{"commentary":{"count":3,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":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":false},"name":"NCT05987241","nct_id":"NCT05987241","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct05987241. 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":750,"size":"focused","size_rule":"Focused: 1–12 commentary sources"},"registry":{"acronym":null,"arms":[{"description":"Patients in Cohort A, Arm I receive nivolumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of tissue during screening and collection of blood throughout the trial. Patients also undergo CT or MRI and may undergo cystoscopy throughout the trial.","label":"Cohort A, Arm I (nivolumab)","type":"ACTIVE_COMPARATOR"},{"description":"Patients in Cohort A, Arm II receive nivolumab IV over 30 minutes and relatlimab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of tissue during screening and collection of blood throughout the trial. Patients also undergo CT or MRI and may undergo cystoscopy throughout the trial.","label":"Cohort A, Arm II (nivolumab, relatlimab)","type":"EXPERIMENTAL"},{"description":"Patients in Cohort B, Arm III receive nivolumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of tissue during screening and collection of blood throughout the trial. Patients also undergo CT or MRI and may undergo cystoscopy throughout the trial.","label":"Cohort B, Arm III (nivolumab)","type":"ACTIVE_COMPARATOR"},{"description":"Patients in Cohort B, Arm IV undergo ctDNA surveillance consisting of collection of tissue and blood during screening and collection of blood only on study and during follow up. Patients who convert to ctDNA(+) during surveillance then receive nivolumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of tissue during screening and collection of blood throughout the trial. Patients also undergo CT or MRI and may undergo cystoscopy throughout the trial.","label":"Cohort B, Arm IV (ctDNA surveillance, nivolumab)","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2030-09-02","type":"ESTIMATED"},"conditions":["Muscle Invasive Bladder Urothelial Carcinoma","Muscle Invasive Renal Pelvis Urothelial Carcinoma","Muscle Invasive Ureter Urothelial Carcinoma","Muscle Invasive Urethral Urothelial Carcinoma","Stage II Bladder Urothelial Carcinoma AJCC v6 and v7","Stage III Bladder Urothelial Carcinoma AJCC v6 and v7","Stage IV Bladder Urothelial Carcinoma AJCC v7"],"enrollment":{"count":992,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Biospecimen Collection","type":"PROCEDURE"},{"name":"cfDNA or ctDNA Measurement","type":"OTHER"},{"name":"Computed Tomography","type":"PROCEDURE"},{"name":"Cystoscopy","type":"PROCEDURE"},{"name":"Magnetic Resonance Imaging","type":"PROCEDURE"},{"name":"Nivolumab","type":"BIOLOGICAL"},{"name":"Questionnaire Administration","type":"OTHER"},{"name":"Relatlimab","type":"BIOLOGICAL"}],"last_update":"2026-10-09","lead_sponsor":"National Cancer Institute (NCI)","official_title":"MODERN: An Integrated Phase 2/3 and Phase 3 Trial of MRD-Based Optimization of ADjuvant ThErapy in URothelial CaNcer","overall_status":"RECRUITING","phases":["PHASE2","PHASE3"],"primary_completion_date":{"date":"2030-09-02","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Proportion of patients who are circulating tumor DNA negative (ctDNA[-]) (Cohort A Phase II)","timeFrame":"At week 12 from treatment start date"},{"measure":"Overall survival (OS) (Cohort A Phase III)","timeFrame":"From randomization until death due to any cause, assessed up to 5 years after completion of study treatment"},{"measure":"Disease-Free Survival (DFS) (Cohort B)","timeFrame":"From randomization until confirmed disease recurrence as assessed by the treating physician or death due to any cause, assessed up to 5 years after completion of study treatment"}],"references":[],"start_date":{"date":"2024-02-02","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study","url":"https://clinicaltrials.gov/study/NCT05987241"},"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/nct05987241"}