A phase 2 trial of avelumab in men with aggressive-variant or neuroendocrine prostate cancer.

ABSTRACT:

Background

Men with progressive neuroendocrine or aggressive-variant metastatic prostate cancer (NEPC/AVPC) have a poor prognosis and limited treatment options, and immunotherapy has not been tested in such patients.

Methods

We conducted an open label single center phase 2 trial (NCT03179410) of men with progressive NEPC/AVPC either defined by histology or AVPC criteria. Avelumab (10 mg/kg every 2 weeks) was administered until progression or unacceptable toxicity. The primary endpoint was overall response rate (ORR). Secondary endpoints included ORR, radiographic progression-free survival (rPFS), overall survival, and safety. Correlative studies included longitudinal peripheral blood immune phenotyping. The study was limited by the small number of patients enrolled and by th

SUBMITTER: Brown LC 

PROVIDER: S-EPMC8923335 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature