Phase
Condition
Prostate Disorders
Prostate Cancer, Early, Recurrent
Prostate Cancer
Treatment
Placebo
Dexamethasone
Pembrolizumab
Clinical Study ID
Ages > 18 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Has histologically- or cytologically-confirmed adenocarcinoma of the prostatewithout small cell histology
Has prostate cancer progression while on androgen deprivation therapy (or postbilateral orchiectomy) within 6 months prior to screening
Has current evidence of metastatic disease documented by either bone lesions on bonescan 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, abirateroneacetate, enzalutamide, apalutamide, or darolutamide) for metastatichormone-sensitive prostate cancer (mHSPC) or castration-resistant prostate cancer (CRPC) and either a) progressed through treatment OR b) has become intolerant of thedrug
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 forat least 120 days after the last dose of pembrolizumab or for at least 180 daysafter the last dose of docetaxel (whichever is longer): Refrain from donating spermPLUS Use contraception unless confirmed to be azoospermic (vasectomized or secondaryto medical cause)
Participants must agree to use male condom when engaging in any activity that allowsfor passage of ejaculate to another person of any sex
Has provided newly obtained core or excisional biopsy (obtained within 12 months ofscreening) from soft tissue not previously irradiated (samples from tumorsprogressing in a prior site of radiation are allowed). Participants with bone onlyor bone predominant disease may provide a bone biopsy sample
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1assessed within 7 days of randomization
Exclusion
Exclusion Criteria:
Has a known additional malignancy that is progressing or has required activetreatment in the last 3 years
Has an active autoimmune disease that has required systemic treatment in past 2years
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
Has undergone major surgery including local prostate intervention (excludingprostate biopsy) within 28 days prior to randomization and not recovered adequatelyfrom the toxicities and/or complications
Has a gastrointestinal disorder affecting absorption or is unable to swallowtablets/capsules
Has an active infection (including tuberculosis) requiring systemic therapy
Has a history of (non-infectious) pneumonitis that required steroids or currentpneumonitis
Has known active human immunodeficiency virus (HIV), hepatitis B virus (HBV) orhepatitis C virus (HCV) infection
Has known active central nervous system (CNS) metastases and/or carcinomatousmeningitis
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 IVheart disease)
Has had a prior anti-cancer monoclonal antibody (mAb) prior to randomization or whohas 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/orare known to decrease PSA levels (e.g. saw palmetto) prior to randomization
Has received prior treatment with radium or other therapeutic radiopharmaceuticalsfor 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 anagent 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 ofstudy treatment, or has not recovered (i.e., Grade ≤1 or at baseline) from AEs dueto 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 requirecorticosteroids, 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 ordutasteride), 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 investigationalagent or has used an investigational device within 4 weeks prior to the first doseof study treatment
Has a "superscan" bone scan
Is expecting to conceive or father children within the projected duration of thestudy, starting with the screening visit through 120 days after the last dose ofstudy treatment
Has had an allogenic tissue/solid organ transplant
Study Design
Study Description
Connect with a study center
Second Affiliated hospital of Anhui Medical University-Urology (Site 1339)
Hefei, Anhui 230601
ChinaSite Not Available
Beijing Cancer Hospital ( Site 1305)
Beijing, Beijing 100142
ChinaSite Not Available
Peking University First Hospital ( Site 1303)
Beijing, Beijing 100034
ChinaSite Not Available
Peking University Third Hospital (Site 1304)
Beijing, Beijing 100089
ChinaSite Not Available
The Fifth Medical Center of PLA General Hospital ( Site 1307)
Beijing, Beijing 100071
ChinaSite Not Available
The First Affiliated Hospital of Xiamen University ( Site 1319)
Xiamen, Fujian 361000
ChinaSite Not Available
Sun Yat Sen Memorial Hospital ( Site 1323)
Guangzhou, Guangdong 510220
ChinaSite Not Available
Sun Yat-Sen University Cancer Center (Site 1334)
Guangzhou, Guangdong 510663
ChinaSite Not Available
The First Affiliated Hospital of Guangzhou Medical University ( Site 1330)
Guangzhou, Guangdong 510230
ChinaSite Not Available
Harbin Medical University Cancer Hospital (Site 1326)
Harbin, Heilongjiang 150081
ChinaSite Not Available
Henan Cancer Hospital ( Site 1321)
Zhengzhou, Henan 450008
ChinaSite Not Available
Hubei Cancer Hospital ( Site 1329)
Wuhan, Hubei 430079
ChinaSite Not Available
Hunan Cancer Hospital ( Site 1320)
Changsha, Hunan 410013
ChinaSite Not Available
Nanjing Drum Tower Hospital ( Site 1312)
Nanjing, Jiangsu 210008
ChinaSite Not Available
Fudan University Shanghai Cancer Center ( Site 1300)
Shanghai, Shanghai 201321
ChinaSite Not Available
Renji Hospital Shanghai Jiao Tong University School of Medicine (Site 1335)
Shanghai, Shanghai 200127
ChinaSite Not Available
Zhongshan Hospital Fudan University ( Site 1301)
Shanghai, Shanghai 200032
ChinaSite Not Available
The First Affiliated Hospital of Xi an Jiaotong University (Site 1315)
Xian, Shanxi 710061
ChinaSite Not Available
The Second Affiliated Hospital of Zhejiang University School of Medicine ( Site 1309)
Hangzhou, Zhejiang 310009
ChinaSite Not Available
Zhejiang Provincial People's Hospital ( Site 1310)
Hangzhou, Zhejiang 310014
ChinaSite Not Available
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