What is Pancreatic Adenocarcinoma?
Pancreatic adenocarcinoma (PDAC) begins in the tissues of your pancreas, an organ in your abdomen. Pancreatic cancer is seldom detected at its early stages when it’s most curable. Treatment options are chosen based on consultation with a doctor and may include surgery, chemotherapy, radiation therapy or a combination of these. However, treatments with improved toxicity profiles and activity are a significant unmet medical need and strongly supported by patient advocates.
The purpose of the study is to evaluate the safety and clinical activity of pepinemab in combination with avelumab in patients with metastatic pancreatic adenocarcinoma that has progressed after first line chemotherapy. The combination of pepinemab and avelumab has been shown to be well-tolerated in other clinical trials for patients with lung cancer. In addition, tumor biopsies from these patients showed signs of beneficial immune responses in patients that had reduced or stabilized tumor burden. (https://pubmed.ncbi.nlm.nih.gov/33820783/)
About the Trial
This open label Phase 1/2 trial will evaluate the safety and tolerability of pepinemab in combination with avelumab and assess efficacy of combination therapy in up to 48 participants with metastatic pancreatic adenocarcinoma. All patients will receive the combination of drugs that are being studied; there is no placebo group.
Study Start Date
December 10, 2022
University of Rochester