Pegcetacoplan with modified FOLFIRINOX for metastatic pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase I/II trial combines pegcetacoplan, a drug that targets the immune complement pathway, with mFOLFIRINOX chemotherapy to treat newly diagnosed metastatic pancreatic ductal adenocarcinoma. Phase I focuses on safety and tolerability of the combination while phase II looks for early signs of clinical benefit such as response rates and survival. Patients receive an initial IV dose of pegcetacoplan then self-administer subcutaneous doses three times weekly alongside standard mFOLFIRINOX infusions, with optional on-treatment biopsies and serial blood draws for biomarker studies. Secondary and exploratory aims include monitoring thrombotic events, measuring circulating markers of NETs and endothelial injury, and assessing tumor immune changes in biopsy samples.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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
* Platelets ≥ 100,000/uL
* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
* Aspartate aminotransferase (AST)(serum oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 x institutional ULN or \<=5 ULN in the presence of liver metastasis
* Estimated creatinine clearance ≥ 60 mL/min (Cockcroft-Gault equation)
* Albumin ≥ 3 g/dL
* Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria present
* All patients must either have available archival tumor tissue or undergo new tumor biopsy (if presence of a lesion that can be safely biopsied) before treatment initiation for correlative studies
* Willing and able to self-administer pegcetacoplan (administration by caregiver will be allowed)
* Willing to receive vaccination against Neisseria meningitidis and Streptococcus pneumoniae if not already vaccinated
* Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately

  * Women of child-bearing potential taking part in this study should continue the use of birth control for 6 months after the last study treatment, and should not donate eggs during that timeframe
  * Male participants taking part in this study should continue the use of birth control for 3 months after the last study treatment, and should not donate sperm during that timeframe
* Participant must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

* 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
* Participants with known untreated brain metastases will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Patients with major arterial thromboembolism (ATE) (coronary, cerebral, extremity or splanchnic) or venous thromboembolism (VTE) (pulmonary embolism or deep venous thrombosis) within 6 months from initiation of study treatment are not eligible for participation
* Pregnant or nursing female participants
* Unwilling or unable to follow protocol requirements
* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug

Where it's running

• Roswell Park Cancer Institute
  Buffalo, New York, United States Recruiting

Study contacts

• Principal investigator: Christos Fountzilas — Roswell Park Cancer Institute
• Study coordinator: Sarah Chatley, BS
• Email: Sarah.Chatley@roswellpark.org
• Phone: 716-845-4846

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.