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2026-03-01
2027-10-01
2028-10-01
35
NCT07214298
Roswell Park Cancer Institute
Roswell Park Cancer Institute
INTERVENTIONAL
Pegcetacoplan in Combination With Modified FOLFIRINOX for the Treatment of Metastatic Pancreatic Ductal Adenocarcinoma
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.
PRIMARY OBJECTIVES: I. To determine the safety oxaliplatin, irinotecan, leucovorin calcium (leucovorin), and fluorouracil (mFOLFIRINOX) in combination with pegcetacoplan in patients with newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC). (Phase I) II. To identify preliminary signals of clinical efficacy of the study treatment. (Phase II) SECONDARY OBJECTIVES: I. To evaluate the incidence of major thrombotic events and complications. II. To evaluate the efficacy (overall response rate, overall survival, disease control rate) of the combination treatment in the study population. EXPLORATORY OBJECTIVES: I. To evaluate the effect of therapy on circulating biomarkers of neutrophil extracellular traps (NETs), endothelial cell injury, and cytokine responses. II. For patients who agree to an optional on-treatment biopsy, the effects of therapy on innate and lymphocyte responses in the tumor microenvironment (TME) will be assessed. III. To assess the ability of the combination to control or prevent malignant effusions (pleural or ascites fluid). IV. To evaluate the pegcetacoplan levels in peripheral blood and other biological specimens. OUTLINE: Patients receive pegcetacoplan intravenously (IV) over 30 minutes on day 1 of cycle 1 and prior to mFOLFIRINOX and self-administered subcutaneously (SC) thrice weekly (every 2 days), when due on days in the office it will be given IV over 30 minutes prior to mFOLFIRINOX. Patients receive oxaliplatin IV over 2 hours, irinotecan and leucovorin IV concurrently over 90 minutes, and fluorouracil IV over 48 hours on day 1 of each cycle. Cycles repeat every 14 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo ascites, pleural fluid (if present) and blood sample collection and computed tomography (CT) or magnetic resonance imaging (MRI) throughout the study. Additionally, patients may undergo tumor biopsy throughout the study. After completion of study treatment, patients are followed up at 30 days then every 3 months for up to 3 years.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2025-10-06 | N/A | 2025-10-06 |
2025-10-06 | N/A | 2026-02-06 |
2025-10-09 | N/A | 2026-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Treatment (pegcetacoplan, mFOLFIRINOX) Patients receive pegcetacoplan IV over 30 minutes on day 1 of cycle 1 and prior to mFOLFIRINOX and self-administered SC thrice weekly (every 2 days), when due on days in the office it will be given IV over 30 minutes prior to mFOLFIRINOX. Patients receive | PROCEDURE: Biopsy Procedure
PROCEDURE: Biospecimen Collection
PROCEDURE: Computed Tomography
DRUG: Fluorouracil
DRUG: Irinotecan
DRUG: Leucovorin Calcium
PROCEDURE: Magnetic Resonance Imaging
DRUG: Oxaliplatin
DRUG: Pegcetacoplan
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Incidence of treatment-related adverse events (AE) (Phase I) | Will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 criteria. Will be defined as any grade 3 or higher AE possibly, or definitely related to pegcetacoplan only. Will be summarized as the proportion of evaluable patients with 95% Clopper-Pearson confidence interval. | Up to 30 days after last dose of study treatment |
| Progression-free survival (Phase II) | From treatment initiation until disease progression, death or last disease assessment, assessed at 24 weeks |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | Will be defined as the percentage of patients who have achieved a partial response (PR) or complete response (CR) to the study therapy. The ORR will be summarized as proportions and 90% Clopper-Pearson confidence intervals. | Up to 3 years |
| Overall survival | Will be summarized using Kaplan-Meier estimator. | From treatment until death or last follow-up, assessed up to 3 years |
| Disease control rate (DCR) | Will be defined as the percentage of patients who have achieved CR, PR, or stable disease. The DCR will be summarized as proportions and 90% Clopper-Pearson confidence intervals. | Up to 3 years |
| Incidence of arterial thromboembolism/venous thromboembolism | The occurrence will be summarized as proportions and 90% Clopper-Pearson confidence intervals. | While on study treatment, assessed up to 3 years |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Sarah Chatley, BS Phone Number: 716-845-4846 Email: Sarah.Chatley@roswellpark.org |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
