Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
Name (Synonyms) | Correlation | |
---|---|---|
drug769 | CMP-001 Wiki | 0.58 |
drug2603 | Methylene Blue Wiki | 0.58 |
drug1124 | Control Test Wiki | 0.58 |
Name (Synonyms) | Correlation | |
---|---|---|
D002294 | Carcinoma, Squamous Cell NIH | 0.41 |
D000077195 | Squamous Cell Carcinoma of Head and Neck NIH | 0.41 |
D002277 | Carcinoma NIH | 0.35 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0002860 | Squamous cell carcinoma HPO | 0.41 |
HP:0030731 | Carcinoma HPO | 0.35 |
HP:0005584 | Renal cell carcinoma HPO | 0.29 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0002894 | Neoplasm of the pancreas HPO | 0.26 |
HP:0030358 | Non-small cell lung carcinoma HPO | 0.24 |
HP:0100526 | Neoplasm of the lung HPO | 0.14 |
Navigate: Correlations HPO
There are 3 clinical trials
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.
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 yearsDescription: 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 yearsDescription: 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 yearsDescription: 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 yearsDescription: 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 yearsDescription: 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 yearsDescription: 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 yearsDescription: 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 yearsDescription: 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 yearsDescription: Noncompartmental analysis of the time to maximum concentration (Tmax)
Measure: Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum Time: Up to 3 yearsDescription: 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 yearsDescription: 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 yearsDescription: 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 yearsDescription: Noncompartmental analysis of the accumulation index (AI)
Measure: Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum Time: Up to 3 yearsDescription: Noncompartmental analysis of clearance (CL)
Measure: Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum Time: Up to 3 yearsDescription: Noncompartmental analysis of volume of distribution (Vd)
Measure: Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum Time: Up to 3 yearsDescription: 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 yearsNon-Small Cell Lung Cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. It is the most common form of lung cancer, accounting for around 85% of lung cancers. The purpose of this study is to evaluate the safety and efficacy (how well the study drug works against the disease) of venetoclax in combination with pembrolizumab in participants with NSCLC. Venetoclax is a drug that kills cancer cells by blocking a protein (part of a cell) that allows cancer cells to stay alive. Pembrolizumab is approved drug for the treatment of NSCLC. It works with your immune system to help fight certain cancers. The study is split into two portions - dose escalation and randomization. Participants are assigned one of the three treatment groups to receive pembrolizumab alone or in combination with venetoclax. Each group receives a different treatment. Participants who are at least 18 years of age with a diagnosis of NSCLC will be enrolled. Around 100 participants will be enrolled in the study in approximately 44 sites across United States. Participants will receive intravenous (IV) infusion of pembrolizumab alone or in combination with oral venetoclax tablets. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Description: DLTs are adverse events that are considered to have a reasonable possibility of relationship to the administration of venetoclax and pembrolizumab and cannot be attributed by the investigator to a clearly identifiable cause such as disease progression, concurrent illness or concomitant medication.
Measure: Number of Participants with Dose-Limiting Toxicities (DLTs) Time: Up to 28 DaysDescription: Change in the SLD is assessed by exposure-response modeling
Measure: Change in the Sum of the Longest Diameter (SLD) Time: Up to 35 Cycles (Each Cycle is 21 Days)Description: Maximum plasma concentration (Cmax) of venetoclax
Measure: Maximum Plasma Concentration (Cmax) of Venetoclax Time: Up to Cycle 1 (Each Cycle is 21 Days)Description: Time to maximum observed plasma concentration (Tmax) of venetoclax
Measure: Time to Maximum Observed Plasma Concentration (Tmax) of Venetoclax Time: Up to Cycle 1 (Each Cycle is 21 Days)Description: Area Under the Plasma Concentration-time Curve (AUC) from 0-24 (AUC0-24)
Measure: Area Under the Plasma Concentration-Time Curve Over Time from 0 to 24 (AUC0-24) of Venetoclax in Plasma Time: Up to Cycle 1 (Each Cycle is 21 Days)Description: ORR will be defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR).
Measure: Objective Response Rate (ORR) Time: Up to 35 Cycles (Each Cycle is 21 Days)CMP-001-007 is a Phase 2 study of CMP-001 intratumoral (IT) and pembrolizumab intravenous (IV) administered to participants with head and neck squamous cell carcinoma (HNSCC) who have not been previously treated with a programmed cell death protein 1 (PD-1) blocking antibody. The primary objective of the study is to determine the Investigator-assessed confirmed objective response with CMP-001 in combination with pembrolizumab in subjects with head and neck squamous cell carcinoma (HNSCC) The secondary objectives are to: - To evaluate the safety and tolerability of CMP-001 administered by intratumoral (IT) injection in combination with pembrolizumab in subjects with HNSCC - To evaluate the efficacy of CMP-001 in combination with pembrolizumab in subjects with HNSCC - To evaluate the effect of human papillomavirus (HPV) infection and programmed death-ligand 1 (PD-L1) expressions on the efficacy of CMP-001 in combination with pembrolizumab Participants will continue to receive treatment of CMP-001 and pembrolizumab according to the treatment schedule until a reason for treatment discontinuation is reached.
Description: Objective response is the proportion of subjects that experience confirmed complete or partial response based on RECIST v1.1.
Measure: The objective response (investigator-assessed) to CMP-001 in combination with pembrolizumab in subjects with head and neck squamous cell carcinoma (HNSCC). Time: From first dose of CMP-001 (Week 1 Day 1) until 30 days after the last CMP-001 injection (until a reason for treatment discontinuation occurs)Description: As determined by adverse events, serious adverse events, adverse events leading to discontinuation or death, and severity of adverse events (per NCI CTCAE v 5.0).
Measure: Safety and tolerability of CMP-001 administered by intratumoral (IT) injection in combination with pembrolizumab in subjects with HNSCC. Time: From first dose of CMP-001 (Week 1 Day 1) until 30 days after the last CMP-001 injection (until a reason for treatment discontinuation occurs)Description: Duration of Response (DOR), defined as the time from date of first documented response (CR or PR) to date of documented progressive disease (PD), based on RECIST v1.1 by Investigator assessment (IA). Progression-free Survival (PFS), defined as the time from date of first dose of study drug to date of documented PD based on RECIST v1.1 by IA or death, whichever occurs first. Overall Survival (OS), defined as the time from the date of first dose of study drug to the date of death. iORR, defined as the proportion of subjects with a best overall response (BOR) of immune complete response (iCR) or immune partial response (iPR) based on the immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST) by IA. iDOR, defined as the time from the date of the first immune response (iCR or iPR) to the date of immune confirmed progressive disease (iCPD) by IA. iPFS, defined as the time from date of first dose of study drug to date of iCPD by IA or death, whichever occurs first.
Measure: Efficacy [characterized by DOR, PFS, and OS, along with Immune Objective Response Rate (iORR), Immune Duration of Response (iDOR), and Immune Progression-free Survival (iPFS)] of CMP-001 in combination with pembrolizumab in subjects with HNSCC. Time: From first dose of CMP-001 (Week 1 Day 1) until 30 days after the last CMP-001 injection (until a reason for treatment discontinuation occurs)Description: Evaluated by examining ORR (see above), DOR (see above), and PFS (see above) based on HPV status and PD-L1 expressions (combined positive score [CPS] 20).
Measure: The effect of human papillomavirus (HPV) infection and programmed death ligand 1 (PD-L1) expressions on the efficacy of CMP-001 in combination with pembrolizumab. Time: From first dose of CMP-001 (Week 1 Day 1) until 30 days after the last CMP-001 injection (until a reason for treatment discontinuation occurs)Alphabetical 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