{"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":[["pembrolizumab/quavonlimab","lenvatinib"],["favezelimab/pembrolizumab","lenvatinib"],["belzutifan","pembrolizumab","lenvatinib"]],"indication":"first-line advanced clear-cell renal cell carcinoma","name":"MK-3475-03A","nct_id":"NCT04626479","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=mk-3475-03a-nct04626479. 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":"Participants will receive pembrolizumab/quavonlimab (coformulation of pembrolizumab 400 mg and quavonlimab 25 mg) PLUS lenvatinib 20 mg. Pembrolizumab/quavonlimab will be administered intravenously (IV) once every 6 weeks (Q6W) for up to 17 administrations (up to \\~2 years). Lenvatinib will be administered orally once-daily (QD) until progressive disease or discontinuation.","label":"Coformulation Pembrolizumab/Quavonlimab + Lenvatinib","type":"EXPERIMENTAL"},{"description":"Participants will receive favezelimab/pembrolizumab (coformulation of favezelimab 800 mg and pembrolizumab 200 mg) PLUS lenvatinib 20 mg. Favezelimab/Pembrolizumab will be administered IV once every 3 weeks (Q3W) for up to 35 administrations (up to \\~2 years). Lenvatinib will be administered orally QD until progressive disease or discontinuation.","label":"Coformulation Favezelimab/Pembrolizumab+ Lenvatinib","type":"EXPERIMENTAL"},{"description":"Participants will receive pembrolizumab 400 mg PLUS belzutifan 120 mg PLUS lenvatinib 20 mg. Pembrolizumab will be administered IV Q6W for up to 17 administrations (up to \\~2 years). Both belzutifan and lenvatinib will be administered orally QD until progressive disease or discontinuation.","label":"Pembrolizumab + 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"},{"description":"Participants will receive vibostolimab/pembrolizumab (coformulation of 200 mg vibostolimab and pembrolizumab 200 mg). Vibostolimab/pembrolizumab will be administered IV once every 3 weeks (Q3W) for up to 35 administrations (up to \\~2 years). Belzutifan will be administered orally QD until progressive disease or discontinuation.","label":"Coformulation Vibostolimab/Pembrolizumab+Belzutifan","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2026-08-10","type":"ACTUAL"},"conditions":["Carcinoma, Renal Cell"],"enrollment":{"count":393,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Pembrolizumab","otherNames":["MK-3475","KEYTRUDA®"],"type":"BIOLOGICAL"},{"name":"Favezelimab/Pembrolizumab","otherNames":["MK-4280A"],"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":"Vibostolimab/Pembrolizumab","otherNames":["MK-7684A"],"type":"DRUG"}],"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 (U03): Substudy 03A in First Line Metastatic Participants","overall_status":"COMPLETED","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2026-08-10","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 experience one or more DLTs","timeFrame":"Up to ~21 days"},{"measure":"Efficacy Phase: Number of participants who experience one or more AEs","timeFrame":"Up to ~43 months"},{"measure":"Efficacy Phase: Number of participants who discontinue study treatment due to an AE","timeFrame":"Up to ~43 months"},{"measure":"Efficacy Phase: Objective response rate (ORR)","timeFrame":"Up to ~43 months"}],"references":[{"citation":"Suarez C, Rojas C, Shin SJ, Yanez Weber P, Albiges L, Motzer R, Hammers H, Peer A, Lee JL, Miller WH, Waddell T, Neiman V, Keizman D, Zwenger Kloster A, Weickhardt A, Dziadziuszko R, Suttner L, Sharma M, Burgents JE, Powles T. Novel pembrolizumab-based treatments as first-line therapy in advanced clear-cell renal cell carcinoma: substudy 03A of the open-label, umbrella platform, phase I/II KEYMAKER-U03 trial. Ann Oncol. 2026 Feb;37(2):229-240. doi: 10.1016/j.annonc.2025.10.010. Epub 2025 Oct 18.","pmid":"41115468","type":"RESULT"}],"start_date":{"date":"2020-12-16","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A)","url":"https://clinicaltrials.gov/study/NCT04626479"},"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/mk-3475-03a-nct04626479"}