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Safety and Efficacy of Avelumab in Small Intestinal Adenocarcinoma

Adenocarcinoma Clinical Trial

Official title:
Pilot Study to Investigate the Safety and Efficacy of Avelumab Monotherapy in Patients With Advanced or Metastatic Adenocarcinoma of the Small Intestine

Clinical Trial Summary

This is a single-agent, open label, one-arm phase 2 pilot study of avelumab in patients with advanced or metastatic adenocarcinoma of the small intestine.

Clinical Trial Description

Primary Objectives - To describe any antitumor activity of avelumab monotherapy, as measured by the response rate in patients with advanced or metastatic small intestinal adenocarcinoma. - To describe the safety profile of avelumab monotherapy in patients with advanced or metastatic small intestinal adenocarcinoma. Secondary Objectives - To determine overall survival, progression-free survival, and duration of response of avelumab monotherapy in patients with advanced small intestinal adenocarcinoma. - To evaluate the association of tumor PD-L1 and PD-1 expression, MSI status, lymphocytic infiltration, and somatic mutation burden with response. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03000179
Study type Interventional
Source Vanderbilt-Ingram Cancer Center
Contact
Status Terminated
Phase Phase 2
Start date March 3, 2017
Completion date August 3, 2021
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