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

Eli Lilly and Company567 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

567

Conditions

Pancreatic Cancer

Interventions

PegilodecakinBIOLOGICAL

Pegilodecakin plus FOLFOX

FOLFOXDRUG

FOLFOX Alone

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (130)

Outcomes

Primary Outcomes

Overall Survival

Overall survival is defined as the time from date of randomization to the date of death (due to any cause). For participants whose last known status is alive at the data cutoff date for the analysis, time will be censored as the last contact date prior to the data cutoff date.

Time frame: Randomization to date of death from any cause (Up To 30 Months)

Secondary Outcomes

Progression Free Survival

PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant did not have a complete baseline disease assessment, then PFS was censored at the enrollment date, regardless whether or not objectively determined PD or death had been observed for the participant.

Time frame: Randomization to Progressive Disease (PD) or Date of Death (Up To 30 Months)

Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] That Assessed by Investigator

ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. Participants who discontinued study treatment (for reasons other than progression) before entering concurrent phase were considered to have non-evaluable response.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

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

...and 120 more locations