SNPMiner Trials: Mutation Report
Report for Mutation Q12W
Developed by Shray Alag, 2019.
SNP Clinical Trial Gene
There are 4 clinical trials
Clinical Trials
To evaluate the safety of intravitreal (IVT) Fovista® administered in combination with
anti-VEGF therapy.
NCT02387957 Age-Related Macular Degeneration Drug: Fovista® Drug: bevacizumab Drug: ranibizumab Drug: aflibercept
Subjects will be treated with "combination therapy" of IVT Fovista® and IVT anti-VEGF therapy
every month for the first 5 months (Day 1, Months 1,2,3,4), followed by Q12W (every 12 weeks)
administration (Months 7,10, 13,16, 19 and 22), for a total of 24 months. --- Q12W ---
Primary Outcomes
Description: Number of Patients with Systemic Adverse Events
Measure: Total Numer of Systemic Adverse Events
Time: 2 years
Description: Number of Patients with Other Adverse Events
Measure: Total Number of Other Adverse Events (>5%)
Time: 2 years
This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered
at 8-week intervals or as specified in the protocol following treatment initiation, compared
with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME).
Percentage of Participants in the Faricimab As Specified in Protocol Arm on a Q4W, Q8W, Q12W, or Q16W Treatment Interval at 1 Year. --- Q12W ---
Percentage of Participants in the Faricimab As Specified in Protocol Arm on a Q4W, Q8W, Q12W, or Q16W Treatment Interval at 2 Years. --- Q12W ---
Primary Outcomes
Description: As measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters.
Measure: Average Change From Baseline in Best-Corrected Visual Acuity (BCVA) at 1 Year
Time: Baseline (Day 1) and 1 year
Secondary Outcomes
Measure: Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity (DRS) Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale (DRSS) at 1 Year
Time: Baseline and 1 year
Measure: Change From Baseline in BCVA Over Time
Time: From Baseline up to 2 years
Measure: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline Over Time
Time: From Baseline up to 2 years
Measure: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline Over Time
Time: From Baseline up to 2 years
Measure: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline Over Time
Time: From Baseline up to 2 years
Measure: Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline Over Time
Time: From Baseline up to 2 years
Measure: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline Over Time
Time: From Baseline up to 2 years
Measure: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline Over Time
Time: From Baseline up to 2 years
Measure: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline Over Time
Time: From Baseline up to 2 years
Measure: Percentage of Participants Avoiding a Loss of ≥0 Letters in BCVA From Baseline Over Time
Time: From Baseline up to 2 years
Measure: Percentage of Participants With a ≥2-Step DRS Improvement From Baseline on the ETDRS DRSS Over Time
Time: From Baseline up to 2 years
Measure: Percentage of Participants With a ≥3-Step DRS Improvement From Baseline on the ETDRS DRSS Over Time
Time: From Baseline up to 2 years
Measure: Percentage of Participants Gaining ≥15 Letters or Achieving BCVA of ≥84 Letters Over Time
Time: Up to 2 years
Measure: Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time
Time: Up to 2 years
Measure: Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time
Time: Up to 2 years
Measure: Percentage of Participants Who Develop New Proliferative Diabetic Retinopathy Over Time
Time: Up to 2 years
Measure: Percentage of Participants in the Faricimab As Specified in Protocol Arm on a Q4W, Q8W,
Q12W, or Q16W Treatment Interval at 1 Year
Time: 1 year
Measure: Percentage of Participants in the Faricimab As Specified in Protocol Arm on a Q4W, Q8W,
Q12W, or Q16W Treatment Interval at 2 Years
Time: 2 years
Measure: Change From Baseline in Central Subfield Thickness (CST) Over Time
Time: From Baseline up to 2 years
Measure: Percentage of Participants with Absence of DME Over Time
Time: Up to 2 years
Measure: Percentage of Participants with Absence of Intraretinal Fluid Over Time
Time: Up to 2 years
Measure: Percentage of Participants with Absence of Subretinal Fluid Over Time
Time: Up to 2 years
Measure: Percentage of Participants with Absence of Intraretinal Fluid and Subretinal Fluid Over Time
Time: Up to 2 years
Measure: Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Composite Score Over Time
Time: From Baseline up to 2 years
Measure: Percentage of Participants With Ocular Adverse Events
Time: Up to 2 years
Measure: Percentage of Participants With Non-Ocular Adverse Events
Time: Up to 2 years
Measure: Plasma Concentration of Faricimab Over Time
Time: Pre-dose on Day 1; Weeks 4, 28, 52, 76, and 100; and at Early Termination Visit (up to 2 years)
Measure: Percentage of Participants With Presence of Anti-Drug Antibodies
Time: Pre-dose on Day 1; Weeks 4, 28, 52, 76, and 100; and at Early Termination Visit (up to 2 years)
This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered
at 8-week intervals or as specified in the protocol following treatment initiation, compared
with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME).
Percentage of Participants in the Faricimab As Specified in Protocol Arm on a Q4W, Q8W, Q12W, or Q16W Treatment Interval at 1 Year. --- Q12W ---
Percentage of Participants in the Faricimab As Specified in Protocol Arm on a Q4W, Q8W, Q12W, or Q16W Treatment Interval at 2 Years. --- Q12W ---
Primary Outcomes
Description: As measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters.
Measure: Average Change From Baseline in Best-Corrected Visual Acuity (BCVA) at 1 Year
Time: Baseline (Day 1) and 1 year
Secondary Outcomes
Measure: Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity (DRS) Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale (DRSS) at 1 Year
Time: Baseline and 1 year
Measure: Change From Baseline in BCVA Over Time
Time: From Baseline up to 2 years
Measure: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline Over Time
Time: From Baseline up to 2 years
Measure: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline Over Time
Time: From Baseline up to 2 years
Measure: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline Over Time
Time: From Baseline up to 2 years
Measure: Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline Over Time
Time: From Baseline up to 2 years
Measure: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline Over Time
Time: From Baseline up to 2 years
Measure: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline Over Time
Time: From Baseline up to 2 years
Measure: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline Over Time
Time: From Baseline up to 2 years
Measure: Percentage of Participants Avoiding a Loss of ≥0 Letters in BCVA From Baseline Over Time
Time: From Baseline up to 2 years
Measure: Percentage of Participants With a ≥2-Step DRS Improvement From Baseline on the ETDRS DRSS Over Time
Time: From Baseline up to 2 years
Measure: Percentage of Participants With a ≥3-Step DRS Improvement From Baseline on the ETDRS DRSS Over Time
Time: From Baseline up to 2 years
Measure: Percentage of Participants Gaining ≥15 Letters or Achieving BCVA of ≥84 Letters Over Time
Time: Up to 2 years
Measure: Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time
Time: Up to 2 years
Measure: Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time
Time: Up to 2 years
Measure: Percentage of Participants Who Develop New Proliferative Diabetic Retinopathy Over Time
Time: Up to 2 years
Measure: Percentage of Participants in the Faricimab As Specified in Protocol Arm on a Q4W, Q8W,
Q12W, or Q16W Treatment Interval at 1 Year
Time: 1 year
Measure: Percentage of Participants in the Faricimab As Specified in Protocol Arm on a Q4W, Q8W,
Q12W, or Q16W Treatment Interval at 2 Years
Time: 2 years
Measure: Change From Baseline in Central Subfield Thickness (CST) Over Time
Time: From Baseline up to 2 years
Measure: Percentage of Participants with Absence of DME Over Time
Time: Up to 2 years
Measure: Percentage of Participants with Absence of Intraretinal Fluid Over Time
Time: Up to 2 years
Measure: Percentage of Participants with Absence of Subretinal Fluid Over Time
Time: Up to 2 years
Measure: Percentage of Participants with Absence of Intraretinal Fluid and Subretinal Fluid Over Time
Time: Up to 2 years
Measure: Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Composite Score Over Time
Time: From Baseline up to 2 years
Measure: Percentage of Participants With Ocular Adverse Events
Time: Up to 2 years
Measure: Percentage of Participants With Non-Ocular Adverse Events
Time: Up to 2 years
Measure: Plasma Concentration of Faricimab Over Time
Time: Pre-dose on Day 1; Weeks 4, 28, 52, 76, and 100; and at Early Termination Visit (up to 2 years)
Measure: Percentage of Participants With Presence of Anti-Drug Antibodies
Time: Pre-dose on Day 1; Weeks 4, 28, 52, 76, and 100; and at Early Termination Visit (up to 2 years)
This randomized pilot clinical trial studies the side effects of tremelimumab with or without
tissue cryoablation in treating patients with kidney cancer that has spread to other places
in the body. Tremelimumab binds to a protein called cytotoxic T-lymphocyte-associated protein
4 (CTLA-4), which is found on the surface of T cells (a type of white blood cell).
Tremelimumab may block CTLA-4 and help the immune system kill cancer cells. Cryoablation is a
procedure that uses a hollow, thin tube called a cryoprobe to freeze and destroy cancer
tissue. It is not yet known whether tremelimumab with or without cryoablation is effective in
treating patients with kidney cancer.
NCT02626130 Clear Cell Renal Cell Carcinoma Metastatic Renal Cell Cancer Stage IV Renal Cell Cancer AJCC v7 Procedure: Cryosurgery Other: Laboratory Biomarker Analysis Procedure: Therapeutic Conventional Surgery Biological: Tremelimumab
After surgery or biopsy, patients
receive tremelimumab IV every 4 weeks (Q4W) for 3 doses, and then every 12 weeks (Q12W) in
the absence of disease progression or unacceptable toxicity. --- Q12W ---
After surgery or biopsy, patients receive tremelimumab IV Q4W for 3 doses, and then
Q12W in the absence of disease progression or unacceptable toxicity. --- Q12W ---
Primary Outcomes
Description: Safety will be recorded through the incidence of adverse events, serious adverse events and specific laboratory abnormalities (worst grade) in each treatment arm. Descriptive statistical analyses will be performed to summarize the incidence of adverse events.
Measure: Incidence of adverse events as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
Time: Up to 2 weeks
Description: Extreme toxicities will be defined as any grade 3 or higher adverse event that is possibly, probably, or definitely related to therapy that occurs within the first two cycles of therapy with the following exceptions: any grade 3 or higher adverse event that is potentially treatable with steroids will only count as an extreme toxicity if it does not improve to grade 1 or better within 2 weeks of steroid therapy, grade 3 or 4 amylase or lipase abnormalities that are not associated with symptoms or clinical manifestations of pancreatitis, or grade 3 or 4 drug related endocrinopathies which within two weeks of presentation are adequately controlled with only physiologic hormone replacement therapy.
Measure: Incidence of extreme toxicities as graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
Time: Up to 2 weeks
Secondary Outcomes
Description: Descriptive statistical analyses will be performed to summarize the response rate including summary tables, scatter-plots, box-plots, proportions, 95% credible intervals, median, means, and standard deviations.
Measure: Response rate
Time: Up to 5 years
Description: Differences of indication markers between arms will be compared using a t-test with transformations of non-normal data, as needed. A mixed model accounting for patient effects will be used to analyze the longitudinal data on immunological values over time.
Measure: Changes in indication markers
Time: Up to 5 years
Description: Descriptive statistical analyses will be performed.
Measure: Progression free survival
Time: Up to 5 years
Description: A mixed model accounting for patient effects will be used to analyze the longitudinal data on immunological values over time.
Measure: Longitudinal data on immunological values over time
Time: Up to 13 weeks
HPO Nodes
Genes 14
MFRP HLA-A RLBP1 PRPF8 RDH5 POMGNT1 REEP6 PRPH2 DHDDS ARHGEF18 ARL3 RHO PDE6G NOD2 Genes 3
UBR1 PLVAP PMM2 Genes 11
PTEN CDKN1B APC MLH1 MSH2 FGFR3 KIT DKC1 RSPO1 STK11 NLRP1 Genes 52
FOXE1 VHL MET STK11 HNF1A HNF1B KLLN DLC1 NRAS FN1 LMNA SDHAF2 PIK3CA PRCC MAX KIF1B SRC SLC49A4 BUB1B APC FLCN COL14A1 AKT1 TSC1 TSC2 HABP2 FGFR3 CDC73 KEAP1 MINPP1 CTNNB1 RET DCC FH MDH2 PTEN RNF139 HNF4A AAGAB TMEM127 OGG1 DICER1 EP300 SEC23B SDHA SDHB TFE3 SDHC SDHD AXIN2 BAP1 NOD2