Study of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-641/KEYNOTE-641)

  • STATUS
    Recruiting
  • End date
    Dec 30, 2024
  • participants needed
    1200
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 25 November 2020
Investigator
Toll Free Number
Primary Contact
Macquarie University ( Site 0151) (1.3 mi away) Contact
+219 other location
ct scan
cancer
androgens
MRI
testosterone
metastasis
antiandrogen therapy
androgen suppression
abiraterone
orchiectomy
enzalutamide
serum testosterone
castration-resistant prostate cancer
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 enzalutamide in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC, are abiraterone-nave, or are intolerant to or progressed on abiraterone acetate. There are two primary study hypotheses.

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

Hypothesis 2: The combination of pembrolizumab plus enzalutamide is superior to placebo plus enzalutamide 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 Placebo, Pembrolizumab, Enzalutamide
Clinical Study IdentifierNCT03834493
SponsorMerck Sharp & Dohme Corp.
Last Modified on25 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 Disorders or Prostatic disorder or prostate tumors or prostate tumor or Prostate Cancer or Prostate Cancer, Early, Recurrent or Malignant neo...?
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...?
Do you have any of these conditions: Prostate Disorders or Prostatic disorder or Prostate Cancer or Malignant neoplasm of prostate or prostate tumors or Prostate Cancer, Early, Recurrent ...?
Do you have any of these conditions: Prostatic disorder or Prostate Cancer, Early, Recurrent or prostate tumors or Prostate Disorders or prostate tumor or Prostate Cancer 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 randomization
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)
Is abiraterone-naive or are intolerant to/progressed on abiraterone
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 120 days after the last dose of study treatment: 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 hypersensitivity to pembrolizumab and/or enzalutamide and/or any of their excipients
Has a history of seizure or any condition that may predispose to seizure
Has a history of loss of consciousness within 12 months of screening
Has hypotension (systolic blood pressure <86 millimeters of mercury [mmHg]) or uncontrolled hypertension (systolic blood pressure >170 mmHg or diastolic blood pressure >105 mmHg) at the screening visit
Has bradycardia (heart rate of <50 beats per minute) on the screening electrocardiogram (ECG)
Has history of prostate cancer progression on ketoconazole
Has had prior treatment with enzalutamide, apalutamide, darolutamide or cytochrome P450 (CYP) 17 inhibitor other than abiraterone acetate
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 coinhibitory T-cell receptor
Has received prior treatment with radium or other therapeutic radiopharmaceuticals for prostate cancer
Has received prior treatment with docetaxel or another chemotherapy agent for mCRPC
Has had a prior anti-cancer monoclonal antibody (mAb) prior to randomization
Has used herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (eg, saw palmetto) prior to randomization
Has received a live vaccine within 30 days prior to randomization
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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