{"preliminary_commentary":{"by_channel":{"x_thread":2,"bluesky_thread":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":null,"indication":null,"name":"TNBC-MERIT","nct_id":"NCT02316457","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=tnbc-merit-nct02316457. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. 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_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"TNBC-MERIT","arms":[{"description":"Patients enrolled in ARM1 will receive a treatment with four RNAs. This includes two to three variant RNAs selected from the WAREHOUSE plus p53 RNA. The selection process of RNAs from the warehouse is based on RT-PCR-based profiling of RNA extracted from patient tumor sample specimens, pre-defined cut-offs and algorithms to select the three relevant RNAs for a given patient.","label":"ARM1 IVAC_W_bre1_uID","type":"EXPERIMENTAL"},{"description":"Patients enrolled in ARM2 will optionally receive the WAREHOUSE treatment as described above followed by the personalized IVAC® MUTANOME immunotherapy. The mutation selection process constitutes a multi-step process including identification of somatic mutations by NGS, mutation confirmation and prioritization, selection, and on demand manufacturing.","label":"ARM2 IVAC_W_bre1_uID/IVAC_M_uID","type":"EXPERIMENTAL"},{"description":"Patients enrolled in ARM3 will receive a treatment with four RNAs. This includes two to three variant RNAs selected from the WAREHOUSE plus p53 RNA. The selection process of RNAs from the warehouse is based on RT-PCR-based profiling of RNA extracted from patient tumor sample specimens, pre-defined cut-offs and algorithms to select the three relevant RNAs for a given patient. RBLTet.1 RNA will be added to each RNA applied.","label":"ARM3 IVAC_W_bre1_uID + RBLTet.1","type":"EXPERIMENTAL"}],"collaborators":["Seventh Framework Programme"],"completion_date":{"date":"2023-05-17","type":"ACTUAL"},"conditions":["Breast Cancer (Triple Negative Breast Cancer (TNBC))"],"enrollment":{"count":42,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"IVAC_W_bre1_uID","otherNames":[],"type":"BIOLOGICAL"},{"name":"IVAC_W_bre1_uID/IVAC_M_uID","otherNames":[],"type":"BIOLOGICAL"}],"last_update":"2026-03-13","lead_sponsor":"BioNTech SE","official_title":"First-in-human Clinical Study With RNA-Immunotherapy Combination of IVAC_W_bre1_uID and IVAC_M_uID for Individualized Tumor Therapy in Triple Negative Breast Cancer Patients","overall_status":"COMPLETED","phases":["PHASE1"],"primary_completion_date":{"date":"2020-05-13","type":"ACTUAL"},"primary_outcomes":[{"measure":"Number of Adverse Events as a Measure of Safety and Tolerability of IVAC_W_bre1_uID","timeFrame":"day 120"},{"measure":"Number of Adverse Events as a Measure of Safety and Tolerability of IVAC_W_bre1_uID plus IVAC_M_uID","timeFrame":"up to day 246"}],"references":[{"citation":"Sahin U, Schmidt M, Derhovanessian E, Cortini A, Vogler I, Omokoko T, Godehardt E, Attig S, Newrzela S, Grutzner J, Bidmon N, Bolte S, Brachtendorf S, Stuhlmann T, Langer D, Brune D, Blake J, Feldner A, Lindman H, Schneeweiss A, Eichbaum M, Tureci O. Individualized mRNA vaccines evoke durable T cell immunity in adjuvant TNBC. Nature. 2026 Mar;651(8107):1088-1096. doi: 10.1038/s41586-025-10004-2. Epub 2026 Feb 18.","pmid":"41708868","type":"DERIVED"}],"start_date":{"date":"2016-10","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"RNA-Immunotherapy of IVAC_W_bre1_uID and IVAC_M_uID","url":"https://clinicaltrials.gov/study/NCT02316457"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/tnbc-merit-nct02316457"}