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Be Part of Research - Trial Details - Study of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (MK-3475-365/KEYNOTE-365)

Study of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (MK-3475-365/KEYNOTE-365)

Recruiting

Open to: MALE

Age: 18.0 - N/A

Medical Conditions

Prostatic Neoplasms


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combination therapy in participants with metastatic castration resistant prostate cancer (mCRPC). There will be ten cohorts in this study: Cohort A will receive pembrolizumab + olaparib, Cohort B will receive pembrolizumab + docetaxel + prednisone, Cohort C will receive pembrolizumab + enzalutamide, Cohort D will receive pembrolizumab + abiraterone + prednisone Cohort E will receive pembrolizumab+lenvatinib, Cohort F will receive pembrolizumab+lenvatinib, Cohort G will receive pembrolizumab/vibostolimab coformulation (MK-7684A), Cohort H will receive pembrolizumab/vibostolimab coformulation, Cohort I will receive pembrolizumab+carboplatin+etoposide in Arm 1 and carboplatin+etoposide in Arm 2 and Cohort J will receive belzutifan in Arm1 and Pembrolizumab+belzutifan in Arm 2. Outcome measures will be assessed individually for each cohort.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Nov 2016 Oct 2027

Publications

"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. 2024 Jun 25:S2588-9311(24)00145-7. doi: 10.1016/j.euo.2024.05.013. Online ahead of print."; "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."; "37940446"; "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."; "35397952"

INTERVENTIONAL

Intervention Type : BIOLOGICAL
Intervention Description : IV Q3W

Intervention Arm Group : Pembrolizumab+Abiraterone+Prednisone;Pembrolizumab+Belzutifan;Pembrolizumab+Carboplatin+Etoposide;Pembrolizumab+Docetaxel+Prednisone;Pembrolizumab+Enzalutamide;Pembrolizumab+Lenvatinib: AC;Pembrolizumab+Lenvatinib:t-NE;Pembrolizumab+Olaparib;

Intervention Type : DRUG
Intervention Description : Eight 50-mg capsules PO BID

Intervention Arm Group : Pembrolizumab+Olaparib;

Intervention Type : DRUG
Intervention Description : IV Q3W

Intervention Arm Group : Pembrolizumab+Docetaxel+Prednisone;

Intervention Type : DRUG
Intervention Description : One 5-mg tablet PO BID

Intervention Arm Group : Pembrolizumab+Abiraterone+Prednisone;Pembrolizumab+Docetaxel+Prednisone;

Intervention Type : DRUG
Intervention Description : Four 40-mg capsules, four 40-mg tablets, or two 80-mg tablets PO QD

Intervention Arm Group : Pembrolizumab+Enzalutamide;

Intervention Type : OTHER
Intervention Description : Premedication for Cohort B given PO at 12, 3, and 1 hours prior to docetaxel infusion Q3W

Intervention Arm Group : Pembrolizumab+Docetaxel+Prednisone;

Intervention Type : DRUG
Intervention Description : Two 150-mg tablets PO BID

Intervention Arm Group : Pembrolizumab+Olaparib;

Intervention Type : DRUG
Intervention Description : Two 500-mg or four 250-mg tablets PO QD

Intervention Arm Group : Pembrolizumab+Abiraterone+Prednisone;

Intervention Type : DRUG
Intervention Description : 20 mg PO QD

Intervention Arm Group : Pembrolizumab+Lenvatinib: AC;Pembrolizumab+Lenvatinib:t-NE;

Intervention Type : BIOLOGICAL
Intervention Description : IV Q3W

Intervention Arm Group : Pembrolizumab/Vibostolimab coformulation;Pembrolizumab/Vibostolimab coformulation:t-NE;

Intervention Type : DRUG
Intervention Description : IV Q3W

Intervention Arm Group : Carboplatin+Etoposide;Pembrolizumab+Carboplatin+Etoposide;

Intervention Type : DRUG
Intervention Description : IV on Days 1, 2 and 3 of each cycle

Intervention Arm Group : Carboplatin+Etoposide;Pembrolizumab+Carboplatin+Etoposide;

Intervention Type : BIOLOGICAL
Intervention Description : PO QD

Intervention Arm Group : Belzutifan;Pembrolizumab+Belzutifan;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Merck Sharp & Dohme Ltd.
    Hoddesdon


The study is sponsored by Merck Sharp & Dohme LLC





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Read full details for Trial ID: NCT02861573
Last updated 24 April 2025

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