University of California, San Diego
This is a Phase 2 trial evaluating the combination of cemiplimab with the standard of care chemotherapy agent gemcitabine for the treatment of patients with metastatic pancreatic ductal adenocarcinoma with SWItch/Sucrose Non-Fermentable (SWI/SNF) alterations who have already been treated with FOLFIRINOX (5-fluoruracil, leucovorin, irinotecan, oxaliplatin) or gemcitabine/nab-paclitaxel chemotherapy.
Chemotherapy with FOLFIRINOX (5-fluoruracil, leucovorin, irinotecan, oxaliplatin) or gemcitabine/nab-paclitaxel is the backbone of modern therapy of metastatic pancreatic ductal adenocarcinoma. Generally, the chemotherapy regimen is chosen based on the patient's performance status and ability to tolerate the specific side effect profiles of the two regimens. As many patients with metastatic pancreatic ductal adenocarcinoma suffer from multiple co-morbidities that develop with the disease, they are often subjected to treatment interruptions, dose reductions, and palliative single-agent therapie…
Inclusion Criteria: 1. At least 18 years of age. 2. Ability to understand the nature of this study, comply with study and follow-up procedures, and give written informed consent. 3. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma. Primary tumor can be intact or post-resection with newly developed metastatic disease. 4. Stage IV disease (measurable disease by Immunotherapeutics Response Evaluation Criteria in Solid Tumors is required). 5. Alterations in SWI/SNF complex chromatin remodeling genes (ARID1A, ARID1B, PBRM1, SMARCA4 and SMARCB1, etc.) detected by next gene…
Cemiplimab Plus Gemcitabine
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