{"preliminary_commentary":{"by_channel":{"x_thread":3},"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":"NCT03289962","nct_id":"NCT03289962","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct03289962. 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":null,"arms":[{"description":"Participants will receive autogene cevumeran at escalated dosages.","label":"Phase 1a Flat Dose Escalation: Autogene Cevumeran","type":"EXPERIMENTAL"},{"description":"Participants will receive autogene cevumeran at escalated dosages along with atezolizumab at a fixed dose of 1200 milligrams (mg)","label":"Phase 1b Flat Dose Escalation: Autogene Cevumeran + Atezolizumab","type":"EXPERIMENTAL"},{"description":"Non-small cell lung cancer (NSCLC) or melanoma cancer immunotherapy (CIT)-treated participants will receive autogene cevumeran (at dosage lower than maximum tolerated dose \\[MTD\\] based on available safety data) along with atezolizumab at a fixed dose of 1200 mg.","label":"Phase Ib: Dose Exploration: Autogene Cevumeran + Atezolizumab","type":"EXPERIMENTAL"},{"description":"Participants with different indications as per inclusion criteria will receive autogene cevumeran (at multiple dose levels below MTD based on available safety data) along with atezolizumab at a fixed dose of 1200 mg.","label":"Phase 1b Expansion: Autogene Cevumeran + Atezolizumab","type":"EXPERIMENTAL"},{"description":"CIT-naive patients with selected tumor types who consent to optional serial biopsies will receive autogene cevumeran (at multiple dose levels below MTD based on available safety data) along with atezolizumab at a dixed dose of 1200 mg.","label":"Phase 1b Expansion: Autogene Cevumeran + Atezolizumab (Serial Biopsy)","type":"EXPERIMENTAL"}],"collaborators":["BioNTech SE"],"completion_date":{"date":"2025-07-01","type":"ACTUAL"},"conditions":["Melanoma","Non-Small Cell Lung Cancer","Bladder Cancer","Colorectal Cancer","Triple Negative Breast Cancer","Renal Cancer","Head and Neck Cancer","Other Solid Cancers"],"enrollment":{"count":273,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Autogene cevumeran","otherNames":["RO7198457"],"type":"DRUG"},{"name":"Atezolizumab","otherNames":["Tecentriq","RO5541267","MPDL3280A","An engineered anti-PDL1 antibody"],"type":"DRUG"}],"last_update":"2026-06-08","lead_sponsor":"Genentech, Inc.","official_title":"A Phase 1a/1b Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of RO7198457 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Tumors","overall_status":"COMPLETED","phases":["PHASE1"],"primary_completion_date":{"date":"2025-07-01","type":"ACTUAL"},"primary_outcomes":[{"measure":"Percentage of Participants with Dose-Limiting Toxicities (DLTs)","timeFrame":"Phase 1a: Days 1 to 14 / Phase 1b: Days 1 to 21"},{"measure":"MTD/Recommended Phase 2 Dose (RP2D) of Autogene Cevumeran","timeFrame":"Phase 1a: Days 1 to 14 / Phase 1b: Days 1 to 21"},{"measure":"Percentage of Participants with Adverse Events (AEs)","timeFrame":"Baseline up to end of the study (up to approximately 3 years)"},{"measure":"Percentage of Participants with Immune-Mediated Adverse Events (imAEs)","timeFrame":"Baseline up to end of the study (up to approximately 3 years)"},{"measure":"Percentage of Participants by Number of Treatment Cycles Received","timeFrame":"Baseline up to end of the study (up to approximately 3 years)"},{"measure":"Dose Intensity of Autogene Cevumeran","timeFrame":"Baseline up to end of the study (up to approximately 3 years)"},{"measure":"Change from Baseline in Targeted Vital Signs","timeFrame":"Baseline up to end of study (up to approximately 3 years)"},{"measure":"Change from Baseline in Targeted Clinical Laboratory Test Results","timeFrame":"Baseline up to end of study (up to approximately 3 years)"},{"measure":"Change from Baseline in ECGs","timeFrame":"Baseline up to end of study (up to approximately 3 years)"}],"references":[{"citation":"Lopez J, Powles T, Braiteh F, Siu LL, LoRusso P, Friedman CF, Balmanoukian AS, Gordon M, Yachnin J, Rottey S, Karydis I, Fisher GA, Schmidt M, Schuler M, Sullivan RJ, Burris HA, Galvao V, Henick BS, Dirix L, Jaeger D, Ott PA, Wong KM, Jerusalem G, Schiza A, Fong L, Steeghs N, Leidner RS, Rittmeyer A, Laurie SA, Gort E, Aljumaily R, Melero I, Sabado RL, Rhee I, Mancuso MR, Muller L, Fine GD, Yadav M, Kim L, Leveque VJP, Robert A, Darwish M, Qi T, Zhu J, Zhang J, Twomey P, Rao GK, Low DW, Petry C, Lo AA, Schartner JM, Delamarre L, Mellman I, Lower M, Muller F, Derhovanessian E, Cortini A, Manning L, Maurus D, Brachtendorf S, Lorks V, Omokoko T, Godehardt E, Becker D, Hawner C, Wallrapp C, Albrecht C, Kroner C, Tadmor AD, Diekmann J, Vormehr M, Jork A, Paruzynski A, Lang M, Blake J, Hennig O, Kuhn AN, Sahin U, Tureci O, Camidge DR. Autogene cevumeran with or without atezolizumab in advanced solid tumors: a phase 1 trial. Nat Med. 2025 Jan;31(1):152-164. doi: 10.1038/s41591-024-03334-7. Epub 2025 Jan 6.","pmid":"39762422","type":"DERIVED"}],"start_date":{"date":"2017-12-21","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Autogene Cevumeran (RO7198457) as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Tumors","url":"https://clinicaltrials.gov/study/NCT03289962"},"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/nct03289962"}