Study of Pembrolizumab (MK-3475) Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-na ve Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-921/KEYNOTE-921)

  • STATUS
    Recruiting
  • End date
    Feb 28, 2023
  • participants needed
    1000
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 22 November 2020
Investigator
Toll Free Number
Primary Contact
Macquarie University ( Site 0151) (1.3 mi away) Contact
+211 other location
ct scan
cancer
prednisone
androgens
MRI
dexamethasone
testosterone
metastasis
docetaxel
antiandrogen therapy
androgen suppression
orchiectomy
enzalutamide
serum testosterone
castration-resistant prostate cancer
apalutamide
tumor progression
adenocarcinoma
bisphosphonate
adenocarcinoma of prostate
metastatic castration-resistant prostate cancer
diphosphonates

Summary

The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and docetaxel in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC but have progressed on or are intolerant to Next Generation Hormonal Agent (NHA).

There are two primary study hypotheses.

Hypothesis 1: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone with respect to Overall Survival (OS).

Hypothesis 2: The combination of pembrolizumab plus docetaxel plus prednisone is superior 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.

Details
Treatment prednisone, docetaxel, Placebo, Dexamethasone, Pembrolizumab
Clinical Study IdentifierNCT03834506
SponsorMerck Sharp & Dohme Corp.
Last Modified on22 November 2020

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Eligibility

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you male?
Do you have any of these conditions: Prostate Cancer or Prostate Disorders or Prostatic disorder or Prostate Cancer, Early, Recurrent or Malignant neoplasm of prostate?
Do you have any of these conditions: prostate tumors or Prostate Cancer or Prostate Cancer, Early, Recurrent or prostate tumor or Prostatic disorder or Malignant neoplasm of prostate or P...?
Do you have any of these conditions: Prostate Cancer, Early, Recurrent or Prostatic disorder or prostate tumors or Prostate Cancer or prostate tumor or Prostate Disorders or Malignant neo...?
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

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 5 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
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