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

Status: Active

Description

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

  • 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

Exclusion Criteria

  • 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

Locations & Contacts

Arizona

Tucson
Banner University Medical Center - Tucson
Status: Active
Name Not Available

California

Los Angeles
Translational Oncology Research International
Status: Active
Contact: Sa-Heim Davis
Phone: 310-825-4494
Email: sjdavis@mednet.ucla.edu
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Name Not Available
USC / Norris Comprehensive Cancer Center
Status: Active
Contact: Raluca Dana Agafitei
Phone: 323-865-0467
Email: agafitei@med.usc.edu

District of Columbia

Washington
MedStar Georgetown University Hospital
Status: Active
Name Not Available

Maryland

Towson
UM Saint Joseph Medical Center
Status: Active
Name Not Available

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: Active
Name Not Available
Brigham and Women's Hospital
Status: Active
Name Not Available
Dana-Farber Cancer Institute
Status: Active
Name Not Available

North Carolina

Durham
Duke University Medical Center
Status: Active
Name Not Available

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Name Not Available

Oregon

Portland
OHSU Knight Cancer Institute
Status: Active
Name Not Available

Pennsylvania

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Name Not Available

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: Active
Name Not Available

Trial Objectives and Outline

This is an open-label, multi-center, randomized, Phase 3 study designed to compare the efficacy and safety of pegilodecakin in combination with FOLFOX versus FOLFOX alone in participants with metastatic adenocarcinoma of the pancreas who have progressed on one prior gemcitabine containing regimen.

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Treatment

Lead Organization

Lead Organization
Eli Lilly and Company

Trial IDs

Primary ID 17158
Secondary IDs NCI-2017-00276, 2016-003858-33, J1L-AM-JZGB, AM0010-301
Clinicaltrials.gov ID NCT02923921