NCT03000179

Safety and Efficacy of Avelumab in Small Intestinal Adenocarcinoma

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Avelumab	Avelumab through a vein once every 2 weeks

Timeline

• Start date: 2017-03-03
• Primary completion: 2021-08-03
• Completion: 2021-08-03
• First posted: 2016-12-21
• Last updated: 2022-04-14
• Results posted: 2022-04-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study