The purpose of this study is to evaluate the safety of the combination of cetrelimab,
with apalutamide and to define a population of participants with metastatic
castration-resistant prostate cancer (mCRPC) who respond to treatment with the
combination of cetrelimab and apalutamide.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03551782.
Locations matching your search criteria
United States
California
Los Angeles
UCLA / Jonsson Comprehensive Cancer CenterStatus: Approved
Contact: Jae Young Kwak
Phone: 310-794-5929
This study is of participants originally diagnosed with adenocarcinoma of the prostate
who have now developed mCRPC and who have progressed on therapy with abiraterone acetate
plus prednisone/prednisolone (AA-P), apalutamide, darolutamide, or enzalutamide.
Participants with treatment-emergent small-cell neuroendocrine prostate cancer (t-SCNC)
assessed by the screening biopsy may be considered for this study. Participants must have
confirmed prostate-specific antigen (PSA) progression per Prostate Cancer Clinical Trials
Working Group (PCWG3) criteria. The primary hypothesis is that treatment with cetrelimab
and apalutamide is safe and leads to improvement in the 12-week PSA response rate. The
study consists of an Optional Pre-screening Period, Screening period (28 days prior to
Cycle 1 Day 1), Treatment Period, End-of-Treatment Visit (performed after the last dose
of study drug is administered), and Follow-up Period (participants will have Follow-up
assessment every 12 weeks after the End-of-Treatment Visit). The efficacy, safety, and
pharmacokinetics of cetrelimab in combination with apalutamide will be evaluated.
Lead OrganizationJanssen Pharmaceuticals