{"preliminary_commentary":{"by_channel":{"x_thread":3},"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":false},"commentary_summary":null,"name":"MODERN","nct_id":"NCT05987241","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=modern-nct05987241. 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":"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","otherNames":["Biological Sample Collection","Biospecimen Collected","Sample Collection","Specimen Collection"],"type":"PROCEDURE"},{"name":"cfDNA or ctDNA Measurement","otherNames":["Cell-Free DNA/Circulating Tumor DNA Measurement","cfDNA/ctdDNA Measurement","cfDNA/ctDNA","cfDNA/ctDNA Measurement","Circulating Cell-Free DNA/Circulating Tumor-Derived DNA Measurement"],"type":"OTHER"},{"name":"Computed Tomography","otherNames":["CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized axial tomography (procedure)","Computerized Tomography","Computerized Tomography (CT) scan","CT","CT Scan","Diagnostic CAT Scan","Diagnostic CAT Scan Service Type","tomography"],"type":"PROCEDURE"},{"name":"Cystoscopy","otherNames":["CS"],"type":"PROCEDURE"},{"name":"Magnetic Resonance Imaging","otherNames":["Magnetic Resonance","Magnetic Resonance Imaging (MRI)","Magnetic resonance imaging (procedure)","Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance","MR","MR Imaging","MRI","MRI Scan","MRIs","NMR Imaging","NMRI","Nuclear Magnetic Resonance Imaging","sMRI","Structural MRI"],"type":"PROCEDURE"},{"name":"Nivolumab","otherNames":["ABP 206","BCD-263","BMS 936558","BMS-936558","BMS936558","CMAB819","MDX 1106","MDX-1106","MDX1106","NIVO","Nivolumab Biosimilar ABP 206","Nivolumab Biosimilar BCD-263","Nivolumab Biosimilar CMAB819","ONO 4538","ONO-4538","ONO4538","Opdivo"],"type":"BIOLOGICAL"},{"name":"Questionnaire Administration","otherNames":[],"type":"OTHER"},{"name":"Relatlimab","otherNames":["BMS 986016","BMS-986016","BMS986016","Immunoglobulin G4, Anti-(human Lymphocyte Activation Gene-3 Protein) (Human Heavy Chain), Disulfide with Human Light Chain, Dimer"],"type":"BIOLOGICAL"}],"last_update":"2026-10-27","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":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/modern-nct05987241"}