Study of Pegilodecakin (LY3500518) With FOLFOX Compared to FOLFOX Alone Second-line Tx in Participants With Metastatic Pancreatic Cancer

Completed · Phase 3

Conditions studied: Pancreatic Cancer

In brief

To compare the efficacy of pegilodecakin in combination with FOLFOX versus FOLFOX alone in participants with metastatic pancreatic cancer as measured by overall survival.

Key facts

Study ID

NCT02923921

Run by

Eli Lilly and Company

People needed

567

Starts

2017-03-01

Expected to finish

2020-03-05

Last updated by the study team

2020-10-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The presence of metastatic pancreatic adenocarcinoma
• Measurable disease per RECIST v.1.1
• Participant must have documented tumor progression during or following a gemcitabine containing regimen to treat metastatic disease as established by CT or MRI scan
• Eastern Cooperative Oncology Group Performance Status of 0 - 1
• Participant must have completed prior chemotherapy at least 2 weeks (washout period) prior to randomization and recovered from toxicity to Grade 1 or baseline
• Participants must not have received previous radiation therapy or investigational therapy for the treatment of advanced metastatic disease.
• Participants having received cytotoxic doses of gemcitabine or any other chemotherapy in the adjuvant setting are not eligible for this study
• No peripheral neuropathy
• No known history of dihydropyrimidine dehydrogenase deficiency

You may not qualify if…

• Diagnosis of pancreatic islet neoplasm, acinar cell carcinoma, non- adenocarcinoma (i.e., lymphoma, sarcoma), adenocarcinoma originating from the biliary tree, or cystadenocarcinoma
• Participant on Coumadin and not willing to change to LMWH or oral Factor II or Xa inhibitor with half-life of less than 24 hours.
• Participant has received prior treatment with pegilodecakin or fluoropyrimidine/platinum containing regimen
• Participants who were intolerant of a gemcitabine containing regimen.
• History of positivity for human immunodeficiency virus
• Chronic active or active viral hepatitis A, B, or C infection
• Clinically significant bleeding within two weeks prior to randomization (e.g., gastrointestinal (GI) bleeding, intracranial hemorrhage)
• Pregnant or lactating women
• Participants with a history of immune-mediated neurological disorders such as multiple sclerosis, Guillain-Barré or inflammatory CNS/PNS disorders
• Clinically significant ascites defined as requiring ≥ 1 paracentesis every 2- weeks
• Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e., larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy),within 28 days prior to randomization or anticipated surgery during the study period
• Prior history of receiving immune modulators including, but not limited to, anti-CTLA4, anti-PD1, anti-PD-L1

Where it is running

• Cancer Treatment Centers of America — Goodyear, Arizona, United States
• University of Arizona Cancer Center — Phoenix, Arizona, United States
• Comprehensive Blood and Cancer Center — Bakersfield, California, United States
• St. Joseph Heritage Healthcare — Fullerton, California, United States
• USC Norris Cancer Hospital — Los Angeles, California, United States
• TRIO - Translational Research in Oncology-US, Inc. — Los Angeles, California, United States
• UCLA Medical Center — Los Angeles, California, United States
• Cancer Care Associates Medical Group — Redondo Beach, California, United States
• Central Coast Medical Oncology Corporation — Santa Maria, California, United States
• Rocky Mountain Cancer Center — Denver, Colorado, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• Lynn Cancer Institute Ctr for Hem-Onc — Boca Raton, Florida, United States
• Memorial Regional Hospital/Joe Dimaggio Childrens Hospital — Hollywood, Florida, United States
• Baptist Cancer Institute — Jacksonville, Florida, United States
• Watson Clinic — Lakeland, Florida, United States
• Florida Hospital Cancer Institute — Orlando, Florida, United States
• UF Health Cancer Center- Orlando Health — Orlando, Florida, United States
• Northeast Georgia Cancer Care, LLC — Athens, Georgia, United States
• Southeastern Regional Medical Center — Newnan, Georgia, United States
• Saint Alphonsus Regional Medical Center — Caldwell, Idaho, United States
• Decatur Memorial Hospital — Decatur, Illinois, United States
• Fort Wayne Oncology & Hematology — Fort Wayne, Indiana, United States
• St. Elizabeth Medical Center — Edgewood, Kentucky, United States
• Norton Cancer Institute — Louisville, Kentucky, United States
• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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