drugset / Trial / NCT04926181

Apalutamide Plus Cetrelimab in Patients With Treatment-Emergent Small Cell Neuroendocrine Prostate Cancer

NCT04926181

NaSingle-groupOpen-labelTreatment

Summary

Despite the low androgen receptor (AR) transcriptional activity of treatment-emergent small cell neuroendocrine prostate cancer, there is persistent AR expression observed in the majority of treatment-emergent small-cell neuroendocrine prostate cancer (t-SCNC) biopsies. This indicates that epigenetic dysregulation leads to reprogramming away from an AR-driven transcriptional program. Therefore, continuation of AR blockade in the form of apalutamide may provide additive benefit compared to immune checkpoint blockade alone. The investigators hypothesize that the combination of apalutamide plus cetrelimab will achieve a clinically significant composite response rate with sufficient durability of response in mCRPC patients with evidence of treatment-emergent small cell neuroendocrine prostate cancer

Timeline

Start
2022-03-16
Primary completion
2024-03-31
Completion
2024-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Apalutamide Small molecule 240 mg Oral
Subject Cetrelimab Monoclonal antibody 480 mg Intravenous