{"commentary":{"count":7,"free_build_floor":8,"listing_floor":3,"by_channel":{"youtube":4,"podcast":3},"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":"waveLINE-007","nct_id":"NCT05406401","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=waveline-007-nct05406401. 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":"waveLINE-007","arms":[{"description":"Participants in the dose escalation/confirmation phase receive a dose level of zilovertamab vedotin (from 1.5 mg/Kg up to 2.5 mg/Kg) plus 750 mg/m\\^2 cyclophosphamide, 50 mg/m\\^2 doxorubicin, and 375 mg/m\\^2 rituximab or rituximab biosimilar (truxima) administered by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 8 cycles (up to approximately 5.5 months). Participants also receive 100 mg prednisone or prednisolone per day during Days 1-5 of each 21-day cycle for up to 8 cycles (up to approximately 5.5 months).","label":"Zilovertamab Vedotin + R-CHP: Dose Escalation/Confirmation","type":"EXPERIMENTAL"},{"description":"Participants in the efficacy expansion phase receive the RP2D of zilovertamab vedotin plus 750 mg/m\\^2 cyclophosphamide, 50 mg/m\\^2 doxorubicin, and 375 mg/m\\^2 rituximab or rituximab biosimilar (truxima) administered by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 8 cycles (up to approximately 5.5 months). Participants also receive 100 mg prednisone or prednisolone per day during Days 1-5 of each 21-day cycle for up to 8 cycles (up to approximately 5.5 months).","label":"Zilovertamab Vedotin + R-CHP: Efficacy Expansion","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2029-04-26","type":"ESTIMATED"},"conditions":["Lymphoma, Large B-Cell, Diffuse (DLBCL)"],"enrollment":{"count":60,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Zilovertamab Vedotin","type":"BIOLOGICAL"},{"name":"Cyclophosphamide","type":"DRUG"},{"name":"Doxorubicin","type":"DRUG"},{"name":"Rituximab","type":"BIOLOGICAL"},{"name":"Rituximab Biosimilar","type":"BIOLOGICAL"},{"name":"Prednisone","type":"DRUG"},{"name":"Prednisolone","type":"DRUG"}],"last_update":"2024-10-15","lead_sponsor":"Merck Sharp & Dohme LLC","official_title":"A Multicenter, Open-label, Phase 2 Dose Escalation and Confirmation, and Efficacy Expansion Study of Zilovertamab Vedotin (MK-2140) in Combination With R-CHP in Participants With DLBCL (waveLINE)","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2029-04-26","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Number of Participants Who Experienced Dose-limiting Toxicities (DLTs) in Cycle 1","timeFrame":"Cycle 1 (up to 21 days)"},{"measure":"Number of Participants Who Experienced At Least One AE","timeFrame":"Up to approximately 8 months"},{"measure":"Number of Participants Who Discontinued Study Treatment Due to an AE","timeFrame":"Up to approximately 5.5 months"},{"measure":"Complete Response Rate (CRR) per Lugano Response Criteria","timeFrame":"Up to approximately 60 months"}],"references":[],"start_date":{"date":"2022-07-14","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Zilovertamab Vedotin (MK-2140) in Combination With Cyclophosphamide, Doxorubicin, and Prednisone Plus Rituximab or Rituximab Biosimilar (Truxima) (R-CHP) in Participants With Diffuse Large B-Cell Lymphoma (DLBCL) (MK-2140-007)","url":"https://clinicaltrials.gov/study/NCT05406401"},"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/waveline-007-nct05406401"}