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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1116 | Control Wiki | 0.64 |
| drug913 | Carboplatin Wiki | 0.35 |
| drug3124 | Pembrolizumab Wiki | 0.35 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1184 | Couples' Intervention Wiki | 0.30 |
| drug1114 | Continuous vital sign monitoring - Isansys Patient Status Engine Wiki | 0.30 |
| drug3919 | Sensitivity Intervention Wiki | 0.30 |
| drug74 | 5Fluorouracil Wiki | 0.30 |
| drug3920 | Sensitivity and Couples' Intervention Wiki | 0.30 |
| drug3568 | Radspherin Wiki | 0.30 |
| drug2301 | Laboratory Biomarker Analysis Wiki | 0.30 |
| drug4348 | Test PCR Wiki | 0.30 |
| drug5077 | nasopharyngeal Covid 19 RT-PCR Wiki | 0.30 |
| drug4505 | Tremelimumab Wiki | 0.30 |
| drug1350 | Docetaxel Wiki | 0.30 |
| drug3977 | Simulation Intervention Wiki | 0.30 |
| drug1604 | F-FMISO PET/CT Scan Wiki | 0.30 |
| drug583 | Berzosertib Wiki | 0.30 |
| drug2499 | Machine Learning/AI Algorithm Wiki | 0.30 |
| drug4557 | Ultra Brief Online Mindfulness-based Intervention Wiki | 0.30 |
| drug3040 | PF-07209960 Wiki | 0.30 |
| drug3425 | Proton Therapy Wiki | 0.30 |
| drug769 | CMP-001 Wiki | 0.30 |
| drug994 | Cisplatin Wiki | 0.30 |
| drug58 | 30 Gy over 3 weeks Wiki | 0.30 |
| drug4264 | TDR Wiki | 0.30 |
| drug1819 | Growth Mindset Wiki | 0.30 |
| drug1913 | Hillrom Wiki | 0.30 |
| drug1104 | Conjunctival swab and nasopharyngeal swab Wiki | 0.30 |
| drug1391 | Durvalumab Wiki | 0.21 |
| drug1001 | Clinical Examination Wiki | 0.21 |
| drug109 | ADCT-301 Wiki | 0.21 |
| drug2479 | MSC Wiki | 0.21 |
| drug507 | BI 894999 Wiki | 0.17 |
| drug3386 | Probiotic Wiki | 0.17 |
| drug3497 | Questionnaire Administration Wiki | 0.09 |
| drug4690 | Vitamin C Wiki | 0.08 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D002292 | Carcinoma, Renal Cell NIH | 0.60 |
| D002294 | Carcinoma, Squamous Cell NIH | 0.43 |
| D000077195 | Squamous Cell Carcinoma of Head and Neck NIH | 0.43 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D010534 | Peritoneal Neoplasms NIH | 0.30 |
| D002285 | Carcinoma, Intraductal, Noninfiltrating NIH | 0.30 |
| D002278 | Carcinoma in Situ NIH | 0.30 |
| D000077216 | Carcinoma, Ovarian Epithelial NIH | 0.30 |
| D044584 | Carcinoma, Ductal NIH | 0.30 |
| D018270 | Carcinoma, Ductal, Breast NIH | 0.30 |
| D006528 | Carcinoma, Hepatocellular NIH | 0.30 |
| D010051 | Ovarian Neoplasms NIH | 0.17 |
| D010190 | Pancreatic Neoplasms NIH | 0.13 |
| D064726 | Triple Negative Breast Neoplasms NIH | 0.13 |
| D011471 | Prostatic Neoplasms NIH | 0.12 |
| D001943 | Breast Neoplasms NIH | 0.11 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0030731 | Carcinoma HPO | 1.00 |
| HP:0005584 | Renal cell carcinoma HPO | 0.60 |
| HP:0002860 | Squamous cell carcinoma HPO | 0.43 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0030075 | Ductal carcinoma in situ HPO | 0.30 |
| HP:0001402 | Hepatocellular carcinoma HPO | 0.30 |
| HP:0100615 | Ovarian neoplasm HPO | 0.17 |
| HP:0002894 | Neoplasm of the pancreas HPO | 0.13 |
| HP:0012125 | Prostate cancer HPO | 0.12 |
| HP:0003002 | Breast carcinoma HPO | 0.11 |
Navigate: Correlations HPO
There are 11 clinical trials
The aim of the phase Ia (dose escalation) part of this trial is to assess-> determine the Maximum Tolerated Dose (MTD) using a continuous dosing schedule A, using an intermittent Schedule B (2 weeks on, one week off in 3-week cycles) and the MTD using an intermittent Schedule C (one week on followed by one week off treatment, repeated every two weeks in 4-week cycles) in patients with solid tumours. In the phase Ib expansion part, the aim is to further evaluate the safety profile of BI 894999 at the dose recommended by the data monitoring committee (DMC). Once the MTD has been determined for both schedules A and B in patients with solid tumours, the MTD will be determined as well in patients with diffuse large B-cell lymphoma (DLBCL), using the DMC recommended schedule for solid tumours
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
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 2023Description: 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 2027RATIONALE: 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.
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 yearsDescription: 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 yearsDescription: 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 yearsDescription: 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 yearsDescription: Interval from randomisation to first evidence of metastases or death from RCC
Measure: Metastasis-free survival (MFS): Arm C vs A Time: 6.25 yearsDescription: Interval from randomisation to first evidence of metastases or death from RCC
Measure: Metastasis-free survival (MFS): Arm B vs A Time: 10.54 yearsDescription: Time from randomisation to death from RCC
Measure: RCC specific survival time: Arm C vs A Time: 13.25 yearsDescription: Time from randomisation to death from RCC
Measure: RCC specific survival time: Arm C vs A Time: 20.5 yearsThe 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.
This phase II trial studies how well berzosertib (M6620) and carboplatin with or without docetaxel works in treating patients with castration-resistant prostate cancer that has spread to other places in the body (metastatic). M6620 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving M6620, carboplatin and docetaxel may work better in treating patients with metastatic castration-resistant prostate cancer compared to carboplatin and docetaxel alone.
Description: Defined by radiographic response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or prostate specific antigen [PSA] response of > 50%). Will be conducted using the Cochran-Mantel-Haenszel test, with one-sided p-value of =< 0.05 considered significant.
Measure: Response rate (complete response + partial response) Time: Up to 2 yearsDescription: Assessed by Prostate Cancer Working Group (PCWG)3. PFS to be estimated with the Kaplan Meier methodology. Median and event-free rate at selected time points will be provided with 95% confidence interval.
Measure: Progression-free survival (PFS) Time: From the time of randomization up to 2 yearsDescription: Assessed by PCWG2. PSA progression will be estimated with the Kaplan Meier methodology. Median and event-free rate at selected time points will be provided with 95% confidence interval. Comparison of time to PSA progression between arms will be conducted using the log-rank test.
Measure: Time to PSA progression Time: From the time of randomization up to 2 yearsDescription: Assessed by RECIST 1.1. rPFS will be estimated with the Kaplan Meier methodology. Median and event-free rate at selected time points will be provided with 95% confidence interval.
Measure: Radiographic progression-free survival (rPFS) Time: From the time of randomization up to 2 yearsDescription: Will be summarized according to treatment arm. For toxicity reporting, all adverse events will be graded and analyzed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Type of adverse events, intensity (grading), and attribution will be provided in a listing. All adverse events resulting in discontinuation, dose modification, and/or dosing interruption, and/or treatment delay of drug will also be summarized. Laboratory test results will be classified according to the CTCAE version 5.0.
Measure: Incidence of adverse events Time: Up to 2 yearsDescription: OS will be estimated with the Kaplan Meier methodology. Comparison of OS between arms will be conducted using the log-rank test base on the intention-to-treat approach, where two treatment arms will be compared regardless of cross-over or any subsequent therapy.
Measure: Overall survival (OS) Time: From the time of randomization up to 2 yearsDescription: Gene mutation frequencies and mean +/- standard deviation of quantitative biomarkers will be summarized by arm and in overall population at baseline and/or at end of study.
Measure: Gene mutation frequencies Time: Baseline up to 2 yearsThis 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 yearsRAD-18-001 is a First-In-Man, Dose Escaltion study conducted at 2 sites. The dose escalation will be performed based on a 3 + 3 design. Increasing dose levels starting at 1 MBq will be followed by 2, 4 and 7 MBq. If the highest dose level of 7 MBq is reached without Dose Limiting Toxicicities (which will stop the dose escalation), this will be the recommended dose for further exploration. Acceptability of up to 7 MBq gives the opportunity to explore the doses of the dose escalation split into two administrations, and given as two separate injections 1 week apart. Split doses of 1, 2 and 3.5 MBq will be administered as two injections. Each subject will be followed until disease progression (in the abdominal cavity), or for 12 months after the administration of Radspherin® (whichever comes first).
Description: To investigate safety and toxicity of Radspherin®
Measure: Number of participants with Dose Limiting Toxicities as assessed by CTCAE v5.0. Time: 12 monthsDescription: To determine the MTD of Radspherin®, among the four suggested doses 1, 2, 4 and 7 MBq, as a single intraperitoneal (IP) injection and two repeated IP injections following cytoreductive surgery (CRS)
Measure: Maximum Tolerated Dose (MTD) Time: 21 daysThis study investigates the impact of COVID-19 pandemic on out-of-pocket costs, lost wages, and unemployment in patients with breast cancer undergoing breast surgery. Post-mastectomy reconstructive patients are at high risk for financial toxicity (adverse effects of escalating health care cost on well-being). The goal of this study is to collect information about financial costs patients may have as a result of surgical treatment for cancer with or without breast reconstruction and to learn if COVID-19 affects patient costs of breast reconstruction. This may help researchers demonstrate the financial consequences of undergoing breast surgery.
Description: Will be measured by the Comprehensive Score for financial Toxicity questionnaire. Summary statistics including mean, standard deviation, median, and range for continuous variables, and frequency count and percentage for categorical variables will be provided. Various subgroup analyses may occur. In these cases, continuous variables will be compared using the two-sample t-test and categorical variables will be compared using chi-squared test or Fisher's exact test. Multivariate regression analysis will be performed to account for confounding and to increase the robustness of any causal inference.
Measure: Prevalence of financial toxicity Time: Up to 1 year after completion of studyDescription: Summary statistics including mean, standard deviation, median, and range for continuous variables, and frequency count and percentage for categorical variables will be provided. Various subgroup analyses may occur. In these cases, continuous variables will be compared using the two sample t-test and categorical variables will be compared using chi-squared test or Fisher's exact test. Multivariate regression analysis will be performed to account for confounding and to increase the robustness of any causal inference.
Measure: Correlation between economic disruption from coronavirus disease 2019 (COVID-19) and financial toxicity Time: Up to 1 year after completion of studyDescription: Will be assessed using the Short Form-12 survey. Summary statistics including mean, standard deviation, median, and range for continuous variables, and frequency count and percentage for categorical variables will be provided. Various subgroup analyses may occur. In these cases, continuous variables will be compared using the two-sample t-test and categorical variables will be compared using chi-squared test or Fisher's exact test. Multivariate regression analysis will be performed to account for confounding and to increase the robustness of any causal inference.
Measure: Relationship between financial toxicity and patient reported quality of life Time: Up to 1 year after completion of studyDescription: Will be assessed using the Breast-Q survey. Summary statistics including mean, standard deviation, median, and range for continuous variables, and frequency count and percentage for categorical variables will be provided. Various subgroup analyses may occur. In these cases, continuous variables will be compared using the two-sample t-test and categorical variables will be compared using chi-squared test or Fisher's exact test. Multivariate regression analysis will be performed to account for confounding and to increase the robustness of any causal inference.
Measure: Relationship between financial toxicity and patient reported satisfaction with breast reconstruction Time: Up to 1 year after completion of studySince December 2019, a new disease named COVID-19 linked to a new coronavirus, SARS-CoV2 has emerged in China in the city of Wuhan, Hubei province, spreading very quickly to all 5 continents, and responsible for a pandemic. France is the third most affected country in Europe after Italy and Spain. Groups of patients at a higher risk of developing a severe form of COVID-19 have been defined: this include patients with immunosuppressive disease as cancer or patients with advanced cirrhosis of the liver. Coronavirus liver injury had been described with SARS-CoV 1 and MERS-CoV. There is no data on liver damage associated with COVID-19 infection for compensated or decompensated cirrhotic patients. The objectives of this project are to estimate the incidence of COVID-19 in hepatocellular carcinoma population, both hospital and ambulatory, and to study the impact on the frequency of severe forms, the prognosis, but also liver function, and the management of hepatocellular carcinoma, in this context of pandemic
Description: Incidence of COVID-19 infection in patients with hepatocellular carcinoma in France
Measure: Incidence of COVID-19 infection in patients with hepatocellular carcinoma in France Time: 6 monthsThis 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.
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 yearsDescription: 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 yearsDescription: 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 progressionDescription: Tumor response based on RECIST 1.1
Measure: ORR in Dose Escalation (Part 1) Time: Baseline through up to 2 years or until disease progressionDescription: 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 yearsDescription: 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 yearsDescription: 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 yearsDescription: 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 yearsDescription: 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 yearsDescription: 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 yearsDescription: 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 yearsDescription: 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 yearsDescription: 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 2Description: DCR as assessed using RECIST 1.1
Measure: Disease control rate (DCR) Time: Baseline through up to 2 years or until disease progressionDescription: DOR as assessed using RECIST 1.1
Measure: Duration of response (DOR) Time: Baseline through up to 2 years or until disease progressionDescription: TTP as assessed using RECIST 1.1
Measure: Time to progression (TTP) Time: Baseline through up to 2 years or until disease progressionDescription: PFS as assessed using RECIST 1.1
Measure: Progression free survival (PFS) Time: Baseline through up to 2 years or until disease progressionDescription: Proportion of participants alive
Measure: Overall survival (OS) in the Expansion Cohorts (Part 2) Time: Baseline through up to 2 yearsCMP-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