Last updated on October 2018

Safety and Efficacy of Avelumab in Small Intestinal Adenocarcinoma


Brief description of study

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.

Detailed Study 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.

Clinical Study Identifier: NCT03000179

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Recruitment Status: Open


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