drugset / Trial / NCT03179410

PD-L1 Inhibition as ChecKpoint Immunotherapy for NeuroEndocrine Phenotype Prostate Cancer

NCT03179410 ↗

Phase 2 Completed 15 enrolled Andrew J. Armstrong, MD
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the safety and efficacy of avelumab in patients with metastatic neuroendocrine-like prostate cancer. Eligible men will be started on avelumab every 2 weeks and will stay on therapy until progression or intolerable side effects. The central hypothesis is that PD-L1 inhibition with avelumab will be efficacious based on radiographic responses in a subset of men with metastatic neuroendocrine-like prostate cancer and be reasonably well tolerated, meeting criteria for further study in larger phase 2 and 3 trials based on meeting pre-specified efficacy rates and prolonged PFS in some men.

Timeline

Start
2018-02-01
Primary completion
2020-01-09
Completion
2020-12-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Avelumab Monoclonal antibody 10 mg/kg Intravenous

Indications