{"preliminary_commentary":{"by_channel":{"x_thread":21,"podcast":1},"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":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT02546661\", \"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."},"commentary_summary":null,"drugs_tested":[["durvalumab","fexagratinib (AZD4547)"],["durvalumab","olaparib"],["durvalumab","adavosertib (AZD1775)"]],"indication":null,"name":"BISCAY","nct_id":"NCT02546661","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=biscay-nct02546661. 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":1950,"size":"deep","size_rule":"Deep: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"BISCAY","arms":[{"description":"AZD4547 will be given orally twice daily until disease progression.\n\nPatients who receive AZD4547 as monotherapy will have the option to cross over to durvalumab as monotherapy at the point of objective progression, as long as the following criteria are met:\n\n* The investigator believes it is in the patient's interest to receive durvalumab;\n* The patient consents to the continued treatment;\n* It is clinically appropriate for the patient to continue on durvalumab treatment;\n* The patient satisfies the key eligibility criteria for receiving durvalumab treatment.","label":"Module A: AZD4547 Monotherapy","type":"EXPERIMENTAL"},{"description":"AZD4547 will be given orally twice daily until disease progression. Patients will also receive MEDI 4736 (durvalumab) by IV infusion once every 4 weeks.","label":"Module A: MEDI4736 (durvalumab) + AZD4547","type":"EXPERIMENTAL"},{"description":"MEDI4736 (durvalumab) will be given by IV infusion once every 4 weeks. Olaparib will be given orally twice daily.","label":"Module B: MEDI4736 (durvalumab) + Olaparib","type":"EXPERIMENTAL"},{"description":"MEDI4736 (durvalumab) will be given by IV infusion once every 4 weeks. AZD1775 will be given orally in approximate 12 hour intervals over 3 days (6 doses) on Days 1-3, 8-10, and 15-17 of 28 day cycles.","label":"Module C: MEDI4736 (durvaluamb) + AZD1775","type":"EXPERIMENTAL"},{"description":"MEDI 4736 (durvalumab) will be given by IV infusion once every 4 weeks.","label":"Module D: MEDI4736 (durvalumab) monotherapy","type":"EXPERIMENTAL"},{"description":"MEDI4736 (durvalumab) will be given by IV infusion once every 4 weeks. Vistusertib will be given orally twice per day on an intermittent schedule (2 days on, 5 days off).","label":"Module E: MEDI4736 (durvalumab) + Vistusertib","type":"EXPERIMENTAL"},{"description":"AZD9150 will be given as monotherapy on Days -7, -5, and -3 of a one week lead-in period. Combination dosing with IV AZD9150 followed by IV MEDI4736 (durvalumab) begins on Day 1 of each 28 day cycle. Thereafter AZD9150 is given weekly and MEDI4736 is given once every 4 weeks.","label":"Module F: MEDI4736 (durvaluamb) + AZD9150","type":"EXPERIMENTAL"},{"description":null,"label":"Module G: MEDI4736 + Selumetinib","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2026-11-30","type":"ESTIMATED"},"conditions":["Muscle Invasive Bladder Cancer"],"enrollment":{"count":117,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"AZD4547","otherNames":[],"type":"DRUG"},{"name":"MEDI4736","otherNames":["Durvalumab"],"type":"DRUG"},{"name":"Olaparib","otherNames":["Lynparza"],"type":"DRUG"},{"name":"AZD1775","otherNames":[],"type":"DRUG"},{"name":"Vistusertib","otherNames":[],"type":"DRUG"},{"name":"AZD9150","otherNames":[],"type":"DRUG"},{"name":"Selumetinib","otherNames":[],"type":"DRUG"}],"last_update":"2026-10-01","lead_sponsor":"AstraZeneca","official_title":"An Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Multi-Centre, Multi-arm Phase 1b Study in Patients With Muscle Invasive Bladder Cancer (MIBC) Who Have Progressed on Prior Treatment (BISCAY).","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE1"],"primary_completion_date":{"date":"2020-03-18","type":"ACTUAL"},"primary_outcomes":[{"measure":"Module A: The frequency and nature of adverse events related to AZD4547 monotherapy.","timeFrame":"Adverse events will be assessed at each clinic visit, and at study discontinuation and 90 days after the end of treatment. Clinic visits are generally scheduled weekly."},{"measure":"Module A: The frequency and nature of adverse events related to the combination of intravenous MEDI4736 (durvalumab) and oral AZD4547.","timeFrame":"Adverse events will be assessed at each clinic visit, and at study discontinuation and 90 days after the end of treatment. Clinic visits are generally scheduled weekly."},{"measure":"Module B: The frequency and nature of adverse events related to the combination of intravenous MEDI4736 (durvalumab) and oral olaparib.","timeFrame":"Adverse events will be assessed at each clinic visit, and at study discontinuation and 90 days after the end of treatment. Clinic visits are generally scheduled weekly."},{"measure":"Module C: The frequency and nature of adverse events related to intravenous MEDI4736 (durvalumab) when given in combination with oral AZD1775.","timeFrame":"Adverse events will be assessed at each clinic visit, and at study discontinuation and 90 days after the end of treatment. Clinic visits are generally scheduled weekly."},{"measure":"Module D: The frequency and nature of adverse events related to intravenous MEDI4736 (durvalumab) monotherapy.","timeFrame":"Adverse events will be assessed at each clinic visit, and at study discontinuation and 90 days after the end of treatment. Clinic visits are generally scheduled weekly."},{"measure":"Module E: The frequency and nature of adverse events related to intravenous MEDI4736 (durvalumab) when given in combination with oral vistusertib.","timeFrame":"Adverse events will be assessed at each clinic visit, and at study discontinuation and 90 days after the end of treatment. Clinic visits are generally scheduled weekly."},{"measure":"Module F: The frequency and nature of adverse events related to the combination of intravenous MEDI4736 (durvalumab) and intravenous AZD9150.","timeFrame":"Adverse events will be assessed at each clinic visit, and at study discontinuation and 90 days after the end of treatment. Clinic visits are generally scheduled weekly."},{"measure":"Module G: The frequency and nature of adverse events related to intravenous MEDI4736 (durvalumab) when given in combination with oral selumetinib.","timeFrame":"Adverse events will be assessed at each clinic visit, and at study discontinuation and 90 days after the end of treatment. Clinic visits are generally scheduled weekly."},{"measure":"All Modules: Change from baseline in clinical chemistry parameters.","timeFrame":"Days 1, 8, 15, and 22 of Cycle 1, Days 1, 15, and 22 of Cycles 2 and 3 and every 4 weeks thereafter, and at discontinuation."},{"measure":"All Modules: Change from baseline in haematology parameters.","timeFrame":"Days 1, 8, 15, and 22 of Cycle 1, Days 1, 15, and 22 of Cycles 2 and 3 and every 4 weeks thereafter, and at discontinuation."},{"measure":"All Modules: Change from baseline in urinalysis results.","timeFrame":"Days 1, 8, 15, and 22 of Cycle 1, Days 1, 15, and 22 of Cycles 2 and 3 and every 4 weeks thereafter, and at discontinuation."},{"measure":"All Modules: Change from baseline in vital signs.","timeFrame":"Day 1 of Cycles 1, 2, 3, and 4 and every 4 weeks therafter, and at discontinuation."},{"measure":"All Modules: Change from baseline in physical examination findings.","timeFrame":"Day 1 of Cycles 1, 2, 3, and 4 and every 4 weeks therafter, and at discontinuation."},{"measure":"All Modules: Change from baseline in ECG findings.","timeFrame":"ECGs will be collected at screening, Day 1, Cycle 1and then Day 1 of each cycle from Cycle 2 onwards."},{"measure":"All Modules: Change from baseline in ejection fraction determined by assessing ECHO/MUGA scans.","timeFrame":"Ejection fraction will be measured at screening, on Day 1, Cycle 1, and every 12 weeks thereafter (relative to the first dose of study drug) up to Cycle 7, and then every 16 weeks thereafter."},{"measure":"All Modules: Change from baseline in coagulation parameters","timeFrame":"Coagulation parameters will be measured at screening, on Day 1, Cycle 1, and every 12 weeks thereafter (relative to the first dose of study drug) up to Cycle 7, and then every 16 weeks thereafter."},{"measure":"All Modules: Change from baseline in lipid profile","timeFrame":"Lipid profile will be measured at screening, on Day 1, Cycle 1, and every 12 weeks thereafter (relative to the first dose of study drug) up to Cycle 7, and then every 16 weeks thereafter."}],"references":[{"citation":"Powles T, Carroll D, Chowdhury S, Gravis G, Joly F, Carles J, Flechon A, Maroto P, Petrylak D, Rolland F, Cook N, Balar AV, Sridhar SS, Galsky MD, Grivas P, Ravaud A, Jones R, Cosaert J, Hodgson D, Kozarewa I, Mather R, McEwen R, Mercier F, Landers D. An adaptive, biomarker-directed platform study of durvalumab in combination with targeted therapies in advanced urothelial cancer. Nat Med. 2021 May;27(5):793-801. doi: 10.1038/s41591-021-01317-6. Epub 2021 May 3.","pmid":"33941921","type":"BACKGROUND"},{"citation":"Maia MC, Salgia M, Pal SK. Harnessing cell-free DNA: plasma circulating tumour DNA for liquid biopsy in genitourinary cancers. Nat Rev Urol. 2020 May;17(5):271-291. doi: 10.1038/s41585-020-0297-9. Epub 2020 Mar 17.","pmid":"32203306","type":"DERIVED"}],"start_date":{"date":"2016-12-28","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Phase 1b Study in Pts w/ Muscle Invasive Bladder Cancer","url":"https://clinicaltrials.gov/study/NCT02546661"},"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/biscay-nct02546661"}