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)
Phase 3
Completed
NCT03834493
| Condition | Prostatic Neoplasms |
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| Phase | Phase 3 |
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| Sponsor | Merck Sharp & Dohme LLC |
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| Status | Completed |
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| Enrollment | 1,244 participants |
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| Interventions | Pembrolizumab, Enzalutamide |
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| Start date | Jul 28, 2019 |
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| Completion date | Dec 12, 2022 |
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| Results posted | Dec 20, 2023 |
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Summary
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 |
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| Placebo + Enzalutamide | 27.3 Months |
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| p-value | 0.6621 |
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| Hazard Ratio (HR) | 1.04 (95% CI 0.88–1.22) |
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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 |
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| Placebo + Enzalutamide | 9.0 Months |
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| p-value | 0.4073 |
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| Hazard Ratio (HR) | 0.98 (95% CI 0.84–1.14) |
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Open in BENITIONS
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