Developed by Shray Alag, The Harker School
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Name (Synonyms) | Correlation | |
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drug74 | 5Fluorouracil Wiki | 0.71 |
drug1604 | F-FMISO PET/CT Scan Wiki | 0.71 |
drug3425 | Proton Therapy Wiki | 0.71 |
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There are 2 clinical trials
The purpose of this study is to demonstrate that participants with HPV positive and hypoxia negative T1-2, N1-2c (AJCC, 7th ed.) oropharyngeal squamous cell carcinoma receiving a major de-escalated radiation therapy with 2 cycles of standard chemotherapy is not inferior to comparable subjects treated with the current standard chemoradiation. Given the restrictions of surgery during the COVID19 pandemic, we will start enrolling patients on Cohort B where surgery is not required. Once the COVI19 pandemic is over, we will resume and complete enrollment on Cohort A where surgery is required, prior to continuing enrolling patients on Cohort B. During the COVID-19 pandemic, the research MRIs are optional.
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