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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

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Biological: Pegilodecakin Drug: FOLFOX Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 566 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : September 9, 2019
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Biological: Pegilodecakin
Pegilodecakin plus FOLFOX
Other Names:
  • LY3500518
  • AM0010

Drug: FOLFOX
FOLFOX Alone
Other Names:
  • oxaliplatin
  • 5-FU
  • leucovorin

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.
Drug: FOLFOX
FOLFOX Alone
Other Names:
  • oxaliplatin
  • 5-FU
  • leucovorin




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 36 months after the last participant randomized ]

Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 36 months after the last participant randomized ]
  2. Objective Response Rate [ Time Frame: 36 months after the last participant randomized ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02923921


  Show 130 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
ARMO BioSciences
Investigators
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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

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02923921     History of Changes
Other Study ID Numbers: 17158
J1L-AM-JZGB ( Other Identifier: Eli Lilly and Company )
AM0010-301 ( Other Identifier: ARMO BioSciences )
2016-003858-33 ( EudraCT Number )
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 1, 2019
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Oxaliplatin
Antineoplastic Agents