Correlated Drug Terms (3)

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	Name (Synonyms)	Correlation
drug2531	SOC: Temozolomide Wiki	1.00
drug1351	IGV-001 Cell Immunotherapy Wiki	1.00
drug2122	Placebo Wiki	0.05

Correlated MeSH Terms (1)

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	Name (Synonyms)	Correlation
D005909	Glioblastoma NIH	0.71

Correlated HPO Terms (1)

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	Name (Synonyms)	Correlation
HP:0012174	Glioblastoma multiforme HPO	0.71

Primary Outcomes

Description: PFS is defined as the time from randomization to event or censoring.

Measure: Progression-free Survival (PFS)

Time: Up to 36 months

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Secondary Outcomes

Description: OS is defined as the time from randomization to death due to any cause.

Measure: Overall Survival (OS)

Time: Up to 48 months

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Description: PFS is defined as the time from randomization to event or censoring. MGMT status will be determined per epigenetic analysis from tissue obtained during surgery.

Measure: PFS in Participants With O6-methylguanine-DNA Methyltransferase (MGMT) With Methylation [MGMT+] and MGMT Without Methylation [MGMT-]

Time: Up to 36 months

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Description: OS is defined as the time from randomization to death due to any cause. MGMT status will be determined per epigenetic analysis from tissue obtained during surgery.

Measure: OS in Participants With MGMT+ and MGMT-

Time: Up to 48 months

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Description: EORTC QLQ-C30 contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status/QOL scale. EORTC QLQ-C30 contains 28 questions (4-point scale where 1=Not at all [best] to 4=Very Much [worst]) and 2 questions (7-point scale where 1=Very poor [worst] to 7= Excellent [best]). Raw scores are converted into scale scores ranging from 0 to 100. For the functional scales and the global health status/QOL scale, higher scores represent better QOL; for the symptom scales, lower scores represent better QOL.

Measure: Change From Baseline in Participant-reported Quality of Life (QoL) Questionnaires Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Lif questionnaire (QLQ) -C30 Scores

Time: Baseline, Month 36

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Description: The QLQ-BN20 is a questionnaire specifically designed as the QLQ-C30 supplement for the evaluation of quality of life in brain tumor participants. It includes 4 multi-item sub-scales: future uncertainty, visual disorder, motor dysfunction, communication deficits, and 7 single-item scales: headaches, seizures, drowsiness, itchy skin, hair loss, weakness of legs, and bladder control. All items are rated on a 4-point Likert-type scale ('1=not at all', '2=a little', '3=quite a bit' and '4=very much'), and are linearly transformed to a 0-100 scale, with higher scores indicating more severe symptoms.

Measure: Change From Baseline in Participant-reported QoL Questionnaires Based on EORTC QLQ Brain Module (EORTC QLQ-BN20) Scores

Time: Baseline, Month 36

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Description: The MMSE is an instrument used to assess a participant's global cognitive function. The MMSE assesses orientation to time and place, immediate and delayed recall of words, attention and calculation, language (naming, comprehension and repetition), and spatial ability (copying a figure). The range for MMSE total Score is 0 to 30, with a higher score indicating better cognitive performance.

Measure: Change From Baseline in Mini-Mental Status Examination (MMSE) Scores

Time: Baseline, Month 36

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Description: Time to KPS deterioration was defined as the time from screening to the first date of deterioration of the KPS score. Deterioration of KPS is defined as a stable or increasing steroid dose-dependent stabilization of a KPS score of <70 over 2 consecutive visits no more than 2 months apart. KPS is an 11-level score which ranges between 0 (death) to 100 (complete healthy status); a higher score represents a higher ability to perform daily tasks.

Measure: Time to Definitive Deterioration Karnofsky Performance Status (KPS) Score

Time: Baseline until KPS deterioration (up to 36 months)

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Description: An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 from mild (Grade 1) to death (Grade 5). SAE is an AE or adverse reaction which is considered serious if it results in any of the following outcomes: death, life-threatening AE, require hospitalizations or prolongation of hospitalizations, results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect and is a medically important event.

Measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time: Up to 12 months or until the last progression visit, whichever comes first

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Measure: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities

Time: Up to 12 months or until the last progression visit, whichever comes first

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Measure: Number of Participants With Clinically Significant Vital Signs Measurements

Time: Up to 12 months or until the last progression visit, whichever comes first

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Measure: Number of Participants With Clinically Significant Physical Examination Findings

Time: Up to 12 months or until the last progression visit, whichever comes first

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HP:0012174: Glioblastoma multiforme

Genes 23

SEMA4A MSH6 KRAS PMS1 MSH6 ERBB2 PIK3CA PMS2 IDH1 RPS20 BRCA2 MLH3 FAN1 MSH2 APC PMS2 TP53 TGFBR2 MLH1 MSH2 BMPR1A MLH1 EPCAM

Protein Mutations 27

C797S G20210A G719A K27M L858R L861Q P13K P140K R132C R132G R132H R132L R132S R132V R140L R140Q R140W R172G R172K R172M R172S R172W T790M V600D V600E V600K V600R

SNP 1

rs17782313