A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-641)

Conditions

Metastatic Castration-Resistant Prostate Cancer

Brief summary

Overall Survival (OS), 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 (BICR)

Detailed description

Time to Initiation of the First Subsequent Anti-Cancer Therapy or Death (TFST), Prostate-specific Antigen (PSA) Response Rate, Prostate-specific Antigen (PSA) Undetectable Rate, Objective Response Rate (ORR) 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 (BICR), Duration of Response (DOR) 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 (BICR), Time to Prostate-specific Antigen (PSA) Progression, Time to Radiographic Soft Tissue Progression per Soft Tissue Rules of 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 (BICR), Time to Pain Progression (TTPP), Time to First Symptomatic Skeletal-Related Event (SSRE), Number of Participants Who Experienced At Least One Adverse Event (AE), Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE

Related papers

No related papers found yet.

Interventions

DRUGNormal Saline or Dextrose

DRUGENZALUTAMIDE

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall Survival (OS), 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 (BICR)	—

Secondary

Measure	Time frame
Time to Initiation of the First Subsequent Anti-Cancer Therapy or Death (TFST), Prostate-specific Antigen (PSA) Response Rate, Prostate-specific Antigen (PSA) Undetectable Rate, Objective Response Rate (ORR) 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 (BICR), Duration of Response (DOR) 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 (BICR), Time to Prostate-specific Antigen (PSA) Progression, Time to Radiographic Soft Tissue Progression per Soft Tissue Rules of 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 (BICR), Time to Pain Progression (TTPP), Time to First Symptomatic Skeletal-Related Event (SSRE), Number of Participants	—

Measure

Time frame

Time to Initiation of the First Subsequent Anti-Cancer Therapy or Death (TFST), Prostate-specific Antigen (PSA) Response Rate, Prostate-specific Antigen (PSA) Undetectable Rate, Objective Response Rate (ORR) 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 (BICR), Duration of Response (DOR) 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 (BICR), Time to Prostate-specific Antigen (PSA) Progression, Time to Radiographic Soft Tissue Progression per Soft Tissue Rules of 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 (BICR), Time to Pain Progression (TTPP), Time to First Symptomatic Skeletal-Related Event (SSRE), Number of Participants

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Countries

Austria, Bulgaria, Czechia, France, Germany, Hungary, Ireland, Italy, Netherlands, Poland, Spain

Outcome results

None listed