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    HP:0005584: Renal cell carcinoma

    Developed by Shray Alag, The Harker School
    Sections: Correlations, Clinical Trials, and HPO

    Correlations computed by analyzing all clinical trials.

    Navigate: Clinical Trials and HPO


    Correlated Drug Terms (9)


    Name (Synonyms) Correlation
    drug103 ADCT-301 Wiki 0.58
    drug4092 Tremelimumab Wiki 0.58
    drug1020 Conjunctival swab and nasopharyngeal swab Wiki 0.58
    Name (Synonyms) Correlation
    drug1024 Continuation of ACEi/ARB Wiki 0.58
    drug1287 Durvalumab Wiki 0.58
    drug3900 Taking Time Wiki 0.58
    drug1018 Conexiones Wiki 0.58
    drug1241 Discontinuation of ACEi/ARB Wiki 0.58
    drug2852 Pembrolizumab Wiki 0.41

    Correlated MeSH Terms (4)


    Name (Synonyms) Correlation
    D002292 Carcinoma, Renal Cell NIH 1.00
    D002277 Carcinoma NIH 0.61
    D010190 Pancreatic Neoplasms NIH 0.29
    Name (Synonyms) Correlation
    D064726 Triple Negative Breast Neoplasms NIH 0.26

    Correlated HPO Terms (2)


    Name (Synonyms) Correlation
    HP:0030731 Carcinoma HPO 0.61
    HP:0002894 Neoplasm of the pancreas HPO 0.29

    Clinical Trials

    Navigate: Correlations   HPO

    There are 3 clinical trials


    1 TRACERx Renal (TRAcking Renal Cell Carcinoma Evolution Through Therapy (Rx)) CAPTURE: COVID-19 Antiviral Response in a Pan-tumour Immune Study

    TRACERx Renal: This is a translational study, which, aims to develop prognostic and predictive biomarkers for patients with renal cell carcinoma (RCC). CAPTURE Sub-study: Covid-19 antiviral response in a pan-tumour immune monitoring study

    NCT03226886
    Conditions
    1. Renal Cell Carcinoma
    2. Cancer
    3. Healthy Volunteers
    MeSH:Carcinoma Carcinoma, Renal Cell
    HPO:Carcinoma Clear cell renal cell carcinoma Papillary renal cell carcinoma Renal cell carcinoma

    Primary Outcomes

    Description: Outcomes will be quantified using descriptive statistics with the intention of providing hypothesis-generating data for use in future studies.

    Measure: To validate ITH index and WGII as stage and grade independent prognostic markers of progression free survival in patients with ccRCC mutation in a gene of interest

    Time: From trial activation until trial closure approximately 1st September 2023

    Description: Outcomes will be quantified using descriptive statistics

    Measure: CAPTURE Sub-study: Describe the population characteristics between SARS-CoV-2 positive and negative cancer patients

    Time: From sub-study activation until trial closure approximately 2027
    2 An International Investigator-led Phase III Multi Arm Multi Stage Multi-centre Randomised Controlled Platform Trial of Adjuvant Therapy in Patients With Resected Primary Renal Cell Carcinoma (RCC) at High or Intermediate Risk of Relapse

    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.

    NCT03288532
    Conditions
    1. Renal Cell Carcinoma
    Interventions
    1. Drug: Durvalumab
    2. Drug: Tremelimumab
    MeSH:Carcinoma Carcinoma, Renal Cell
    HPO:Carcinoma Clear cell renal cell carcinoma Papillary renal cell carcinoma Renal cell carcinoma

    Primary Outcomes

    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 years

    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 B vs A

    Time: 10.54 years

    Description: 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 years

    Description: 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 years

    Secondary Outcomes

    Description: Interval from randomisation to first evidence of metastases or death from RCC

    Measure: Metastasis-free survival (MFS): Arm C vs A

    Time: 6.25 years

    Description: Interval from randomisation to first evidence of metastases or death from RCC

    Measure: Metastasis-free survival (MFS): Arm B vs A

    Time: 10.54 years

    Description: Time from randomisation to death from RCC

    Measure: RCC specific survival time: Arm C vs A

    Time: 13.25 years

    Description: Time from randomisation to death from RCC

    Measure: RCC specific survival time: Arm C vs A

    Time: 20.5 years
    3 A Phase 1b, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Camidanlumab Tesirine (ADCT-301) as Monotherapy or in Combination in Patients With Selected Advanced Solid Tumors

    This study evaluates ADCT-301 in patients with Selected Advanced Solid Tumors. Patients will participate in a Treatment Period with 3-week cycles and a Follow-up Period every 12 weeks for up to 1 year after treatment discontinuation.

    NCT03621982
    Conditions
    1. Advanced Solid Tumors With Literature Evidence of CD25(+) Treg Content
    2. Head and Neck Cancer Squamous Cell Carcinoma
    3. Non-small Cell Lung Cancer
    4. Gastric Cancer
    5. Esophageal Cancer
    6. Pancreas Cancer
    7. Bladder Cancer
    8. Renal Cell Carcinoma
    9. Melanoma
    10. Triple-negative Breast Cancer
    11. Ovarian Cancer
    12. Colo-rectal Cancer
    Interventions
    1. Drug: ADCT-301
    2. Biological: Pembrolizumab
    MeSH:Carcinoma Carcinoma, Renal Cell Triple Negative Breast Neoplasms Pancreatic Neoplasms
    HPO:Carcinoma Clear cell renal cell carcinoma Neoplasm of the pancreas Papillary renal cell carcinoma Renal cell carcinoma

    Primary Outcomes

    Description: An AE is defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment.

    Measure: Assessment of Dose Limiting Toxicities in Determination of the Maximum Tolerated Dose Limiting toxicities as defined per protocol, as related to ADCT-301

    Time: Up to 3 years

    Description: Adverse events will be graded according to CTAE v4.0 (or more recent). For events not included in the CTCAE criteria, the severity of the AE will be graded on a scale of 1 to 5.

    Measure: Number of Adverse Events of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or Above

    Time: Up to 3 years

    Description: A SAE is defined as any AE that results in death, is life threatening, requires inpatient hospitalization of prolongation of existing hospitalization (hospitalization for elective procedures or for protocol compliance is not considered an SAE), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgement may jeopardize the patient or may require medical or surgical intervention to prevent any of the outcomes listed above.

    Measure: Number of Serious Adverse Events (SAE)

    Time: Up to 3 years

    Description: AEs will be graded according to CTCAE v.4.0 (or more recent). For events not included in the CTCAE criteria, the severity of the AE will be graded on a scale of 1 to 5.

    Measure: Number of SAEs of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or Above

    Time: Up to 3 years

    Measure: Number of Dose Interruptions and/or Dose Reductions

    Time: Up to 3 years

    Measure: Number of Dose Limiting Toxicities

    Time: Up to 3 years

    Measure: Number of Participants who Experience a Clinically Significant Change in Baseline in Laboratory Values

    Time: Up to 3 years

    Measure: Number of Participants who Experience a Clinically Significant Change in Baseline in Vital Signs

    Time: Up to 3 years

    Measure: Number of Participants who Experience a Clinically Significant Change in Baseline in Electrocardiogram (ECG) Results

    Time: Up to 3 years

    Measure: Number of Particpants who Experience a Clinically Significant Change in Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status

    Time: Up to 3 years

    Secondary Outcomes

    Description: Overall response rate (ORR) according to the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1

    Measure: Evaluate the preliminary anti-tumor activity of camidanlumab tesirine

    Time: Up to 3 years

    Description: Duration of response (DOR) defined as the time from the first documentation of tumor response to disease progression as per RECIST v1.1

    Measure: Evaluate the preliminary anti-tumor activity of camidanlumab tesirine

    Time: Up to 3 years

    Description: Progression-free survival (PFS) defined as the time between start of treatment and the first documentation of recurrence or progression as per RECIST v1.1

    Measure: Evaluate the preliminary anti-tumor activity of camidanlumab tesirine

    Time: Up to 3 years

    Description: Overall survival (OS) defined as the time between the start of treatment and death from any cause

    Measure: Evaluate the preliminary anti-tumor activity of camidanlumab tesirine

    Time: Up to 3 years

    Description: Noncompartmental analysis of the maximum concentration (Cmax)

    Measure: Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 in serum

    Time: Up to 3 years

    Description: Noncompartmental analysis of the time to maximum concentration (Tmax)

    Measure: Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum

    Time: Up to 3 years

    Description: Noncompartmental analysis of the area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0 last)

    Measure: Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum

    Time: Up to 3 years

    Description: Noncompartmental analysis of the area under the concentration-time curve from time zero to infinity (AUC0-∞)

    Measure: Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum

    Time: Up to 3 years

    Description: Noncompartmental analysis of the area under the concentration-time curve from time zero to the end of the dosing interval (AUC0-τ)

    Measure: Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum

    Time: Up to 3 years

    Description: Noncompartmental analysis of the accumulation index (AI)

    Measure: Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum

    Time: Up to 3 years

    Description: Noncompartmental analysis of clearance (CL)

    Measure: Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum

    Time: Up to 3 years

    Description: Noncompartmental analysis of volume of distribution (Vd)

    Measure: Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum

    Time: Up to 3 years

    Description: ADA titers if applicable, neutralizing activity to camidanlumab tesirine after treatment with camidanlumab tesirine.

    Measure: Number of confirmed positive anti-drug antibody (ADA) responses

    Time: Up to 3 years

    HPO Nodes


    Reports

    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.

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