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    The value 'Show more Show more Revision: v2.9.0' has been updated to 'Show less MedlinePlus Genetics related topics: Bladder cancer MedlinePlus related topics: Bladder Cancer Drug Information available for: Pembrolizumab FDA Drug and Device Resources Show less Design Details Primary Purpose : Treatment Allocation : N/A Interventional Model : Single Group Assignment Masking : None (Open Label) Arms and Interventions Participant Group/Arm Intervention/Treatment Experimental : Pembrolizumab Pembrolizumab to be administered via IV 200mg 3 weekly commenced concurrently with chemoradiotherapy, and continuing until 12 week cystoscopy. Drug : Pembrolizumab 200 mg/m2, IV (in the vein) on day 1 every three weeks (Weeks 1, 3, 7, 10, 13, 16 and 19). until progression or unacceptable toxicity develops. Drug : Cisplatin 35 mg/m2, IV (in the vein) every week for six weeks. Radiation : Radiotherapy 2.00Gy once daily for 32 fractions, 5 fractions/week over six weeks and two days (a total of 64Gy). Primary Outcome Measures Outcome Measure Measure Description Time Frame Number of patients with grade 3 or 4 acute toxicities (excluding grade 3 or 4 urinary toxicities) that are related to study drug, graded according to CTCAE v4.03. 19 weeks of treatment with Pembrolizumab Secondary Outcome Measures Outcome Measure Measure Description Time Frame The efficacy of the addition of pembrolizumab to concurrent chemoradiation regimen using the best response achieved, as assessed by cystoscopy at weeks 19 and 31 of the trial (12 and 24 weeks post completion of chemoradiotherapy). Week 19 (12 weeks post chemotherapy) and Week 31 (24 weeks post chemotherapy) where cystoscopic examinations take place. The number of patients to develop metastatic disease (i.e. the rate of metastatic disease), as assessed by CT scan. Through study completion, an average of 7 years. The number of patients having a salvage cystectomy (i.e. the rate of salvage cystectomy), as assessed by cystoscopy. Through study completion, an average of 7 years. Other Outcome Measures Outcome Measure Measure Description Time Frame The abundance and composition of tumour infiltrating lymphocytes, as assessed by immunohistochemical analysis, of patients pre-treatment tissue samples. Resected tumour specimens will be available from the patients enrolled on the trial. These pre-treatment specimens will be comprehensively profiled for the abundance and composition of tumour infiltrating lymphocytes (CD4, CD8, CD3, CD20 and FoxP3 positive cells) by immunohistochemistry using the state-of-the-art Vectra Automated Imaging system which enables multiplexed immunohistochemical analysis. Through study completion, an average of 7 years. Changes in gene expression in CD3+ cells pre and post-treatment as assessed by RNAseq analysis to assess for gene expression changes associated with immune activation. Through study completion, an average of 7 years. Changes in the immune regulatory molecules OX-40/LAG3/PD1/ICOS on T cell subsets as assessed by flow cytometry. Blood samples collected prior to treatment, at the end of chemoradiotherapy, and after 24 weeks will be collected from the patients on the trial. PBMCs will be isolated using Ficoll, and changes in specific immune subpopulations (number/ratio) determined by multi-parameter FACS. Changes in the immune regulatory molecules OX-40/LAG3/PD1/ICOS on T cell subsets will be assessed by flow cytometry. Through study completion, an average of 7 years.
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