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Report for Clinical Trial NCT03244384
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
Phase III Randomized Adjuvant Study of MK-3475 (Pembrolizumab) in Muscle Invasive and Locally Advanced Urothelial Carcinoma (AMBASSADOR) Versus Observation
This randomized phase III trial studies how well pembrolizumab works in treating patients with bladder cancer that has spread into the deep muscle of the bladder wall (muscle-invasive) or urothelial cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced). Monoclonal antibodies recognizing and blocking checkpoint molecules can enhance the patient's immune response and therefore help fight cancer. Pembrolizumab is one of the monoclonal antibodies that block the PD-1 axis and can interfere with the ability of tumor cells to grow.
NCT03244384 Localized Renal Pelvis and Ureter Urothelial Carcinoma Locally Advanced Bladder Urothelial Carcinoma Locally Advanced Renal Pelvis and Ureter Urothelial Carcinoma Locally Advanced Ureter Urothelial Carcinoma Locally Advanced Urothelial Carcinoma Stage II Bladder Urothelial Carcinoma AJCC v6 and v7 Stage II Renal Pelvis and Ureter Cancer AJCC v7 Stage II Ureter Cancer AJCC v7 Stage III Bladder Urothelial Carcinoma AJCC v6 and v7 Stage III Renal Pelvis and Ureter Cancer AJCC v7 Stage III Ureter Cancer AJCC v7 MeSH: Carcinoma Carcinoma, Transitional Cell Ureteral Neoplasms Kidney Neoplasms
HPO: Carcinoma Neoplasm of the ureter Renal neoplasm
6 Interventions
Name: Clinical Observation
Description: Undergo observationType: OtherArm B (observation)
Name: Laboratory Biomarker Analysis
Description: Correlative studiesType: OtherArm A (pembrolizumab) Arm B (observation)
Name: Pembrolizumab
Description: Given IVType: BiologicalArm A (pembrolizumab)
Name: Pharmacological Study
Description: Correlative studiesType: OtherArm A (pembrolizumab) Arm B (observation)
Name: Quality-of-Life Assessment
Description: Ancillary studiesType: OtherArm A (pembrolizumab) Arm B (observation)
Name: Questionnaire Administration
Description: Ancillary studiesType: OtherArm A (pembrolizumab) Arm B (observation)
Primary Outcomes
Description: The stratified proportional hazards model will be the primary analysis. The hazard ratio and its 95% confidence interval from the stratified Cox model with a single treatment covariate will be reported. The unstratified hazard ratio will also be presented.
Measure: Overall survival Time: From randomization to the date of death from any cause, assessed up to 5 yearsDescription: The stratified proportional hazards model will be the primary analysis. The hazard ratio and its 95% confidence interval from the stratified Cox model with a single treatment covariate will be reported. The unstratified hazard ratio will also be presented.
Measure: Disease-free survival Time: From randomization to the first metastatic recurrence (presence of any recurrent disease), or death, whichever occurs first, assessed up to 5 yearsSecondary Outcomes
Description: The stratified proportional hazards model will be the primary analysis. The hazard ratio and its 95% confidence interval from the stratified Cox model with a single treatment covariate will be reported. The unstratified hazard ratio will also be presented.
Measure: Overall survival in PD-L1 positive and negative patients Time: From randomization to the date of death from any cause, assessed up to 5 yearsDescription: The stratified proportional hazards model will be the primary analysis. The hazard ratio and its 95% confidence interval from the stratified Cox model with a single treatment covariate will be reported. The unstratified hazard ratio will also be presented.
Measure: Disease-free survival in PD-L1 positive and negative patients Time: From randomization to the first metastatic recurrence (presence of any recurrent disease), or death, whichever occurs first, assessed up to 5 yearsPurpose: Treatment
Allocation: Randomized
Parallel Assignment
There is one SNP
SNPs
1 rs11568821
PHARMCOGENOMIC STUDY OBJECTIVES: I. To investigate the effect of PDCD1 single-nucleotide polymorphism (SNP) rs11568821 on severe (grade 3 or higher) immune-related toxicity in the MK-3475 (pembrolizumab)-treated cohort.