{"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","enzalutamide"]],"indication":"metastatic castration-resistant prostate cancer","name":"KEYNOTE-641","nct_id":"NCT03834493","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=keynote-641-nct03834493. 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":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Participants receive 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) PLUS enzalutamide 160 mg administered orally (PO) once a day (QD) continuously until progression.","label":"Pembrolizumab + Enzalutamide","type":"EXPERIMENTAL"},{"description":"Participants receive placebo by IV infusion administered on Day 1 Q3W for up to 35 cycles (approximately 2 years) PLUS enzalutamide 160 mg administered PO QD continuously until progression.","label":"Placebo + Enzalutamide","type":"PLACEBO_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2026-06-08","type":"ACTUAL"},"conditions":["Prostatic Neoplasms"],"enrollment":{"count":1244,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Pembrolizumab","otherNames":["KEYTRUDA®","MK-3475"],"type":"BIOLOGICAL"},{"name":"Enzalutamide","otherNames":["XTANDI®"],"type":"DRUG"},{"name":"Placebo","otherNames":["Normal saline or dextrose infusion"],"type":"DRUG"}],"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 Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-641)","overall_status":"TERMINATED","phases":["PHASE3"],"primary_completion_date":{"date":"2022-12-12","type":"ACTUAL"},"primary_outcomes":[{"measure":"Overall Survival (OS)","timeFrame":"Up to 40 months (through database cut-off date of 12-Dec-2022)"},{"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","timeFrame":"Up to 40 months (through database cut-off date of 12-Dec-2022)"}],"references":[{"citation":"Graff JN, Burotto M, Fong PC, Pook DW, Zurawski B, Manneh Kopp R, Salinas J, Bylow KA, Kramer G, Ratta R, Kwiatkowski M, Retz M, Kwak C, Arranz Arija JA, Gurney H, Matsubara N, Villanueva L, Todenhofer T, Liang LW, Todoric J, Imai K, Stenzl A; KEYNOTE-641 Investigators. Pembrolizumab plus enzalutamide versus placebo plus enzalutamide for chemotherapy-naive metastatic castration-resistant prostate cancer: the randomized, double-blind, phase III KEYNOTE-641 study. Ann Oncol. 2025 Aug;36(8):976-987. doi: 10.1016/j.annonc.2025.05.007. Epub 2025 May 16.","pmid":"40383193","type":"RESULT"},{"citation":"Graff JN, Liang LW, Kim J, Stenzl A. KEYNOTE-641: a Phase III study of pembrolizumab plus enzalutamide for metastatic castration-resistant prostate cancer. Future Oncol. 2021 Aug;17(23):3017-3026. doi: 10.2217/fon-2020-1008. Epub 2021 May 28.","pmid":"34044584","type":"DERIVED"}],"start_date":{"date":"2019-07-28","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-641/KEYNOTE-641)","url":"https://clinicaltrials.gov/study/NCT03834493"},"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-641-nct03834493"}