{"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":[["nivolumab","lirilumab"],["nivolumab"]],"indication":"cisplatin-ineligible muscle-invasive bladder cancer","name":"PrE0807","nct_id":"NCT03532451","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=pre0807-nct03532451. 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":"PrE0807","arms":[{"description":"Nivolumab 480 mg IV on week 0 and week 4","label":"Cohort 1: Nivolumab","type":"EXPERIMENTAL"},{"description":"Nivolumab 480 mg IV and Lirilumab 240 mg on week 0 and week 4","label":"Cohort 2: Nivolumab/Lirilumab","type":"EXPERIMENTAL"}],"collaborators":["Bristol-Myers Squibb"],"completion_date":{"date":"2022-10-05","type":"ACTUAL"},"conditions":["Bladder Cancer"],"enrollment":{"count":43,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Nivolumab","otherNames":["Opdivo"],"type":"DRUG"},{"name":"Nivolumab/Lirilumab","otherNames":["Opdivo","BMS-986015"],"type":"DRUG"}],"last_update":"2024-09-19","lead_sponsor":"PrECOG, LLC.","official_title":"Phase Ib Feasibility Trial of Neoadjuvant Nivolumab/Lirilumab in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer","overall_status":"COMPLETED","phases":["PHASE1"],"primary_completion_date":{"date":"2020-11-27","type":"ACTUAL"},"primary_outcomes":[{"measure":"Grade 3 or Higher Treatment Related Adverse Events as Assessed by CTCAE V5.0","timeFrame":"16 months"}],"references":[{"citation":"Grivas P, Koshkin VS, Chu X, Cole S, Jain RK, Dreicer R, Cetnar JP, Sundi D, Gartrell BA, Galsky MD, Woo B, Li-Ning-Tapia E, Hahn NM, Carducci MA. PrECOG PrE0807: A Phase 1b Feasibility Trial of Neoadjuvant Nivolumab Without and with Lirilumab in Patients with Muscle-invasive Bladder Cancer Ineligible for or Refusing Cisplatin-based Neoadjuvant Chemotherapy. Eur Urol Oncol. 2024 Aug;7(4):914-922. doi: 10.1016/j.euo.2023.11.022. Epub 2023 Dec 27.","pmid":"38155060","type":"RESULT"}],"start_date":{"date":"2019-03-22","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Phase Ib Feasibility Trial of Neoadjuvant Nivolumab/Lirilumab in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer","url":"https://clinicaltrials.gov/study/NCT03532451"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/pre0807-nct03532451"}