|drug4114||standard chemotherapy Wiki||0.58|
|drug872||Conjunctival swab and nasopharyngeal swab Wiki||0.58|
|drug3782||anti-CD40 antibody (CDX-1140) Wiki||0.58|
|drug2483||Phone Administration of Questionnaires Wiki||0.58|
|drug873||Connected devices measurements Wiki||0.58|
|drug3564||UCPVax + Nivolumab Wiki||0.58|
|drug869||Computerized Talking Touchscreen Wiki||0.58|
|drug1281||FLT3 Ligand (CDX-301) Wiki||0.58|
|D002289||Carcinoma, Non-Small-Cell Lung NIH||0.77|
|D008175||Lung Neoplasms NIH||0.37|
There are 3 clinical trials
The main purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of YH25448 when given orally to participants with epidermal growth factor receptor single activating mutation positive (EGFRm+) locally advanced or metastatic Non Small Cell Lung Cancer (NSCLC).
Description: An adverse event is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.Measure: Part D: Number of Participants with Adverse Event as a Measure of Safety and Tolerability Time: Up to 2 years
Description: Plasma Concentration of YH25448 after administration of single dose will be evaluated.Measure: Part D: Plasma Concentration of YH25448 After Administration of Single Dose (SD) Time: Up to 2 years
Description: Plasma Concentration of YH25448 after administration of multiple dose will be evaluated.Measure: Part D: Plasma Concentration of YH25448 After Administration of Multiple Dose (MD) Time: Up to 2 years
Description: Plasma Concentration of YH25448 metabolites (M6 and M7) after administration of single and multiple dose will be evaluated.Measure: Part D: Plasma Concentration of YH25448 Metabolites (M6 and M7) After Administration of Single and Multiple Dose Time: Up to 2 years
Description: ORR is defined as the percentage of participants who have at least one confirmed Partial response (PR) or Complete response (CR) (according to Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) prior to disease progression or recurrence. CR is defined when all target lesions (TLs) and non-target lesions (NTLs) present at baseline have disappeared (with the exception of lymph nodes which must be less than (<)10 millimeters (mm) to be considered non-pathological) and no new lesions have developed since baseline. PR is defined when the sum of diameters of the TLs has decreased by 30 percent (%) or more compared to baseline (with no evidence of progression) and the NTLs are at least stable with no evidence of new lesions.Measure: Part D: Overall Response Rate (ORR) Time: Up to 2 years
Description: DoR is defined as the time from the date of first documented responses until date of documented progression or death whichever comes first.Measure: Part D: Duration of Response (DoR) Time: Up to 2 years
Description: DCR is defined as the percentage of participants with a best overall, extracranial and intracranial response of CR, PR or Stable Disease (SD). CR is defined as disappearance of all target lesions since baseline. Any pathological lymph nodes selected as target lesions must have a reduction in short axis to < 10 mm. PR is defined as At least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters. SD is defined as Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm for extracranial and intracranial lesion, respectively.Measure: Part D: Disease Control Rate (DCR) Time: Up to 2 years
Description: Tumor shrinkage is measured at each visit by the percentage change in the sum of the diameters of target lesions compared to baseline measured as greater than or equal to (>=) 10 mm in the longest lesion diameter with computed tomography (CT) or magnetic resonance imaging (MRI).Measure: Part D: Tumor Shrinkage Time: Up to 2 years
Description: PFS is defined as the time from first dosing date until documented disease progression or death from any cause whichever occur first based on investigator assessment using RECIST 1.1. PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm for extracranial and intracranial lesion, respectively.Measure: Part D: Progression Free Survival (PFS) Time: Up to 2 years
Description: OS is defined as the interval between the date of first dose and the date of participants death due to any cause.Measure: Part D: Overall Survival (OS) Time: Up to 2 years
Lung cancer is the most commonly diagnosed malignancy and the leading cause of cancer-related mortality both in men and women worldwide. The past few years have demonstrated great progress in the field of tumor immunotherapy through agents that address mechanisms of immune escape notably, so called immune checkpoint inhibitors (ICB). Indeed, ICB have emerged as a fatal weapon in the anticancer treatment arsenal. Anti-PD-1 and anti-PD-L1 antibodies have shown promising results in several cancers including Non-small Cell Lung Cancer (NSCLC) patients. Although such ICB extend patient's survival compared with conventional systemic therapies, they fail to control cancer progression in a significant proportion of patients which can reach up to 50-60% in NSCLC. Recent literature highlights a range of factors involved in the heterogeneous responses and failures to ICB therapies. The challenge is how can ICB treatment efficacy be extended to majority patients? To respond to this question, to increase the success of immunotherapy, immuno-oncology community develops combinations approaches. The aim of these project is to evaluate the efficacy of Nivolumab plus a novel CD4Th1 inducer anti-cancer vaccine in NSCLC patients. Nivolumab (NIVO), which is an anti-PD-1 antibody, has shown promising results in 2nd line treatment for advanced NSCLC. UCPVax is a therapeutic anti-cancer vaccine based on the telomerase-derived helper peptides designed to induce strong TH1 CD4 T cell responses in cancer patients (NCT02818426).
Description: PFS is defined by the duration from the date of initiation of the treatment to the disease progression (RECIST) or death from any cause whichever occurs first, censoring cases without progression at the date of last disease assessment.Measure: 6 months Progression-Free Survival (PFS) rate Time: 6 months after the date of initiation of treatment (1st day of 1st cycle of chemotherapy)
The purpose of this study is to test a new way of treating the most common form of lung cancer. The investigators are testing a combination of radiotherapy with two new forms of immunotherapy. This study is testing the safety and effectiveness of this treatment approach as compared to standard treatment options.
Description: Death Any ≥ Grade 3 non-hematological toxicity, with the following exceptions: Grade 3 alopecia, vitiligo, or endocrinopathies controlled by hormone replacement therapy Grade 3 nausea that resolves to ≤ grade 2 with or without treatment within 72 hours Grade 3 vomiting and diarrhea that resolves to ≤ grade 2 with or without treatment within 72 hours Grade 3 fatigue that resolves to ≤ grade 2 within 5 days Grade 3 hypertension in the absence of maximal medical therapy Grade 3 adverse event of tumor flare (defined as local pain, irritation, or rash localized at sites of known or suspected tumor) of ≤ 7 days in duration Grade 3 amylase or lipase abnormalities that are not associated with symptoms or clinical manifestations of pancreatitis. It is recommended to consult with the Principal Investigator for grade 4 amylase or lipase abnormalities Grade 3 clinically significant laboratory abnormalities that are asymptomatic and can be reversed within 72 hours, however: Any Grade 4Measure: Phase I: Dose-limiting toxicity (DLT), defined as follows: Time: up to 8 weeks after initiation of study therapy
Description: Length of time that patient survives from time of study registrationMeasure: Overall survival (OS) duration Time: From date of registration until the date of death from any cause, assessed up to 2 years
Description: The clinical benefit rate (CBR) will be defined as the percentage of subjects who achieve best response of confirmed CR or PR, or stable disease (SD) for at least four months.Measure: Radiographic responses using descriptive statistics Time: From date of registration, assessed up to 4 months
Description: Summary statistics (mean, standard deviation, median, 25th and 75th percentiles, and range) and the mean change from baseline of linear-transformed scores will be reported for all the items and subscales of the EORTC QLQ-C30 questionnaire and the QLQ-LC13, according to the EORTC scoring manual guidelines. higher scores are a better level of functioningMeasure: Quality of Life using EORTC QLQ-LC13 (quality of Life Questionnaire, Lung Cancer) Time: 1 year
Description: Summary statistics (mean, standard deviation, median, 25th and 75th percentiles, and range) and the mean change from baseline of linear-transformed scores will be reported for all the items and subscales of the EORTC QLQ-C30 questionnaire and the QLQ-LC13, according to the EORTC scoring manual guidelines. Most items are scored 1 to 4, higher scores are a better level of functioning.Measure: Quality of Life using QLQ-C30 (Quality of Life Questionnaire) Time: 1 year
Description: Average daily step countsMeasure: Daily step count using descriptive statistics Time: 1 year
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