{"commentary":{"count":23,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":16,"youtube":4,"podcast":3},"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\": \"NCT04724018\", \"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":"NCT04724018","nct_id":"NCT04724018","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct04724018. 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":null,"arms":[{"description":"Participants will be given the study drugs Enfortumab Vedotin and then Sacituzumab Govitecan on Days 1 and 8 of a 21-day study cycle. Dose escalation and de-escalation for the Sacituzumab Govitecan (SG) and Enfortumab vedotin-ejfv (EV) combination will be guided using the Bayesian optimal interval (BOIN) design with up to 4 dose level escalations.","label":"Dose Escalation Sacituzumab Govitecan (SG) and Enfortumab vedotin-ejfv (EV)","type":"EXPERIMENTAL"},{"description":"Participants will be given the study drugs Enfortumab Vedotin and then Sacituzumab Govitecan on Days 1 and 8 of each 21-day study cycle. Three dose levels of this drug combination will be studied with 3-18 patients per dose level depending on treatment-related dose limiting toxicities.","label":"Dose Expansion Sacituzumab Govitecan (SG) and Enfortumab vedotin-ejfv (EV)","type":"EXPERIMENTAL"},{"description":"Participants will be given a triplet regimen of Enfortumab Vedotin 1.25mg/kg, Sacituzumab Govitecan 7.5mg/kg (D1 and D8 every three weeks), and Pembrolizumab 200mg (D1 every 3 weeks) or 400 mg (D1 every 6 weeks) as a front-line therapy. Dose reductions of Enfortumab Vedotin to 1, 0.75 and 0.5 mg/kg will be permitted while Sacituzumab Govitecan can be dose reduced to 5 mg/kg. No dose reductions of Pembrolizumab are permitted. Following C1D1, drugs may be held independently per investigator discretion. A safety run-in will be conducted for the first 12 patients to evaluate the tolerability of the triplet regimen using Bayesian toxicity monitoring (BTOX). The first stage will enroll 6 patients, and if there are 2 or fewer DLTs, then next 6 patients will be enrolled. The study will be halted if there are 5 or more DLTs observed among the total of 12 evaluable patients.","label":"Sacituzumab Govitecan (SG) and Enfortumab vedotin-ejfv (EV) and Pembrolizumab","type":"EXPERIMENTAL"}],"collaborators":["Gilead Sciences"],"completion_date":{"date":"2028-05-01","type":"ESTIMATED"},"conditions":["Urothelial Cancer","Metastatic Urothelial Carcinoma","Metastatic Urothelial Carcinoma of the Renal Pelvis and Ureter","Bladder Cancer"],"enrollment":{"count":106,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Sacituzumab Govitecan (SG)","type":"DRUG"},{"name":"Enfortumab vedotin-ejfv (EV)","type":"DRUG"},{"name":"Pembrolizumab","type":"DRUG"}],"last_update":"2025-11-04","lead_sponsor":"Dana-Farber Cancer Institute","official_title":"Combinations of Sacituzumab Govitecan Plus Enfortumab Vedotin and Pembrolizumab for Metastatic Urothelial Carcinoma: the Double Antibody Drug Conjugate (DAD) and Double Antibody Drug Conjugate With Immunotherapy (DAD-IO) Phase I/II Trial","overall_status":"RECRUITING","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2027-02-01","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Maximum Tolerated Dose (MTD) of Sacituzumab Govitecan (SG) and Enfortumab vedotin-ejfv (EV) in Combination","timeFrame":"21 days"},{"measure":"Dose-limiting toxicity (DLT) of Sacituzumab Govitecan (SG) and Enfortumab Vedotin in combination","timeFrame":"21 days"},{"measure":"Efficacy of Sacituzumab Govitecan (SG) and Enfortumab Vedotin in combination","timeFrame":"21 days"},{"measure":"Efficacy of Sacituzumab Govitecan (SG) and Enfortumab Vedotin and Pembrolizumab in combination","timeFrame":"21 days"}],"references":[{"citation":"McGregor BA, Sonpavde GP, Kwak L, Regan MM, Gao X, Hvidsten H, Mantia CM, Wei XX, Berchuck JE, Berg SA, Ravi PK, Michaelson MD, Choueiri TK, Bellmunt J. The Double Antibody Drug Conjugate (DAD) phase I trial: sacituzumab govitecan plus enfortumab vedotin for metastatic urothelial carcinoma. Ann Oncol. 2024 Jan;35(1):91-97. doi: 10.1016/j.annonc.2023.09.3114. Epub 2023 Oct 21.","pmid":"37871703","type":"DERIVED"}],"start_date":{"date":"2021-05-20","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Sacituzumab Govitecan Plus EV in Metastatic UC","url":"https://clinicaltrials.gov/study/NCT04724018"},"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/nct04724018"}