SWI/SNF complex alterations as a biomarker of immunotherapy efficacy in pancreatic cancer.
Gregory P Botta, Shumei Kato, Hitendra Patel...
https://pubmed.ncbi.nlm.nih.gov/34375311Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID06790602
A Single-arm, Open-label, Phase II Trial of Cemiplimab Plus Gemcitabine as Second-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma Harboring SWItch/Sucrose Non-Fermentable (SWI/SNF) Alterations
Led by University of California, San Diego · Updated on 2026-06-08
43
Participants Needed
1
Research Sites
74 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
Researchers are studying metastatic pancreatic ductal adenocarcinoma (mPDAC) in patients with specific genetic changes called SWI/SNF 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 gemcitabine/nab-paclitaxel) but need better treatment options due to limited responses or intolerance to prior therapies. Participants receive cemiplimab intravenously at a dose of 3 mg/kg every two weeks and gemcitabine intravenously at 1000 mg/m² 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.
CONDITIONS
Brief Title
Cemiplimab Plus Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- At least 18 years of age.
- Ability to understand the study, comply with procedures, and provide written informed consent.
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma with metastatic disease.
- Stage IV disease with measurable tumors.
- Presence of SWI/SNF gene alterations detected by next generation sequencing.
- One previous line of chemotherapy for pancreatic ductal adenocarcinoma (not immunotherapy).
- Last chemotherapy dose more than 14 days before starting study treatment.
- Last radiation therapy dose more than 28 days before starting study treatment.
- Eastern Cooperative Oncology Group performance score of 0 or 1.
- Adequate bone marrow, liver, and kidney function as specified.
- Corrected QT interval less than 470 milliseconds.
- Participants not able to have children or agreeing to use contraception during and 6 months after treatment.
- Negative pregnancy test within 72 hours before starting treatment if applicable.
You will not qualify if you...
- More than one previous systemic or investigational therapy for metastatic pancreatic ductal adenocarcinoma.
- Autoimmune disease treated within the past 12 months.
- History of organ or bone marrow transplant.
- History of interstitial lung disease.
- Stroke or brain hemorrhage within 6 months prior to enrollment.
- Previous malignancy within 3 years except certain skin cancers or in-situ cancers.
- Prior immune checkpoint inhibitor therapy.
- Known bleeding disorders.
- Current use of warfarin or vitamin K antagonists.
- Current use of strong cytochrome P450 3A inhibitors.
- Known brain or central nervous system metastases.
- Any condition that places the participant at high risk or affects study results per investigator judgment.
- Life expectancy less than 3 months.
- Active uncontrolled HIV, hepatitis B or C infection, or immunodeficiency.
- Receipt of live vaccine within 4 weeks before starting study treatment.
- Significant cardiovascular disease or recent major heart events.
- Major surgery within 4 weeks before starting treatment.
- Pregnancy or breastfeeding.
- Known allergy to cemiplimab, gemcitabine, or study components.
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Until disease progression or discontinuation
Participants receive cemiplimab plus gemcitabine intravenously until disease progression or discontinuation for other reasons.
Cemiplimab every 2 weeks and gemcitabine on days 1, 8, and 15 of each 28-day cycle
Trial Site Locations
Total: 1 location
1
University of California, San Diego
La Jolla, California, United States, 92093
Actively Recruiting
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Research Team
G
Gregory P Botta, MD, PhD
G
Gastrointestinal Research Team
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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