{"preliminary_commentary":{"by_channel":{"x_thread":5,"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":false},"commentary_summary":null,"drugs_tested":[["nivolumab","ipilimumab"],["nivolumab","sunitinib"],["nivolumab","pazopanib"]],"indication":"clear-cell metastatic renal cell carcinoma","name":"CheckMate 016","nct_id":"NCT01472081","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=checkmate-016-nct01472081. 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":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Nivolumab 0.3, 2.0 (starting dose), 5.0 mg/kg solution intravenously every 21 days until Progressive disease (PD), toxicity or discontinue for other reasons\n\nSunitinib 50 mg capsule by mouth on Days 1-28 of 42 day cycle until Progressive disease (PD), toxicity or discontinue for other reasons","label":"Arm S: Nivolumab + Sunitinib","type":"EXPERIMENTAL"},{"description":"Nivolumab 0.3, 2.0 (starting dose), 5.0 mg/kg solution intravenously every 21 days until Progressive disease (PD), toxicity or discontinue for other reasons\n\nPazopanib 800 mg tablet by mouth daily until Progressive disease (PD), toxicity or discontinue for other reasons","label":"Arm P: Nivolumab + Pazopanib","type":"EXPERIMENTAL"},{"description":"Nivolumab 3 mg/kg solution intravenously (IV) every 21 days during Induction phase and every 14 days during Maintenance phase until Progressive disease (PD), toxicity or discontinue for other reasons\n\nIpilimumab 1mg/kg solution intravenously (IV) every 21 days during Induction phase (Ipilimumab will not be administered during Maintenance phase) until Progressive disease (PD), toxicity or discontinue for other reasons","label":"Arm I-1: Nivolumab + Ipilimumab","type":"EXPERIMENTAL"},{"description":"Nivolumab 1mg/kg solution intravenously (IV) every 21 days during Induction phase and 3mg/kg solution intravenously (IV) every 14 days during Maintenance phase\n\nIpilimumab 3mg/kg solution intravenously (IV) every 21 days during Induction phase. Ipilimumab will not be administered during Maintenance phase","label":"Arm I-3: Nivolumab + Ipilimumab","type":"EXPERIMENTAL"},{"description":"Nivolumab 3mg/kg solution intravenously (IV) every 21 days during Induction phase and 3mg/kg solution intravenously (IV) every 14 days during Maintenance phase\n\nIpilimumab 3mg/kg solution intravenously (IV) every 21 days during Induction phase. Ipilimumab will not be administered during Maintenance phase","label":"Arm IN-3: Nivolumab+Ipilimumab","type":"EXPERIMENTAL"}],"collaborators":["Ono Pharmaceutical Co., Ltd."],"completion_date":{"date":"2021-06-03","type":"ACTUAL"},"conditions":["Renal Cell Carcinoma","Clear-cell Metastatic Renal Cell Carcinoma"],"enrollment":{"count":194,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Nivolumab","otherNames":["BMS-936558 (MDX-1106)"],"type":"BIOLOGICAL"},{"name":"Pazopanib","otherNames":["Votrient (Pazopanib hydrochloride)"],"type":"BIOLOGICAL"},{"name":"Sunitinib","otherNames":["Sutent®","Sunitinib Malate"],"type":"DRUG"},{"name":"Ipilimumab","otherNames":["YERVOY™"],"type":"BIOLOGICAL"}],"last_update":"2021-12-02","lead_sponsor":"Bristol-Myers Squibb","official_title":"A Phase 1 Study of Nivolumab (BMS-936558) Plus Sunitinib, Pazopanib or Ipilimumab in Subjects With Metastatic Renal Cell Carcinoma","overall_status":"COMPLETED","phases":["PHASE1"],"primary_completion_date":{"date":"2016-02-02","type":"ACTUAL"},"primary_outcomes":[{"measure":"Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation","timeFrame":"From date of first dose to date of last dose plus 100 days (assessed up to March 2016, approximately 49 months)"}],"references":[{"citation":"Amin A, Plimack ER, Ernstoff MS, Lewis LD, Bauer TM, McDermott DF, Carducci M, Kollmannsberger C, Rini BI, Heng DYC, Knox J, Voss MH, Spratlin J, Berghorn E, Yang L, Hammers HJ. Safety and efficacy of nivolumab in combination with sunitinib or pazopanib in advanced or metastatic renal cell carcinoma: the CheckMate 016 study. J Immunother Cancer. 2018 Oct 22;6(1):109. doi: 10.1186/s40425-018-0420-0.","pmid":"30348216","type":"DERIVED"},{"citation":"Dorff TB, Pal SK, Quinn DI. Novel tyrosine kinase inhibitors for renal cell carcinoma. Expert Rev Clin Pharmacol. 2014 Jan;7(1):67-73. doi: 10.1586/17512433.2014.862496. Epub 2013 Dec 2.","pmid":"24308791","type":"DERIVED"}],"start_date":{"date":"2012-02-09","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Nivolumab (BMS-936558; MDX-1106) in Combination With Sunitinib, Pazopanib, or Ipilimumab in Subjects With Metastatic Renal Cell Carcinoma (RCC) (CheckMate 016)","url":"https://clinicaltrials.gov/study/NCT01472081"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/checkmate-016-nct01472081"}