Clinical Trials List
Protocol NumberMK-3475-921
NCT Number(ClinicalTrials.gov Identfier)NCT03834506
Completed
2019-04-01 - 2023-07-18
Phase III
Recruiting5
A Phase 3, Randomized, Double-blind Study of Pembrolizumab (MK-3475) Plus Docetaxel Plus Prednisone Versus Placebo Plus Docetaxel Plus Prednisone in Participants With Chemotherapy-naïve Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Have Progressed on a Next Generation Hormonal Agent (NHA) (KEYNOTE-921)
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Trial Applicant
Merck Sharp & Dohme (I.A.) LLC
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Sponsor
Merck Sharp & Dohme Corp.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Yen-Hwa Chang Division of Urology
- 朱力行 Division of Nuclear Medicine
- Chien-Hsin Ting 無
- Hsiao-Jen Chung Division of Urology
- 沈書慧 Division of Radiology
- Tzu-Ping Lin Division of Urology
- Tzu-chun Wei Division of Urology
- 潘競成 Division of Others
- 陳威任 Division of Urology
- William Huang 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chi-Ping Huang Division of Urology
- Wei-Ching Lin Division of Radiology
- Chi-Rei Yang Division of Urology
- Yi-Huei Chang Division of Urology
- 陳冠亨 無
- Po-Jen Hsiao Division of Urology
- Su-Peng Yeh Division of Hematology & Oncology
- Han Chang 無
- Po-Fan Hsieh Division of Urology
- Hsi-Chin Wu Division of Urology
- Che-Hung Lin Division of Hematology & Oncology
- Ching-Chan Lin Division of Hematology & Oncology
- 謝德鈞 Division of Nuclear Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 裘坤元 Division of Urology
- 盧嘉文 Division of Urology
- 蔡世傳 Division of Nuclear Medicine
- Shian-Shiang Wang Division of Urology
- 熊小澐 Division of Radiology
- Chuan-Shu Chen Division of Urology
- 洪晟鈞 Division of Urology
- Jian-Ri Li Division of Urology
- Cheng-Kuang Yang Division of Urology
- 王樹吉 Division of Urology
- Cheng-Che Chen Division of Urology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 劉展榮 Division of Urology
- Wu-Chou Su Division of Hematology & Oncology
- Yuh-Shyan Tsai Division of Urology
- Jiann-Hui Ou Division of Urology
- Jui-Hung Tsai Division of Hematology & Oncology
- Che-Yuan Hu Division of Urology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Ying-Chun Shen Division of Hematology & Oncology
- CHUNG-HSIN CHEN Division of Urology
- CHING-CHU LU Division of Nuclear Medicine
- JHE-CYUAN GUO Division of Hematology & Oncology
- PO-MING CHOW Division of Urology
- 王中傑 無
- Yeong-Shiau Pu Division of Urology
- YU-CHUAN LU Division of Urology
- - - Division of Urology
- YEN-HENG LIN Division of Radiology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Objectives
Primary Objectives
1. To compare pembrolizumab plus docetaxel plus prednisone to placebo plus docetaxel plus prednisone with respect to OS
2. To compare pembrolizumab plus docetaxel plus prednisone to placebo plus docetaxel plus prednisone 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 (BICR)
Test Drug
Keytruda
Active Ingredient
Pembrolizumab
Dosage Form
IVT
Dosage
100 mg/ 4 mL/vial
Endpoints
Primary Outcome Measures :
1.Overall Survival (OS) [ Time Frame: Up to approximately 28 months ]
Time from randomization to death due to any cause
2.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 [ Time Frame: Up to approximately 28 months ]
Time from randomization to radiographic progression, or death due to any cause, whichever occurs first
1.Overall Survival (OS) [ Time Frame: Up to approximately 28 months ]
Time from randomization to death due to any cause
2.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 [ Time Frame: Up to approximately 28 months ]
Time from randomization to radiographic progression, or death due to any cause, whichever occurs first
Inclution Criteria
Inclusion Criteria:
Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
Has prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months prior to screening
Has current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography/magnetic resonance imaging (CT/MRI)
Has received prior treatment with one (but not more than one) NHA (eg, abiraterone acetate, enzalutamide, apalutamide, or darolutamide) for metastatic hormone-sensitive prostate cancer (mHSPC) or castration-resistant prostate cancer (CRPC) and either a) progressed through treatment OR b) has become intolerant of the drug
Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<2.0 nM)
Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses prior to randomization
Participants must agree to the following during the study treatment period and for at least 120 days after the last dose of pembrolizumab or for at least 180 days after the last dose of docetaxel (whichever is longer): Refrain from donating sperm PLUS Use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause)
Participants must agree to use male condom when engaging in any activity that allows for passage of ejaculate to another person of any sex
Has provided newly obtained core or excisional biopsy (obtained within 12 months of screening) from soft tissue not previously irradiated (samples from tumors progressing in a prior site of radiation are allowed). Participants with bone only or bone predominant disease may provide a bone biopsy sample
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization
Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
Has prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months prior to screening
Has current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography/magnetic resonance imaging (CT/MRI)
Has received prior treatment with one (but not more than one) NHA (eg, abiraterone acetate, enzalutamide, apalutamide, or darolutamide) for metastatic hormone-sensitive prostate cancer (mHSPC) or castration-resistant prostate cancer (CRPC) and either a) progressed through treatment OR b) has become intolerant of the drug
Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<2.0 nM)
Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses prior to randomization
Participants must agree to the following during the study treatment period and for at least 120 days after the last dose of pembrolizumab or for at least 180 days after the last dose of docetaxel (whichever is longer): Refrain from donating sperm PLUS Use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause)
Participants must agree to use male condom when engaging in any activity that allows for passage of ejaculate to another person of any sex
Has provided newly obtained core or excisional biopsy (obtained within 12 months of screening) from soft tissue not previously irradiated (samples from tumors progressing in a prior site of radiation are allowed). Participants with bone only or bone predominant disease may provide a bone biopsy sample
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization
Exclusion Criteria
Exclusion Criteria:
Has a known additional malignancy that is progressing or has required active treatment in the last 3 years
Has an active autoimmune disease that has required systemic treatment in past 2 years
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
Has undergone major surgery including local prostate intervention (excluding prostate biopsy) within 28 days prior to randomization and not recovered adequately from the toxicities and/or complications
Has a gastrointestinal disorder affecting absorption or is unable to swallow tablets/capsules
Has an active infection (including tuberculosis) requiring systemic therapy
Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
Has known active human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients
Has symptomatic congestive heart failure (New York Heart Association Class III or IV heart disease)
Has had a prior anti-cancer monoclonal antibody (mAb) prior to randomization or who has not recovered (i.e., Grade ≤1 or at baseline) from AEs due to mAbs
Has used herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g. saw palmetto) prior to randomization
Has received prior treatment with radium or other therapeutic radiopharmaceuticals for prostate cancer
Has received prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137)
Has received prior treatment with docetaxel or another chemotherapy agent for mCRPC
Has hypersensitivity to docetaxel or polysorbate 80
Is currently receiving either strong or moderate inhibitors of cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration of the study
Has received prior targeted small molecule therapy or abiraterone acetate, enzalutamide, apalutamide, or darolutamide within 4 weeks prior to the first dose of study treatment, or has not recovered (i.e., Grade ≤1 or at baseline) from AEs due to a previously administered agent
Has received prior radiotherapy to within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis
Has received a live vaccine within 30 days prior to randomization
Has received treatment with 5α reductase inhibitors (eg, finasteride or dutasteride), estrogens, and/or cyproterone within 4 weeks prior to randomization
Has received prior treatment with ketoconazole for prostate cancer
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment
Has a "superscan" bone scan
Is expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment
Has had an allogenic tissue/solid organ transplant
Has a known additional malignancy that is progressing or has required active treatment in the last 3 years
Has an active autoimmune disease that has required systemic treatment in past 2 years
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
Has undergone major surgery including local prostate intervention (excluding prostate biopsy) within 28 days prior to randomization and not recovered adequately from the toxicities and/or complications
Has a gastrointestinal disorder affecting absorption or is unable to swallow tablets/capsules
Has an active infection (including tuberculosis) requiring systemic therapy
Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
Has known active human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients
Has symptomatic congestive heart failure (New York Heart Association Class III or IV heart disease)
Has had a prior anti-cancer monoclonal antibody (mAb) prior to randomization or who has not recovered (i.e., Grade ≤1 or at baseline) from AEs due to mAbs
Has used herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g. saw palmetto) prior to randomization
Has received prior treatment with radium or other therapeutic radiopharmaceuticals for prostate cancer
Has received prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137)
Has received prior treatment with docetaxel or another chemotherapy agent for mCRPC
Has hypersensitivity to docetaxel or polysorbate 80
Is currently receiving either strong or moderate inhibitors of cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration of the study
Has received prior targeted small molecule therapy or abiraterone acetate, enzalutamide, apalutamide, or darolutamide within 4 weeks prior to the first dose of study treatment, or has not recovered (i.e., Grade ≤1 or at baseline) from AEs due to a previously administered agent
Has received prior radiotherapy to within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis
Has received a live vaccine within 30 days prior to randomization
Has received treatment with 5α reductase inhibitors (eg, finasteride or dutasteride), estrogens, and/or cyproterone within 4 weeks prior to randomization
Has received prior treatment with ketoconazole for prostate cancer
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment
Has a "superscan" bone scan
Is expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment
Has had an allogenic tissue/solid organ transplant
The Estimated Number of Participants
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Taiwan
15 participants
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Global
1000 participants
