Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
Navigate: Correlations HPO
There is one clinical trial.
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 therapyDescription: 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 treatmentAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
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