{"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,"drugs_tested":null,"indication":null,"name":"NCT02496208","nct_id":"NCT02496208","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct02496208. 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":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Patients receive cabozantinib s-malate PO QD on days 1-28 and nivolumab IV over 30 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After 21 cycles, patients receive nivolumab IV over 30 minutes every 4 weeks in the absence of disease progression or unacceptable toxicity. After progression, patients may receive cabozantinib s-malate PO, nivolumab IV, and ipilimumab IV at the part II RP2D for 4 cycles followed by cabozantinib s-malate PO QD and nivolumab IV every 2 weeks or 4 weeks if post-cycle 21 in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography or magnetic resonance imaging and collection of blood samples throughout the trial. Patients may also undergo echocardiography at baseline and biopsies throughout the trial.","label":"Part I (cabozantinib s-malate, nivolumab)","type":"EXPERIMENTAL"},{"description":"See detailed description.","label":"Part II (cabozantinib s-malate, nivolumab, ipilimumab)","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2027-07-30","type":"ESTIMATED"},"conditions":["Bladder Small Cell Neuroendocrine Carcinoma","Bladder Squamous Cell Carcinoma","Bladder Urothelial Carcinoma","Clear Cell Renal Cell Carcinoma","Invasive Bladder Plasmacytoid Urothelial Carcinoma","Invasive Bladder Sarcomatoid Urothelial Carcinoma","Invasive Sarcomatoid Urothelial Carcinoma","Kidney Medullary Carcinoma","Malignant Genitourinary System Neoplasm","Malignant Solid Neoplasm","Penile Carcinoma","Penile Squamous Cell Carcinoma","Renal Cell Carcinoma","Renal Pelvis Urothelial Carcinoma","Sarcomatoid Renal Cell Carcinoma","Stage III Bladder Cancer AJCC v8","Stage III Penile Cancer AJCC v8","Stage III Renal Cell Cancer AJCC v8","Stage III Renal Pelvis and Ureter Cancer AJCC v8","Stage III Renal Pelvis Cancer AJCC v8","Stage III Ureter Cancer AJCC v8","Stage III Urethral Cancer AJCC v8","Stage IV Bladder Cancer AJCC v8","Stage IV Penile Cancer AJCC v8","Stage IV Renal Cell Cancer AJCC v8","Stage IV Renal Pelvis and Ureter Cancer AJCC v8","Stage IV Ureter Cancer AJCC v8","Stage IV Urethral Cancer AJCC v8","Ureter Urothelial Carcinoma","Urethral Urothelial Carcinoma"],"enrollment":{"count":152,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Biopsy Procedure","otherNames":["Biopsy","BIOPSY_TYPE","Bx"],"type":"PROCEDURE"},{"name":"Biospecimen Collection","otherNames":["Biological Sample Collection","Biospecimen Collected","Sample Collection","Specimen Collection"],"type":"PROCEDURE"},{"name":"Cabozantinib S-malate","otherNames":["BMS-907351","Cabometyx","Cometriq","XL 184","XL-184","XL184"],"type":"DRUG"},{"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":"Echocardiography Test","otherNames":["EC","Echocardiography"],"type":"PROCEDURE"},{"name":"Ipilimumab","otherNames":["Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody","BMS 734016","BMS-734016","BMS734016","Ipilimumab Biosimilar CS1002","MDX 010","MDX-010","MDX-CTLA4","MDX010","Yervoy"],"type":"BIOLOGICAL"},{"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"}],"last_update":"2026-10-15","lead_sponsor":"National Cancer Institute (NCI)","official_title":"A Phase 1 Study of Cabozantinib Plus Nivolumab (CaboNivo) Alone or in Combination With Ipilimumab (CaboNivoIpi) in Patients With Advanced/Metastatic Urothelial Carcinoma and Other Genitourinary Tumors","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE1"],"primary_completion_date":{"date":"2027-07-30","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Recommended phase II dose (Phase I)","timeFrame":"Up to 4-6 weeks"},{"measure":"Incidence of adverse events (Phase I)","timeFrame":"Up to 30 days post treatment"}],"references":[{"citation":"Apolo AB, Girardi DM, Niglio SA, Nadal R, Kydd AR, Simon N, Ley L, Cordes LM, Chandran E, Steinberg SM, Lee S, Lee MJ, Rastogi S, Sato N, Cao L, Banday AR, Boudjadi S, Merino MJ, Toubaji A, Akbulut D, Redd B, Bagheri H, Costello R, Gurram S, Agarwal PK, Chalfin HJ, Valera V, Streicher H, Wright JJ, Sharon E, Figg WD, Parnes HL, Gulley JL, Saraiya B, Pal SK, Quinn D, Stein MN, Lara PN, Bottaro DP, Mortazavi A. Final Results From a Phase I Trial and Expansion Cohorts of Cabozantinib and Nivolumab Alone or With Ipilimumab for Advanced/Metastatic Genitourinary Tumors. J Clin Oncol. 2024 Sep 1;42(25):3033-3046. doi: 10.1200/JCO.23.02233. Epub 2024 Jul 2.","pmid":"38954785","type":"DERIVED"},{"citation":"Girardi DM, Niglio SA, Mortazavi A, Nadal R, Lara P, Pal SK, Saraiya B, Cordes L, Ley L, Ortiz OS, Cadena J, Diaz C, Bagheri H, Redd B, Steinberg SM, Costello R, Chan KS, Lee MJ, Lee S, Yu Y, Gurram S, Chalfin HJ, Valera V, Figg WD, Merino M, Toubaji A, Streicher H, Wright JJ, Sharon E, Parnes HL, Ning YM, Bottaro DP, Cao L, Trepel JB, Apolo AB. Cabozantinib plus Nivolumab Phase I Expansion Study in Patients with Metastatic Urothelial Carcinoma Refractory to Immune Checkpoint Inhibitor Therapy. Clin Cancer Res. 2022 Apr 1;28(7):1353-1362. doi: 10.1158/1078-0432.CCR-21-3726.","pmid":"35031545","type":"DERIVED"},{"citation":"Apolo AB, Nadal R, Girardi DM, Niglio SA, Ley L, Cordes LM, Steinberg SM, Sierra Ortiz O, Cadena J, Diaz C, Mallek M, Davarpanah NN, Costello R, Trepel JB, Lee MJ, Merino MJ, Bagheri MH, Monk P, Figg WD, Gulley JL, Agarwal PK, Valera V, Chalfin HJ, Jones J, Streicher H, Wright JJ, Ning YM, Parnes HL, Dahut WL, Bottaro DP, Lara PN Jr, Saraiya B, Pal SK, Stein MN, Mortazavi A. Phase I Study of Cabozantinib and Nivolumab Alone or With Ipilimumab for Advanced or Metastatic Urothelial Carcinoma and Other Genitourinary Tumors. J Clin Oncol. 2020 Nov 1;38(31):3672-3684. doi: 10.1200/JCO.20.01652. Epub 2020 Sep 11.","pmid":"32915679","type":"DERIVED"}],"start_date":{"date":"2015-07-22","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Cabozantinib S-malate and Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Genitourinary Tumors","url":"https://clinicaltrials.gov/study/NCT02496208"},"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/nct02496208"}