{"commentary":{"count":30,"free_build_floor":8,"listing_floor":3,"by_channel":{"youtube":16,"podcast":13,"x_thread":1},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT04634877\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"NCT04634877","nct_id":"NCT04634877","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct04634877. The price is fixed at order. We build the report after the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1250,"size":"standard","size_rule":"Standard: 13–40 commentary sources"},"registry":{"acronym":null,"arms":[{"description":"Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 6 cycles followed by pembrolizumab 400 mg IV on Day 1 of each 6-week cycle (Q6W) for an additional 6 cycles. During the Q3W dosing period of pembrolizumab, participants receive concurrent standard of care (SoC) chemotherapy for 4 or 6 cycles. Participants optionally receive radiotherapy starting within 6 weeks of completion of SoC chemotherapy. The SoC chemotherapy regimen includes carboplatin AUC 5 or 6 IV Q3W plus paclitaxel 175 mg/m\\^2 IV Q3W. In the event of severe hypersensitivity to, or an AE requiring discontinuation of, carboplatin or paclitaxel, cisplatin or docetaxel may be substituted after investigator consults with sponsor. The SoC radiotherapy regimen may include, at the discretion of the investigator, external beam radiotherapy (EBRT) ≥4500 cGY with variable dose frequency, with or without cisplatin 50 mg/m\\^2 IV on days 1 and 29 of EBRT, and/or brachytherapy radiation.","label":"Pembrolizumab + Chemotherapy","type":"EXPERIMENTAL"},{"description":"Participants receive placebo to pembrolizumab intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 6 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 6 cycles. During the Q3W dosing period of placebo, participants receive concurrent standard of care (SoC) chemotherapy for 4 or 6 cycles. Participants optionally receive radiotherapy starting within 6 weeks of completion of SoC chemotherapy. The SoC chemotherapy regimen includes carboplatin AUC 5 or 6 IV Q3W plus paclitaxel 175 mg/m\\^2 IV Q3W. In the event of severe hypersensitivity to, or an AE requiring discontinuation of, carboplatin or paclitaxel, cisplatin or docetaxel may be substituted after investigator consults with sponsor. The SoC radiotherapy regimen may include, at the discretion of the investigator, external beam radiotherapy (EBRT) ≥4500 cGY with variable dose frequency, with or without cisplatin 50 mg/m\\^2 IV on days 1 and 29 of EBRT, and/or brachytherapy radiation.","label":"Placebo + Chemotherapy","type":"PLACEBO_COMPARATOR"}],"collaborators":["European Network of Gynaecological Oncological Trial Groups (ENGOT)","Gynecologic Oncology Group"],"completion_date":{"date":"2026-11-20","type":"ESTIMATED"},"conditions":["Endometrial Neoplasms"],"enrollment":{"count":990,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Pembrolizumab","type":"BIOLOGICAL"},{"name":"Carboplatin","type":"DRUG"},{"name":"Paclitaxel","type":"DRUG"},{"name":"Placebo for pembrolizumab","type":"DRUG"},{"name":"Docetaxel","type":"DRUG"},{"name":"Cisplatin","type":"DRUG"},{"name":"External Beam Radiotherapy (EBRT)","type":"RADIATION"},{"name":"Cisplatin (as radiosensitizer)","type":"DRUG"},{"name":"Brachytherapy","type":"RADIATION"}],"last_update":"2026-09-18","lead_sponsor":"Merck Sharp & Dohme LLC","official_title":"A Phase 3, Randomized, Double-Blind Study of Pembrolizumab Versus Placebo in Combination With Adjuvant Chemotherapy With or Without Radiotherapy for the Treatment of Newly Diagnosed High-Risk Endometrial Cancer After Surgery With Curative Intent (KEYNOTE-B21 / ENGOT-en11 / GOG-3053)","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2026-11-20","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Disease-Free Survival (DFS) as Assessed Radiographically by Investigator or by Histopathologic Confirmation of Suspected Disease Recurrence","timeFrame":"Up to approximately 42 months"},{"measure":"Overall Survival (OS)","timeFrame":"Up to approximately 54 months"}],"references":[{"citation":"Van Gorp T, Cibula D, Lv W, Backes F, Ortac F, Hasegawa K, Lindemann K, Savarese A, Laenen A, Kim YM, Bodnar L, Barretina-Ginesta MP, Gilbert L, Pothuri B, Chen X, Flores MB, Levy T, Colombo N, Papadimitriou C, Buchanan T, Hanker LC, Eminowicz G, Rob L, Black D, Lichfield J, Lin G, Orlowski R, Keefe S, Lortholary A, Slomovitz B; ENGOT-en11/GOG-3053/KEYNOTE-B21 investigators. ENGOT-en11/GOG-3053/KEYNOTE-B21: a randomised, double-blind, phase III study of pembrolizumab or placebo plus adjuvant chemotherapy with or without radiotherapy in patients with newly diagnosed, high-risk endometrial cancer. Ann Oncol. 2024 Nov;35(11):968-980. doi: 10.1016/j.annonc.2024.08.2242. Epub 2024 Sep 14.","pmid":"39284383","type":"RESULT"},{"citation":"Slomovitz BM, Cibula D, Lv W, Ortac F, Hietanen S, Backes F, Kikuchi A, Lorusso D, Danska-Bidzinska A, Samouelian V, Barretina-Ginesta MP, Vulsteke C, Lai CH, Pothuri B, Zhang Y, Magallanes-Maciel M, Amit A, Guarneri V, Zagouri F, Bell M, Welz J, Eminowicz G, Hruda M, Willmott LJ, Lichfield J, Wang W, Orlowski R, Aktan G, Gladieff L, Van Gorp T. Pembrolizumab or Placebo Plus Adjuvant Chemotherapy With or Without Radiotherapy for Newly Diagnosed, High-Risk Endometrial Cancer: Results in Mismatch Repair-Deficient Tumors. J Clin Oncol. 2025 Jan 20;43(3):251-259. doi: 10.1200/JCO-24-01887. Epub 2024 Oct 16.","pmid":"39411812","type":"RESULT"}],"start_date":{"date":"2021-01-10","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053)","url":"https://clinicaltrials.gov/study/NCT04634877"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct04634877"}