Actively Recruiting
Pegcetacoplan in Combination With Modified FOLFIRINOX for the Treatment of Metastatic Pancreatic Ductal Adenocarcinoma
Led by Roswell Park Cancer Institute · Updated on 2026-04-30
35
Participants Needed
1
Research Sites
136 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase I/II trial tests the effect of pegcetacoplan in combination with oxaliplatin, irinotecan, leucovorin, and fluorouracil (mFOLFIRINOX) in treating patients with pancreatic ductal adenocarcinoma (PDAC) that has spread from where it first started (primary site) to other places in the body (metastatic). Pegcetacoplan works by targeting the immune complement process, a part of the immune system that defends against bacteria and may limit tumor progression and improve the immune system's response against tumor cells. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's deoxyribonucleic acid (DNA) and may kill tumor cells. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. Leucovorin is a drug used to lessen the toxic effects of substances that block the action of folic acid. Leucovorin is a form of folic acid. It is a type of chemoprotective agent and a type of chemosensitizing agent. Fluorouracil stops cells from making DNA and it may kill tumor cells. It is a type of antimetabolite. Giving pegcetacoplan in combination with mFOLFIRINOX may be safe, tolerable, and/or effecting in treating patients with metastatic PDAC. This trial also evaluates the effect of pegcetacoplan on the incidence of major thrombotic events and the resulting complications. Thrombosis is a common complication in patients with PDAC. Thrombosis occurs when blood clots block veins or arteries. Complications of thrombosis, such as stroke or heart attack, can be life-threatening. Giving pegcetacoplan may help prevent blood clots from forming and decrease the risk of major thrombotic events.
CONDITIONS
Official Title
Pegcetacoplan in Combination With Modified FOLFIRINOX for the Treatment of Metastatic Pancreatic Ductal Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Absolute neutrophil count of 1,500/uL or higher
- Platelet count of 100,000/uL or higher
- Total bilirubin less than or equal to 1.5 times the institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3 times the institutional ULN
- Estimated creatinine clearance of 60 mL/min or higher (Cockcroft-Gault equation)
- Albumin level of 3 g/dL or higher
- Measurable disease according to RECIST 1.1 criteria
- Available archival tumor tissue or willingness to undergo new tumor biopsy if safe before treatment
- Willing and able to self-administer pegcetacoplan or have a caregiver assist
- Willing to receive vaccination against Neisseria meningitidis and Streptococcus pneumoniae if not already vaccinated
- Women of child-bearing potential must use adequate contraception before and for 6 months after treatment; men must use contraception for 3 months after treatment
- Able to understand the investigational nature of the study and provide written informed consent
You will not qualify if you...
- Previous chemotherapy for pancreatic ductal adenocarcinoma, except gemcitabine-based therapy completed at least 6 months before metastatic disease diagnosis
- Toxicities from prior treatment greater than grade 1 except alopecia and fatigue
- Refractory ascites or pleural effusion requiring frequent drainage or indwelling catheter
- Untreated bowel or gastric outlet obstruction, except if adequately palliated within 6 weeks
- Known untreated brain metastases
- Uncontrolled illnesses such as active infection, symptomatic heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social issues limiting compliance
- Major arterial or venous thromboembolism within 6 months before starting study treatment
- Pregnant or nursing women
- Unwilling or unable to follow study protocol
- Any condition deemed by the investigator to make the participant unsuitable for study drug treatment
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
Research Team
S
Sarah Chatley, BS
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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