{"preliminary_commentary":{"by_channel":{"x_thread":11,"podcast":3,"youtube":2},"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\": \"NCT03317158\", \"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","gemcitabine","docetaxel"],["durvalumab","tremelimumab","gemcitabine","docetaxel"],["intravesical NAI","gemcitabine","docetaxel"]],"indication":"BCG-unresponsive, BCG-relapsing, high-risk BCG-naive non-muscle invasive bladder cancer","name":"ADAPT-BLADDER","nct_id":"NCT03317158","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=adapt-bladder-nct03317158. 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":1250,"size":"standard","size_rule":"Standard: 151–300 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"ADAPT-BLADDER","arms":[{"description":"Durvalumab monotherapy","label":"Phase 1: Cohort 1","type":"EXPERIMENTAL"},{"description":"Durvalumab plus BCG","label":"Phase 1: Cohort 2","type":"EXPERIMENTAL"},{"description":"Durvalumab plus External Beam Radiotherapy (EBRT)\n\n(BCG re-treatment) - Cross-over to Durvalumab Monotherapy","label":"Phase 1: Cohort 3","type":"EXPERIMENTAL"},{"description":"Durvalumab + Gemcitabine/Intravesical Docetaxel (Gem/Doc)\n\nThe sequence of administration is flexible to allow for scheduling of both the infusion and intravesical treatments.","label":"Phase 1: Cohort 4","type":"EXPERIMENTAL"},{"description":"NOTE: Cohort 5 was abandoned prior to any patients enrolled.\n\nDurvalumab + Tremelimumab + Gem/Doc\n\nThe sequence of administration is flexible to allow for scheduling of both the infusion and intravesical treatments. For the intravenous medications, durvalumab should be administered first followed by tremelimumab.","label":"Phase 1: Cohort 5","type":"EXPERIMENTAL"},{"description":"Intravesical NAI plus Gemcitabine","label":"Phase 1: Cohort 6","type":"EXPERIMENTAL"},{"description":"Durvalumab + Gemcitabine/Intravesical Docetaxel (Gem/Doc)\n\nThe sequence of administration is flexible to allow for scheduling of both the infusion and intravesical treatments.","label":"Phase 2: Cohort 4 Expansion","type":"EXPERIMENTAL"},{"description":"Intravesical NAI plus Gemcitabine and Docetaxel","label":"Phase 1: Cohort 7","type":"EXPERIMENTAL"},{"description":"Subcutaneous NAI plus Intravesical NAI plus Gemcitabine and Docetaxel","label":"Phase 1: Cohort 8","type":"EXPERIMENTAL"},{"description":"Additional Regimens TBD","label":"Phase 1: Cohort 9","type":"EXPERIMENTAL"}],"collaborators":["AstraZeneca","Hoosier Cancer Research Network","ImmunityBio, Inc."],"completion_date":{"date":"2029-12-31","type":"ESTIMATED"},"conditions":["Urothelial Carcinoma","Bladder Cancer"],"enrollment":{"count":186,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Durvalumab (Cohort 1-3)","otherNames":["Imfinzi"],"type":"DRUG"},{"name":"External Beam Radiotherapy (EBRT)","otherNames":[],"type":"RADIATION"},{"name":"Bacillus Calmette-Guérin (BCG)","otherNames":[],"type":"BIOLOGICAL"},{"name":"Gemcitabine","otherNames":["Gemzar"],"type":"DRUG"},{"name":"Docetaxel","otherNames":["Taxotere"],"type":"DRUG"},{"name":"Tremelimumab","otherNames":[],"type":"BIOLOGICAL"},{"name":"Durvalumab (Cohort 4/5)","otherNames":["Imfinzi"],"type":"DRUG"},{"name":"To be determined","otherNames":[],"type":"OTHER"},{"name":"Intravesical NAI (Cohorts 6-7)","otherNames":[],"type":"DRUG"},{"name":"Subcutaneous NAI (Cohort 8)","otherNames":[],"type":"DRUG"}],"last_update":"2026-07-15","lead_sponsor":"Noah Hahn, M.D.","official_title":"PhAse 1/2 StuDy of Modern ImmunotherApy in BCG-Unresponsive, BCG-RelaPsing, and High-Risk BCG-Naive Non-muscle Invasive UroThelial Carcinoma of the BLADDER","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2028-12-31","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Phase 1: Determine the recommended phase 2 dose (RP2D) from BCG-unresponsive non-muscle invasive bladder cancer (NMIBC)","timeFrame":"6 months"},{"measure":"Phase 2: Determine the complete response rate within individual phase 2 expansion cohorts of BCG-unresponsive, BCG-relapsing/persistent, and high-risk BCG-naïve NMIBC subjects treated with each study regimen","timeFrame":"6 months"}],"references":[],"start_date":{"date":"2017-11-21","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Modern Immunotherapy in BCG-Unresponsive, BCG-Relapsing and High Risk BCG-Naive Non-Muscle Invasive Urothelial Carcinoma of the Bladder","url":"https://clinicaltrials.gov/study/NCT03317158"},"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/adapt-bladder-nct03317158"}