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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02923921
Registration number
NCT02923921
Ethics application status
Date submitted
30/09/2016
Date registered
5/10/2016
Date last updated
19/10/2020
Titles & IDs
Public title
Study of Pegilodecakin (LY3500518) With FOLFOX Compared to FOLFOX Alone Second-line Tx in Participants With Metastatic Pancreatic Cancer
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Scientific title
Randomized Study of AM0010 in Combination With FOLFOX Compared to FOLFOX Alone as Second-line Tx in Pts With Metastatic Pancreatic Cancer That Has Progressed During or Following a First-Line Gemcitabine Containing Regimen
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Secondary ID [1]
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J1L-AM-JZGB
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Secondary ID [2]
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17158
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Universal Trial Number (UTN)
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Trial acronym
Sequoia
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pancreatic Cancer
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Condition category
Condition code
Cancer
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Pancreatic
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Pegilodecakin
Treatment: Drugs - FOLFOX
Experimental: Pegilodecakin + FOLFOX - Pegilodecakin 5 microgram per kilogram (µg/kg) dosed as one of the following 2 fixed doses: 0.4 milligram (mg) for participants weighing =80 kg or 0.8 mg for participants weighing>80 kg on Days 1-5 and Days 8-12 subcutaneously (SC) plus FOLFOX [dl-Leucovorin (dl-LV) 400 milligram per meter square (mg/m2) and oxaliplatin 85 mg/m2 followed by bolus 5-fluorouracil (5-FU) 400 mg/m2 and a 46 to 48 hour infusion of 5- FU 2400 mg/m2] initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression. After discontinuation of FOLFOX in the absence of tumor progression [that is (i.e., completion of the planned 12 cycles or unacceptable FOLFOX related toxicity], Pegilodecakin 10µg/kg maintenance treatment administered as one of the 2 fixed doses, either 0.8 mg for participants weighing =80 kg or 1.6 mg for participants weighing>80 kg.
Active Comparator: FOLFOX - 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 for up to 12 cycles or until disease progression.
Other interventions: Pegilodecakin
Pegilodecakin plus FOLFOX
Treatment: Drugs: FOLFOX
FOLFOX Alone
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival
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Assessment method [1]
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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.
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Timepoint [1]
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Randomization to date of death from any cause (Up To 30 Months)
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Secondary outcome [1]
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Progression Free Survival
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Assessment method [1]
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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.
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Timepoint [1]
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Randomization to Progressive Disease (PD) or Date of Death (Up To 30 Months)
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Secondary outcome [2]
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Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] That Assessed by Investigator
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Assessment method [2]
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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.
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Timepoint [2]
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Randomization to PD (Up To 30 Months)
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Secondary outcome [3]
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Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD): Disease Control Rate (DCR)
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Assessment method [3]
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Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. 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 LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. 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.
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Timepoint [3]
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Randomization to Objective Progressive Disease or Start of New Anti-Cancer Therapy (Up To 30 Months)
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Secondary outcome [4]
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Duration of Response (DOR)
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Assessment method [4]
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DOR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR were defined using the 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 LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date. 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.
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Timepoint [4]
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Randomization to Progressive Disease (PD) or Date of Death (Up To 30 Months)
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Secondary outcome [5]
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Percentage of Participants Alive at 1 Year (12-Month Survival Rate)
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Assessment method [5]
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The 12-month survival rate is defined as the percentage of participants who have not died 12 months after the date of randomization.
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Timepoint [5]
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From randomization to until the date of first documented date of death from any cause within 12 months
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Phase
Phase 3
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
5/03/2020
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Sample size
Target
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Accrual to date
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Final
567
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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St Vincent's Hospital - Sydney
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Warringal Private Hospital - Heidelberg
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Cabrini Hospital Malvern - Malvern
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St John of God Murdoch Hospital - Murdoch
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2010 - Sydney
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3084 - Heidelberg
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3144 - Malvern
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6150 - Murdoch
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Surrey
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Eli Lilly and Company
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Address
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ARMO BioSciences
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02923921
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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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)
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Eli Lilly and Company
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02923921
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