{"preliminary_commentary":{"by_channel":{"x_thread":2,"podcast":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":false},"commentary_summary":null,"drugs_tested":[["pembrolizumab/quavonlimab"],["favezelimab/pembrolizumab"],["pembrolizumab","MK-4830"]],"indication":"second-line metastatic renal cell carcinoma","name":"KEYMAKER-U03","nct_id":"NCT04626518","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=keymaker-u03-nct04626518. 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":"Participants will receive pembrolizumab/quavonlimab (coformulation of pembrolizumab 400 mg and quavonlimab 25 mg). Pembrolizumab/quavonlimab will be administered intravenously (IV) once every 6 weeks (Q6W) for up to 17 administrations (up to \\~2 years).","label":"Coformulation Pembrolizumab/Quavonlimab","type":"EXPERIMENTAL"},{"description":"Participants will receive favezelimab/pembrolizumab (coformulation of favezelimab 800 mg and pembrolizumab 200 mg). Favezelimab/Pembrolizumab will be administered IV once every 3 weeks (Q3W) for up to 35 administrations (up to \\~2 years).","label":"Coformulation Favezelimab/Pembrolizumab","type":"EXPERIMENTAL"},{"description":"Participants will receive pembrolizumab 200 mg PLUS MK-4830 800 mg. Both pembrolizumab and MK-4830 will be administered IV Q3W for up to 35 administrations (up to \\~2 years).","label":"Pembrolizumab + MK-4830","type":"EXPERIMENTAL"},{"description":"Participants will receive pembrolizumab 400 mg PLUS belzutifan 120 mg. Pembrolizumab will be administered IV Q6W for up to 17 administrations (up to \\~ 2 years). Belzutifan will be administered orally once-daily (QD) until progressive disease or discontinuation.","label":"Pembrolizumab + Belzutifan","type":"EXPERIMENTAL"},{"description":"Participants will receive Belzutifan 120 mg PLUS lenvatinib 20 mg. Both belzutifan and lenvatinib will be administered orally QD until progressive disease or discontinuation.","label":"Belzutifan + Lenvatinib","type":"EXPERIMENTAL"},{"description":"Participants will receive pembrolizumab 400 mg PLUS lenvatinib 20 mg. Pembrolizumab will be administered IV Q6W for up to 17 administrations (up to \\~2 years). Lenvatinib will be administered orally QD until progressive disease or discontinuation.","label":"Pembrolizumab + Lenvatinib","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2026-07-23","type":"ACTUAL"},"conditions":["Carcinoma, Renal Cell"],"enrollment":{"count":263,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Pembrolizumab","otherNames":["MK-3475","KEYTRUDA®"],"type":"BIOLOGICAL"},{"name":"MK-4830","otherNames":[],"type":"BIOLOGICAL"},{"name":"Belzutifan","otherNames":["MK-6482","WELIREG™"],"type":"DRUG"},{"name":"Lenvatinib","otherNames":["MK-7902","E7080","LENVIMA®"],"type":"DRUG"},{"name":"Pembrolizumab/Quavonlimab","otherNames":["MK-1308A"],"type":"BIOLOGICAL"},{"name":"Favezelimab/Pembrolizumab","otherNames":["MK-4280A"],"type":"BIOLOGICAL"}],"last_update":"2026-09-25","lead_sponsor":"Merck Sharp & Dohme LLC","official_title":"A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants With RCC (KEYMAKER-U03): Substudy 03B in Second-Line Metastatic Participants","overall_status":"COMPLETED","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2026-07-23","type":"ACTUAL"},"primary_outcomes":[{"measure":"Safety Lead-in Phase: Number of participants who experience one or more dose-limiting toxicities (DLTs)","timeFrame":"Up to ~21 days"},{"measure":"Safety Lead-in Phase: Number of participants who experience one or more adverse events (AEs)","timeFrame":"Up to ~21 days"},{"measure":"Safety Lead-in Phase: Number of participants who discontinue study treatment due to an AE","timeFrame":"Up to ~21 days"},{"measure":"Efficacy Phase: Number of participants who experienced DLTs","timeFrame":"Up to ~21 days"},{"measure":"Efficacy Phase: Number of participants who experience one or more AEs","timeFrame":"Up to ~56 months"},{"measure":"Efficacy Phase: Number of participants who discontinue study treatment due to an AE","timeFrame":"Up to ~56 months"},{"measure":"Efficacy Phase: Objective response rate (ORR)","timeFrame":"Up to ~56 months"}],"references":[],"start_date":{"date":"2020-12-17","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B/KEYMAKER-U03)","url":"https://clinicaltrials.gov/study/NCT04626518"},"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/keymaker-u03-nct04626518"}