Clinical trial · no report yet · Phase 1/Phase 2
KEYNOTE-365
Study of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (MK-3475-365/KEYNOTE-365)
- NCT02861573 ↗
- Active, not recruiting
- Merck Sharp & Dohme LLC
- Standard
We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Preliminary discovery
Commentary in our index that names this trial so far
Podcasts, YouTube videos and X posts we have indexed. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build.
| Channel | Found | |
|---|---|---|
| X threads | 9 | |
| Podcasts | 7 | |
| YouTube | 1 |
The trial
ClinicalTrials.gov- Official title
- Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)
- Phase
- Phase 1/Phase 2
- Status
- Active, not recruiting
- Conditions
- Metastatic Castration-Resistant Prostate Cancer
- Interventions
- Pembrolizumab 200 mg; Olaparib 400 mg; Docetaxel 75 mg/m^2; Prednisone 5 mg; Enzalutamide 160 mg; Dexamethasone 8 mg; Olaparib 300 mg; Abiraterone acetate 1000 mg; Lenvatinib; Pembrolizumab/Vibostolimab coformulation; Carboplatin; Etoposide; Belzutifan 120mg
- Arms
- Pembrolizumab+Olaparib · Experimental
- Pembrolizumab+Docetaxel+Prednisone · Experimental
- Pembrolizumab+Enzalutamide · Experimental
- Pembrolizumab+Abiraterone+Prednisone · Experimental
- Pembrolizumab+Lenvatinib: AC · Experimental
- Pembrolizumab+Lenvatinib:t-NE · Experimental
- Pembrolizumab/Vibostolimab coformulation · Experimental
- Pembrolizumab/Vibostolimab coformulation:t-NE · Experimental
- Pembrolizumab+Carboplatin+Etoposide · Experimental
- Carboplatin+Etoposide · Experimental
- Belzutifan · Experimental
- Pembrolizumab+Belzutifan · Experimental
- Enrollment
- 1,200 (estimated)
- Primary outcomes
- Percentage of Participants With a Decrease of ≥50% in Prostatic Specific Antigen (PSA)
- Number of Participants with Adverse Events (AEs)
- Number of Participants Discontinuing Study Drug Due to AEs
- 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)
- Sponsor
- Merck Sharp & Dohme LLC
- Start
- Nov 17, 2016
- Primary completion
- Oct 22, 2027 (estimated)
- Results posted
- No
- Registry record
- NCT02861573 · updated Jul 13, 2026
Publications
linked from the registry- 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. PubMed 38926066
- 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. PubMed 37940446
- 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. PubMed 42070919
- 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. PubMed 40796417
- 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. PubMed 35397952