{"commentary":{"count":114,"free_build_floor":8,"listing_floor":3,"by_channel":{"podcast":39,"x_thread":38,"youtube":37},"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\": \"NCT04221945\", \"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":"NCT04221945","nct_id":"NCT04221945","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct04221945. 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":1950,"size":"deep","size_rule":"Deep: 41+ commentary sources"},"registry":{"acronym":null,"arms":[{"description":"Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by pembrolizumab 400 mg IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of pembrolizumab, participants receive concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\\^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays).","label":"chemoradiotherapy + pembrolizumab","type":"EXPERIMENTAL"},{"description":"Participants receive placebo for pembrolizumab IV on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of placebo, participants receive concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\\^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays).","label":"chemoradiotherapy + placebo for pembrolizumab","type":"EXPERIMENTAL"}],"collaborators":["GOG Foundation","European Network of Gynaecological Oncological Trial Groups (ENGOT)"],"completion_date":{"date":"2026-01-26","type":"ACTUAL"},"conditions":["Uterine Cervical Neoplasms"],"enrollment":{"count":1060,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Pembrolizumab","type":"BIOLOGICAL"},{"name":"Placebo for pembrolizumab","type":"DRUG"},{"name":"Cisplatin","type":"DRUG"},{"name":"External Beam Radiotherapy (EBRT)","type":"RADIATION"},{"name":"Brachytherapy","type":"RADIATION"}],"last_update":"2026-02-20","lead_sponsor":"Merck Sharp & Dohme LLC","official_title":"A Randomized, Phase 3, Double-Blind Study of Chemoradiotherapy With or Without Pembrolizumab for the Treatment of High-risk, Locally Advanced Cervical Cancer (KEYNOTE-A18/ENGOT-cx11/GOG-3047)","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2025-01-07","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator","timeFrame":"Up to approximately 55 months"},{"measure":"Overall Survival (OS)","timeFrame":"Up to approximately 55 months"}],"references":[{"citation":"Lorusso D, Xiang Y, Hasegawa K, Scambia G, Leiva M, Ramos-Elias P, Acevedo A, Sukhin V, Cloven N, Pereira de Santana Gomes AJ, Contreras Mejia F, Reiss A, Ayhan A, Lee JY, Saevets V, Zagouri F, Gilbert L, Sehouli J, Tharavichitkul E, Lindemann K, Lazzari R, Chang CL, Lampe R, Zhu H, Oaknin A, Christiaens M, Polterauer S, Usami T, Li K, Yamada K, Toker S, Keefe SM, Pignata S, Duska LR; ENGOT-cx11/GOG-3047/KEYNOTE-A18 investigators. Pembrolizumab or placebo with chemoradiotherapy followed by pembrolizumab or placebo for newly diagnosed, high-risk, locally advanced cervical cancer (ENGOT-cx11/GOG-3047/KEYNOTE-A18): a randomised, double-blind, phase 3 clinical trial. Lancet. 2024 Apr 6;403(10434):1341-1350. doi: 10.1016/S0140-6736(24)00317-9. Epub 2024 Mar 20.","pmid":"38521086","type":"RESULT"},{"citation":"Lorusso D, Xiang Y, Hasegawa K, Scambia G, Leiva M, Ramos-Elias P, Acevedo A, Cvek J, Randall L, Pereira de Santana Gomes AJ, Contreras Mejia F, Helpman L, Akilli H, Lee JY, Saevets V, Zagouri F, Gilbert L, Sehouli J, Tharavichitkul E, Lindemann K, Colombo N, Chang CL, Bednarikova M, Zhu H, Oaknin A, Christiaens M, Petru E, Usami T, Liu P, Yamada K, Toker S, Keefe SM, Pignata S, Duska LR; ENGOT-cx11/GOG-3047/KEYNOTE-A18 investigators. Pembrolizumab or placebo with chemoradiotherapy followed by pembrolizumab or placebo for newly diagnosed, high-risk, locally advanced cervical cancer (ENGOT-cx11/GOG-3047/KEYNOTE-A18): overall survival results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2024 Oct 5;404(10460):1321-1332. doi: 10.1016/S0140-6736(24)01808-7. Epub 2024 Sep 14.","pmid":"39288779","type":"RESULT"},{"citation":"Randall L, Xiang Y, Matsumoto T, Giannarelli D, Milla DP, Lopez KA, Acevedo A, Vizkeleti J, Salani R, Nogueira-Rodrigues A, Mejia FC, Korach J, Akilli H, Lee JY, Saevets VV, Samouelian V, Sehouli J, Tharavichikul E, Sukhin V, Colombo N, Chang CL, Cueva JF, Lalondrelle S, Petru E, Szamreta E, Nguyen AM, Yamada K, Li K, Pignata S, Lorusso D. Patient-reported outcomes from the phase 3, randomized, double-blind, placebo-controlled ENGOT-cx11/GOG-3047/KEYNOTE-A18 study of pembrolizumab plus concurrent chemoradiotherapy in participants with high-risk locally advanced cervical cancer. Gynecol Oncol. 2025 Aug;199:88-95. doi: 10.1016/j.ygyno.2025.06.003. Epub 2025 Jun 30.","pmid":"40592026","type":"DERIVED"}],"start_date":{"date":"2020-05-12","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of Chemoradiotherapy With or Without Pembrolizumab (MK-3475) For The Treatment of Locally Advanced Cervical Cancer (MK-3475-A18/KEYNOTE-A18/ENGOT-cx11/GOG-3047)","url":"https://clinicaltrials.gov/study/NCT04221945"},"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/nct04221945"}