{"preliminary_commentary":{"by_channel":{"x_thread":19,"youtube":4,"podcast":4},"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\": \"NCT02960906\", \"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":{"generated_at":"2026-10-31T08:02:21.150Z","note":"Automated from all 27 indexed sources (Sep 2018 – Oct 2025). Each question is raised in at least two. Not an Erudio report: no source links. Not medical advice.","passages_read":27,"text":"- Whether molecular profiling can guide treatment choice\n- Which molecular signatures may distinguish benefit from immunotherapy versus VEGF-targeted therapy\n- Whether biomarker-guided treatment can be validated and implemented in routine practice\n\nAlso discussed: second-line treatment, IMDC criteria."},"drugs_tested":[["nivolumab","ipilimumab"],["nivolumab"],["pazopanib"]],"indication":"first-line metastatic clear cell renal cell carcinoma","name":"BIONIKK","nct_id":"NCT02960906","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=bionikk-nct02960906. 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":"BIONIKK","arms":[{"description":"ccRCC molecular subgroup 1 -\\> randomisation: subjects with ccRCC1 treated with nivolumab 240mg IV every 2 weeks until disease progression, unacceptable toxicity or other reasons specified in the protocol.\n\nStarting from the Cycle 7 possibility to switch from nivolumab 240 mg every 2 weeks to 480 mg every 4 weeks according to the Investigator's preference.","label":"ccRCC molecular subgroup 1: 1A","type":"EXPERIMENTAL"},{"description":"ccRCC molecular subgroup 1 -\\> randomisation: subjects with ccRCC1 treated with nivolumab 3 mg/kg IV combined with ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then nivolumab 240mg IV every 2 weeks until disease progression, unacceptable toxicity or other reasons specified in the protocol.\n\nStarting from the Cycle 7 possibility to switch from nivolumab 240 mg every 2 weeks to 480 mg every 4 weeks according to the Investigator's preference.","label":"ccRCC molecular subgroup 1: 1B","type":"EXPERIMENTAL"},{"description":"ccRCC molecular subgroup 4 -\\> randomisation: subjects with ccRCC1 treated with nivolumab 240mg IV every 2 weeks until disease progression, unacceptable toxicity or other reasons specified in the protocol.\n\nStarting from the Cycle 7 possibility to switch from nivolumab 240 mg every 2 weeks to 480 mg every 4 weeks according to the Investigator's preference.","label":"ccRCC molecular subgroup 4: 4A","type":"EXPERIMENTAL"},{"description":"ccRCC molecular subgroup 4 -\\> randomisation: subjects with ccRCC1 treated with nivolumab 3 mg/kg IV combined with ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then nivolumab 240mg IV every 2 weeks until disease progression, unacceptable toxicity or other reasons specified in the protocol.\n\nStarting from the Cycle 7 possibility to switch from nivolumab 240 mg every 2 weeks to 480 mg every 4 weeks according to the Investigator's preference.","label":"ccRCC molecular subgroup 4: 4B","type":"EXPERIMENTAL"},{"description":"ccRCC molecular subgroup 2 -\\> randomisation: TKI (sunitinib 50mg daily or Pazopanib 800mg daily) according to investigator's choice until disease progression, unacceptable toxicity or other reasons specified in the protocol.","label":"ccRCC molecular subgroup 2: 2C","type":"EXPERIMENTAL"},{"description":"ccRCC molecular subgroup 2 -\\> randomisation: subjects with ccRCC1 treated with nivolumab 3 mg/kg IV combined with ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then nivolumab 240mg IV every 2 weeks until disease progression, unacceptable toxicity or other reasons specified in the protocol.\n\nStarting from the Cycle 7 possibility to switch from nivolumab 240 mg every 2 weeks to 480 mg every 4 weeks according to the Investigator's preference.","label":"ccRCC molecular subgroup 2: 2B","type":"EXPERIMENTAL"},{"description":"ccRCC molecular subgroup 3 -\\> randomisation: subjects with ccRCC1 treated with nivolumab 3 mg/kg IV combined with ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then nivolumab 240mg IV every 2 weeks until disease progression, unacceptable toxicity or other reasons specified in the protocol.\n\nStarting from the Cycle 7 possibility to switch from nivolumab 240 mg every 2 weeks to 480 mg every 4 weeks according to the Investigator's preference.","label":"ccRCC molecular subgroup 3: 3B","type":"EXPERIMENTAL"},{"description":"ccRCC molecular subgroup 3 -\\> randomisation: TKI (sunitinib 50mg daily or Pazopanib 800mg daily) according to investigator's choice until disease progression, unacceptable toxicity or other reasons specified in the protocol.","label":"ccRCC molecular subgroup 3: 3C","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2021-02-15","type":"ACTUAL"},"conditions":["Clear Cell Metastatic Renal Cell Carcinoma"],"enrollment":{"count":200,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Nivolumab","otherNames":["BMS-936558","Opdivo"],"type":"DRUG"},{"name":"Ipilimumab","otherNames":["YERVOY","BMS-734016"],"type":"DRUG"},{"name":"Pazopanib","otherNames":["Votrient"],"type":"DRUG"},{"name":"Sunitinib","otherNames":["Sutent"],"type":"DRUG"}],"last_update":"2021-04-26","lead_sponsor":"Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie","official_title":"A Phase 2 BIOmarker Driven Trial With Nivolumab and Ipilimumab or VEGFR tKi in Naïve Metastatic Kidney Cancer","overall_status":"COMPLETED","phases":["PHASE2"],"primary_completion_date":{"date":"2021-02-15","type":"ACTUAL"},"primary_outcomes":[{"measure":"ORR evaluation according to molecular groups (ccRCC1 to 4) and assigned treatment","timeFrame":"54 months"}],"references":[{"citation":"Davidson G, Helleux A, Vano YA, Lindner V, Fattori A, Cerciat M, Elaidi RT, Verkarre V, Sun CM, Chevreau C, Bennamoun M, Lang H, Tricard T, Fridman WH, Sautes-Fridman C, Su X, Plassard D, Keime C, Thibault-Carpentier C, Barthelemy P, Oudard SM, Davidson I, Malouf GG. Mesenchymal-like Tumor Cells and Myofibroblastic Cancer-Associated Fibroblasts Are Associated with Progression and Immunotherapy Response of Clear Cell Renal Cell Carcinoma. Cancer Res. 2023 Sep 1;83(17):2952-2969. doi: 10.1158/0008-5472.CAN-22-3034.","pmid":"37335139","type":"DERIVED"},{"citation":"Vano YA, Elaidi R, Bennamoun M, Chevreau C, Borchiellini D, Pannier D, Maillet D, Gross-Goupil M, Tournigand C, Laguerre B, Barthelemy P, Coquan E, Gravis G, Houede N, Cancel M, Huillard O, Beuzeboc P, Fournier L, Mejean A, Cathelineau X, Doumerc N, Paparel P, Bernhard JC, de la Taille A, Bensalah K, Tricard T, Waeckel T, Pignot G, Braychenko E, Caruso S, Sun CM, Verkarre V, Lacroix G, Moreira M, Meylan M, Bougouin A, Phan L, Thibault-Carpentier C, Zucman-Rossi J, Fridman WH, Sautes-Fridman C, Oudard S. Nivolumab, nivolumab-ipilimumab, and VEGFR-tyrosine kinase inhibitors as first-line treatment for metastatic clear-cell renal cell carcinoma (BIONIKK): a biomarker-driven, open-label, non-comparative, randomised, phase 2 trial. Lancet Oncol. 2022 May;23(5):612-624. doi: 10.1016/S1470-2045(22)00128-0. Epub 2022 Apr 4.","pmid":"35390339","type":"DERIVED"},{"citation":"Epaillard N, Simonaggio A, Elaidi R, Azzouz F, Braychenko E, Thibault C, Sun CM, Moreira M, Oudard S, Vano YA. BIONIKK: A phase 2 biomarker driven trial with nivolumab and ipilimumab or VEGFR tyrosine kinase inhibitor (TKI) in naive metastatic kidney cancer. Bull Cancer. 2020 Jun;107(5S):eS22-eS27. doi: 10.1016/S0007-4551(20)30283-6.","pmid":"32620212","type":"DERIVED"}],"start_date":{"date":"2017-05-31","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A BIOmarker Driven Trial With Nivolumab and Ipilimumab or VEGFR tKi in Naïve Metastatic Kidney Cancer","url":"https://clinicaltrials.gov/study/NCT02960906"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/bionikk-nct02960906"}