{"commentary":{"count":29,"free_build_floor":8,"listing_floor":3,"by_channel":{"podcast":12,"youtube":11,"x_thread":6},"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\": \"NCT02631447\", \"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":"SECOMBIT","nct_id":"NCT02631447","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=secombit-nct02631447. 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":"SECOMBIT","arms":[{"description":"Combo Target (LGX818 450 mg p.o. od + MEK162 45 mg p.o. bid) until PD; then Combo Immuno (nivolumab 1 mg/kg solution IV combined with ipilimumab 3 mg/kg solution IV every 3 weeks for 4 doses then nivolumab 3 mg/kg solution IV every 2 weeks) until PD","label":"Arm A: Combo Target/Combo Immuno","type":"EXPERIMENTAL"},{"description":"Combo Immuno (nivolumab 1 mg/kg solution IV combined with ipilimumab 3 mg/kg solution IV every 3 weeks for 4 doses then nivolumab 3 mg/kg solution IV every 2 weeks) until PD; then Combo Target (LGX818 450 mg p.o. od + MEK162 45 mg p.o. bid) until PD","label":"Arm B: Como immuno/Combo Target","type":"EXPERIMENTAL"},{"description":"Combo Target (LGX818 450 mg p.o. od + MEK162 45 mg p.o. bid) for 8 weeks followed by Combo Immuno (nivolumab 1 mg/kg solution IV combined with ipilimumab 3 mg/kg solution IV every 3 weeks for 4 doses then nivolumab 3 mg/kg solution IV every 2 weeks) until PD; then Combo Target (LGX818 450 mg p.o. od + MEK162 45 mg p.o. bid) until PD","label":"Arm C: Sandwich","type":"EXPERIMENTAL"}],"collaborators":["Clinical Research Technology S.r.l."],"completion_date":{"date":"2024-05-31","type":"ACTUAL"},"conditions":["Metastatic Melanoma"],"enrollment":{"count":251,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"LGX818","type":"DRUG"},{"name":"MEK162","type":"DRUG"},{"name":"Nivolumab","type":"DRUG"},{"name":"Ipilimumab","type":"DRUG"}],"last_update":"2024-06-07","lead_sponsor":"Fondazione Melanoma Onlus","official_title":"A Three Arms Prospective, Randomized Phase II Study to Evaluate the Best Sequential Approach With Combo Immunotherapy (Ipilimumab/Nivolumab) and Combo Target Therapy (LGX818/MEK162) in Patients With Metastatic Melanoma and BRAF Mutation","overall_status":"COMPLETED","phases":["PHASE2"],"primary_completion_date":{"date":"2024-05-31","type":"ACTUAL"},"primary_outcomes":[{"measure":"Overall Survival","timeFrame":"Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 24 month"}],"references":[{"citation":"Helgadottir H, Capone M, Ridolfi L, Zambelli A, Piccin L, Gogas H, Tucci M, Quaglino P, Del Vecchio M, Minisini AM, Spagnolo F, Rutkowski P, Ferraresi V, Arance A, Guida M, Maiello E, Lebbe C, Bulgarelli J, Chiarion Sileni V, Paone M, Melero I, Trojaniello C, Bergqvist M, Dummer R, Giannarelli D, Palmieri G, Ascierto PA. Circulating thymidine kinase activity predicts survival and optimal treatment sequencing in BRAF-mutated metastatic melanoma in the SECOMBIT trial. Clin Cancer Res. 2026 Aug 4. doi: 10.1158/1078-0432.CCR-26-1402. Online ahead of print.","pmid":"42550831","type":"DERIVED"},{"citation":"Ascierto PA, Mandala M, Ferrucci PF, Guidoboni M, Rutkowski P, Ferraresi V, Arance A, Guida M, Maiello E, Gogas H, Richtig E, Quaglino P, Lebbe C, Helgadottir H, Queirolo P, Spagnolo F, Tucci M, Del Vecchio M, Gonzalez-Cao M, Minisini AM, De Placido S, Sanmamed MF, Casula M, Bulgarelli J, Pisano M, Piccinini C, Piccin L, Cossu A, Mallardo D, Paone M, Vitale MG, Melero I, Grimaldi AM, Giannarelli D, Palmieri G, Dummer R, Sileni VC. Sequencing of Checkpoint or BRAF/MEK Inhibitors on Brain Metastases in Melanoma. NEJM Evid. 2024 Oct;3(10):EVIDoa2400087. doi: 10.1056/EVIDoa2400087. Epub 2024 Sep 24.","pmid":"39315864","type":"DERIVED"},{"citation":"Ascierto PA, Casula M, Bulgarelli J, Pisano M, Piccinini C, Piccin L, Cossu A, Mandala M, Ferrucci PF, Guidoboni M, Rutkowski P, Ferraresi V, Arance A, Guida M, Maiello E, Gogas H, Richtig E, Fierro MT, Lebbe C, Helgadottir H, Queirolo P, Spagnolo F, Tucci M, Del Vecchio M, Cao MG, Minisini AM, De Placido S, Sanmamed MF, Mallardo D, Paone M, Vitale MG, Melero I, Grimaldi AM, Giannarelli D, Dummer R, Sileni VC, Palmieri G. Sequential immunotherapy and targeted therapy for metastatic BRAF V600 mutated melanoma: 4-year survival and biomarkers evaluation from the phase II SECOMBIT trial. Nat Commun. 2024 Jan 2;15(1):146. doi: 10.1038/s41467-023-44475-6.","pmid":"38167503","type":"DERIVED"},{"citation":"Ascierto PA, Mandala M, Ferrucci PF, Guidoboni M, Rutkowski P, Ferraresi V, Arance A, Guida M, Maiello E, Gogas H, Richtig E, Fierro MT, Lebbe C, Helgadottir H, Queirolo P, Spagnolo F, Tucci M, Del Vecchio M, Gonzales Cao M, Minisini AM, De Placido S, Sanmamed MF, Mallardo D, Curvietto M, Melero I, Palmieri G, Grimaldi AM, Giannarelli D, Dummer R, Chiarion Sileni V. Sequencing of Ipilimumab Plus Nivolumab and Encorafenib Plus Binimetinib for Untreated BRAF-Mutated Metastatic Melanoma (SECOMBIT): A Randomized, Three-Arm, Open-Label Phase II Trial. J Clin Oncol. 2023 Jan 10;41(2):212-221. doi: 10.1200/JCO.21.02961. Epub 2022 Sep 1.","pmid":"36049147","type":"DERIVED"}],"start_date":{"date":"2016-11-14","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Sequential Combo Immuno and Target Therapy (SECOMBIT) Study","url":"https://clinicaltrials.gov/study/NCT02631447"},"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/secombit-nct02631447"}