Phase 2 Study of Cemiplimab Combined With Gemcitabine for Second-line Treatment of Metastatic Pancreatic Adenocarcinoma With SWISNF Gene Alterations

What this Trial Is About

Researchers are studying metastatic pancreatic ductal adenocarcinoma mPDAC in patients with specific genetic changes called SWISNF alterations. The trial evaluates the combination of cemiplimab, an immune checkpoint inhibitor, with the standard chemotherapy drug gemcitabine. This Phase 2 study focuses on patients who have already been treated with other chemotherapy regimens FOLFIRINOX or gemcitabinenab-paclitaxel but need better treatment options due to limited responses or intolerance to prior therapies. Participants receive cemiplimab intravenously at a dose of 3 mgkg every two weeks and gemcitabine intravenously at 1000 mgm on days 1, 8, and 15 of each 28-day cycle. Treatment continues until the disease progresses or other reasons require stopping. The combination is studied to assess its safety and effects on survival and tumor response in this patient group. During the trial, patients are monitored for overall survival as the main outcome, tracked over seven months. Researchers will evaluate treatment responses, side effects, and other health measures. Patients undergo regular clinical assessments and laboratory tests to check blood counts, liver and kidney function, heart rhythm, and pregnancy status when applicable. The study lasts until disease progression or discontinuation, with ongoing follow-up for safety and treatment effects.

Cemiplimab Plus Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma