Cemiplimab Plus Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma (NCT06790602) | Clinical Trial Compass
RecruitingPhase 2
Cemiplimab Plus Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma
United States43 participantsStarted 2026-04
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. At least 18 years of age.
✓. Ability to understand the nature of this study, comply with study and follow-up procedures, and give written informed consent.
✓. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma. Primary tumor can be intact or post-resection with newly developed metastatic disease.
✓. Stage IV disease (measurable disease by Immunotherapeutics Response Evaluation Criteria in Solid Tumors is required).
✓. 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.
✓. One previous line of therapy for pancreatic ductal adenocarcinoma (NOT immunotherapy or cellular therapy).
✓. Last dose of chemotherapy administered \> 14 days prior to the initiation of study therapy.
✓. Last dose of radiation therapy or administered \> 28 days prior to the initiation of study therapy.
Exclusion criteria
✕. Two or more lines of systemic or previous investigational therapy for metastatic pancreatic ductal adenocarcinoma.
✕. History of any autoimmune disease requiring treatment within the past 12 months prior to enrollment.