open label Addition of Avelumab to standard treatment avelumab: add on of avelumab 10mg/kg IV to standard therapy
Neoplasms benign, malignant and unspecified (incl cysts and polyps) tumor progression	90.0% 27/30 • Number of events 27 • over the course of 52 weeks of the study

Other adverse events

Measure	Newly Diagnosed GBM n=30 participants at risk single arm, open label Addition of Avelumab to standard treatment avelumab: add on of avelumab 10mg/kg IV to standard therapy
Hepatobiliary disorders hepatic enzymes elevation	16.7% 5/30 • Number of events 5 • over the course of 52 weeks of the study

Additional Information

Dr Francois Jacques

Clinique Neuro-Outaouais

Phone: 819-777-2500

Email: francois.jacques@neuro-outaouais.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place