Safety and Efficacy of Avelumab in Small Intestinal Adenocarcinoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03000179|
Recruitment Status : Active, not recruiting
First Posted : December 21, 2016
Last Update Posted : August 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma||Drug: Avelumab||Phase 2|
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study to Investigate the Safety and Efficacy of Avelumab Monotherapy in Patients With Advanced or Metastatic Adenocarcinoma of the Small Intestine|
|Actual Study Start Date :||March 3, 2017|
|Estimated Primary Completion Date :||April 15, 2022|
|Estimated Study Completion Date :||April 15, 2023|
Experimental: Avelumab Monotherapy
Participants receive avelumab by IV infusion following pretreatment with H1 blockers and acetaminophen once every 2 weeks.
Avelumab through a vein once every 2 weeks
- Overall response rate as measured using RECIST 1.1 [ Time Frame: Measured every 8 weeks through study completion, an average of 1 year ]To describe any antitumor activity of avelumab monotherapy, as measured by the response rate in patients with advanced or metastatic small intestinal adenocarcinoma.
- Number of patients with each worst‐grade toxicity [ Time Frame: On‐study date to 30 days following final dose of study drug ]To describe the safety profile of avelumab monotherapy in patients with advanced or metastatic small intestinal adenocarcinoma
- Overall survival [ Time Frame: Every 3 months after completing treatment up to 5 years ]On study date until death from any cause
- Progression free survival [ Time Frame: On‐study date to lesser of date of progression or date of death from any cause measured up to 3 years after treatment ]On‐study date until disease progression or death
- Duration of response [ Time Frame: Date of first partial or complete response as defined by RECIST 1.1 criteria to date of recurrence or disease progression up to 3 years ]Time from documentation of tumor response to disease progression
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03000179
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Dana Cardin, M.D.||Vanderbilt-Ingram Cancer Center|