A Phase II Clinical Trial of Nivolumab and Temozolomide for Neuroendocrine Neoplasms.

ABSTRACT:

Purpose

Treatment options are limited in patients with metastatic neuroendocrine neoplasms (NEN). We present the results for a phase II trial of combination nivolumab and temozolomide in patients with advanced NEN along with results of immune changes in peripheral blood.

Patients and methods

NCT03728361 is a nonrandomized, phase II study of nivolumab and temozolomide in patients with NEN. The primary endpoint was response rate using RECIST 1.1. Secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety. Immune profiling was performed by mass cytometry to evaluate the effect on peripheral blood immune cell subsets.

Results

Among all 28 patients with NEN, the confirmed response rate was 9/28 [32.1%, 95% confidence interval (CI): 15.9

SUBMITTER: Owen DH 

PROVIDER: S-EPMC9932582 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature