Phase 3
Completed N=567
Study of Pegilodecakin (LY3500518) With FOLFOX Compared to FOLFOX Alone Second-line Tx in Participants With Metastatic Pancreatic Cancer
Source: ClinicalTrials.gov NCT02923921 ↗Enrolled (actual)
567
Serious AEs
41.2%
Results posted
Oct 2020
Primary outcomePrimary: Overall Survival — 5.78; 6.28 Months — p=0.6565
◆ Published Evidence
Highly cited
110citations · ~22 / year
Randomized Phase III Study of FOLFOX Alone or With Pegilodecakin as Second-Line Therapy in Patients With Metastatic Pancreatic Cancer That Progressed After Gemcitabine (SEQUOIA).
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.
Linked Publications
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Randomized Phase III Study of FOLFOX Alone or With Pegilodecakin as Second-Line Therapy in Patients With Metastatic Pancreatic Cancer That Progressed After Gemcitabine (SEQUOIA).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
5.78; 6.28 | 0.6565 |
| SECONDARY Progression Free Survival |
2.14; 2.10 | 0.8144 |
| SECONDARY Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] That Assessed by Investigator |
4.6; 5.6 | 0.7044 |
| SECONDARY Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD): Disease Control Rate (DCR) |
42.8; 36.6 | 0.1463 |
| SECONDARY Duration of Response (DOR) |
4.99; 5.17 | 0.9952 |
| SECONDARY Percentage of Participants Alive at 1 Year (12-Month Survival Rate) |
14.7; 19.1 | 0.2298 |
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
Data sourced from ClinicalTrials.gov (NCT02923921) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.