Pegcetacoplan + Chemotherapy for Pancreatic Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment combination for individuals with pancreatic cancer that has spread. It combines pegcetacoplan, which boosts the immune system's ability to fight cancer, with a chemotherapy mix called mFOLFIRINOX. The trial aims to determine if this combination can safely and effectively treat pancreatic cancer and prevent dangerous blood clots. Individuals with confirmed metastatic pancreatic cancer, who have not received prior chemotherapy for it and can manage self-injections, might be suitable for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to get a clear answer.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that pegcetacoplan has been well-tolerated in various conditions. In one study with adults, no new safety issues emerged over three years. Serious side effects occurred in about 55% of patients, but only 4.5% were linked to pegcetacoplan itself.
When combined with mFOLFIRINOX for treating pancreatic cancer, this treatment aims to enhance the immune system's ability to fight cancer and reduce the risk of blood clots, which are common in pancreatic cancer patients. While specific safety data for this combination in pancreatic cancer is not detailed, the previous safety record of pegcetacoplan offers some reassurance. As this trial is in its early stages, monitoring for any side effects is crucial. Researchers will closely observe participants to ensure the treatment's safety.12345Why are researchers excited about this trial's treatments?
Unlike the standard chemotherapy options for pancreatic cancer, such as gemcitabine and nab-paclitaxel, pegcetacoplan offers a unique approach by targeting the complement system, which is part of the immune system. This treatment is combined with mFOLFIRINOX, a powerful chemotherapy regimen, to potentially enhance its effectiveness. Researchers are excited about pegcetacoplan because its mechanism could improve the immune response against cancer cells, offering hope for better outcomes in a notoriously difficult-to-treat cancer.
What evidence suggests that this trial's treatments could be effective for pancreatic cancer?
In this trial, participants will receive a combination treatment of pegcetacoplan with mFOLFIRINOX chemotherapy. Research has shown that pegcetacoplan targets a part of the immune system that might help stop tumor growth. Studies have found that this immune system component can cause issues in pancreatic cancer. Pegcetacoplan has shown promise in other conditions by improving blood health, suggesting it might help prevent blood clots—a major risk in pancreatic cancer. Although data on pegcetacoplan specifically for pancreatic cancer is limited, its mechanism offers hope for effectiveness.16789
Who Is on the Research Team?
Christos Fountzilas
Principal Investigator
Roswell Park Cancer Institute
Are You a Good Fit for This Trial?
This trial is for patients with metastatic pancreatic ductal adenocarcinoma (PDAC). Participants should have PDAC that has spread from its original site. Specific eligibility criteria are not provided, but typically include factors like age, health status, and previous treatments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pegcetacoplan in combination with mFOLFIRINOX. Pegcetacoplan is administered intravenously on day 1 of cycle 1 and subcutaneously thrice weekly. mFOLFIRINOX is administered intravenously on day 1 of each cycle. Cycles repeat every 14 days for up to 8 cycles.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion. Follow-up occurs at 30 days post-treatment and then every 3 months for up to 3 years.
What Are the Treatments Tested in This Trial?
Interventions
- Fluorouracil
- Irinotecan
- Oxaliplatin
- Pegcetacoplan
Trial Overview
The trial tests pegcetacoplan combined with mFOLFIRINOX chemotherapy (oxaliplatin, irinotecan, leucovorin, fluorouracil) in treating metastatic PDAC. It aims to see if this combination can limit tumor growth and improve immune response against cancer cells while also reducing blood clot risks.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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 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 CT or MRI throughout the study. Additionally, patients may undergo tumor biopsy throughout the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Roswell Park Cancer Institute
Lead Sponsor
Citations
Study Details | NCT07214298 | Pegcetacoplan in ...
This phase I/II trial tests the effect of pegcetacoplan in combination with oxaliplatin, irinotecan, leucovorin, and fluorouracil (mFOLFIRINOX) ...
Complement pathway activation mediates pancreatic cancer ...
These studies demonstrate that complement activation contributes to the skeletal muscle pathology and dysfunction in PDAC.
3.
onclive.com
onclive.com/view/pegcetacoplan-outperforms-current-standard-of-care-in-paroxysmal-nocturnal-hemoglobinuriaPegcetacoplan Outperforms Current Standard of Care in ...
Regarding the secondary end points, transfusion avoidance was achieved in 85% of patients (n = 35) with pegcetacoplan versus 15% of patients (n ...
Treatment with Gemcitabine (Gemzar) for Six Months After ...
Response data were reported for 23 patients. There were five partial responses (22%), four confirmed partial responses (17%), 13 patients with stable disease ( ...
Empaveli (pegcetacoplan SC) / Apellis, SOBI
Delicious. October 20, 2025. New One-Year Data Reinforcing the Robust and Sustained Efficacy of EMPAVELI (pegcetacoplan) in C3G and Primary IC-MPGN to be ...
Safety and Efficacy of Pegcetacoplan in Adult Patients with ...
Conclusion: Pegcetacoplan sustained long-term improvements in hemoglobin concentrations, fatigue reduction, and transfusion burden. Long-term ...
215014Orig1s000 - accessdata.fda.gov
should include an integrated safety dataset and patient level data including data on pegcetacoplan dosing, meningococcal and pneumococcal vaccination status ...
Efficacy and Safety Maintained up to 3 Years in Adults with ...
No new safety concerns were identified over 3 years. Serious adverse events were reported in 73 (55.3%) patients, deemed pegcetacoplan related in 6 (4.5%) ...
9.
sfj-pharma.com
sfj-pharma.com/apellis-reports-positive-top-line-results-from-phase-3-head-to-head-study-of-pegcetacoplan-apl-2-2/Apellis Reports Positive Top-line Results from Phase 3 ...
Top-line data show that pegcetacoplan met the study's primary efficacy endpoint, demonstrating superiority to eculizumab with a statistically significant ...
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