{"preliminary_commentary":{"by_channel":{"x_thread":13,"youtube":2},"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\": \"NCT03117309\", \"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":"HCRN GU16-260","nct_id":"NCT03117309","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=hcrn-gu16-260-nct03117309. 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":"Nivolumab 240mg; Nivolumab 360mg","label":"PART A: Nivolumab","type":"EXPERIMENTAL"},{"description":"Nivolumab 3mg/kg and Ipilimumab 1mg/kg; Nivolumab 360mg","label":"PART B: Nivolumab + Ipilimumab","type":"EXPERIMENTAL"}],"collaborators":["Bristol-Myers Squibb","Hoosier Cancer Research Network"],"completion_date":{"date":"2025-01-23","type":"ACTUAL"},"conditions":["Advanced Renal Cell Carcinoma"],"enrollment":{"count":164,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Nivolumab 240 mg","otherNames":["OPDIVO"],"type":"DRUG"},{"name":"Ipilimumab 1mg/kg","otherNames":["Yervoy"],"type":"DRUG"},{"name":"Nivolumab 3mg/kg","otherNames":["OPDIVO"],"type":"DRUG"},{"name":"Nivolumab 360mg","otherNames":["OPDIVO"],"type":"DRUG"}],"last_update":"2025-07-10","lead_sponsor":"Michael B. Atkins, MD","official_title":"Phase II Study of Front Line Therapy With Nivolumab and Salvage Nivolumab + Ipilimumab in Patients With Advanced Renal Cell Carcinoma. HCRN: GU16-260","overall_status":"COMPLETED","phases":["PHASE2"],"primary_completion_date":{"date":"2022-03-25","type":"ACTUAL"},"primary_outcomes":[{"measure":"1-year Progression Free Survival (PFS) Rate for ccRCC Patients","timeFrame":"1 year"}],"references":[{"citation":"Atkins MB, Jegede OA, Haas NB, McDermott DF, Bilen MA, Stein M, Sosman JA, Alter R, Plimack ER, Ornstein MC, Hurwitz M, Peace DJ, Signoretti S, Denize T, Cimadamore A, Wu CJ, Braun D, Einstein D, Catalano PJ, Hammers H. Phase II study of nivolumab and salvage nivolumab/ipilimumab in treatment-naive patients with advanced non-clear cell renal cell carcinoma (HCRN GU16-260-Cohort B). J Immunother Cancer. 2023 Mar;11(3):e004780. doi: 10.1136/jitc-2022-004780.","pmid":"36948504","type":"DERIVED"},{"citation":"Atkins MB, Jegede OA, Haas NB, McDermott DF, Bilen MA, Stein M, Sosman JA, Alter R, Plimack ER, Ornstein M, Hurwitz M, Peace DJ, Signoretti S, Denize T, Cimadamore A, Wu CJ, Braun D, Einstein D, Catalano PJ, Hammers H. Phase II Study of Nivolumab and Salvage Nivolumab/Ipilimumab in Treatment-Naive Patients With Advanced Clear Cell Renal Cell Carcinoma (HCRN GU16-260-Cohort A). J Clin Oncol. 2022 Sep 1;40(25):2913-2923. doi: 10.1200/JCO.21.02938. Epub 2022 Apr 20.","pmid":"35442713","type":"DERIVED"}],"start_date":{"date":"2017-04-24","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of Front Line Therapy With Nivolumab and Salvage Nivolumab + Ipilimumab in Patients With Advanced Renal Cell Carcinoma","url":"https://clinicaltrials.gov/study/NCT03117309"},"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/hcrn-gu16-260-nct03117309"}