Actively Recruiting
A Phase I/II Study of Complement Inhibition with Pegcetacoplan Combined with Modified FOLFIRINOX for Metastatic Pancreatic Ductal Adenocarcinoma
Led by Roswell Park Cancer Institute · Updated on 2026-06-08
35
Participants Needed
1
Research Sites
32 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of pegcetacoplan with modified FOLFIRINOX chemotherapy to treat patients with metastatic pancreatic ductal adenocarcinoma (PDAC), a type of pancreatic cancer that has spread to other parts of the body. This phase I/II trial aims to assess the safety and preliminary effectiveness of this combination treatment. The study also investigates whether pegcetacoplan can reduce the risk of serious blood clots, which are common complications in PDAC patients and may cause life-threatening events such as strokes or heart attacks. Participants receive pegcetacoplan intravenously during the first cycle and prior to chemotherapy, then self-administer it subcutaneously three times a week. The chemotherapy regimen includes oxaliplatin, irinotecan, leucovorin, and fluorouracil given intravenously on day 1 of each 14-day cycle for up to 8 cycles, unless the disease progresses or side effects become unacceptable. Throughout the treatment, patients may undergo optional tumor biopsies and fluid or blood sample collections, as well as imaging scans like CT or MRI to monitor disease status. After completing treatment, participants are followed up 30 days later and then every 3 months for up to 3 years. The study tracks safety by monitoring treatment-related side effects and evaluates clinical outcomes such as progression-free survival and overall response. Researchers also explore the effects of treatment on blood clot events, immune system markers, and tumor environments to better understand how the therapy works and its potential benefits for patients with metastatic PDAC.
CONDITIONS
Brief 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 at least 1,500/uL
- Platelet count of at least 100,000/uL
- Total bilirubin less than or equal to 1.5 times the institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels less than or equal to 3 times the institutional ULN
- Estimated creatinine clearance of at least 60 mL/min
- Albumin level of at least 3 g/dL
- Measurable disease according to RECIST 1.1 criteria
- Available archival tumor tissue or willingness to undergo new tumor biopsy before treatment
- Ability and willingness to self-administer pegcetacoplan (caregiver administration allowed)
- Willingness to receive vaccinations against Neisseria meningitidis and Streptococcus pneumoniae if not already vaccinated
- Use of adequate contraception for participants of child-bearing potential during and after the study
- Understanding of the investigational nature of the study and signing informed consent
You will not qualify if you...
- Previous chemotherapy for pancreatic ductal adenocarcinoma, except gemcitabine-based therapy completed at least 6 months prior to metastatic disease
- 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 unless adequately palliated within 6 weeks
- Known untreated brain metastases
- Uncontrolled illnesses such as active infection, symptomatic heart failure, unstable angina, arrhythmias, or psychiatric illness affecting compliance
- Major arterial or venous thromboembolism within 6 months prior to study treatment
- Pregnant or nursing females
- Unwillingness or inability to follow protocol requirements
- Any condition deemed by the investigator as unsuitable for study drug administration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Up to approximately 4 months (8 cycles of 14 days each)
Participants receive pegcetacoplan intravenously and subcutaneously combined with modified FOLFIRINOX chemotherapy every 14 days for up to 8 cycles, unless disease progresses or toxicity occurs. They may also undergo tumor biopsies, ascites or pleural fluid and blood sample collections, and imaging scans throughout treatment.
Office visits every 14 days for treatment; self-administered subcutaneous pegcetacoplan thrice weekly
Duration - Up to 3 years
After completing treatment, participants are followed up to monitor health and disease status with visits at 30 days post-treatment and then every 3 months for up to 3 years.
Visits at 30 days post-treatment, then every 3 months
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
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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