Nivolumab plus ipilimumab, with or without enzalutamide, in AR-V7-expressing metastatic castration-resistant prostate cancer: A phase-2 nonrandomized clinical trial.

ABSTRACT:

Background

AR-V7-positive metastatic prostate cancer is a lethal phenotype with few treatment options and poor survival.

Methods

The two-cohort nonrandomized Phase 2 study of combined immune checkpoint blockade for AR-V7-expressing metastatic castration-resistant prostate cancer (STARVE-PC) evaluated nivolumab (3 mg/kg) plus ipilimumab (1 mg/kg), without (Cohort 1) or with (Cohort 2) the anti-androgen enzalutamide. Co-primary endpoints were safety and prostate-specific antigen (PSA) response rate. Secondary endpoints included time-to-PSA-progression-free survival (PSA-PFS), time-to-clinical/radiographic-PFS, objective response rate (ORR), PFS lasting greater than 24 weeks, and overall survival (OS).

Results

Thirty patients were treated with ipilimumab plus nivolumab (

SUBMITTER: Shenderov E 

PROVIDER: S-EPMC8018565 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature