Safety and Efficacy of Avelumab in Small Intestinal Adenocarcinoma
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Adenocarcinoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 ade...
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.
Tracking Information
- NCT #
- NCT03000179
- Collaborators
- National Cancer Institute (NCI)
- EMD Serono
- Investigators
- Principal Investigator: Dana Cardin, M.D. Vanderbilt-Ingram Cancer Center
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