{"preliminary_commentary":{"by_channel":{"bluesky_thread":2,"x_thread":1},"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":false},"name":"NCT04179162","nct_id":"NCT04179162","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct04179162. 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":"Eligible patients will receive combination intravesical chemoimmunotherapy. Treatment is sequential, with twice-weekly intravesical gemcitabine given at weeks 1, 4, 7, and 10, for a total of 8 doses, administered in a standard fashion. In phase I, the dose of gemcitabine will depend on the dose level being assessed for the determination of the MTD. phase II, 1 dose level will be given (the MTD from phase I). Fixed doses of once-weekly intravesical BCG therapy (TICE strain, 50 mg) will be given at weeks 2 (+/- 2 days), 3 (+/- 2 days), 5 (+/- 2 days), 6 (+/- 2 days), 8 (+/- 2 days), and 9 (+/- 2 days), for a total of 6 doses, also administered in a standard fashion. All intravesical therapy will be administered in the chemotherapy suite on an outpatient basis, in accordance with standard clinical practice. Intravesical therapies will be retained in the bladder for up to 2 h (BCG) or 1 h (gemcitabine), or as tolerated.","label":"Bacillus Calmette-Guérin (BCG) and Gemcitabine","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2027-11","type":"ESTIMATED"},"conditions":["Non-Muscle Invasive Bladder Cancer (NMIBC)"],"enrollment":{"count":54,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Bacillus Calmette-Guérin (BCG)","otherNames":[],"type":"DRUG"},{"name":"Gemcitabine","otherNames":[],"type":"DRUG"}],"last_update":"2026-08-11","lead_sponsor":"Memorial Sloan Kettering Cancer Center","official_title":"Phase I/II Trial of Bacillus Calmette-Guérin (BCG) and Intravesical Gemcitabine for Patients With BCG-Relapsing High-Grade Non-Muscle Invasive Bladder Cancer","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2027-11","type":"ESTIMATED"},"primary_outcomes":[{"measure":"evaluate the MTD (Phase I)","timeFrame":"1 year"},{"measure":"proportion of patients who are disease free","timeFrame":"6 months after the start of treatment"}],"references":[],"start_date":{"date":"2019-11-22","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Bacillus Calmette-Guérin (BCG) and Gemcitabine in People With High-Grade Non-Muscle Invasive Bladder Cancer That Came Back After BCG Treatment","url":"https://clinicaltrials.gov/study/NCT04179162"},"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/nct04179162"}