{"commentary":{"count":7,"free_build_floor":8,"listing_floor":3,"by_channel":{"podcast":6,"youtube":1},"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":false},"name":"OpACIN","nct_id":"NCT02437279","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=opacin-nct02437279. 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":750,"size":"focused","size_rule":"Focused: 1–12 commentary sources"},"registry":{"acronym":"OpACIN","arms":[{"description":"Post-surgery infusion for 12 weeks with the combination of ipilimumab+nivolumab","label":"Arm A","type":"ACTIVE_COMPARATOR"},{"description":"A split design 6 weeks upfront surgery and 6 weeks post-surgery infusion with the combination of ipilimumab+nivolumab","label":"Arm B","type":"ACTIVE_COMPARATOR"}],"collaborators":["Bristol-Myers Squibb"],"completion_date":{"date":"2025-06","type":"ESTIMATED"},"conditions":["Stage III Skin Melanoma"],"enrollment":{"count":20,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Surgery of the tumor","type":"PROCEDURE"},{"name":"Infusion with ipilimumab 3 mg/kg q3wks","type":"DRUG"},{"name":"Infusion with nivolumab 1 mg/kg q3wks","type":"DRUG"}],"last_update":"2022-04-15","lead_sponsor":"The Netherlands Cancer Institute","official_title":"Feasibility Study to Identify the Optimal Adjuvant Combination Scheme of Ipilimumab and Nivolumab in Stage III Melanoma Patients","overall_status":"UNKNOWN","phases":["PHASE1"],"primary_completion_date":{"date":"2018-06-28","type":"ACTUAL"},"primary_outcomes":[{"measure":"The alteration in magnitude of the neo-antigen specific T cell response in the time interval pre- to post-adjuvant therapy in peripheral blood","timeFrame":"12 weeks from baseline"},{"measure":"Safety as measured by SUSARs.","timeFrame":"12 weeks from baseline"},{"measure":"The alteration in breadth of the neo-antigen specific T cell response in the time interval pre- to post-adjuvant therapy in peripheral blood","timeFrame":"12 weeks from baseline"},{"measure":"Feasibility as measured adherence to the timelines in the study protocol.","timeFrame":"12 weeks from baseline"}],"references":[{"citation":"Zijlker LP, van der Burg SJC, Blank CU, Zuur CL, Klop WMC, Wouters MWMJ, van Houdt WJ, van Akkooi ACJ. Surgical outcomes of lymph node dissections for stage III melanoma after neoadjuvant systemic therapy are not inferior to upfront surgery. Eur J Cancer. 2023 May;185:131-138. doi: 10.1016/j.ejca.2023.03.003. Epub 2023 Mar 7.","pmid":"36989829","type":"DERIVED"},{"citation":"Gorry C, McCullagh L, O'Donnell H, Barrett S, Schmitz S, Barry M, Curtin K, Beausang E, Barry R, Coyne I. Neoadjuvant treatment for stage III and IV cutaneous melanoma. Cochrane Database Syst Rev. 2023 Jan 17;1(1):CD012974. doi: 10.1002/14651858.CD012974.pub2.","pmid":"36648215","type":"DERIVED"},{"citation":"Versluis JM, Reijers ILM, Rozeman EA, Menzies AM, van Akkooi ACJ, Wouters MW, Ch'ng S, Saw RPM, Scolyer RA, van de Wiel BA, Schilling B, Long GV, Blank CU. Neoadjuvant ipilimumab plus nivolumab in synchronous clinical stage III melanoma. Eur J Cancer. 2021 May;148:51-57. doi: 10.1016/j.ejca.2021.02.012. Epub 2021 Mar 15.","pmid":"33735809","type":"DERIVED"},{"citation":"Rozeman EA, Hoefsmit EP, Reijers ILM, Saw RPM, Versluis JM, Krijgsman O, Dimitriadis P, Sikorska K, van de Wiel BA, Eriksson H, Gonzalez M, Torres Acosta A, Grijpink-Ongering LG, Shannon K, Haanen JBAG, Stretch J, Ch'ng S, Nieweg OE, Mallo HA, Adriaansz S, Kerkhoven RM, Cornelissen S, Broeks A, Klop WMC, Zuur CL, van Houdt WJ, Peeper DS, Spillane AJ, van Akkooi ACJ, Scolyer RA, Schumacher TNM, Menzies AM, Long GV, Blank CU. Survival and biomarker analyses from the OpACIN-neo and OpACIN neoadjuvant immunotherapy trials in stage III melanoma. Nat Med. 2021 Feb;27(2):256-263. doi: 10.1038/s41591-020-01211-7. Epub 2021 Feb 8.","pmid":"33558721","type":"DERIVED"}],"start_date":{"date":"2016-11-24","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study to Identify the Optimal Adjuvant Combination Scheme of Ipilimumab and Nivolumab in Melanoma Patients","url":"https://clinicaltrials.gov/study/NCT02437279"},"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/opacin-nct02437279"}