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D002292: Carcinoma, Renal Cell

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 (12)


Name (Synonyms) Correlation
drug1116 Control Wiki 0.53
drug1184 Couples' Intervention Wiki 0.50
drug3919 Sensitivity Intervention Wiki 0.50
Name (Synonyms) Correlation
drug3920 Sensitivity and Couples' Intervention Wiki 0.50
drug4505 Tremelimumab Wiki 0.50
drug3977 Simulation Intervention Wiki 0.50
drug3040 PF-07209960 Wiki 0.50
drug1819 Growth Mindset Wiki 0.50
drug1391 Durvalumab Wiki 0.35
drug109 ADCT-301 Wiki 0.35
drug3124 Pembrolizumab Wiki 0.29
drug4690 Vitamin C Wiki 0.13

Correlated MeSH Terms (4)


Name (Synonyms) Correlation
D002277 Carcinoma NIH 0.60
D000077195 Squamous Cell Carcinoma of Head and Neck NIH 0.35
D010190 Pancreatic Neoplasms NIH 0.22
Name (Synonyms) Correlation
D064726 Triple Negative Breast Neoplasms NIH 0.22

Correlated HPO Terms (3)


Name (Synonyms) Correlation
HP:0005584 Renal cell carcinoma HPO 1.00
HP:0030731 Carcinoma HPO 0.60
HP:0002894 Neoplasm of the pancreas HPO 0.22

Clinical Trials

Navigate: Correlations   HPO

There are 4 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
4 Phase 1 Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, and Anti-Tumor Activity of PF-07209960 in Participants With Advanced or Metastatic Solid Tumors

This is a first-in-human, Phase 1, open label, multicenter, multiple dose, dose escalation and dose expansion study intended to evaluate the safety, pharmacokinetic, pharmacodynamic, and potential clinical benefit of PF-07209960, an anti-PD-1 targeting IL-15 fusion protein, in participants with selected locally advanced or metastatic solid tumors for whom no standard therapy is available, or would not be an appropriate option in the opinion of the participant and their treating physician, or participants who have refused standard therapy. The study contains 2 parts, single agent Dose Escalation (Part 1) to determine the recommended dose of PF-07209960, followed by Dose Expansion (Part 2) in selected tumor types at the recommended dose.

NCT04628780
Conditions
  1. Non-small-cell Lung Cancer
  2. Squamous Cell Carcinoma of the Head and Neck
  3. Renal Cell Carcinoma
  4. Urothelial Carcinoma
  5. Ovarian Carcinoma
Interventions
  1. Biological: PF-07209960
MeSH:Carcinoma Carcinoma, Renal Cell Squamous Cell Carcinoma Squamous Cell Carcinoma of Head and Neck
HPO:Carcinoma Clear cell renal cell carcinoma Papillary renal cell carcinoma Renal cell carcinoma

Primary Outcomes

Description: DLTs will be evaluated during Cycle 1 (a cycle is 28 days) in Part 1. The number of DLTs will be used to determine the optimal dose

Measure: Number of participants with dose limiting toxicities (DLTs) in Dose Escalation (Part 1)

Time: Baseline through 28 days after first dose (Cycle 1)

Description: AEs as characterized by type, frequency, severity (graded by CTCAE v.5.0; CRS graded by ASTCT criteria), timing, seriousness, and relationship to study drug

Measure: Number of participants with adverse events (AEs)

Time: Baseline through up to 2 years

Description: Laboratory abnormalities as characterized by type, frequency, severity (graded by CTCAE v.5.0), and timing

Measure: Number of participants with clinically significant laboratory abnormalities

Time: Baseline through up to 2 years

Description: Tumor response based on RECIST 1.1

Measure: Objective response rate (ORR) in the Expansion cohorts (Part 2)

Time: Baseline through up to 2 years or until disease progression

Secondary Outcomes

Description: Tumor response based on RECIST 1.1

Measure: ORR in Dose Escalation (Part 1)

Time: Baseline through up to 2 years or until disease progression

Description: PK assessment for PF-07209960

Measure: Single dose: Maximal concentration (Cmax)

Time: Cycle 1 (each cycle is 28 days), Cycle 2, and Day 1 of each subsequent cycle, and at the End of Treatment visit, up to about 2 years

Description: PK assessment for PF-07209960

Measure: Single dose: Time to maximal plasma concentration (Tmax)

Time: Cycle 1 (each cycle is 28 days), Cycle 2, and Day 1 of each subsequent cycle, and at the End of Treatment visit, up to about 2 years

Description: PK assessment for PF-07209960

Measure: Single dose: Area Under the Curve within one dosing interval (AUCtau)

Time: Cycle 1 (each cycle is 28 days), Cycle 2, and Day 1 of each subsequent cycle, and at the End of Treatment visit, up to about 2 years

Description: PK assessment for PF-07209960

Measure: Multiple dose: Maximum observed steady state plasma concentration (Cmax,ss)

Time: Cycle 1 (each cycle is 28 days), Cycle 2, and Day 1 of each subsequent cycle, and at the End of Treatment visit, up to about 2 years

Description: PK assessment for PF-07209960

Measure: Multiple dose: Time to reach Maximum Observed Steady State Plasma Concentration (Tmax,ss)

Time: Cycle 1 (each cycle is 28 days), Cycle 2, and Day 1 of each subsequent cycle, and at the End of Treatment visit, up to about 2 years

Description: PK assessment for PF-07209960

Measure: Multiple dose: Area Under the curve within one dose interval at steady state (AUCtau,ss)

Time: Cycle 1 (each cycle is 28 days), Cycle 2, and Day 1 of each subsequent cycle, and at the End of Treatment visit, up to about 2 years

Description: PK assessment for PF-07209960

Measure: Lowest concentration (Ctrough) reached before the next dose is administered

Time: Cycle 1 (each cycle is 28 days), Cycle 2, and day 1 of each subsequent cycle, and at the End of Treatment visit, up to about 2 years

Description: Incidence, titers, and endogenous IL-15 cross-reactivity of anti-drug antibody and neutralizing antibody against PF-07209960

Measure: Immunogenicity in Expansion Cohorts (Part 2)

Time: Cycle 1 (each cycle is 28 days), Cycle 2, and Day 1 of each subsequent cycle, and at the End of Treatment visit, up to about 2 years

Description: Effect of PF-07209960 therapy on immune cells in tumor biopsies

Measure: Intratumor T cells in pre-treatment vs. on-treatment tumor biopsy samples in Expansion Cohorts (Part 2)

Time: Baseline through start of Cycle 2

Description: DCR as assessed using RECIST 1.1

Measure: Disease control rate (DCR)

Time: Baseline through up to 2 years or until disease progression

Description: DOR as assessed using RECIST 1.1

Measure: Duration of response (DOR)

Time: Baseline through up to 2 years or until disease progression

Description: TTP as assessed using RECIST 1.1

Measure: Time to progression (TTP)

Time: Baseline through up to 2 years or until disease progression

Description: PFS as assessed using RECIST 1.1

Measure: Progression free survival (PFS)

Time: Baseline through up to 2 years or until disease progression

Description: Proportion of participants alive

Measure: Overall survival (OS) in the Expansion Cohorts (Part 2)

Time: Baseline through up to 2 years

HPO Nodes


Reports

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.

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Interventions

4,818 reports on interventions/drugs

MeSH

706 reports on MeSH terms

HPO

306 reports on HPO terms

All Terms

Alphabetical index of all Terms

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