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Safety and Efficacy of Avelumab in Small Bowel Adenocarcinoma
Dana B Cardin1, Jill Gilbert1, Jennifer G Whisenant1
1Vanderbilt-Ingram Cancer Center, Nashville, TN; Department of Medicine (Hematology & Oncology), Vanderbilt University Medical Center; Nashville, TN.
Introduction:
Small bowel adenocarcinomas (SBAs) are rare and frequently treated like large intestinal adenocarcinomas. However, SBAs have a very different microenvironment and could respond differently to the same therapies. Our previous data suggested that SBAs might benefit from targeting the PD-1/PD-L1 axis based on PD-L1 staining in almost 50% of SBA tissue samples tested. Thus, we designed a phase 2 study to explore safety and efficacy of avelumab in SBA.
Patients And Methods:
Patients with advanced or metastatic disease were enrolled; ampullary tumors were considered part of the duodenum and allowed. Prior PD-1/PD-L1 inhibition was not allowed. Avelumab (10 mg/kg) was given every 2 weeks, and imaging was performed every 8 weeks. Primary endpoint was response rate.
Results:
Eight patients (n = 5, small intestine; n = 3, ampullary) were enrolled, with a majority (88%) being male and a median age of 61 years. Of 7 efficacy-evaluable patients, 2 (29%) experienced partial responses; stable disease occurred in 3 additional patients (71%). Median progression-free survival was 3.35 months. Most frequent, related toxicities were anemia, fatigue, and infusion-related reaction (25% each), mostly grade ≤2; grade 3 hypokalemia and hyponatremia occurred in one patient, and another reported grade 4 diabetic ketoacidosis.
Conclusions:
Despite the observed benefit, accrual was slower than expected and the study was closed early due to feasibility. A general clinic observation was that patients were receiving immunotherapy off-label as the availability of these agents increased. Off-label availability and disease rarity were likely drivers of insufficient accrual.
Insights
This phase 2 study explored avelumab for small bowel adenocarcinomas (SBAs). Two patients showed partial responses, but the study closed early due to slow accrual, highlighting challenges in rare cancer research.
Area of Science:
- Oncology
- Immunotherapy
- Gastrointestinal Cancers
Background:
- Small bowel adenocarcinomas (SBAs) are rare and distinct from large intestinal cancers.
- SBAs may benefit from PD-1/PD-L1 axis targeting, as indicated by PD-L1 expression in tumor samples.
Purpose of the Study:
- To evaluate the safety and efficacy of avelumab in patients with advanced or metastatic SBAs.
- To determine the response rate of avelumab in this patient population.
Main Methods:
- A phase 2 study enrolled patients with advanced/metastatic SBAs.
- Avelumab was administered at 10 mg/kg every 2 weeks.
- Response rate was the primary endpoint; imaging occurred every 8 weeks.
Main Results:
- Eight patients (5 small intestine, 3 ampullary) were enrolled.
- Two of seven efficacy-evaluable patients (29%) achieved partial responses; 3 (71%) had stable disease.
- Median progression-free survival was 3.35 months; common toxicities included anemia and fatigue.
Conclusions:
- Avelumab demonstrated some clinical benefit in SBAs, with partial responses observed.
- The study closed early due to slow accrual, likely influenced by off-label immunotherapy use and disease rarity.
- Feasibility challenges were encountered in enrolling patients for this rare cancer study.
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