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.
Histologically or cytologically confirmed metastatic PDAC
Age ≥ 18 years of age
Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
Absolute neutrophil count ≥ 1,500/uL
Previous chemotherapy for PDAC. Gemcitabine-based post- or pre-operative therapy is allowed provided that the last dose and or surgical resection was at least 6 months prior to the documentation of metastatic disease, whichever occurred last
Toxicities from prior treatment grade > 1 with the exemption of alopecia and fatigue
Refractory ascites or pleural effusion (requiring para- or thoracentesis weekly or more frequently or use of indwelling catheter for palliation)
Untreated bowel or gastric outlet obstruction; patients with ≤ 6 weeks from such an event who are adequately palliated are allowed to participate
Single group
Biopsy Procedure
Procedure/SurgeryUndergo tumor biopsy
Biospecimen Collection
Procedure/SurgeryUndergo ascites, pleural fluid and blood sample collection
Computed Tomography
Procedure/SurgeryUndergo CT
Fluorouracil
DrugGiven IV
Irinotecan
DrugGiven IV
Leucovorin Calcium
DrugGiven IV
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Oxaliplatin
DrugGiven IV
Pegcetacoplan
DrugGiven IV and SC
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.
Progression-free survival (Phase II)
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.
Overall survival
Will be summarized using Kaplan-Meier estimator.
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.
Incidence of arterial thromboembolism/venous thromboembolism
The occurrence will be summarized as proportions and 90% Clopper-Pearson confidence intervals.
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