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

• Status: Completed
• Trial end date: 2020-03-05
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ARMO BioSciences; Eli Lilly and Company
• Collaborator: ARMO BioSciences
• Treatments: Leucovorin; Oxaliplatin

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