Covid 19 Research using Clinical Trials (Home Page)
HP:0012174: Glioblastoma multiformeHPO
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (7)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug2531 | SOC: Temozolomide Wiki | 0.71 |
| drug2397 | Reduced Dose Bevacizumab Wiki | 0.71 |
| drug2703 | Standard of Care (SOC): Radiation Therapy Wiki | 0.71 |
| drug1351 | IGV-001 Cell Immunotherapy Wiki | 0.71 |
| drug2681 | Standard Dose Bevacizumab Wiki | 0.71 |
| drug1883 | Nivolumab Wiki | 0.41 |
| drug2122 | Placebo Wiki | 0.04 |
Correlated HPO Terms (0)
| Name (Synonyms) | Correlation |
|---|
There are 2 clinical trials
Clinical Trials
1 CA209-382 A Randomized Phase 2 Open Label Study of Nivolumab Plus Standard Dose Bevacizumab Versus Nivolumab Plus Low Dose Bevacizumab in Recurrent Glioblastoma (GBM)
The purpose of this study is to test the effectiveness (how well the drug works), safety and tolerability of an investigational drug called nivolumab (also known as BMS-936558) in glioblastoma (a malignant tumor, or GBM), when added to bevacizumab. Nivolumab is an antibody (a kind of human protein) that is being tested to see if it will allow the body's immune system to work against glioblastoma tumors. Opdivo (Nivolumab) is currently FDA approved in the United States for melanoma (a type of skin cancer), non-small cell lung cancer, renal cell cancer (a type of kidney cancer), Hodgkin's lymphoma but is not approved in glioblastoma. Nivolumab may help your immune system detect and attack cancer cells. Bevacizumab is a drug which works on the blood vessel that supply the tumor and potentially can starve the tumor by cutting off the blood supply to these tumors. Bevacizumab is commercially available and FDA approved for patients with recurrent glioblastoma. This study has two study groups. Arm 1 will receive the study drug Nivolumab 240mg and bevacizumab 10 mg (standard dose) every 2 weeks and Arm 2 will receive the study drug Nivolumab 240 mg and bevacizumab 3 mg (reduced dose) every 2 weeks. A process will be used to assign patients, by chance, to one of the study groups. Neither patients nor doctors can choose which group patients are in. This is done by chance because no one knows if one study group is better or worse than the other. 90 total patients are expected to participate in this study (45 patients in each arm). Your total participation in this study from the time you have signed the informed consent to your last visit, including follow-up visits, may be more than three years (depending on what effect the treatment has on your cancer, and how well you tolerate the treatment).
NCT03452579 Glioblastoma Drug: Nivolumab Drug: Standard Dose Bevacizumab Drug: Reduced Dose Bevacizumab MeSH:Glioblastoma
HPO:Glioblastoma multiforme
Primary Outcomes
Description: The proportion of subjects in the analysis population who remain alive for at least twelve months following initiation of study therapy.
Measure: Overall Survival at 12 Months Time: Up to 12 months after beginning therapy
Secondary Outcomes
Description: Time from beginning of treatment to death
Measure: Overall Survival Time: Up to 3 years after beginning treatment
Description: Proportion of subjects in the analysis population who have complete response (CR) or partial response (PR) using Radiologic Assessment in Neuro-Oncology criteria (RANO) criteria.
Measure: Overall Response Rate Time: Up to 3 years after beginning treatment
Description: Time from first RANO response to disease progression in subjects who achieve a PR or better
Measure: Duration of Response Time: Up to 3 years after beginning treatment
Description: Defined as the time from allocation to the first documented disease progression according to RANO or death due to any cause, whichever occurs first
Measure: Progression-Free Survival Time: Up to 3 years after beginning treatment
Description: The proportion of subjects in the analysis population who remain progression-free for at least six months following initiation of study therapy
Measure: Progression-Free Survival at Six Months Time: Up to six months after beginning treatment
2 A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Safety and Efficacy of IGV-001, an Autologous Cell Immunotherapy With Antisense Oligonucleotide (IMV-001) Targeting IGF-1R, in Newly Diagnosed Patients With Glioblastoma Multiforme - the ImmuneSense Study
Primary Outcomes
Description: The proportion of subjects in the analysis population who remain alive for at least twelve months following initiation of study therapy.
Measure: Overall Survival at 12 Months Time: Up to 12 months after beginning therapySecondary Outcomes
Description: Time from beginning of treatment to death
Measure: Overall Survival Time: Up to 3 years after beginning treatmentDescription: Proportion of subjects in the analysis population who have complete response (CR) or partial response (PR) using Radiologic Assessment in Neuro-Oncology criteria (RANO) criteria.
Measure: Overall Response Rate Time: Up to 3 years after beginning treatmentDescription: Time from first RANO response to disease progression in subjects who achieve a PR or better
Measure: Duration of Response Time: Up to 3 years after beginning treatmentDescription: Defined as the time from allocation to the first documented disease progression according to RANO or death due to any cause, whichever occurs first
Measure: Progression-Free Survival Time: Up to 3 years after beginning treatmentDescription: The proportion of subjects in the analysis population who remain progression-free for at least six months following initiation of study therapy
Measure: Progression-Free Survival at Six Months Time: Up to six months after beginning treatmentThe purpose of this study is to assess progression-free survival (PFS) in newly diagnosed Glioblastoma Multiforme (GBM) participants treated with IGV-001 as compared with placebo.
NCT04485949 Glioblastoma Multiforme Glioblastoma Biological: IGV-001 Cell Immunotherapy Biological: Placebo Procedure: Standard of Care (SOC): Radiation Therapy Drug: SOC: Temozolomide MeSH:Glioblastoma
HPO:Glioblastoma multiforme
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
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
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
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
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
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
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
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)
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
Measure: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities Time: Up to 12 months or until the last progression visit, whichever comes first
Measure: Number of Participants With Clinically Significant Vital Signs Measurements Time: Up to 12 months or until the last progression visit, whichever comes first
Measure: Number of Participants With Clinically Significant Physical Examination Findings Time: Up to 12 months or until the last progression visit, whichever comes first
HPO Nodes
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
Primary Outcomes
Description: PFS is defined as the time from randomization to event or censoring.
Measure: Progression-free Survival (PFS) Time: Up to 36 monthsSecondary Outcomes
Description: OS is defined as the time from randomization to death due to any cause.
Measure: Overall Survival (OS) Time: Up to 48 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 36Description: 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 36Description: 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 36Description: 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)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 firstMeasure: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities Time: Up to 12 months or until the last progression visit, whichever comes first
Measure: Number of Participants With Clinically Significant Vital Signs Measurements Time: Up to 12 months or until the last progression visit, whichever comes first
Measure: Number of Participants With Clinically Significant Physical Examination Findings Time: Up to 12 months or until the last progression visit, whichever comes first