{"preliminary_commentary":{"by_channel":{"x_thread":11,"podcast":4,"youtube":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\": \"NCT04191096\", \"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","enzalutamide"]],"indication":"metastatic hormone-sensitive prostate cancer","name":"KEYNOTE-991","nct_id":"NCT04191096","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=keynote-991-nct04191096. 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":"Starting on Day 1 of each 21-day cycle, participants receive 200 mg pembrolizumab IV every 3 weeks (Q3W) for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally once daily, while maintaining continuous ADT with a luteinizing-hormone releasing hormone (LHRH) agonist or antagonist during study treatment. Participants will continue to receive enzalutamide and ADT until criteria for discontinuation are met.","label":"Pembrolizumab + Enzalutamide + ADT","type":"EXPERIMENTAL"},{"description":"Starting on Day 1 of each 21-day cycle, participants receive placebo IV Q3W for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally once daily, while maintaining continuous ADT with a LHRH agonist or antagonist during study treatment. Participants will continue to receive enzalutamide and ADT until criteria for discontinuation are met.","label":"Placebo + Enzalutamide + ADT","type":"PLACEBO_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2026-04-08","type":"ACTUAL"},"conditions":["Metastatic Hormone-Sensitive Prostate Cancer"],"enrollment":{"count":1251,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Pembrolizumab","otherNames":["KEYTRUDA®","MK-3475"],"type":"BIOLOGICAL"},{"name":"Enzalutamide","otherNames":["XTANDI®"],"type":"DRUG"},{"name":"Androgen Deprivation Therapy (ADT)","otherNames":[],"type":"DRUG"},{"name":"Placebo","otherNames":[],"type":"OTHER"}],"last_update":"2026-09-28","lead_sponsor":"Merck Sharp & Dohme LLC","official_title":"A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) Plus Enzalutamide Plus ADT Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (KEYNOTE-991)","overall_status":"TERMINATED","phases":["PHASE3"],"primary_completion_date":{"date":"2022-10-31","type":"ACTUAL"},"primary_outcomes":[{"measure":"Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)","timeFrame":"Up to approximately 32 months"},{"measure":"Overall Survival (OS)","timeFrame":"Up to approximately 32 months"}],"references":[{"citation":"Gratzke C, Kwiatkowski M, De Giorgi U, Martins da Trindade K, De Santis M, Armstrong AJ, Niu C, Liu Y, Poehlein CH. KEYNOTE-991: pembrolizumab plus enzalutamide and androgen deprivation for metastatic hormone-sensitive prostate cancer. Future Oncol. 2023 Jan 27. doi: 10.2217/fon-2022-0776. Online ahead of print.","pmid":"36705526","type":"DERIVED"}],"start_date":{"date":"2020-02-12","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/KEYNOTE-991)","url":"https://clinicaltrials.gov/study/NCT04191096"},"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-991-nct04191096"}