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- Check4 days agoChange DetectedThe website has been updated to version v2.10.0, adding two more conditions and noting that the study now includes 10 locations, while the previous version v2.9.7 has been removed.SummaryDifference0.6%
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- Check32 days agoChange DetectedThe value 'Show more Show more Revision: v2.9.0' has been updated to 'Show less Genetic and Rare Diseases Information Center resources: Renal Cell Carcinoma FDA Drug and Device Resources Show less Design Details Primary Purpose : Treatment Allocation : N/A Interventional Model : Single Group Assignment Interventional Model Description: This is an open label Phase 2 screening trial in subjects. Masking : None (Open Label) Arms and Interventions Participant Group/Arm Intervention/Treatment Experimental : Stereotactic Body Radiotherapy Image Guided, Stereotactic Body Radiotherapy (27 Gy over 3 fractions) to 1-3 lesions. Treatment with the checkpoint inhibitor will continue until progression at the discretion of the treating physician or unacceptable toxicity. Radiation : Stereotactic Body Radiotherapy (27 Gy over 3 fractions) Biological : Ipilimumab, Nivolumab, Pembrolizumab or Atezolizumab The checkpoint inhibitor that the patient was already receiving should be continued according to the standard schedule and dose of administration as determined by the treating physician. Immune Checkpoint Inhibitors include Ipilimumab (Melanoma) Nivolumab (Melanoma, Renal, NSCLC), Pembrolizumab (Melanoma, NSCLC), Atezolizumab (Bladder) Primary Outcome Measures Outcome Measure Measure Description Time Frame evaluate overall response rate (ORR) in non-irradiated lesions during the first 24 weeks after treatment initiation as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in patients with limited progression receiving hypofractionated radiotherapy. ORR rate is defined as the number of patients treated to a given arm with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the total number of patients. 24 weeks Keywords Provided by Memorial Sloan Kettering Cancer Center Radiation Immunotherapy/Checkpoint Inhibitors 18-359 Additional Relevant MeSH Terms Neoplasms Neoplasms by Site Urologic Neoplasms Urogenital Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Urologic Diseases Male Urogenital Diseases Kidney Diseases Kidney Neoplasms Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action Pembrolizumab Nivolumab Ipilimumab Atezolizumab Studies a U.S. FDA-Regulated Drug Product Yes Studies a U.S. FDA-Regulated Device Product No Product Manufactured in and Exported from the U.S. No Helpful Links Provided by Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center Revision: v2.9.1'.SummaryDifference17%
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