{"commentary":{"count":7,"free_build_floor":8,"listing_floor":3,"by_channel":{"youtube":4,"podcast":3},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":false},"name":"NCT03055013","nct_id":"NCT03055013","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct03055013. The price is fixed at order. We build the report after the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–12 commentary sources"},"registry":{"acronym":null,"arms":[{"description":"Patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 14 days for 2 cycles. Patients then undergo partial or radical nephrectomy 7-28 days later. Patients then receive nivolumab over 30 IV on day 1. Treatment repeats every 14 days for 6 cycles, and then every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity.\n\nPatients enrolled after Amendment 4 receive nivolumab IV over 30 minutes on day 1. Patients then undergo partial or radical nephrectomy 7-28 days later. Patient then receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 4 weeks for up to 9 cycles in the absence of disease progression or unacceptable toxicity.","label":"Arm A (nivolumab + nephrectomy)","type":"EXPERIMENTAL"},{"description":"Patients undergo partial or radical nephrectomy within 8 weeks after registration followed by observation.","label":"Arm B (nephrectomy only)","type":"ACTIVE_COMPARATOR"}],"collaborators":["Canadian Cancer Trials Group"],"completion_date":{"date":"2031-06-09","type":"ESTIMATED"},"conditions":["Metastatic Renal Cell Carcinoma","Sarcomatoid Renal Cell Carcinoma","Stage II Renal Cell Cancer AJCC v7","Stage III Renal Cell Cancer AJCC v7","Unclassified Renal Cell Carcinoma"],"enrollment":{"count":819,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Nephrectomy","type":"PROCEDURE"},{"name":"Nivolumab","type":"BIOLOGICAL"},{"name":"Patient Observation","type":"OTHER"},{"name":"Quality-of-Life Assessment","type":"OTHER"},{"name":"Questionnaire Administration","type":"OTHER"}],"last_update":"2026-08-28","lead_sponsor":"National Cancer Institute (NCI)","official_title":"A Phase 3 RandOmized Study Comparing PERioperative Nivolumab vs. Observation in Patients With Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2023-05-24","type":"ACTUAL"},"primary_outcomes":[{"measure":"Recurrence-free Survival (RFS) Rate at 5 Years","timeFrame":"Assessed at 20 weeks, 40 weeks, then every 3 months for patients <2 years from randomization, then every 6 months for 3 years"}],"references":[{"citation":"Buti S, Kim SE, Maffezzoli M, Allaf ME, Giudice GC, Banna GL, Taguchi S, Haas NB, Carducci MA. A prospective external validation of the GRade, Age, Nodes and Tumor score in the ECOG-ACRIN EA8143 PROSPER trial. Oncologist. 2026 Mar 9;31(4):oyag041. doi: 10.1093/oncolo/oyag041.","pmid":"41693026","type":"DERIVED"},{"citation":"Allaf ME, Kim SE, Master V, McDermott DF, Harshman LC, Cole SM, Drake CG, Signoretti S, Akgul M, Baniak N, Li-Ning E, Palmer MB, Emamekhoo H, Adra N, Kaimakliotis H, Ged Y, Pierorazio PM, Abel EJ, Bilen MA, Ogan K, Moon HH, Ramaswamy KA, Singer EA, Mayer TM, Lohrey J, Margulis V, Gills J, Delacroix SE, Waples MJ, James AC, Wang P, Choueiri T, Michaelson MD, Kapoor A, Heng DY, Shuch B, Leibovich BC, Lara PN, Manola J, Maskens D, Battle D, Uzzo R, Bratslavsky G, Haas NB, Carducci MA. Perioperative nivolumab versus observation in patients with renal cell carcinoma undergoing nephrectomy (PROSPER ECOG-ACRIN EA8143): an open-label, randomised, phase 3 study. Lancet Oncol. 2024 Aug;25(8):1038-1052. doi: 10.1016/S1470-2045(24)00211-0. Epub 2024 Jun 25.","pmid":"38942046","type":"DERIVED"},{"citation":"Marconi L, Sun M, Beisland C, Klatte T, Ljungberg B, Stewart GD, Dabestani S, Choueiri TK, Bex A. Prevalence, Disease-free, and Overall Survival of Contemporary Patients With Renal Cell Carcinoma Eligible for Adjuvant Checkpoint Inhibitor Trials. Clin Genitourin Cancer. 2021 Apr;19(2):e92-e99. doi: 10.1016/j.clgc.2020.12.005. Epub 2021 Jan 7.","pmid":"33526329","type":"DERIVED"}],"start_date":{"date":"2017-04-28","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Nivolumab in Treating Patients With Localized Kidney Cancer Undergoing Nephrectomy","url":"https://clinicaltrials.gov/study/NCT03055013"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct03055013"}