Cemiplimab Plus Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma
Trial Parameters
Brief Summary
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.
Eligibility Criteria
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 generation sequencing performed prior to enrollment on an ultrasound-guided core biopsy of the primary tumor. 6. One previous line of therapy for pancreatic ductal adenocarcinoma (NOT immunotherapy or cellular therapy). 7. Last dose of chemotherapy administered \> 14 days prior to the initiation of study therapy. 8. Last dose of radiation therapy or administered \> 28 days prior to the initiation of st