Actively Recruiting
Cemiplimab Plus Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma
Led by University of California, San Diego · Updated on 2026-04-09
43
Participants Needed
1
Research Sites
191 weeks
Total Duration
On this page
Sponsors
U
University of California, San Diego
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cemiplimab Plus Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age.
- Ability to understand the study, follow procedures, and provide written consent.
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma with intact primary tumor or post-resection metastatic disease.
- Stage IV disease with measurable tumor by Immunotherapeutics Response Evaluation Criteria in Solid Tumors.
- Presence of SWI/SNF complex chromatin remodeling gene alterations confirmed by next generation sequencing on tumor biopsy.
- One previous line of therapy for pancreatic ductal adenocarcinoma (excluding immunotherapy or cellular therapy).
- Last chemotherapy dose given more than 14 days before starting study therapy.
- Last radiation therapy dose given more than 28 days before starting study therapy.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Adequate bone marrow function with neutrophil count ≥ 1,500 cells/μL, platelet count ≥ 100,000 cells/μL, and hemoglobin ≥ 9.0 g/dL.
- Adequate liver function with bilirubin ≤ 1.5 times upper limit of normal (except for Gilbert's syndrome), AST ≤ 3.0 (or ≤ 5.0 with liver metastases), ALT ≤ 3.0 (or ≤ 5.0 with liver metastases).
- Adequate kidney function with serum creatinine ≤ 1.5 times upper limit of normal.
- Corrected QT interval average < 470 milliseconds on triplicate ECG.
- Participants not of childbearing potential, or those who agree to use contraception during and 6 months after treatment, are not breastfeeding, and have a negative pregnancy test within 72 hours before therapy.
- Participants able to cause pregnancy must use effective contraception during the study and for at least 6 months after last cemiplimab dose.
You will not qualify if you...
- Two or more prior systemic or investigational therapies for metastatic pancreatic ductal adenocarcinoma.
- Autoimmune disease requiring treatment within 12 months before enrollment.
- History of organ or bone marrow transplant.
- History of interstitial lung disease.
- Stroke or intracranial hemorrhage within 6 months before enrollment.
- Previous malignancy within past 3 years except in-situ or basal/squamous cell skin cancers.
- Any prior immune checkpoint inhibitor therapy.
- Known bleeding disorders such as hemophilia or von Willebrand's disease.
- Current use of warfarin or vitamin K antagonists (low molecular weight heparin or factor Xa inhibitors allowed).
- Current use of strong cytochrome P450 3A inhibitors.
- Known brain or central nervous system metastases.
- Other diseases or conditions that increase risk or affect study results, as judged by investigator.
- Life expectancy less than 3 months.
- Active uncontrolled HIV, hepatitis B or C, or immunodeficiency.
- Receipt of live vaccine within 4 weeks before study medication.
- Significant cardiovascular disease or recent heart events within 6 months.
- Major surgery requiring general anesthesia within 4 weeks before study treatment.
- Pregnancy or breastfeeding.
- Known allergy to cemiplimab, gemcitabine, or study components.
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of California, San Diego
La Jolla, California, United States, 92093
Actively Recruiting
Research Team
G
Gregory P Botta, MD, PhD
CONTACT
G
Gastrointestinal Research Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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