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Trial record 1 of 1 for:    NCT02923921
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Study of Pegilodecakin (LY3500518) With FOLFOX Compared to FOLFOX Alone Second-line Tx in Participants With Metastatic Pancreatic Cancer (Sequoia)

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ClinicalTrials.gov Identifier: NCT02923921
Recruitment Status : Active, not recruiting
First Posted : October 5, 2016
Last Update Posted : October 4, 2019
Sponsor:
Collaborator:
ARMO BioSciences
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE September 30, 2016
First Posted Date  ICMJE October 5, 2016
Last Update Posted Date October 4, 2019
Actual Study Start Date  ICMJE March 1, 2017
Actual Primary Completion Date September 9, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2019)
Overall Survival [ Time Frame: 36 months after the last participant randomized ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 3, 2016)
Overall Survival [ Time Frame: 36 months after the last patient randomized ]
Change History Complete list of historical versions of study NCT02923921 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2019)
  • Progression Free Survival [ Time Frame: 36 months after the last participant randomized ]
  • Objective Response Rate [ Time Frame: 36 months after the last participant randomized ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2016)
  • Progression Free Survival [ Time Frame: 36 months after the last patient randomized ]
  • Objective Response Rate [ Time Frame: 36 months after the last patient randomized ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Pegilodecakin (LY3500518) With FOLFOX Compared to FOLFOX Alone Second-line Tx in Participants With Metastatic Pancreatic Cancer
Official Title  ICMJE Randomized Study of AM0010 in Combination With FOLFOX Compared to FOLFOX Alone as Second-line Tx in Pts With Meta Pancreatic Cancer That Has Progressed During or Following a First-Line Gemcitabine Containing Regimen
Brief 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.
Detailed Description 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE
  • Biological: Pegilodecakin
    Pegilodecakin plus FOLFOX
    Other Names:
    • LY3500518
    • AM0010
  • Drug: FOLFOX
    FOLFOX Alone
    Other Names:
    • oxaliplatin
    • 5-FU
    • leucovorin
Study Arms  ICMJE
  • Experimental: ARM 1
    Pegilodecakin (5 μg/kg) dosed on Days 1-5 and Days 8-12 SQ plus FOLFOX (dl-LV 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5-FU 400 mg/m2 and a 46-hour infusion of 5-FU 2400 mg/m2) initiated on Day 1 of a 14-day cycles or until disease progression.
    Interventions:
    • Biological: Pegilodecakin
    • Drug: FOLFOX
  • Active Comparator: ARM 2
    FOLFOX (dl-LV 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5-FU 400 mg/m2 and a 46-hour infusion of 5-FU 2400 mg/m2) initiated on Day 1 of a 14-day cycles or until disease progression.
    Intervention: Drug: FOLFOX
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 3, 2016)
566
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2020
Actual Primary Completion Date September 9, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Canada,   France,   Germany,   Italy,   Korea, Republic of,   Poland,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries Ireland
 
Administrative Information
NCT Number  ICMJE NCT02923921
Other Study ID Numbers  ICMJE 17158
J1L-AM-JZGB ( Other Identifier: Eli Lilly and Company )
AM0010-301 ( Other Identifier: ARMO BioSciences )
2016-003858-33 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: http://www.clinicalstudydatarequest.com
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE ARMO BioSciences
Investigators  ICMJE
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date October 1, 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP