{"commentary":{"count":19,"free_build_floor":8,"listing_floor":3,"by_channel":{"podcast":12,"youtube":6,"x_thread":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":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT02977052\", \"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":"OpACIN-neo","nct_id":"NCT02977052","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=opacin-neo-nct02977052. 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":1250,"size":"standard","size_rule":"Standard: 13–40 commentary sources"},"registry":{"acronym":"OpACIN-neo","arms":[{"description":"Patients receive 2 courses standard combination of ipilimumab 3 mg/kg + nivolumab 1 mg/kg q3wk prior to surgery at week 6. Blood for PBMCs and biopsies will be taken for translation research.","label":"Arm A: 2 courses ipi 3 + nivo 1","type":"EXPERIMENTAL"},{"description":"Patients receive 2 courses ipilimumab 1 mg/kg + nivolumab 3 mg/kg q3wk prior to surgery at week 6. Blood for PBMCs and biopsies will be taken for translation research.","label":"Arm B: 2 courses ipi 1 + nivo 3","type":"EXPERIMENTAL"},{"description":"Patients receive 2 courses of ipilimumab 3 mg/kg q3wks, directly followed (\\> 2 hours and \\< 24 hours) by 2 courses nivolumab 3 mg/kg every 2 weeks prior to surgery at week 6. Blood for PBMCs and biopsies will be taken for translation research.","label":"Arm C: 2 courses ipi 3 + 2 courses nivo 3","type":"EXPERIMENTAL"},{"description":"Patients will be treated with 2 courses ipilimumab and nivolumab at the dose level defined as the winner dosing scheme from OpACIN-neo, which is the dosing schedule of arm B.\n\nSurgery and adjuvant therapy\n\n* Patients achieving a pCR or pnCR will not undergo CLND and will not receive any adjuvant treatment. Structural follow-up will be perfomed every 12 weeks by CT, ultrasound of regional lymph nodes.\n* Patients achieving a pPR will undergo CLND and start structural follow-up (including CT and physical examination) every 12 weeks thereafter without any adjuvant treatment.\n* Patients achieving no response (pNR) will undergo CLND and start at week 12 with adjuvant nivolumab 480mg q4wks for 52 weeks + radiotherapy (according to patient's and physicians' decision). In patients that are BRAF V600E/K mutation positive, adjuvant BRAF+MEK","label":"PRADO extension cohort","type":"EXPERIMENTAL"}],"collaborators":["Bristol-Myers Squibb"],"completion_date":{"date":"2025-06","type":"ESTIMATED"},"conditions":["Malignant Melanoma Stage III"],"enrollment":{"count":186,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Ipilimumab","type":"DRUG"},{"name":"Nivolumab","type":"DRUG"},{"name":"Surgery","type":"PROCEDURE"},{"name":"Blood for PBMCs","type":"PROCEDURE"},{"name":"Biopsies","type":"PROCEDURE"}],"last_update":"2023-11-15","lead_sponsor":"The Netherlands Cancer Institute","official_title":"Multicenter Phase 2 Study to Identify of the Optimal Neo-Adjuvant Combination Scheme of Ipilimumab and Nivolumab (OpACIN-neo)","overall_status":"UNKNOWN","phases":["PHASE2"],"primary_completion_date":{"date":"2020-01-03","type":"ACTUAL"},"primary_outcomes":[{"measure":"Safety as measured by the frequency of grade 3/4 immune-related adverse events, using CTCAE 4.03","timeFrame":"During the first 12 weeks."},{"measure":"Response rate according to RECIST 1.1","timeFrame":"At 6 weeks"},{"measure":"Pathological response according to central pathological revision, according to pathological response criteria","timeFrame":"At 6 weeks"},{"measure":"Pathologic response rate according to central revision of the marked index lymph node","timeFrame":"At 6 weeks, prior surgery"},{"measure":"RFS at 24 months in patients achieving pCR or pnCR in their marked index lymph node and did not undergo CLND. RFS will be calculated from date of resection of the marked lymph node.","timeFrame":"24 months"},{"measure":"RFS at 24 months in patients with pNR and being subsequently treated with adjuvant nivolumab+optional radiotherapy (or dabrafenib/trametinib if BRAFV600E pos. and treatment is approved). RFS will be calculated from day of resection of marked lymph node.","timeFrame":"24 months"}],"references":[{"citation":"Hoeijmakers LL, Dimitriadis P, Wijnen SCMA, Reijers ILM, Lopez-Yurda M, Menzies AM, Broeks A, Cornelissen S, Torres Acosta A, van der Wal A, Saw RPM, Versluis JM, van Houdt WJ, Wouters MW, Romano J, Rozeman EA, Grijpink-Ongering LG, Kapiteijn E, van der Veldt AAM, Suijkerbuijk KPM, Eriksson H, Hospers GAP, van der Hage JA, Grunhagen DJ, Witkamp AJ, Lijnsvelt JM, Klop WMC, Zuur CL, Bruining A, Al-Mamgani A, Pennington TE, Shannon KF, Ch'ng S, Colebatch AJ, Gonzalez M, Spillane AJ, Haanen JBAG, Rawson RV, Scolyer RA, van de Wiel BA, van Akkooi ACJ, Long GV, Blank CU. Neoadjuvant ipilimumab plus nivolumab in melanoma: 5-year survival and biomarker analysis from the phase 2 PRADO-trial. Nat Med. 2026 Mar;32(3):952-963. doi: 10.1038/s41591-025-04158-9. Epub 2026 Jan 28.","pmid":"41606118","type":"DERIVED"},{"citation":"Fraterman I, Reijers ILM, Dimitriadis P, Broeks A, Gonzalez M, Menzies AMM, Lopez-Yurda M, Kapiteijn E, van der Veldt AAM, Suijkerbuijk KPM, Hospers GAP, Long GV, Blank CU, van de Poll-Franse LV. Association between pretreatment emotional distress and neoadjuvant immune checkpoint blockade response in melanoma. Nat Med. 2023 Dec;29(12):3090-3099. doi: 10.1038/s41591-023-02631-x. Epub 2023 Nov 13.","pmid":"37957378","type":"DERIVED"},{"citation":"Hoefsmit EP, Vollmy F, Rozeman EA, Reijers ILM, Versluis JM, Hoekman L, van Akkooi ACJ, Long GV, Schadendorf D, Dummer R, Altelaar M, Blank CU. Systemic LRG1 Expression in Melanoma is Associated with Disease Progression and Recurrence. Cancer Res Commun. 2023 Apr 20;3(4):672-683. doi: 10.1158/2767-9764.CRC-23-0015. eCollection 2023 Apr.","pmid":"37089863","type":"DERIVED"},{"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":"Reijers ILM, Menzies AM, van Akkooi ACJ, Versluis JM, van den Heuvel NMJ, Saw RPM, Pennington TE, Kapiteijn E, van der Veldt AAM, Suijkerbuijk KPM, Hospers GAP, Rozeman EA, Klop WMC, van Houdt WJ, Sikorska K, van der Hage JA, Grunhagen DJ, Wouters MW, Witkamp AJ, Zuur CL, Lijnsvelt JM, Torres Acosta A, Grijpink-Ongering LG, Gonzalez M, Jozwiak K, Bierman C, Shannon KF, Ch'ng S, Colebatch AJ, Spillane AJ, Haanen JBAG, Rawson RV, van de Wiel BA, van de Poll-Franse LV, Scolyer RA, Boekhout AH, Long GV, Blank CU. Personalized response-directed surgery and adjuvant therapy after neoadjuvant ipilimumab and nivolumab in high-risk stage III melanoma: the PRADO trial. Nat Med. 2022 Jun;28(6):1178-1188. doi: 10.1038/s41591-022-01851-x. Epub 2022 Jun 5.","pmid":"35661157","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"},{"citation":"Rozeman EA, Menzies AM, van Akkooi ACJ, Adhikari C, Bierman C, van de Wiel BA, Scolyer RA, Krijgsman O, Sikorska K, Eriksson H, Broeks A, van Thienen JV, Guminski AD, Acosta AT, Ter Meulen S, Koenen AM, Bosch LJW, Shannon K, Pronk LM, Gonzalez M, Ch'ng S, Grijpink-Ongering LG, Stretch J, Heijmink S, van Tinteren H, Haanen JBAG, Nieweg OE, Klop WMC, Zuur CL, Saw RPM, van Houdt WJ, Peeper DS, Spillane AJ, Hansson J, Schumacher TN, Long GV, Blank CU. Identification of the optimal combination dosing schedule of neoadjuvant ipilimumab plus nivolumab in macroscopic stage III melanoma (OpACIN-neo): a multicentre, phase 2, randomised, controlled trial. Lancet Oncol. 2019 Jul;20(7):948-960. doi: 10.1016/S1470-2045(19)30151-2. Epub 2019 May 31.","pmid":"31160251","type":"DERIVED"}],"start_date":{"date":"2016-11-24","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Optimal Neo-adjuvant Combination Scheme of Ipilimumab and Nivolumab","url":"https://clinicaltrials.gov/study/NCT02977052"},"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-neo-nct02977052"}