{"preliminary_commentary":{"by_channel":{"x_thread":7,"youtube":5,"podcast":3},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT03055013\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"commentary_summary":null,"name":"PROSPER RCC","nct_id":"NCT03055013","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=prosper-rcc-nct03055013. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1250,"size":"standard","size_rule":"Standard: 151–300 verified statements, estimated at 14 per indexed commentary source"},"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","otherNames":[],"type":"PROCEDURE"},{"name":"Nivolumab","otherNames":["ABP 206","BCD-263","BMS 936558","BMS-936558","BMS936558","CMAB819","MDX 1106","MDX-1106","MDX1106","NIVO","Nivolumab Biosimilar ABP 206","Nivolumab Biosimilar BCD-263","Nivolumab Biosimilar CMAB819","ONO 4538","ONO-4538","ONO4538","Opdivo"],"type":"BIOLOGICAL"},{"name":"Patient Observation","otherNames":["Active Surveillance","deferred therapy","expectant management","Observation","Watchful Waiting"],"type":"OTHER"},{"name":"Quality-of-Life Assessment","otherNames":["Quality of Life Assessment"],"type":"OTHER"},{"name":"Questionnaire Administration","otherNames":[],"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":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/prosper-rcc-nct03055013"}