{"preliminary_commentary":{"by_channel":{"x_thread":15,"podcast":4,"youtube":3,"x_video":1},"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\": \"NCT03203473\", \"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,"name":"OMNIVORE","nct_id":"NCT03203473","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=omnivore-nct03203473. 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":1950,"size":"deep","size_rule":"Deep: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"* Therapy with nivolumab IV every 2 weeks\n* Serial imaging assessments every 8 weeks\n* After confirmatory scans, patients are assigned to Arm A or Arm B.","label":"Overall cohort: Initial Primary Treatment with Nivolumab (induction phase)","type":"EXPERIMENTAL"},{"description":"Patients with persistent response (complete or partial response) to induction nivolumab are assigned to Arm A (Observation Arm).\n\n* Patients discontinued nivolumab after allocation to Arm A.\n* Serial imaging assessments every 8 weeks.\n* If scans persistently show PR/CR, patients remained on observation.\n* If progressive disease develops, therapy with nivolumab (480 mg IV every 4 weeks) will be resumed.\n* If there is subsequent progression on nivolumab monotherapy, ipilimumab (1 mg/kg IV every 3 weeks x 2 doses) is added.\n* If progression after nivolumab + ipilimumab, therapy discontinued. If SD/PR/CR, nivolumab is continued until progression.","label":"Arm A: Observation Arm (for patients with persistent response to induction nivolumab)","type":"EXPERIMENTAL"},{"description":"Patients with confirmed SD/PD to induction nivolumab are allocated to Arm B (Combination Therapy Arm).\n\n* In combination therapy, patients received nivolumab 3 mg/kg and ipilimumab 1 mg/kg intravenously every 3 weeks for two doses.\n* After then nivolumab will be continued at 480 mg IV every 4 weeks until disease progression.\n* Arm B patients undergo imaging at 12 weeks and then every 8 weeks.","label":"Arm B: Nivolumab+Ipilimumab then nivolumab alone (for patients with SD/PD to induction nivolumab)","type":"EXPERIMENTAL"}],"collaborators":["Bristol-Myers Squibb"],"completion_date":{"date":"2026-12-28","type":"ESTIMATED"},"conditions":["Renal Cancer"],"enrollment":{"count":85,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Ipilimumab","otherNames":["Yervoy"],"type":"DRUG"},{"name":"Nivolumab","otherNames":["Opdivo"],"type":"DRUG"}],"last_update":"2026-08-12","lead_sponsor":"Toni Choueiri, MD","official_title":"Phase II Study of Optimized Management of NIVOlumab Based on REsponse in Patients With Advanced Renal Cell Carcinoma (OMNIVORE Study)","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2021-11-30","type":"ACTUAL"},"primary_outcomes":[{"measure":"Percentage of Subjects With Persistent Partial Response (PR) or Complete Response (CR) at 1 Year Since Nivolumab Discontinuation (Arm A Only)","timeFrame":"From nivolumab discontinuation until 1 year after discontinuation with nivolumab"},{"measure":"Percentage of Subjects With Stable or Progressive Disease (SD/PD) to Nivolumab Induction That Convert to Complete or Partial Response (CR/PR) Upon the Addition of Ipilimumab to Nivolumab (Arm B Only)","timeFrame":"For arm B patients, from arm B treatment (nivolumab+ipilimumab) initiation until last imaging assessment during the treatment; assessed up to 22 months."}],"references":[{"citation":"McKay RR, Serzan M, Xie W, McGregor BA, Braun D, Wei X, Kyriakopoulos C, Zakharia Y, Maughan BL, Rose T, Stadler WM, Mcdermott DF, Choueiri TK. Long-term follow-up from the OMNIVORE trial: response-adaptive nivolumab and ipilimumab in advanced renal cell carcinoma. J Immunother Cancer. 2026 Jul 1;14(7):e015501. doi: 10.1136/jitc-2026-015501.","pmid":"42386345","type":"DERIVED"},{"citation":"Bootsma M, McKay RR, Emamekhoo H, Bade RM, Schehr JL, Mannino MC, Singh A, Wolfe SK, Schultz ZD, Sperger J, Xie W, Signoretti S, Kyriakopoulos CE, Kosoff D, Abel EJ, Helzer KT, Rydzewski N, Bakhtiar H, Shi Y, Blitzer G, Bassetti M, Floberg J, Yu M, Sethakorn N, Sharifi M, Harari PM, Choueiri TK, Lang JM, Zhao SG. Longitudinal Molecular Profiling of Circulating Tumor Cells in Metastatic Renal Cell Carcinoma. J Clin Oncol. 2022 Nov 1;40(31):3633-3641. doi: 10.1200/JCO.22.00219. Epub 2022 May 26.","pmid":"35617646","type":"DERIVED"},{"citation":"Bade RM, Schehr JL, Emamekhoo H, Gibbs BK, Rodems TS, Mannino MC, Desotelle JA, Heninger E, Stahlfeld CN, Sperger JM, Singh A, Wolfe SK, Niles DJ, Arafat W, Steinharter JA, Jason Abel E, Beebe DJ, Wei XX, McKay RR, Choueri TK, Lang JM. Development and initial clinical testing of a multiplexed circulating tumor cell assay in patients with clear cell renal cell carcinoma. Mol Oncol. 2021 Sep;15(9):2330-2344. doi: 10.1002/1878-0261.12931. Epub 2021 Mar 3.","pmid":"33604999","type":"DERIVED"},{"citation":"McKay RR, McGregor BA, Xie W, Braun DA, Wei X, Kyriakopoulos CE, Zakharia Y, Maughan BL, Rose TL, Stadler WM, McDermott DF, Harshman LC, Choueiri TK. Optimized Management of Nivolumab and Ipilimumab in Advanced Renal Cell Carcinoma: A Response-Based Phase II Study (OMNIVORE). J Clin Oncol. 2020 Dec 20;38(36):4240-4248. doi: 10.1200/JCO.20.02295. Epub 2020 Oct 27.","pmid":"33108238","type":"DERIVED"}],"start_date":{"date":"2017-10-26","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of Optimized Management of Nivolumab Based on Response in Patients With Advanced RCC (OMNIVORE Study)","url":"https://clinicaltrials.gov/study/NCT03203473"},"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/omnivore-nct03203473"}