Study on Pegcetacoplan with Chemotherapy for Treating Advanced Pancreatic Cancer

Sponsor: Roswell Park Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT07214298

Provider View

This clinical trial is testing a new treatment combining pegcetacoplan with chemotherapy drugs to see if it can help treat pancreatic cancer that has spread to other parts of the body. The study aims to find out if this combination is safe and effective in reducing tumors and preventing blood clots.

Patient Parameters

Program Overview

This study is exploring a new treatment for pancreatic cancer that has spread beyond its original site. The treatment combines pegcetacoplan, which targets the immune system, with a chemotherapy regimen called mFOLFIRINOX. The goal is to see if this combination can safely and effectively shrink tumors and reduce the risk of blood clots, which are common in pancreatic cancer patients. Participants will receive the treatment over several cycles and undergo various tests to monitor their health and the treatment's effects.

Description

The main goals of this study are to determine if the combination of pegcetacoplan with chemotherapy drugs (oxaliplatin, irinotecan, leucovorin, and fluorouracil) is safe for patients with advanced pancreatic cancer and to see if it can effectively reduce tumors. The study will also look at how well the treatment prevents blood clots, which can lead to serious complications like strokes or heart attacks.

Participants will receive pegcetacoplan through an IV and as a self-administered injection, along with chemotherapy every two weeks for up to eight cycles. Throughout the study, patients will have regular scans and tests to check the cancer's response to the treatment and to monitor for any side effects. After completing the treatment, patients will have follow-up visits for up to three years to track their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with metastatic pancreatic cancer confirmed by lab tests.
  • Aged 18 years or older.
  • In good overall health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate blood cell counts and organ function, including:
    • Neutrophil count of at least 1,500/uL.
    • Platelet count of at least 100,000/uL.
    • Total bilirubin level within 1.5 times the normal limit.
    • Liver enzymes (AST/ALT) within 3 times the normal limit.
    • Kidney function with creatinine clearance of at least 60 mL/min.
    • Albumin level of at least 3 g/dL.
  • Have measurable cancer according to standard criteria.
  • Provide a tumor sample for research purposes.
  • Willing and able to self-administer pegcetacoplan or have a caregiver assist.
  • Agree to receive vaccinations against certain infections if not already vaccinated.
  • Use effective birth control during the study and for a specified time after treatment.
  • Understand the study and agree to sign informed consent.

Exclusion Criteria

  • Have received previous chemotherapy for pancreatic cancer, except under specific conditions.
  • Have severe side effects from prior treatments, except for hair loss and fatigue.
  • Have uncontrolled fluid buildup in the abdomen or chest.
  • Have untreated blockages in the bowel or stomach.
  • Have untreated brain metastases.
  • Have serious uncontrolled illnesses, such as heart failure or infections.
  • Have had major blood clots within six months before starting the study.
  • Are pregnant or breastfeeding.
  • Are unable or unwilling to follow the study requirements.
  • Have any condition that makes participation unsafe according to the study doctor.

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