{"preliminary_commentary":{"by_channel":{"x_thread":2,"youtube":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":false},"name":"IMCODE 001","nct_id":"NCT03815058","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=imcode-001-nct03815058. 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":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"IMCODE001","arms":[{"description":"Participants will receive at least one cycle of 200 mg pembrolizumab monotherapy by intravenous (IV) infusion followed by 200 mg pembrolizumab IV infusion every 3 weeks (Q3W) plus a recommended dose of autogene cevumeran.","label":"Safety Run-in Period: Autogene Cevumeran + Pembrolizumab","type":"EXPERIMENTAL"},{"description":"Participants will receive 200 mg pembrolizumab administered by IV infusion Q3W. Participants in Arm A have the option to cross over to combination treatment with autogene cevumeran plus pembrolizumab (Arm B) after confirmed disease progression.","label":"Randomized Period: Arm A: Pembrolizumab","type":"ACTIVE_COMPARATOR"},{"description":"Participants will receive at least one cycle of 200 mg pembrolizumab monotherapy by IV infusion followed by 200 mg pembrolizumab IV infusion Q3W plus a recommended dose of autogene cevumeran.","label":"Randomized Period: Arm B: Autogene Cevumeran + Pembrolizumab","type":"EXPERIMENTAL"}],"collaborators":["BioNTech SE"],"completion_date":{"date":"2025-01-21","type":"ACTUAL"},"conditions":["Advanced Melanoma"],"enrollment":{"count":131,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Autogene cevumeran","otherNames":["RO7198457"],"type":"BIOLOGICAL"},{"name":"Pembrolizumab","otherNames":["Keytruda"],"type":"DRUG"}],"last_update":"2026-01-30","lead_sponsor":"Genentech, Inc.","official_title":"A Phase II, Open-Label, Multicenter, Randomized Study of the Efficacy and Safety of RO7198457 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Previously Untreated Advanced Melanoma","overall_status":"COMPLETED","phases":["PHASE2"],"primary_completion_date":{"date":"2025-01-21","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v.1.1) After Randomization","timeFrame":"From randomization to PD or death (up to approximately 60 months)"}],"references":[],"start_date":{"date":"2018-12-21","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran (RO7198457) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Participants With Previously Untreated Advanced Melanoma.","url":"https://clinicaltrials.gov/study/NCT03815058"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/imcode-001-nct03815058"}