Phase 3 Study of Pembrolizumab plus Enzalutamide in mCRPC

Phase 1

Recruiting

Conditions: Metastatic Castration-Resistant Prostate Cancer
MedDRA version: 21.1Level: LLTClassification code: 10076506Term: Castration-resistant prostate cancer Class: 10029104
MedDRA version: 21.1Level: PTClassification code: 10036909Term: Prostate cancer metastatic Class: 100000004864
Therapeutic area: Diseases [C] - Neoplasms [C04]

Registration Number: CTIS2022-500785-10-00

Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Male

Target Recruitment: 1164

Inclusion Criteria

Histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology, Prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months prior to randomization, 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), Ongoing androgen deprivation with serum testosterone <50 ng/dL (<2.0 nM)

Exclusion Criteria

Known additional malignancy that is progressing or has required active treatment in the last 3 years, Active autoimmune disease that has required systemic treatment in past 2 years, Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy, Gastrointestinal disorder affecting absorption or is unable to swallow tablets/capsules, Known active human immunodeficiency virus (HIV), concurrent active hepatitis B virus (HBV) or known active hepatitis C virus (HCV) infection, History of seizure or any condition that may predispose to seizure, Received prior treatment with radium or other therapeutic radiopharmaceuticals for prostate cancer