{"commentary":{"count":263,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":118,"podcast":73,"youtube":70,"x_video":2},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT04949113\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"NADINA","nct_id":"NCT04949113","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nadina-nct04949113. The price is fixed at order. We build the report after 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: 41+ commentary sources"},"registry":{"acronym":"NADINA","arms":[{"description":"2 cycles of neoadjuvant ipilimumab (80mg) + nivolumab (240mg) every 3 weeks followed by a total lymph node dissection (TLND) and if applicable, resection of in-transit metastases.\n\nPatients with a pathologic partial or non-response in arm A will also receive adjuvant nivolumab 480 mg every 4 weeks 11 cycles. In case of BRAF V600E/K mutation-positivity, patients will be treated with adjuvant dabrafenib plus trametinib for 46 weeks instead.","label":"A: Neoadjuvant","type":"EXPERIMENTAL"},{"description":"Standard upfront total lymph node dissection (TLND) and if applicable, resection of in-transit metastases followed by 12 cycles adjuvant nivolumab 480 mg every 4 weeks","label":"B: Adjuvant","type":"ACTIVE_COMPARATOR"}],"collaborators":["Bristol-Myers Squibb"],"completion_date":{"date":"2028-12-19","type":"ESTIMATED"},"conditions":["Malignant Melanoma Stage III"],"enrollment":{"count":423,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Neoadjuvant ipilimumab + nivolumab","type":"DRUG"},{"name":"Adjuvant nivolumab","type":"DRUG"}],"last_update":"2024-03-08","lead_sponsor":"The Netherlands Cancer Institute","official_title":"Multicenter Phase 3 Trial Comparing Neoadjuvant Ipilimumab Plus Nivolumab Versus Standard Adjuvant Nivolumab in Macroscopic Stage III Melanoma - NADINA","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2024-01-12","type":"ACTUAL"},"primary_outcomes":[{"measure":"Comparison of event-free survival (EFS) in the neoadjuvant and adjuvant group.","timeFrame":"Analysis will be performed after 132 events, though not later than after 2 years follow-up of all patients."}],"references":[{"citation":"Blank CU, Lucas MW, Scolyer RA, van de Wiel BA, Menzies AM, Lopez-Yurda M, Hoeijmakers LL, Saw RPM, Lijnsvelt JM, Maher NG, Pulleman SM, Gonzalez M, Torres Acosta A, van Houdt WJ, Lo SN, Kuijpers AMJ, Spillane A, Klop WMC, Pennington TE, Zuur CL, Shannon KF, Seinstra BA, Rawson RV, Haanen JBAG, Ch'ng S, Naipal KAT, Stretch J, van Thienen JV, Rtshiladze MA, Wilgenhof S, Kapoor R, Meerveld-Eggink A, Grijpink-Ongering LG, van Akkooi ACJ, Reijers ILM, Gyorki DE, Grunhagen DJ, Speetjens FM, Vliek SB, Placzke J, Spain L, Stassen RC, Amini-Adle M, Lebbe C, Faries MB, Robert C, Ascierto PA, van Rijn R, van den Berkmortel FWPJ, Piersma D, van der Westhuizen A, Vreugdenhil G, Aarts MJB, Stevense-den Boer MAM, Atkinson V, Khattak M, Andrews MC, van den Eertwegh AJM, Boers-Sonderen MJ, Hospers GAP, Carlino MS, de Groot JB, Kapiteijn E, Suijkerbuijk KPM, Rutkowski P, Sandhu S, van der Veldt AAM, Long GV. Neoadjuvant Nivolumab and Ipilimumab in Resectable Stage III Melanoma. N Engl J Med. 2024 Nov 7;391(18):1696-1708. doi: 10.1056/NEJMoa2402604. Epub 2024 Jun 2.","pmid":"38828984","type":"DERIVED"},{"citation":"Long GV, Menzies AM, Scolyer RA. Neoadjuvant Checkpoint Immunotherapy and Melanoma: The Time Is Now. J Clin Oncol. 2023 Jun 10;41(17):3236-3248. doi: 10.1200/JCO.22.02575. Epub 2023 Apr 27.","pmid":"37104746","type":"DERIVED"}],"start_date":{"date":"2021-07-08","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Neoadjuvant Ipilimumab Plus Nivolumab Versus Standard Adjuvant Nivolumab in Macroscopic Stage III Melanoma","url":"https://clinicaltrials.gov/study/NCT04949113"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nadina-nct04949113"}