Abstract
Current treatment options for men with metastatic castration-resistant prostate cancer (mCRPC) are noncurative, and median survival upon development of mCRPC is approximately 3 years. The novel hormonal agent enzalutamide has an established role in the mCRPC treatment paradigm, and emerging evidence suggests potential synergism with enzalutamide and the PD-1 inhibitor pembrolizumab in men with mCRPC. Here, we describe the design and rationale for the multicenter, randomized, double-blind, Phase III KEYNOTE-641 study, which will be conducted to compare the efficacy and safety of pembrolizumab plus enzalutamide with that of enzalutamide plus placebo in mCRPC. Clinical trial registration: NCT03834493 (ClinicalTrials.gov).
Keywords:
PD-1; PD-L1; castration resistant; enzalutamide; mCRPC; pembrolizumab; prostate cancer.
MeSH terms
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Adult
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Antibodies, Monoclonal, Humanized / administration & dosage*
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Antibodies, Monoclonal, Humanized / adverse effects
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Antineoplastic Combined Chemotherapy Protocols / administration & dosage*
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Antineoplastic Combined Chemotherapy Protocols / adverse effects
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Benzamides / administration & dosage*
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Benzamides / adverse effects
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Clinical Trials, Phase III as Topic
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Double-Blind Method
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Humans
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Male
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Middle Aged
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Multicenter Studies as Topic
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Nitriles / administration & dosage*
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Nitriles / adverse effects
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Phenylthiohydantoin / administration & dosage*
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Phenylthiohydantoin / adverse effects
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Placebos / administration & dosage
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Placebos / adverse effects
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Progression-Free Survival
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Prostatic Neoplasms, Castration-Resistant / drug therapy*
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Prostatic Neoplasms, Castration-Resistant / mortality
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Prostatic Neoplasms, Castration-Resistant / pathology
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Randomized Controlled Trials as Topic
Substances
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Antibodies, Monoclonal, Humanized
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Benzamides
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Nitriles
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Placebos
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Phenylthiohydantoin
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enzalutamide
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pembrolizumab
Associated data
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ClinicalTrials.gov/NCT03834493