Study of Pegilodecakin (LY3500518) With FOLFOX Compared to FOLFOX Alone Second-line Tx in Participants With Metastatic Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Pegilodecakin; FOLFOX
Intervention description: Pegilodecakin plus FOLFOX; FOLFOX Alone
Intervention MeSH terms: Leucovorin; Oxaliplatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 567.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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

Eligibility criteria:

        Inclusion Criteria:

          1. The presence of metastatic pancreatic adenocarcinoma

          2. Measurable disease per RECIST v.1.1

          3. Participant must have documented tumor progression during or following a gemcitabine
             containing regimen to treat metastatic disease as established by CT or MRI scan

          4. Eastern Cooperative Oncology Group Performance Status of 0 - 1

          5. Participant must have completed prior chemotherapy at least 2 weeks (washout period)
             prior to randomization and recovered from toxicity to Grade 1 or baseline

          6. Participants must not have received previous radiation therapy or investigational
             therapy for the treatment of advanced metastatic disease.

          7. Participants having received cytotoxic doses of gemcitabine or any other chemotherapy
             in the adjuvant setting are not eligible for this study

          8. No peripheral neuropathy

          9. No known history of dihydropyrimidine dehydrogenase deficiency

        Exclusion Criteria:

          1. Diagnosis of pancreatic islet neoplasm, acinar cell carcinoma, non- adenocarcinoma
             (i.e., lymphoma, sarcoma), adenocarcinoma originating from the biliary tree, or
             cystadenocarcinoma

          2. 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.

          3. Participant has received prior treatment with pegilodecakin or
             fluoropyrimidine/platinum containing regimen

          4. Participants who were intolerant of a gemcitabine containing regimen.

          5. History of positivity for human immunodeficiency virus

          6. Chronic active or active viral hepatitis A, B, or C infection

          7. Clinically significant bleeding within two weeks prior to randomization (e.g.,
             gastrointestinal (GI) bleeding, intracranial hemorrhage)

          8. Pregnant or lactating women

          9. Participants with a history of immune-mediated neurological disorders such as multiple
             sclerosis, Guillain-Barré or inflammatory CNS/PNS disorders

         10. Clinically significant ascites defined as requiring ≥ 1 paracentesis every 2- weeks

         11. 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

         12. Prior history of receiving immune modulators including, but not limited to,
             anti-CTLA4, anti-PD1, anti-PD-L1