{"commentary":{"count":30,"free_build_floor":8,"listing_floor":3,"by_channel":{"youtube":16,"podcast":7,"x_thread":6,"x_video":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\": \"NCT06385080\", \"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":"OrigAMI-4","nct_id":"NCT06385080","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=origami-4-nct06385080. 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":"OrigAMI-4","arms":[{"description":"Participants will receive subcutaneous injection of amivantamab monotherapy 1600 milligrams (mg) (2240 mg, if body weight \\>=80 kilograms \\[kg\\]) on Cycle 1 Day 1 and 2400 mg (3360 mg, if body weight \\>=80 kg) once every week (q1w) for the remainder of Cycle 1 (Days 8 and 15), and every 3 weeks (q3w) from Cycle 2 onwards.","label":"Cohort 1: Amivantamab Monotherapy (Dose Expansion)","type":"EXPERIMENTAL"},{"description":"Participants will receive subcutaneous injection of amivantamab 1600 mg (2240 mg, if body weight \\>=80 kg) on Cycle 1 Day 1 and 2400 mg (3360 mg, if body weight \\>=80 kg) q1w for the remainder of Cycle 1 (Days 8 and 15), and q3w from Cycle 2 onwards, along with intravenous (IV) injection of pembrolizumab 200 mg q3w (on Day 1 of each 21-day cycle).","label":"Cohort 2: Amivantamab + Pembrolizumab (Dose Expansion Including Safety Run-in)","type":"EXPERIMENTAL"},{"description":"Participants will receive subcutaneous injection of amivantamab 1600 mg (2240 mg, if body weight \\>=80 kg) on Cycle 1 Day 1 and 2400 mg (3360 mg, if body weight \\>=80 kg) q1w for the remainder of Cycle 1 (Days 8 and 15), and q3w from Cycle 2 onwards, along with intravenous injection of paclitaxel 175 mg/m\\^2 q3w (on Day 1 of each 21-day cycle) in dose confirmation Cohort 3A. The recommended Phase 2 combination dose (RP2CD) of amivantamab will be determined in conjunction with study evaluation team (SET) in this dose confirmation Cohort 3A.","label":"Cohort 3A (Dose Confirmation): Amivantamab + Paclitaxel","type":"EXPERIMENTAL"},{"description":"Participants will receive subcutaneous injection of amivantamab at the determined RP2CD in addition to intravenous injection of paclitaxel 175 mg/m\\^2 q3w (on Day 1 of each 21-day cycle) as confirmed by SET in Cohort 3A.","label":"Cohort 3B (Dose Expansion): Amivantamab + Paclitaxel","type":"EXPERIMENTAL"},{"description":"Participants will receive subcutaneous injection of amivantamab monotherapy 1600 mg (2240 mg, if body weight \\>=80 kg) on Cycle 1 Day 1 and 2400 mg (3360 mg, if body weight \\>=80 kg) q1w for the remainder of Cycle 1 (Days 8 and 15), and q3w from Cycle 2 onwards.","label":"Cohort 4: Amivantamab Monotherapy","type":"EXPERIMENTAL"},{"description":"Participants will receive subcutaneous injection of amivantamab 1600 mg (2240 mg, if body weight \\>=80 kg) on Cycle 1 Day 1 and 2400 mg (3360 mg, if body weight \\>=80 kg) q1w for the remainder of Cycle 1 (Days 8 and 15), and q3w from Cycle 2 onwards in addition to intravenous injection of pembrolizumab 200 mg on Day 1 of each cycle, and carboplatin (area under the concentration-time curve \\[AUC\\] 5 milligram per milliliter \\[mg/ml\\]\\*min) q3w on Day 1 of Cycles 1-6.","label":"Cohort 5: Pembrolizumab + Amivantamab + Carboplatin (Dose Expansion)","type":"EXPERIMENTAL"},{"description":"Participants will receive subcutaneous injection of amivantamab 1600 mg (2240 mg, if body weight \\>=80 kg) on Cycle 1 Day 1 and 2400 mg (3360 mg, if body weight \\>=80 kg) q1w for the remainder of Cycle 1 (Days 8 and 15), and q3w from Cycle 2, along with intravenous injection of pembrolizumab 200 mg q3w (on Day 1 of each 21-day cycle) (Neoadjuvant Phase). In the adjuvant phase, pembrolizumab IV (200 mg) will be administered q3w from Adjuvant Cycle 1 Day 1 to Adjuvant Cycle 15 Day 1 and amivantamab SC 2,400 mg (3,360 mg for \\>80 kg) will be administered q3w from Adjuvant Cycle 4 Day 1 to Adjuvant Cycle 15 Day 1.","label":"Cohort 6: Amivantamab + Pembrolizumab","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2033-07-28","type":"ESTIMATED"},"conditions":["Squamous Cell Carcinoma of Head and Neck"],"enrollment":{"count":287,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Amivantamab","type":"BIOLOGICAL"},{"name":"Pembrolizumab","type":"BIOLOGICAL"},{"name":"Paclitaxel","type":"DRUG"},{"name":"Carboplatin","type":"DRUG"}],"last_update":"2026-09-25","lead_sponsor":"Janssen Research & Development, LLC","official_title":"A Phase 1b/2, Open-label Study of Amivantamab Monotherapy and Amivantamab in Addition to Other Therapeutic Agents in Participants With Head and Neck Squamous Cell Carcinoma","overall_status":"RECRUITING","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2032-12-27","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Cohorts 1, 2, 3B, 4 and 5: Objective Response Rate","timeFrame":"2 years and 2 months"},{"measure":"Cohort 3A: Number of Participants With Dose-limiting Toxicities (DLT)","timeFrame":"Up to 21 days"},{"measure":"Cohort 3A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Severity","timeFrame":"2 years and 1 month"},{"measure":"Cohort 6: Major Pathologic Response (MPR)","timeFrame":"2 years and 2 months"}],"references":[{"citation":"Burtness B, Rosenberg AJ, Calderon B, Lim SM, Yang MH, Li SH, Kadowaki S, Swiecicki PL, Geiger JL, Ince W, Hahn D, Guo Y, Adkins D, Metcalf R, Ahn MJ, Sukari A, Brana I, Keam B, Tanaka H, Sheth S, Oliva M, Lyu X, Curtin JC, Toyoizumi K, Xie J, Wade M, Diorio B, Kapoor A, Yilmaz E, Baig M, Kim P, Verheijen RB, Shah S, Harrington KJ; OrigAMI-4 Cohort 1 Investigators. Amivantamab in Recurrent/Metastatic Head and Neck Squamous Cell Cancer After Checkpoint Inhibitor and Chemotherapy: Pivotal Results From the Phase Ib/II OrigAMI-4 Study. J Clin Oncol. 2026 May 31:JCO2601042. doi: 10.1200/JCO-26-01042. Online ahead of print.","pmid":"42218660","type":"DERIVED"}],"start_date":{"date":"2024-04-22","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer","url":"https://clinicaltrials.gov/study/NCT06385080"},"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/origami-4-nct06385080"}