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)

Фаза 3 Завершено NCT03834493

Заболевание	Prostatic Neoplasms
Фаза	Фаза 3
Спонсор	Merck Sharp & Dohme LLC
Статус	Завершено
Участники	1,244 участн.
Вмешательство	Pembrolizumab, Enzalutamide
Дата начала	28.07.2019
Дата завершения	12.12.2022
Публикация результатов	20.12.2023

Кратко

The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and enzalutamide in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC, are abiraterone-naïve, or are intolerant to or progressed on abiraterone acetate. There are two primary study hypotheses. Hypothesis 1: The combination of pembrolizumab plus enzalutamide is superior to placebo plus enzalutamide with respect to Overall Survival (OS). Hypothesis 2: The combination of pembrolizumab plus enzalutamide is superior to placebo plus enzalutamide with respect to 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.

Overall Survival (OS)

Up to 40 months (through database cut-off date of 12-Dec-2022) · Months

Pembrolizumab + Enzalutamide	24.7 Months
Placebo + Enzalutamide	27.3 Months

p-value	0.6621
Hazard Ratio (HR)	1.04 (95% CI 0.88–1.22)

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

Up to 40 months (through database cut-off date of 12-Dec-2022) · Months

Pembrolizumab + Enzalutamide	10.4 Months
Placebo + Enzalutamide	9.0 Months

p-value	0.4073
Hazard Ratio (HR)	0.98 (95% CI 0.84–1.14)

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Все исследования

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