{"preliminary_commentary":{"by_channel":{"x_thread":8,"youtube":1},"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\": \"NCT03729245\", \"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":"PIVOT-09","nct_id":"NCT03729245","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=pivot-09-nct03729245. 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":"Patients in Arm A will receive bempegaldesleukin in combination with nivolumab.","label":"Combination of bempegaldesleukin + nivolumab","type":"EXPERIMENTAL"},{"description":"Patients in Arm B will receive the Investigator's choice of either one of two treatment options.","label":"sunitinib or cabozantinib","type":"ACTIVE_COMPARATOR"}],"collaborators":["Bristol-Myers Squibb"],"completion_date":{"date":"2022-10-19","type":"ACTUAL"},"conditions":["Renal Cell Carcinoma","Metastatic Renal Cell Carcinoma"],"enrollment":{"count":623,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"bempegaldesleukin","otherNames":["BEMPEG","BMS-986321"],"type":"BIOLOGICAL"},{"name":"sunitinib","otherNames":["Sutent®"],"type":"DRUG"},{"name":"nivolumab","otherNames":["Opdivo®","BMS-936558"],"type":"BIOLOGICAL"},{"name":"cabozantinib","otherNames":["Cabometyx®"],"type":"DRUG"}],"last_update":"2023-04-11","lead_sponsor":"Nektar Therapeutics","official_title":"A Phase 3 Randomized Open Label Study to Compare NKTR-214 Combined With Nivolumab to the Investigator's Choice of Sunitinib or Cabozantinib in Patients With Previously Untreated Advanced Renal Cell Carcinoma","overall_status":"TERMINATED","phases":["PHASE3"],"primary_completion_date":{"date":"2022-01-07","type":"ACTUAL"},"primary_outcomes":[{"measure":"Objective Response Rate (ORR) Per mRECIST 1.1 by BICR in IMDC All-risk Patients and Intermediate- or Poor (I/P)-Risk Patients With Previously Untreated Advanced RCC","timeFrame":"Approximately 32 months"},{"measure":"Overall Survival (OS) in IMDC All-Risk and Intermediate- or Poor-risk Patients With Previously Untreated Advanced RCC","timeFrame":"Approximately 32 months"}],"references":[{"citation":"Tannir NM, Formiga MN, Penkov K, Kislov N, Vasiliev A, Gunnar Skare N, Hong W, Dai S, Tang L, Qureshi A, Zalevsky J, Tagliaferri MA, George D, Agarwal N, Pal S. Bempegaldesleukin Plus Nivolumab Versus Sunitinib or Cabozantinib in Previously Untreated Advanced Clear Cell Renal Cell Carcinoma: A Phase III Randomized Study (PIVOT-09). J Clin Oncol. 2024 Aug 10;42(23):2800-2811. doi: 10.1200/JCO.23.02082. Epub 2024 Jun 5.","pmid":"38838287","type":"DERIVED"}],"start_date":{"date":"2018-12-18","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Bempegaldesleukin (NKTR-214: BEMPEG) in Combination With Nivolumab Compared With the Investigator's Choice of a Tyrosine Kinase Inhibitor (TKI) Therapy (Either Sunitinib or Cabozantinib Monotherapy) for Advanced Metastatic Renal Cell Carcinoma (RCC)","url":"https://clinicaltrials.gov/study/NCT03729245"},"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/pivot-09-nct03729245"}