{"preliminary_commentary":{"by_channel":{"x_thread":106,"youtube":41,"podcast":38,"x_video":8},"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\": \"NCT03288532\", \"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,"drugs_tested":[["durvalumab"],["durvalumab","tremelimumab"]],"indication":"intermediate- or high-risk resected renal cell carcinoma","name":"RAMPART","nct_id":"NCT03288532","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=rampart-nct03288532. 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":1950,"size":"deep","size_rule":"Deep: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"RAMPART","arms":[{"description":"Participants randomised to Arm A will be allocated to active monitoring for 1 year, in line with current standard-of-care in resected primary RCC at high or intermediate risk of relapse","label":"Arm A (active monitoring)","type":"NO_INTERVENTION"},{"description":"Participants randomised to Arm B will receive durvalumab (1500mg) 4 weekly for 1 year (13 cycles maximum)","label":"Arm B (durvalumab monotherapy)","type":"EXPERIMENTAL"},{"description":"Participants randomised to Arm C will receive durvalumab (administered as per arm B, i.e. 13 cycles maximum) and tremelimumab (75mg) on day 1 and week 4 visits (i.e. 2 cycles)","label":"Arm C (durvalumab + tremelimumab)","type":"EXPERIMENTAL"}],"collaborators":["AstraZeneca","Kidney Cancer UK","Cancer Research UK"],"completion_date":{"date":"2034-12-01","type":"ESTIMATED"},"conditions":["Renal Cell Carcinoma"],"enrollment":{"count":1750,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Durvalumab","otherNames":[],"type":"DRUG"},{"name":"Tremelimumab","otherNames":[],"type":"DRUG"}],"last_update":"2020-09-07","lead_sponsor":"University College, London","official_title":"An International Investigator-led Phase III Multi Arm Multi Stage Multi-centre Randomised Controlled Platform Trial of Adjuvant Therapy in Patients With Resected Primary Renal Cell Carcinoma (RCC) at High or Intermediate Risk of Relapse","overall_status":"RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2024-07-01","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Disease Free Survival (DFS): Arm C vs A","timeFrame":"6.25 years"},{"measure":"Disease Free Survival (DFS): Arm B vs A","timeFrame":"10.54 years"},{"measure":"Overall Survival (OS): Arm C vs A (high risk patients only)","timeFrame":"13.25 years"},{"measure":"Overall Survival (OS): Arm B vs A (high risk patients only)","timeFrame":"20.5 years"}],"references":[{"citation":"Oza B, Frangou E, Smith B, Bryant H, Kaplan R, Choodari-Oskooei B, Powles T, Stewart GD, Albiges L, Bex A, Choueiri TK, Davis ID, Eisen T, Fielding A, Harrison D, McWhirter A, Mulhere S, Nathan P, Rini B, Ritchie A, Scovell S, Shakeshaft C, Stockler MR, Thorogood N, Parmar MKB, Larkin J, Meade A. RAMPART: A phase III multi-arm multi-stage trial of adjuvant checkpoint inhibitors in patients with resected primary renal cell carcinoma (RCC) at high or intermediate risk of relapse. Contemp Clin Trials. 2021 Sep;108:106482. doi: 10.1016/j.cct.2021.106482. Epub 2021 Sep 16.","pmid":"34538402","type":"DERIVED"},{"citation":"Meade A, Oza B, Frangou E, Smith B, Bryant H, Kaplan R, Choodari-Oskooei B, Powles T, Stewart GD, Albiges L, Bex A, Choueiri TK, Davis ID, Eisen T, Fielding A, Harrison DJ, McWhirter A, Mulhere S, Nathan P, Rini B, Ritchie A, Scovell S, Shakeshaft C, Stockler MR, Thorogood N, Larkin J, Parmar MKB. RAMPART: A model for a regulatory-ready academic-led phase III trial in the adjuvant renal cell carcinoma setting. Contemp Clin Trials. 2021 Sep;108:106481. doi: 10.1016/j.cct.2021.106481. Epub 2021 Sep 16.","pmid":"34538401","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":"2018-07-19","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Renal Adjuvant MultiPle Arm Randomised Trial","url":"https://clinicaltrials.gov/study/NCT03288532"},"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/rampart-nct03288532"}