{"preliminary_commentary":{"by_channel":{"x_thread":10,"podcast":7,"youtube":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT02861573\", \"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."},"name":"KEYNOTE-365","nct_id":"NCT02861573","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=keynote-365-nct02861573. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. 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_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 adenocarcinoma (AC) mCRPC in Cohort A will receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week dosing cycle (Q3W) and olaparib 400 mg capsules or 300 mg tablets by mouth (PO) twice a day (BID) continuously from Day 1 of Cycle 1. Treatment with pembrolizumab will continue until progression or a maximum of 35 treatment cycles (up to 2 years). Treatment with olaparib will continue until progression. Participants who must discontinue 1 of the 2 drugs in the combination due to adverse events may continue the study with the other combination drug.","label":"Pembrolizumab+Olaparib","type":"EXPERIMENTAL"},{"description":"Participants with AC mCRPC in Cohort B will receive pembrolizumab 200 mg IV on Day 1 Q3W, docetaxel 75 mg/m\\^2 IV on Day 1 Q3W, and prednisone 5 mg tablet PO BID continuously from Day 1 of Cycle 1. Participants will only be permitted to receive a maximum of 10 cycles of docetaxel and prednisone. Treatment with pembrolizumab will continue for a maximum of 35 cycles (up to 2 years) or until progression. Participants who must discontinue 1 of the 2 drugs due to adverse events in the combination may continue the study with the other combination drug.","label":"Pembrolizumab+Docetaxel+Prednisone","type":"EXPERIMENTAL"},{"description":"Participants with AC mCRPC in Cohort C will receive pembrolizumab 200 mg IV on Day 1 Q3W and enzalutamide 160 mg PO every day (QD) continuously from Day 1 of Cycle 1. Treatment with pembrolizumab will continue until progression or a maximum of 35 treatment cycles (up to 2 years). Treatment with enzalutamide will continue until progression. Participants who must discontinue 1 of the 2 drugs in the combination due to adverse events may continue the study with the other combination drug.","label":"Pembrolizumab+Enzalutamide","type":"EXPERIMENTAL"},{"description":"Participants with AC mCRPC in Cohort D will receive pembrolizumab 200 mg IV on Day 1 Q3W, abiraterone acetate 1000 mg PO QD and prednisone 5 mg tablet PO BID continuously from Day 1 of Cycle 1. Treatment with pembrolizumab will continue for a maximum of 35 cycles (up to 2 years) or until progression. Participants who must discontinue 1 of the 2 drugs due to adverse events in the combination may continue the study with the other combination drug.","label":"Pembrolizumab+Abiraterone+Prednisone","type":"EXPERIMENTAL"},{"description":"Participants with AC mCRPC in Cohort E will receive pembrolizumab 200 mg IV on Day 1 Q3W, and lenvatinib 20 mg PO QD continuously from Day 1 of Cycle 1. Treatment with pembrolizumab will continue for a maximum of 35 cycles (up to 2 years) or until progression. Participants who must discontinue 1 of the 2 drugs due to adverse events in the combination may continue the study with the other combination drug.","label":"Pembrolizumab+Lenvatinib: AC","type":"EXPERIMENTAL"},{"description":"Participants with neuroendocrine (t-NE) mCRPC in Cohort F will receive pembrolizumab 200 mg IV on Day 1 Q3W, and lenvatinib 20 mg PO QD continuously from Day 1 of Cycle 1. Treatment with pembrolizumab will continue for a maximum of 35 cycles (up to 2 years) or until progression. Participants who must discontinue 1 of the 2 drugs due to adverse events in the combination may continue the study with the other combination drug.","label":"Pembrolizumab+Lenvatinib:t-NE","type":"EXPERIMENTAL"},{"description":"Participants with AC mCRPC in Cohort G will receive a coformulation fixed dose combination of 200 mg pembrolizumab and 200 mg vibostolimab (MK-7684) Q3W IV from Day 1 of Cycle 1. Treatment will continue for a maximum of 35 cycles (up to 2 years) or until progression.","label":"Pembrolizumab/Vibostolimab coformulation","type":"EXPERIMENTAL"},{"description":"Participants with t-NE mCRPC in Cohort H will receive a coformulation fixed dose combination of 200 mg pembrolizumab and 200 mg vibostolimab (MK-7684) Q3W IV from Day 1 of Cycle 1. Treatment will continue for a maximum of 35 cycles (up to 2 years) or until progression.","label":"Pembrolizumab/Vibostolimab coformulation:t-NE","type":"EXPERIMENTAL"},{"description":"Participants with neuroendocrine mCRPC in Cohort I Arm 1 will receive pembrolizumab 200 mg IV on Day 1 Q3W + carboplatin titrated to an area under the plasma drug concentration-time curve \\[AUC\\] 5 IV on Day 1 Q3W + etoposide 100 mg/m\\^2 IV on Days 1, 2, and 3 Q3W. Treatment with pembrolizumab will continue for a maximum of 35 cycles (up to 2 years) or until progression. Treatment with carboplatin+etoposide will continue for a maximum of 4 cycles (up to 2.8 months). Participants who must discontinue 1 or 2 of the 3 drugs due to adverse events in the combination may continue the study with the other combination drug/drugs.","label":"Pembrolizumab+Carboplatin+Etoposide","type":"EXPERIMENTAL"},{"description":"Participants with neuroendocrine mCRPC in Cohort I Arm 2 will receive carboplatin titrated to an area under the plasma drug concentration-time curve \\[AUC\\] 5 IV on Day 1 Q3W + etoposide 100 mg/m\\^2 IV on Days 1, 2, and 3 Q3W. Treatment will continue for a maximum of 35 cycles (up to 2 years) or until progression. Treatment with carboplatin+etoposide will continue for a maximum of 4 cycles (up to 2.8 months). Participants who must discontinue 1 of the 2 drugs due to adverse events in the combination may continue the study with the other combination drug.","label":"Carboplatin+Etoposide","type":"EXPERIMENTAL"},{"description":"Participants with AC mCRPC in Cohort J will receive belzutifan 120mg QD in the initial cohort. If an efficacy signal is detected in this arm based on a totality of evidence, Cohort J may be expanded further where participants will be randomized 1:1 to receive either belzutifan 120 mg QD or belzutifan 120 mg QD and pembrolizumab 200 mg Q3W. Treatment will continue for a maximum of 35 cycles (up to 2 years) or until progression.","label":"Belzutifan","type":"EXPERIMENTAL"},{"description":"Participants with AC mCRPC in Cohort J will receive belzutifan 120mg QD in the initial cohort. If an efficacy signal is detected in this arm based on a totality of evidence, Cohort J may be expanded further where participants will be randomized 1:1 to receive either belzutifan 120 mg QD or belzutifan 120 mg QD and pembrolizumab 200 mg Q3W. Treatment will continue for a maximum of 35 cycles (up to 2 years) or until progression.","label":"Pembrolizumab+Belzutifan","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2028-07-24","type":"ESTIMATED"},"conditions":["Metastatic Castration-Resistant Prostate Cancer"],"enrollment":{"count":1200,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Pembrolizumab 200 mg","otherNames":["KEYTRUDA®","MK-3475"],"type":"BIOLOGICAL"},{"name":"Olaparib 400 mg","otherNames":["LYNPARZA®","MK-7339"],"type":"DRUG"},{"name":"Docetaxel 75 mg/m^2","otherNames":["TAXOTERE®"],"type":"DRUG"},{"name":"Prednisone 5 mg","otherNames":[],"type":"DRUG"},{"name":"Enzalutamide 160 mg","otherNames":["XTANDI®"],"type":"DRUG"},{"name":"Dexamethasone 8 mg","otherNames":[],"type":"OTHER"},{"name":"Olaparib 300 mg","otherNames":["LYNPARZA®","MK-7339"],"type":"DRUG"},{"name":"Abiraterone acetate 1000 mg","otherNames":["ZYTIGA®"],"type":"DRUG"},{"name":"Lenvatinib","otherNames":["LENVIMA®","MK-7902"],"type":"DRUG"},{"name":"Pembrolizumab/Vibostolimab coformulation","otherNames":["MK-7684A"],"type":"BIOLOGICAL"},{"name":"Carboplatin","otherNames":["PARAPLATIN®"],"type":"DRUG"},{"name":"Etoposide","otherNames":["TOPOSAR™"],"type":"DRUG"},{"name":"Belzutifan 120mg","otherNames":["WELIREG™"],"type":"BIOLOGICAL"}],"last_update":"2026-07-13","lead_sponsor":"Merck Sharp & Dohme LLC","official_title":"Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2027-10-22","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Percentage of Participants With a Decrease of ≥50% in Prostatic Specific Antigen (PSA)","timeFrame":"From Baseline Measured Every 3 Weeks Until Radiographic Progression Estimated to be Approximately 2 Years"},{"measure":"Number of Participants with Adverse Events (AEs)","timeFrame":"Assessed Every 3 Weeks Over the Duration of the Study Which is Estimated to be Approximately 2 Years"},{"measure":"Number of Participants Discontinuing Study Drug Due to AEs","timeFrame":"Assessed Every 3 Weeks Over the Duration of the Study Which is Estimated to be Approximately 2 Years"},{"measure":"Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR)","timeFrame":"Assessed Over the Duration of the Study Which is Estimated to be Approximately 2 Years"}],"references":[{"citation":"Yu EY, Ferrario C, Linch MD, Stoeckle M, Laguerre B, Arranz JA, Todenhofer T, Fong PC, Piulats JM, Berry W, Emmenegger U, Mourey L, Joshua AM, Mar N, Appleman LJ, Conter HJ, Gravis G, Li XT, Schloss C, Poehlein C, de Bono JS. Pembrolizumab plus Abiraterone Acetate and Prednisone in Patients with Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer: Results from KEYNOTE-365 Cohort D. Eur Urol Oncol. 2025 Jun;8(3):641-651. doi: 10.1016/j.euo.2024.05.013. Epub 2024 Jun 25.","pmid":"38926066","type":"RESULT"},{"citation":"Yu EY, Berry WR, Gurney H, Retz M, Conter HJ, Laguerre B, Fong PCC, Ferrario C, Todenhofer T, Gravis G, Piulats JM, Emmenegger U, Shore ND, Romano E, Mourey L, Li XT, Poehlein CH, Schloss C, Appleman LJ, de Bono JS. Pembrolizumab and Enzalutamide in Patients with Abiraterone Acetate-Pretreated Metastatic Castration-Resistant Prostate Cancer: Cohort C of the Phase 1b/2 KEYNOTE-365 Study. Eur Urol Oncol. 2024 Jun;7(3):509-518. doi: 10.1016/j.euo.2023.10.008. Epub 2023 Nov 7.","pmid":"37940446","type":"RESULT"},{"citation":"Augustin M, Laguerre B, Baldini C, Zedan AH, Gonzalez-Billalabeitia E, Fong PC, Zukov R, Hammerer P, Prentice M, Shore N, Necchi A, Todenhofer T, Kessler ER, Kose F, Gurney H, Valderrama BP, Zhu P, Imai K, Liu Y, McDermott R. Pembrolizumab Plus Lenvatinib in Participants with Docetaxel-pretreated Metastatic Castration-resistant Prostate Cancer: Results from KEYNOTE-365 Cohort E. Eur Urol Oncol. 2026 May 2:S2588-9311(26)00084-2. doi: 10.1016/j.euo.2026.03.026. Online ahead of print.","pmid":"42070919","type":"DERIVED"},{"citation":"Fong PC, Kwiatkowski M, Mosca A, Valderrama BP, Li C, Huang YH, Zedan AH, Kuc K, Wiechno P, Laguerre B, Gonzalez-Billalabeitia E, Osipov M, Sener Dede D, Goh JC, Daugaard G, Zhu P, Imai K, Liu Y, Arranz Arija JA. Vibostolimab Coformulated with Pembrolizumab in Participants with Docetaxel-pretreated Metastatic Castration-resistant Prostate Cancer: KEYNOTE-365 Cohort G. Eur Urol Focus. 2026 Mar;12(2):168-173. doi: 10.1016/j.euf.2025.07.018. Epub 2025 Aug 11.","pmid":"40796417","type":"DERIVED"},{"citation":"Yu EY, Kolinsky MP, Berry WR, Retz M, Mourey L, Piulats JM, Appleman LJ, Romano E, Gravis G, Gurney H, Bogemann M, Emmenegger U, Joshua AM, Linch M, Sridhar S, Conter HJ, Laguerre B, Massard C, Li XT, Schloss C, Poehlein CH, de Bono JS. Pembrolizumab Plus Docetaxel and Prednisone in Patients with Metastatic Castration-resistant Prostate Cancer: Long-term Results from the Phase 1b/2 KEYNOTE-365 Cohort B Study. Eur Urol. 2022 Jul;82(1):22-30. doi: 10.1016/j.eururo.2022.02.023. Epub 2022 Apr 6.","pmid":"35397952","type":"DERIVED"}],"start_date":{"date":"2016-11-17","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (MK-3475-365/KEYNOTE-365)","url":"https://clinicaltrials.gov/study/NCT02861573"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/keynote-365-nct02861573"}