{"preliminary_commentary":{"by_channel":{"x_thread":91,"podcast":52,"youtube":41},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT04960709\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"name":"VOLGA","nct_id":"NCT04960709","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=volga-nct04960709. 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":1950,"size":"deep","size_rule":"Deep: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"VOLGA","arms":[{"description":"Participants will receive 3 preoperative 21-day cycles of Durvalumab + Enfortumab Vedotin and 2 cycles of Tremelimumab, followed by radical cystectomy, followed by 1 cycle of postoperative Tremelimumab and 9 cycles of Durvalumab. Each postoperative cycle is 28 days.","label":"Durvalumab + Tremelimumab + Enfortumab Vedotin","type":"EXPERIMENTAL"},{"description":"Participants will receive 3 preoperative 21-day cycles of Durvalumab + Enfortumab Vedotin, followed by radical cystectomy, followed by 9 cycles of Durvalumab. Each postoperative cycle is 28 days.","label":"Durvalumab + Enfortumab vedotin","type":"EXPERIMENTAL"},{"description":"Participants may receive SoC (nivolumab approved as adjuvant treatment for MIBC based on high risk criteria) per approved label in the country OR Participants receive standard of care surgery (radical cystectomy) alone.","label":"Cystectomy with or without approved Adjuvant Therapy.","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2028-09-08","type":"ESTIMATED"},"conditions":["Muscle Invasive Bladder Cancer"],"enrollment":{"count":712,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Durvalumab","otherNames":["IMFINZI","MEDI4736"],"type":"DRUG"},{"name":"Tremelimumab","otherNames":[],"type":"DRUG"},{"name":"Enfortumab Vedotin","otherNames":["PADCEV"],"type":"DRUG"},{"name":"Radical Cystectomy","otherNames":[],"type":"PROCEDURE"}],"last_update":"2026-06-04","lead_sponsor":"AstraZeneca","official_title":"A Phase III Randomized, Open-Label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab in Combination With Tremelimumab and Enfortumab Vedotin or Durvalumab in Combination With Enfortumab Vedotin for Perioperative Treatment in Patients Ineligible for Cisplatin or Who Refuse Cisplatin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer (VOLGA)","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2026-03-02","type":"ACTUAL"},"primary_outcomes":[{"measure":"To assess the safety and tolerability as evaluated by adverse events occurring throughout the study (Safety Run-In part)","timeFrame":"At completion of study treatment by the last patient and at 3 months."},{"measure":"To assess the safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as assessed by vital signs (blood pressure in mmHg) (Safety Run-In part)","timeFrame":"Up to 84 months"},{"measure":"To assess the safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as assessed by vital signs (pulse rate) in beats per minute (Safety Run-In part)","timeFrame":"Up to 84 months"},{"measure":"To assess the safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as assessed by vital signs (respiration rate) in breaths per minute (Safety Run-In part)","timeFrame":"Up to 84 months"},{"measure":"To assess the safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as assessed by vital signs (temperature) in degrees Celsius (Safety Run-In part)","timeFrame":"Up to 84 months"},{"measure":"To assess the safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as assessed by abnormality in clinical chemistry by liver function (Safety Run-In part)","timeFrame":"Up to 84 months"},{"measure":"Safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin or who refuse cisplatin as assessed by abnormality in clinical chemistry by kidney function (Safety Run-In part)","timeFrame":"Up to 84 months"},{"measure":"To assess the safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as assessed by abnormality in clinical chemistry by thyroid function (Safety Run-In part)","timeFrame":"Up to 84 months"},{"measure":"To assess the safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as assessed by abnormality in haematology (Safety Run-In part)","timeFrame":"Up to 84 months"},{"measure":"To assess the safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as as assessed by ECG (pulse rate) (Safety Run-In part)","timeFrame":"Up to 84 months"},{"measure":"Changes in WHO/ECOG performance status (Safety Run-In part)","timeFrame":"Up to 84 months"},{"measure":"Compare efficacy of durvalumab + tremelimumab + EV (Arm 1) relative to cystectomy (Arm 3) and durvalumab + EV (Arm 2) relative to cystectomy (Arm 3) on EFS (Main Study)","timeFrame":"Up to 3 years"}],"references":[],"start_date":{"date":"2021-08-05","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Treatment Combination of Durvalumab, Tremelimumab and Enfortumab Vedotin or Durvalumab and Enfortumab Vedotin in Patients With Muscle Invasive Bladder Cancer Ineligible to Cisplatin or Who Refuse Cisplatin","url":"https://clinicaltrials.gov/study/NCT04960709"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/volga-nct04960709"}