{"preliminary_commentary":{"by_channel":{"x_thread":5},"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":[["avelumab","gemcitabine","carboplatin"]],"indication":"cisplatin-ineligible muscle-invasive urothelial carcinoma","name":"SWOG GAP","nct_id":"NCT04871529","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=swog-gap-nct04871529. 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":null,"arms":[{"description":"Patients receive avelumab IV over 60 minutes on day 1. Treatment repeats every 14 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up 4 in the absence of disease progression or unacceptable toxicity. Within 4-8 weeks after final systemic therapy, patients undergo standard of care surgery.","label":"Arm A (avelumab, gemcitabine, carboplatin, surgery)","type":"EXPERIMENTAL"},{"description":"Patients undergo standard of care surgery.","label":"Arm B (surgery)","type":"EXPERIMENTAL"}],"collaborators":["National Cancer Institute (NCI)"],"completion_date":{"date":"2024-06-26","type":"ACTUAL"},"conditions":["Bladder Carcinoma Infiltrating the Muscle of the Bladder Wall","Infiltrating Renal Pelvis and Ureter Urothelial Carcinoma","Stage II Bladder Cancer AJCC v8"],"enrollment":{"count":6,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Therapeutic Conventional Surgery","otherNames":[],"type":"PROCEDURE"},{"name":"Avelumab","otherNames":["1537032-82-8","Bavencio","Immunoglobulin G1-lambda1","Anti-(Homo sapiens CD274 (Programmed Death Ligand 1, PDL1, pd-l1, B7 Homolog 1, B7H1))","Homo sapiens Monoclonal Antibody","MSB-0010718C","MSB0010718C"],"type":"DRUG"},{"name":"Gemcitabine Hydrochloride","otherNames":["1-(2-Oxo-4-amino-1,2-dihydropyrimidin-1-yl)-2-deoxy-2,2-difluororibose, hydrochloride","122111-03-9","2''Deoxy-2'',2''-Difluorocytidine Hydrochloride","dFdCyd","Difluorodeoxycytidine Hydrochloride","FF 10832","FF-10832","FF10832","Gemcitabine HCI","Gemzar","LY-188011","LY188011"],"type":"DRUG"},{"name":"Carboplatin","otherNames":["(SP-4-2)-diammine[1,1-cyclobutanedicarboxylato(2--)-O,O'']platinum","1,1-cyclobutanedicarboxylic acid platinum complex","41575-94-4","Blastocarb","Carboplat","Carboplatin Hexal","Carboplatino","Carboplatinum","Carbosin","Carbosol","Carbotec","CBDCA","cis-diammine(1,1-cyclobutanedicarboxylato) platinum(II)","Cis-Diammine(cyclobutane-1,1-dicarboxylato)platinum","cis-diammine(cyclobutanedicarboxylato)platinum II","Displata","Ercar","JM-8","Nealorin","Novoplatinum","Paraplatin","Paraplatin AQ","Paraplatine","platinum","diammine(1,1-cyclobutanedicarboxylato(2-))-, (SP-4-2)"],"type":"DRUG"}],"last_update":"2024-12-30","lead_sponsor":"SWOG Cancer Research Network","official_title":"Randomized Phase II Trial of Gemcitabine, Avelumab and Carboplatin vs. No Neoadjuvant Therapy Preceding Surgery for Cisplatin-Ineligible Muscle-Invasive Urothelial Carcinoma: SWOG GAP TRIAL","overall_status":"TERMINATED","phases":["PHASE2"],"primary_completion_date":{"date":"2023-11-14","type":"ACTUAL"},"primary_outcomes":[{"measure":"Pathologic Complete Response","timeFrame":"Measured once - at the time of surgery"}],"references":[],"start_date":{"date":"2022-08-10","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Testing the Addition of an Anti-Cancer Immunotherapy Drug, Avelumab, to Gemcitabine and Carboplatin Chemotherapy Prior to Surgery in Muscle Invasive Urinary Tract Cancer vs. Surgery Alone in Patients Who Are Not Able to Receive Cisplatin Therapy (SWOG GAP TRIAL)","url":"https://clinicaltrials.gov/study/NCT04871529"},"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/swog-gap-nct04871529"}