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Trial 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.

Acronym:

KEYNOTE 641

ACTRN/NCT /ethics:

NCT03834493

Scientific title:

Phase III, randomised, double-blind trial of pembrolizumab (MK-3475) plus enzalutamde vs placebo plus enzalutamide in participants with mCRPC

Sponsor / Cooperative group:

Merck Sharp & Dohme Corp.

Trial & Patient Characteristics

Cancer TypeProstate
Trial TypeTreatment
PhasePhase III
Age Range18 years and older
SexMale
Tumour Stream Prostate
Cancer StageMetastatic or Widespread
Anticipated Start Date2019-07-28
Anticipated End Date2024-04-30

Participating Hospitals

HospitalRoyal Adelaide Hospital
Clinical Trial CoordinatorAnne Milton
Emailanne.milton@sa.gov.au
Phone08 7074 2342
Principal InvestigatorProfessor Hsiang Tan
Recruitment StatusRecruiting