Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
Name (Synonyms) | Correlation | |
---|---|---|
drug4505 | Tremelimumab Wiki | 0.71 |
drug2454 | MEDI5395 Wiki | 0.71 |
drug1819 | Growth Mindset Wiki | 0.71 |
Name (Synonyms) | Correlation | |
---|---|---|
D002292 | Carcinoma, Renal Cell NIH | 0.35 |
D002277 | Carcinoma NIH | 0.21 |
D009369 | Neoplasms, NIH | 0.10 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0005584 | Renal cell carcinoma HPO | 0.35 |
HP:0030731 | Carcinoma HPO | 0.21 |
HP:0002664 | Neoplasm HPO | 0.10 |
Navigate: Correlations HPO
There are 2 clinical trials
RATIONALE: The current global standard of care after nephrectomy for localised RCC therefore remains active monitoring (i.e., observation by clinical and radiological means). 30-40% patients with initially localised RCC develop metastatic disease following nephrectomy. Need for adjuvant therapy is most marked in the high risk population where outcomes are predictably poor. However, the risk of recurrence in patients who are of intermediate risk of recurrence is not insignificant. Unfortunately, despite showing efficacy in advanced RCC, the results in the adjuvant setting, so far, are inconclusive. AIM: RAMPART is a phase III Multi-Arm Multi-Stage randomised controlled platform trial, initiated with three arms. The trial is assessing if durvalumab monotherapy or the combination of durvalumab and tremelimumab can improve Disease Free Survival (DFS) or Overall Survival (OS) compared to the current global standard-of-care (active monitoring). At the start of recruitment, patients with Leibovich scores 3 to 11 will be eligible for randomisation. Accrual of intermediate risk patients (Leibovich scores 3 5) will stop after 3 years or when intermediate risk patients contribute 25% of the total accrual target, whichever is earlier. Recruitment of patients with Leibovich scores 6 to 11 will continue until the accrual target is reached.
Description: Interval from randomisation to first evidence of local recurrence, new primary RCC, distant metastases, or death from any cause, whichever occurs first.
Measure: Disease Free Survival (DFS): Arm C vs A Time: 6.25 yearsDescription: Interval from randomisation to first evidence of local recurrence, new primary RCC, distant metastases, or death from any cause, whichever occurs first.
Measure: Disease Free Survival (DFS): Arm B vs A Time: 10.54 yearsDescription: All-cause mortality, the time from randomisation to death from any cause (including RCC).
Measure: Overall Survival (OS): Arm C vs A (high risk patients only) Time: 13.25 yearsDescription: All-cause mortality, the time from randomisation to death from any cause (including RCC).
Measure: Overall Survival (OS): Arm B vs A (high risk patients only) Time: 20.5 yearsDescription: Interval from randomisation to first evidence of metastases or death from RCC
Measure: Metastasis-free survival (MFS): Arm C vs A Time: 6.25 yearsDescription: Interval from randomisation to first evidence of metastases or death from RCC
Measure: Metastasis-free survival (MFS): Arm B vs A Time: 10.54 yearsDescription: Time from randomisation to death from RCC
Measure: RCC specific survival time: Arm C vs A Time: 13.25 yearsDescription: Time from randomisation to death from RCC
Measure: RCC specific survival time: Arm C vs A Time: 20.5 yearsThe reason for the study is to find out if MEDI5395 and durvalumab will work and be safe for the treatment of solid tumors.
Description: The occurrence of DLTs will be used to establish the maximum tolerated dose (MTD) of MEDI5395.
Measure: Number of subjects with adverse events (AEs) serious adverse events (SAEs) and dose limiting toxicities (DLTs). Time: From the time of informed consent until 90 days after the last dose of investigational product (MEDI5395 or durvalumab)Description: The ORR is defined as the proportion of subjects with confirmed response (CR) or confirmed partial response (PR).
Measure: Objective response rate (ORR) Time: Estimated to be from the time of informed consent for approximately 2.5 yearsDescription: The DCR will be estimated by the proportion of disease control. Disease control is defined as CR, PR or stable disease.
Measure: Disease Control Rate (DCR) Time: Estimated to be from the time of informed consent for approximately 2.5 yearsDescription: The DoR is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
Measure: Duration of Response (DoR) Time: Estimated to be from the time of informed consent for approximately 2.5 yearsDescription: The TTR is defined as the time from the start of treatment with any investigational product until the first documentation of a subsequently confirmed objective response.
Measure: Time To Response (TTR) Time: Estimated to be from the time of informed consent for approximately 2.5 yearsDescription: PFS will be measured from the start of treatment with any investigational product until the first documentation of disease progression or death due to any cause, whichever occurs first.
Measure: Progression Free Survival (PFS) Time: Estimated to be from the time of informed consent for approximately 2.5 yearsDescription: OS will be measured from the start of treatment with investigational product until death due to any cause.
Measure: Overall Survival (OS) Time: Estimated to be from the time of informed consent for approximately 2.5 yearsDescription: MEDI5395 concentrations in blood will be tabulated by dose cohort along with descriptive statistics.
Measure: MEDI5395 viral genome copies in blood collected over time Time: Estimated to be from the time of informed consent for approximately 6 monthsDescription: GM-CSF protein concentrations in blood will be tabulated by dose cohort along with descriptive statistics.
Measure: Granulocyte-macrophage colony-stimulating factor (GM-CSF) concentrations in blood collected over time Time: Estimated to be from the time of informed consent for approximately 6 monthsDescription: Immunogenic response to MEDI5395 will be assessed by summarizing the number of subjects who develop detectable anti-MEDI5395 neutralizing antibodies
Measure: Number of subjects who develop detectable anti-MEDI5395 neutralizing antibodies Time: Estimated to be from the time of informed consent until approximately 90 days after the last dose of last investigational productDescription: Immunogenic response to MEDI5395 will be assessed by summarizing the percentage of subjects who develop detectable anti-MEDI5395 neutralizing antibodies
Measure: Percentage of subjects who develop detectable anti-MEDI5395 neutralizing antibodies Time: Estimated to be from the time of informed consent until approximately 90 days after the last dose of last investigational productDescription: CD8 T cell infiltration and PD-L1 expression in tumors pre and post dosing will be assessed using validated IHC assays.
Measure: The number of cluster of differentiation 8 (CD8) positive cells and programmed death-ligand 1(PD-L1) expressing cells within biopsies will be assessed. Time: Estimated to be from the time of informed consent until 4 weeks after the first dose of MEDI5395Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 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