|drug3491||SOC: Temozolomide Wiki||0.71|
|drug1850||IGV-001 Cell Immunotherapy Wiki||0.71|
|drug3733||Standard of Care (SOC): Radiation Therapy Wiki||0.71|
There are 2 clinical trials
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).
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
Description: Time from beginning of treatment to deathMeasure: 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 betterMeasure: 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 firstMeasure: 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 therapyMeasure: Progression-Free Survival at Six Months Time: Up to six months after beginning treatment
The 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.
Description: PFS is defined as the time from randomization to event or censoring.Measure: Progression-free Survival (PFS) Time: Up to 36 months
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
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports