{"preliminary_commentary":{"by_channel":{"x_thread":11,"podcast":2},"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\": \"NCT02787005\", \"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":null,"drugs_tested":[["pembrolizumab"],["pembrolizumab","enzalutamide"]],"indication":"metastatic castration-resistant prostate cancer","name":"KEYNOTE-199","nct_id":"NCT02787005","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=keynote-199-nct02787005. 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":1250,"size":"standard","size_rule":"Standard: 151–300 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Participants with programmed cell death ligand 1 (PD-L1)-positive, measurable disease receive pembrolizumab 200 mg via intravenous infusion on Day 1 of every 3-week cycle for up to 2 years.","label":"Cohort 1: PD-L1 positive with measurable disease","type":"EXPERIMENTAL"},{"description":"Participants with PD-L1 negative, measurable disease receive pembrolizumab 200 mg via intravenous infusion on Day 1 of every 3-week cycle for up to 2 years.","label":"Cohort 2: PD-L1 negative with measurable disease","type":"EXPERIMENTAL"},{"description":"Participants with bone metastases and non-measurable disease receive pembrolizumab 200 mg via intravenous infusion on Day 1 of every 3-week cycle for up to 2 years.","label":"Cohort 3: Bone metastases with non-measurable disease","type":"EXPERIMENTAL"},{"description":"Participants with Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)-measureable disease receive pembrolizumab 200 mg via intravenous infusion on Day 1 of every 3-week cycle for up to 2 years.","label":"Cohort 4: RECIST 1.1-measureable disease","type":"EXPERIMENTAL"},{"description":"Participants with bone metastases only or bone-predominant disease receive pembrolizumab 200 mg via intravenous infusion on Day 1 of every 3-week cycle for up to 2 years.","label":"Cohort 5: Bone metastases only or bone-predominant disease","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2022-02-28","type":"ACTUAL"},"conditions":["Metastatic Castration-resistant Prostate Cancer"],"enrollment":{"count":388,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Pembrolizumab","otherNames":["MK-3475","KEYTRUDA®"],"type":"BIOLOGICAL"}],"last_update":"2024-11-21","lead_sponsor":"Merck Sharp & Dohme LLC","official_title":"Phase II Trial of Pembrolizumab (MK-3475) in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-199)","overall_status":"COMPLETED","phases":["PHASE2"],"primary_completion_date":{"date":"2022-02-28","type":"ACTUAL"},"primary_outcomes":[{"measure":"Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (Cohort 1, Cohort 2, Cohort 4 and Cohorts 1 and 2 Combined)","timeFrame":"Up to ~52 months"}],"references":[{"citation":"Antonarakis ES, Piulats JM, Gross-Goupil M, Goh J, Ojamaa K, Hoimes CJ, Vaishampayan U, Berger R, Sezer A, Alanko T, de Wit R, Li C, Omlin A, Procopio G, Fukasawa S, Tabata KI, Park SH, Feyerabend S, Drake CG, Wu H, Qiu P, Kim J, Poehlein C, de Bono JS. Pembrolizumab for Treatment-Refractory Metastatic Castration-Resistant Prostate Cancer: Multicohort, Open-Label Phase II KEYNOTE-199 Study. J Clin Oncol. 2020 Feb 10;38(5):395-405. doi: 10.1200/JCO.19.01638. Epub 2019 Nov 27.","pmid":"31774688","type":"RESULT"},{"citation":"Graff JN, Hoimes CJ, Gerritsen WR, Vaishampayan UN, Elliott T, Hwang C, Ten Tije AJ, Omlin A, McDermott RS, Fradet Y, Tagawa ST, Kilari D, Ferrario C, Uemura H, Jones RJ, Fukasawa S, Peer A, Niu C, Poehlein CH, Qiu P, Suttner L, de Wit R, Schloss C, de Bono JS, Antonarakis ES. Pembrolizumab plus enzalutamide for metastatic castration-resistant prostate cancer progressing on enzalutamide: cohorts 4 and 5 of the phase 2 KEYNOTE-199 study. Prostate Cancer Prostatic Dis. 2025 Jun;28(2):411-418. doi: 10.1038/s41391-024-00865-5. Epub 2024 Aug 12.","pmid":"39134652","type":"RESULT"},{"citation":"Cristescu R, Aurora-Garg D, Albright A, Xu L, Liu XQ, Loboda A, Lang L, Jin F, Rubin EH, Snyder A, Lunceford J. Tumor mutational burden predicts the efficacy of pembrolizumab monotherapy: a pan-tumor retrospective analysis of participants with advanced solid tumors. J Immunother Cancer. 2022 Jan;10(1):e003091. doi: 10.1136/jitc-2021-003091.","pmid":"35101941","type":"DERIVED"}],"start_date":{"date":"2016-07-01","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of Pembrolizumab (MK-3475) in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)(MK-3475-199/KEYNOTE-199)","url":"https://clinicaltrials.gov/study/NCT02787005"},"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/keynote-199-nct02787005"}