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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT02923921
Collaborator
ARMO BioSciences (Industry)
567
Enrollment
130
Locations
2
Arms
36.1
Actual Duration (Months)
4.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
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.

Study Design

Study Type:
Interventional
Actual Enrollment :
567 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 Metastatic Pancreatic Cancer That Has Progressed During or Following a First-Line Gemcitabine Containing Regimen
Actual Study Start Date :
Mar 1, 2017
Actual Primary Completion Date :
Sep 9, 2019
Actual Study Completion Date :
Mar 5, 2020

Arms and Interventions

ArmIntervention/Treatment
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.

Biological: Pegilodecakin
Pegilodecakin plus FOLFOX
Other Names:
  • LY3500518
  • AM0010
  • Drug: FOLFOX
    FOLFOX Alone
    Other Names:
  • oxaliplatin
  • 5-FU
  • leucovorin
  • 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.

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

    Primary Outcome Measures

    1. Overall Survival [Randomization to date of death from any cause (Up To 30 Months)]

      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.

    Secondary Outcome Measures

    1. Progression Free Survival [Randomization to Progressive Disease (PD) or Date of Death (Up To 30 Months)]

      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.

    2. Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] That Assessed by Investigator [Randomization to PD (Up To 30 Months)]

      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.

    3. Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD): Disease Control Rate (DCR) [Randomization to Objective Progressive Disease or Start of New Anti-Cancer Therapy (Up To 30 Months)]

      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.

    4. Duration of Response (DOR) [Randomization to Progressive Disease (PD) or Date of Death (Up To 30 Months)]

      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.

    5. Percentage of Participants Alive at 1 Year (12-Month Survival Rate) [From randomization to until the date of first documented date of death from any cause within 12 months]

      The 12-month survival rate is defined as the percentage of participants who have not died 12 months after the date of randomization.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Banner MD Anderson Cancer CenterGilbertArizonaUnited States85234
    2Cancer Treatment Centers of AmericaGoodyearArizonaUnited States85338
    3University of Arizona Cancer CenterPhoenixArizonaUnited States85004
    4Comprehensive Blood and Cancer CenterBakersfieldCaliforniaUnited States93309
    5St. Joseph Heritage HealthcareFullertonCaliforniaUnited States92935
    6USC Norris Cancer HospitalLos AngelesCaliforniaUnited States90033
    7TRIO - Translational Research in Oncology-US, Inc.Los AngelesCaliforniaUnited States90095
    8UCLA Medical CenterLos AngelesCaliforniaUnited States90095
    9Cancer Care Associates Medical GroupRedondo BeachCaliforniaUnited States90277
    10Central Coast Medical Oncology CorporationSanta MariaCaliforniaUnited States93454
    11Rocky Mountain Cancer CenterDenverColoradoUnited States80218
    12Georgetown University Medical CenterWashingtonDistrict of ColumbiaUnited States20007
    13Lynn Cancer Institute Ctr for Hem-OncBoca RatonFloridaUnited States33486
    14Memorial Regional Hospital/Joe Dimaggio Childrens HospitalHollywoodFloridaUnited States33021
    15Baptist Cancer InstituteJacksonvilleFloridaUnited States32207
    16Watson ClinicLakelandFloridaUnited States33805
    17Florida Hospital Cancer InstituteOrlandoFloridaUnited States32804
    18UF Health Cancer Center- Orlando HealthOrlandoFloridaUnited States32806
    19Northeast Georgia Cancer Care, LLCAthensGeorgiaUnited States30607
    20Southeastern Regional Medical CenterNewnanGeorgiaUnited States30265
    21Saint Alphonsus Regional Medical CenterCaldwellIdahoUnited States83605
    22Decatur Memorial HospitalDecaturIllinoisUnited States62526
    23Fort Wayne Oncology & HematologyFort WayneIndianaUnited States46815
    24St. Elizabeth Medical CenterEdgewoodKentuckyUnited States41017
    25Norton Cancer InstituteLouisvilleKentuckyUnited States40202
    26Hematology Oncology ClinicBaton RougeLouisianaUnited States70808
    27New England Cancer Specialists - ScarboroughScarboroughMaineUnited States04074
    28Committee on Clinical Investigations (CCI)- Beth Isreal Deaconess Medical Center IRBBostonMassachusettsUnited States02215
    29University of Massachusetts Medical CenterWorcesterMassachusettsUnited States01655
    30Virginia Piper Cancer InstituteMinneapolisMinnesotaUnited States55407
    31St Louis Cancer CareBridgetonMissouriUnited States63044
    32Summit Medical GroupSummitNew JerseyUnited States07902
    33North Shore Hematology Oncology AssociatesEast SetauketNew YorkUnited States11733
    34Winthrop University HospitalMineolaNew YorkUnited States11501
    35Duke University Medical CenterDurhamNorth CarolinaUnited States27710
    36Novant Health, Oncology Research InstituteWinston-SalemNorth CarolinaUnited States27103
    37Gabrail Cancer CenterCantonOhioUnited States44718
    38University of Oklahoma Health Sciences CenterOklahoma CityOklahomaUnited States73190
    39Oregon Health and Science UniversityPortlandOregonUnited States97239
    40Gettysburg Cancer CenterGettysburgPennsylvaniaUnited States17325
    41Eastern Regional Medical CenterPhiladelphiaPennsylvaniaUnited States19124
    42UPMC Hillman Cancer CenterPittsburghPennsylvaniaUnited States15232-1305
    43Sarah Cannon Research Institute SCRINashvilleTennesseeUnited States37203
    44Tennessee Oncology PLLCNashvilleTennesseeUnited States37203
    45Texas Oncology-Austin MidtownAustinTexasUnited States78705
    46Texas Oncology-Plano EastPlanoTexasUnited States75075
    47Texas Oncology - San Antonio Medical CenterSan AntonioTexasUnited States78240
    48US OncologyThe WoodlandsTexasUnited States77380
    49Hope Cancer Center of East TexasTylerTexasUnited States75701
    50Texas Oncology - TylerTylerTexasUnited States75702
    51Texas Oncology-Wichital Falls Texoma Cancer CenterWichita FallsTexasUnited States76310
    52University of Utah School of MedicineSalt Lake CityUtahUnited States84132
    53Virginia Cancer InstituteRichmondVirginiaUnited States23230
    54Medical Oncology Associates, PSSpokaneWashingtonUnited States99208
    55MultiCare Regional Cancer Center - AuburnTacomaWashingtonUnited States98002
    56Aurora West Allis Medical CenterGreen BayWisconsinUnited States54308
    57Medical College of WisconsinMilwaukeeWisconsinUnited States53226
    58St Vincent's HospitalSydneyNew South WalesAustralia2010
    59Warringal Private HospitalHeidelbergVictoriaAustralia3084
    60Cabrini Hospital MalvernMalvernVictoriaAustralia3144
    61St John of God Murdoch HospitalMurdochWestern AustraliaAustralia6150
    62KH der Barmherzigen Schwestern Linz BetriebsGesmbHLinzOberösterreichAustria4010
    63Universitätsklinikum GrazGrazSteiermarkAustria8036
    64Universitätsklinikum SalzburgSalzburgAustria5020
    65ImeldaziekenhuisBonheidenBelgium2820
    66Hospital Universitaire Erasme BrusselBrusselBelgium1070
    67Universitair Ziekenhuis BrusselBrusselBelgium1090
    68Grand Hopital de Charleroi-Site Notre-DameCharleroiBelgium6000
    69Universitair Ziekenhuis AntwerpenEdegemBelgium2650
    70Universitair Ziekenhuis GentGentBelgium9000
    71AZ GroeningeKortrijkBelgium8500
    72Universitaire Ziekenhuizen Leuven - Campus GasthuisbergLeuvenBelgium3000
    73Clinique St Elisabeth NamurNamurBelgium5000
    74CHU Dinant Godinne - UCL NamurYvoirBelgium5530
    75Toronto Sunnybrook Regional Cancer CenterTorontoOntarioCanadaM4N 3M5
    76McGill UniversityMontrealQuebecCanadaH3A 1A1
    77CHU de Besancon Hopital Jean MinjozBesancon CedexFrance25030
    78Hopital de la Pitie SalpetriereParis CEDEX 13France75651
    79CHU la MiletriePoitiersFrance86021
    80Hôpital Nord Franche-ComtéTrevenansFrance90400
    81Städtisches Klinikum MünchenMünchenBayernGermany81737
    82Kliniken Essen-Mitte Ev. Huyssens-StiftungEssenNordrhein-WestfalenGermany45136
    83Universitätsklinikum Carl Gustav CarusDresdenSachsenGermany01307
    84Charité Universitätsmedizin BerlinBerlinGermany13353
    85St Josef-Hospital BochumBochumGermany
    86Universitätsklinikum FreiburgFreiburgGermany
    87Asklepios Klinik AltonaHamburgGermany22763
    88Istituto Scientifico Romagnolo - Studio e la Cura dei TumoriMeldolaForliItaly47014
    89Fondazione Piemonte l'Oncologia-Istituto Ricerca Cura CancroCandioloTorinoItaly
    90Ospedale le TorretteAnconaItaly60100
    91Azienda Ospedaliera Universitaria Ospedale San Martino di GenovaGenovaItaly16132
    92IRCCS Ospedale San RaffaeleMilanoItaly20132
    93Ospedale Niguarda Ca GrandaMilanoItaly20162
    94AOU dell'Università degli Studi della Campania Luigi VanvitelliNaplesItaly
    95Istituto Oncologico VenetoPadovaItaly35128
    96Policlinico San MatteoPaviaItaly27100
    97Arcispedale Santa Maria Nuova Azienda Ospedaliera di Reggio EmiliaReggio EmiliaItaly42123
    98Universita Campus BiomedicoRomaItaly00155
    99Dong-A University Medical CenterBusanBusan Gwang'yeogsiKorea, Republic of49201
    100Chonnam National University Hwasun HospitalHwasun-gunJeonnamKorea, Republic of519-809
    101Severance Hospital Yonsei University Health SystemSeoulKoreaKorea, Republic of03722
    102Samsung Medical CenterSeoulKoreaKorea, Republic of06351
    103Seoul St. Mary's HospitalSeoulKoreaKorea, Republic of06591
    104Asan Medical CenterSeoulKorea, Republic of05505
    105Uniwersyteckie Centrum KliniczneGdanskPoland80-952
    106Szp.Kliniczny Przemienienia Panskiego UM im.K.MarcinkowskiegPoznanPoland60-569
    107Centrum Medyczne MedykRzeszowPoland35-025
    108Wojewodzki Szpital ZespolonyTorunPoland87-100
    109Hospital Duran I ReynalsHospitaled DE LlobreBarcelonaSpain08907
    110Hospital Clinico Universitario de SantiagoSantiago de CompostelaLa CorunaSpain15706
    111Hospital General Universitario AlicanteAlicanteSpain03010
    112Hospital de la Santa Creu i Sant PauBarcelonaSpain08025
    113Hospital Universitari Vall d'HebronBarcelonaSpain08035
    114Hospital Universitario Germans Trias i PujolBarcelonaSpain
    115Hospital General YagueBurgosSpain9005
    116C.H. Regional Reina SofiaCórdobaSpain14001
    117Hospital General Universitario Gregorio MarañonMadridSpain28007
    118Hospital Universitario Ramon y CajalMadridSpain28034
    119Hospital Universitario 12 de OctubreMadridSpain28041
    120Hospital Madrid Norte SanchinarroMadridSpain28050
    121Regional University Hospital in MalagaMalagaSpain29011
    122Hospital Universitario Virgen del RocioSevillaSpain41013
    123Tri-Service General HospitalNeihu TaipeiTaiwan11490
    124National Cheng Kung University HospitalTainanTaiwan704
    125Taipei Veterans General HospitalTaipeiTaiwan11217
    126Addenbrookes HospitalCambridgeCambridgeshireUnited KingdomCB2 0QQ
    127Hammersmith HospitalActonLondonUnited KingdomW12 0HS
    128Velindre HospitalCardiffSouth GlamorganUnited KingdomCF14 2TL
    129University College London Hospital Foundation TrustLondonSurreyUnited KingdomNW1 2BU
    130Guys/St. Thomas HospitalLondonSurreyUnited KingdomSE1 9RT

    Sponsors and Collaborators

    • Eli Lilly and Company
    • ARMO BioSciences

    Investigators

    • 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

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT02923921
    Other Study ID Numbers:
    • 17158
    • J1L-AM-JZGB
    • AM0010-301
    • 2016-003858-33
    First Posted:
    Oct 5, 2016
    Last Update Posted:
    Oct 19, 2020
    Last Verified:
    Apr 15, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment DetailIn the Participant Flow, participants who completed were those who died due to any cause or were alive and on study at conclusion but off treatment.
    Arm/Group TitlePegilodecakin + FOLFOXFOLFOX
    Arm/Group DescriptionPegilodecakin 5 microgram per kilogram (μg/kg) dosed as one of the following 2 fixed doses: 0.4 milligram (mg) for participants weighing less than or equal to (≤) 80 kg or 0.8 mg for participants weighing greater than (>) 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.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.
    Period Title: Overall Study
    STARTED283284
    Received at Least 1 Dose of Study Drug278251
    Safety Population278251
    COMPLETED230227
    NOT COMPLETED5357

    Baseline Characteristics

    Arm/Group TitlePegilodecakin + FOLFOXFOLFOXTotal
    Arm/Group DescriptionPegilodecakin 5 μg/kg dosed as one of the following 2 fixed doses: 0.4 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 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.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.Total of all reporting groups
    Overall Participants283284567
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    63.8
    (9.0)
    64.1
    (9.9)
    64.0
    (9.4)
    Sex: Female, Male (Count of Participants)
    Female
    135
    47.7%
    132
    46.5%
    267
    47.1%
    Male
    148
    52.3%
    152
    53.5%
    300
    52.9%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    9
    3.2%
    6
    2.1%
    15
    2.6%
    Not Hispanic or Latino
    263
    92.9%
    265
    93.3%
    528
    93.1%
    Unknown or Not Reported
    11
    3.9%
    13
    4.6%
    24
    4.2%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    1
    0.4%
    0
    0%
    1
    0.2%
    Asian
    59
    20.8%
    55
    19.4%
    114
    20.1%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    1
    0.4%
    1
    0.2%
    Black or African American
    8
    2.8%
    8
    2.8%
    16
    2.8%
    White
    207
    73.1%
    213
    75%
    420
    74.1%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    8
    2.8%
    7
    2.5%
    15
    2.6%
    Region of Enrollment (Count of Participants)
    United States
    93
    32.9%
    89
    31.3%
    182
    32.1%
    United Kingdom
    5
    1.8%
    4
    1.4%
    9
    1.6%
    Spain
    42
    14.8%
    31
    10.9%
    73
    12.9%
    Canada
    2
    0.7%
    7
    2.5%
    9
    1.6%
    South Korea
    48
    17%
    41
    14.4%
    89
    15.7%
    Austria
    3
    1.1%
    10
    3.5%
    13
    2.3%
    Belgium
    17
    6%
    19
    6.7%
    36
    6.3%
    Taiwan
    5
    1.8%
    10
    3.5%
    15
    2.6%
    Poland
    8
    2.8%
    5
    1.8%
    13
    2.3%
    Italy
    28
    9.9%
    39
    13.7%
    67
    11.8%
    France
    9
    3.2%
    2
    0.7%
    11
    1.9%
    Australia
    14
    4.9%
    16
    5.6%
    30
    5.3%
    Germany
    9
    3.2%
    11
    3.9%
    20
    3.5%

    Outcome Measures

    1. Primary Outcome
    TitleOverall Survival
    DescriptionOverall 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 FrameRandomization to date of death from any cause (Up To 30 Months)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants. The number of participants censored were Pegilodecakin + FOLFOX = 63 and FOLFOX = 73.
    Arm/Group TitlePegilodecakin + FOLFOXFOLFOX
    Arm/Group DescriptionPegilodecakin 5 μg/kg dosed as one of the following 2 fixed doses: 0.4 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 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.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.
    Measure Participants283284
    Median (95% Confidence Interval) [Months]
    5.78
    6.28
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Pegilodecakin + FOLFOX, FOLFOX
    Comments The primary test to compare overall survival between treatment arms was the two-sided log-rank test, stratified by region and prior therapy. The estimate of the hazard ration (HR) - (Pegilodecakin + FOLFOX Arm / FOLFOX Arm) and the corresponding 95% CI was computed using a Cox proportional hazards model stratified by randomization stratification factors. Randomization stratification factors were based on the data recorded in interactive voice response system (IVRS).
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesisp-Value0.6565
    Comments
    MethodLog Rank
    Comments
    Method of EstimationEstimation ParameterHazard Ratio (HR)
    Estimated Value1.045
    Confidence Interval (2-Sided) 95%
    0.863 to 1.265
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    TitleProgression Free Survival
    DescriptionPFS 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 FrameRandomization to Progressive Disease (PD) or Date of Death (Up To 30 Months)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants. The number of participants censored were Pegilodecakin + FOLFOX = 45 and FOLFOX = 86.
    Arm/Group TitlePegilodecakin + FOLFOXFOLFOX
    Arm/Group DescriptionPegilodecakin 5 μg/kg dosed as one of the following 2 fixed doses: 0.4 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 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.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.
    Measure Participants283284
    Median (95% Confidence Interval) [Months]
    2.14
    2.10
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Pegilodecakin + FOLFOX, FOLFOX
    Comments The estimate of hazard ratio (HR) was stratified by region and prior therapy.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesisp-Value0.8144
    Comments
    MethodLog Rank
    Comments
    Method of EstimationEstimation ParameterHazard Ratio (HR)
    Estimated Value0.981
    Confidence Interval (2-Sided) 95%
    0.808 to 1.190
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Secondary Outcome
    TitlePercentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] That Assessed by Investigator
    DescriptionORR 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.
    Time FrameRandomization to PD (Up To 30 Months)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants.
    Arm/Group TitlePegilodecakin + FOLFOXFOLFOX
    Arm/Group DescriptionPegilodecakin 5 μg/kg dosed as one of the following 2 fixed doses: 0.4 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 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.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.
    Measure Participants283284
    Number [Percentage of participants]
    4.6
    1.6%
    5.6
    2%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Pegilodecakin + FOLFOX, FOLFOX
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesisp-Value0.7044
    CommentsP-value is calculated by Exact Cochran-Mantel-Haenszel test stratified by the randomization strata Prior Therapy - interactive voice response system (IVRS), Geographic Region - IVRS.
    MethodCochran-Mantel-Haenszel
    Comments
    Method of EstimationEstimation ParameterOdds Ratio (OR)
    Estimated Value0.8
    Confidence Interval (2-Sided) 95%
    0.4 to 1.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Secondary Outcome
    TitlePercentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD): Disease Control Rate (DCR)
    DescriptionDisease 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.
    Time FrameRandomization to Objective Progressive Disease or Start of New Anti-Cancer Therapy (Up To 30 Months)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants.
    Arm/Group TitlePegilodecakin + FOLFOXFOLFOX
    Arm/Group DescriptionPegilodecakin 5 μg/kg dosed as one of the following 2 fixed doses: 0.4 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 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.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.
    Measure Participants283284
    Number [Percentage of participants]
    42.8
    15.1%
    36.6
    12.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Pegilodecakin + FOLFOX, FOLFOX
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesisp-Value0.1463
    CommentsP-value is calculated by Exact Cochran-Mantel-Haenszel test stratified by the randomization strata Prior Therapy - interactive voice response system (IVRS), Geographic Region - IVRS.
    MethodCochran-Mantel-Haenszel
    Comments
    Method of EstimationEstimation ParameterOdds Ratio (OR)
    Estimated Value1.3
    Confidence Interval (2-Sided) 95%
    0.9 to 1.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    5. Secondary Outcome
    TitleDuration of Response (DOR)
    DescriptionDOR 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.
    Time FrameRandomization to Progressive Disease (PD) or Date of Death (Up To 30 Months)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who achieved an objective response of CR or PR. The number of participants censored were Pegilodecakin + FOLFOX = 4 and FOLFOX = 7.
    Arm/Group TitlePegilodecakin + FOLFOXFOLFOX
    Arm/Group DescriptionPegilodecakin 5 μg/kg dosed as one of the following 2 fixed doses: 0.4 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 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.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.
    Measure Participants1316
    Median (95% Confidence Interval) [Months]
    4.99
    5.17
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Pegilodecakin + FOLFOX, FOLFOX
    Comments The estimate of hazard ratio (HR) was stratified by region and prior therapy.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesisp-Value0.9952
    Comments
    MethodLog Rank
    Comments
    Method of EstimationEstimation ParameterHazard Ratio (HR)
    Estimated Value1.008
    Confidence Interval (2-Sided) 95%
    0.370 to 2.741
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    6. Secondary Outcome
    TitlePercentage of Participants Alive at 1 Year (12-Month Survival Rate)
    DescriptionThe 12-month survival rate is defined as the percentage of participants who have not died 12 months after the date of randomization.
    Time FrameFrom randomization to until the date of first documented date of death from any cause within 12 months

    Outcome Measure Data

    Analysis Population Description
    All randomized participants.
    Arm/Group TitlePegilodecakin + FOLFOXFOLFOX
    Arm/Group DescriptionPegilodecakin 5 μg/kg dosed as one of the following 2 fixed doses: 0.4 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 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.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.
    Measure Participants283284
    Number (95% Confidence Interval) [Percentage of participants]
    14.7
    5.2%
    19.1
    6.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Pegilodecakin + FOLFOX, FOLFOX
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesisp-Value0.2298
    Comments
    MethodLog Rank
    Comments
    Method of EstimationEstimation ParameterMean Difference (Final Values)
    Estimated Value-4.4
    Confidence Interval (2-Sided) 95%
    -11.6 to 2.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments

    Adverse Events

    Time FrameBaseline Up To 36 Months
    Adverse Event Reporting Description All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
    Arm/Group TitlePegilodecakin + FOLFOXFOLFOX
    Arm/Group DescriptionPegilodecakin 5 μg/kg dosed as one of the following 2 fixed doses: 0.4 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 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.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.
    All Cause Mortality
    Pegilodecakin + FOLFOXFOLFOX
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total217/278 (78.1%) 188/251 (74.9%)
    Serious Adverse Events
    Pegilodecakin + FOLFOXFOLFOX
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total123/278 (44.2%) 95/251 (37.8%)
    Blood and lymphatic system disorders
    Anaemia3/278 (1.1%) 51/251 (0.4%) 2
    Febrile neutropenia3/278 (1.1%) 31/251 (0.4%) 1
    Neutropenia2/278 (0.7%) 33/251 (1.2%) 4
    Thrombocytopenia1/278 (0.4%) 10/251 (0%) 0
    Cardiac disorders
    Acute myocardial infarction0/278 (0%) 01/251 (0.4%) 1
    Angina pectoris2/278 (0.7%) 20/251 (0%) 0
    Atrial fibrillation0/278 (0%) 02/251 (0.8%) 2
    Cardiac arrest1/278 (0.4%) 11/251 (0.4%) 1
    Cardiac failure acute0/278 (0%) 01/251 (0.4%) 1
    Gastrointestinal disorders
    Abdominal distension3/278 (1.1%) 30/251 (0%) 0
    Abdominal pain11/278 (4%) 143/251 (1.2%) 3
    Abdominal pain lower0/278 (0%) 01/251 (0.4%) 1
    Abdominal pain upper1/278 (0.4%) 11/251 (0.4%) 1
    Ascites2/278 (0.7%) 21/251 (0.4%) 1
    Colitis2/278 (0.7%) 21/251 (0.4%) 1
    Constipation2/278 (0.7%) 21/251 (0.4%) 1
    Diarrhoea2/278 (0.7%) 35/251 (2%) 5
    Duodenal obstruction1/278 (0.4%) 11/251 (0.4%) 1
    Duodenal stenosis1/278 (0.4%) 10/251 (0%) 0
    Duodenal ulcer haemorrhage1/278 (0.4%) 10/251 (0%) 0
    Dyspepsia0/278 (0%) 01/251 (0.4%) 1
    Gastric haemorrhage1/278 (0.4%) 10/251 (0%) 0
    Gastritis0/278 (0%) 01/251 (0.4%) 1
    Gastroduodenal ulcer1/278 (0.4%) 10/251 (0%) 0
    Gastrointestinal haemorrhage2/278 (0.7%) 21/251 (0.4%) 1
    Gastrointestinal stenosis0/278 (0%) 01/251 (0.4%) 1
    Haematemesis0/278 (0%) 02/251 (0.8%) 2
    Ileal perforation1/278 (0.4%) 10/251 (0%) 0
    Intestinal obstruction1/278 (0.4%) 13/251 (1.2%) 3
    Large intestinal obstruction0/278 (0%) 01/251 (0.4%) 1
    Nausea3/278 (1.1%) 40/251 (0%) 0
    Obstruction gastric0/278 (0%) 01/251 (0.4%) 1
    Oesophageal stenosis0/278 (0%) 01/251 (0.4%) 1
    Pancreatitis acute1/278 (0.4%) 10/251 (0%) 0
    Small intestinal haemorrhage0/278 (0%) 01/251 (0.4%) 1
    Small intestinal obstruction3/278 (1.1%) 32/251 (0.8%) 2
    Stomatitis1/278 (0.4%) 10/251 (0%) 0
    Upper gastrointestinal haemorrhage1/278 (0.4%) 11/251 (0.4%) 1
    Vomiting7/278 (2.5%) 85/251 (2%) 5
    General disorders
    Asthenia2/278 (0.7%) 21/251 (0.4%) 1
    Euthanasia1/278 (0.4%) 10/251 (0%) 0
    Fatigue1/278 (0.4%) 22/251 (0.8%) 2
    General physical health deterioration3/278 (1.1%) 32/251 (0.8%) 3
    Generalised oedema1/278 (0.4%) 10/251 (0%) 0
    Hyperpyrexia0/278 (0%) 01/251 (0.4%) 1
    Malaise1/278 (0.4%) 10/251 (0%) 0
    Mucosal inflammation0/278 (0%) 01/251 (0.4%) 1
    Multiple organ dysfunction syndrome1/278 (0.4%) 11/251 (0.4%) 1
    Oedema peripheral1/278 (0.4%) 10/251 (0%) 0
    Pyrexia13/278 (4.7%) 157/251 (2.8%) 7
    Hepatobiliary disorders
    Bile duct obstruction1/278 (0.4%) 11/251 (0.4%) 1
    Bile duct stenosis1/278 (0.4%) 10/251 (0%) 0
    Cholangitis6/278 (2.2%) 82/251 (0.8%) 2
    Cholangitis acute2/278 (0.7%) 30/251 (0%) 0
    Cholecystitis1/278 (0.4%) 10/251 (0%) 0
    Cholecystitis acute1/278 (0.4%) 10/251 (0%) 0
    Hepatic cirrhosis1/278 (0.4%) 10/251 (0%) 0
    Hepatic function abnormal1/278 (0.4%) 10/251 (0%) 0
    Hepatic pain0/278 (0%) 01/251 (0.4%) 1
    Jaundice cholestatic3/278 (1.1%) 33/251 (1.2%) 3
    Immune system disorders
    Anaphylactic reaction1/278 (0.4%) 10/251 (0%) 0
    Infections and infestations
    Abdominal sepsis1/278 (0.4%) 10/251 (0%) 0
    Bacteraemia3/278 (1.1%) 31/251 (0.4%) 1
    Bacterial disease carrier0/278 (0%) 01/251 (0.4%) 1
    Biliary sepsis0/278 (0%) 02/251 (0.8%) 2
    Biliary tract infection3/278 (1.1%) 31/251 (0.4%) 4
    Cellulitis1/278 (0.4%) 20/251 (0%) 0
    Cholangitis infective0/278 (0%) 01/251 (0.4%) 1
    Clostridium difficile colitis2/278 (0.7%) 20/251 (0%) 0
    Device related infection4/278 (1.4%) 50/251 (0%) 0
    Device related sepsis0/278 (0%) 01/251 (0.4%) 1
    Diverticulitis0/278 (0%) 01/251 (0.4%) 1
    Enterobacter sepsis0/278 (0%) 01/251 (0.4%) 1
    Enterocolitis infectious1/278 (0.4%) 10/251 (0%) 0
    Escherichia sepsis1/278 (0.4%) 11/251 (0.4%) 1
    Gastroenteritis1/278 (0.4%) 10/251 (0%) 0
    Gastroenteritis norovirus1/278 (0.4%) 10/251 (0%) 0
    Klebsiella sepsis0/278 (0%) 01/251 (0.4%) 1
    Liver abscess1/278 (0.4%) 11/251 (0.4%) 1
    Lower respiratory tract infection0/278 (0%) 01/251 (0.4%) 1
    Peritonsillar abscess0/278 (0%) 01/251 (0.4%) 1
    Pneumococcal sepsis0/278 (0%) 01/251 (0.4%) 1
    Pneumocystis jirovecii pneumonia1/278 (0.4%) 10/251 (0%) 0
    Pneumonia7/278 (2.5%) 84/251 (1.6%) 4
    Pneumonia cryptococcal0/278 (0%) 01/251 (0.4%) 1
    Respiratory tract infection1/278 (0.4%) 10/251 (0%) 0
    Sepsis10/278 (3.6%) 104/251 (1.6%) 4
    Septic shock4/278 (1.4%) 70/251 (0%) 0
    Urinary tract infection1/278 (0.4%) 11/251 (0.4%) 1
    Urosepsis0/278 (0%) 01/251 (0.4%) 1
    Viral infection1/278 (0.4%) 10/251 (0%) 0
    Injury, poisoning and procedural complications
    Craniocerebral injury0/278 (0%) 01/251 (0.4%) 1
    Fibula fracture1/278 (0.4%) 10/251 (0%) 0
    Hip fracture2/278 (0.7%) 21/251 (0.4%) 1
    Infusion related reaction1/278 (0.4%) 10/251 (0%) 0
    Overdose1/278 (0.4%) 10/251 (0%) 0
    Tibia fracture1/278 (0.4%) 10/251 (0%) 0
    Investigations
    Blood bilirubin increased3/278 (1.1%) 44/251 (1.6%) 6
    Neutrophil count decreased1/278 (0.4%) 11/251 (0.4%) 1
    Platelet count decreased2/278 (0.7%) 30/251 (0%) 0
    Metabolism and nutrition disorders
    Adult failure to thrive1/278 (0.4%) 10/251 (0%) 0
    Cachexia1/278 (0.4%) 10/251 (0%) 0
    Decreased appetite1/278 (0.4%) 11/251 (0.4%) 1
    Dehydration3/278 (1.1%) 31/251 (0.4%) 1
    Diabetes mellitus0/278 (0%) 01/251 (0.4%) 1
    Diabetic ketoacidosis1/278 (0.4%) 10/251 (0%) 0
    Diabetic metabolic decompensation0/278 (0%) 01/251 (0.4%) 1
    Failure to thrive1/278 (0.4%) 10/251 (0%) 0
    Hypercalcaemia1/278 (0.4%) 10/251 (0%) 0
    Hyperglycaemia1/278 (0.4%) 10/251 (0%) 0
    Hypokalaemia1/278 (0.4%) 11/251 (0.4%) 1
    Hyponatraemia2/278 (0.7%) 21/251 (0.4%) 1
    Lactic acidosis1/278 (0.4%) 10/251 (0%) 0
    Musculoskeletal and connective tissue disorders
    Back pain0/278 (0%) 03/251 (1.2%) 3
    Bursitis1/278 (0.4%) 10/251 (0%) 0
    Flank pain0/278 (0%) 01/251 (0.4%) 1
    Muscular weakness0/278 (0%) 01/251 (0.4%) 1
    Musculoskeletal pain1/278 (0.4%) 11/251 (0.4%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia1/278 (0.4%) 10/251 (0%) 0
    Tumour pain1/278 (0.4%) 21/251 (0.4%) 1
    Nervous system disorders
    Cerebral ischaemia0/278 (0%) 01/251 (0.4%) 1
    Cerebrovascular accident1/278 (0.4%) 10/251 (0%) 0
    Ischaemic stroke1/278 (0.4%) 11/251 (0.4%) 1
    Lethargy1/278 (0.4%) 10/251 (0%) 0
    Metabolic encephalopathy1/278 (0.4%) 10/251 (0%) 0
    Neuropathy peripheral0/278 (0%) 01/251 (0.4%) 1
    Sciatica0/278 (0%) 01/251 (0.4%) 1
    Transient ischaemic attack0/278 (0%) 01/251 (0.4%) 1
    Product Issues
    Device breakage0/278 (0%) 01/251 (0.4%) 1
    Device failure1/278 (0.4%) 10/251 (0%) 0
    Device occlusion3/278 (1.1%) 30/251 (0%) 0
    Psychiatric disorders
    Completed suicide0/278 (0%) 01/251 (0.4%) 1
    Mental status changes1/278 (0.4%) 10/251 (0%) 0
    Suicide attempt1/278 (0.4%) 10/251 (0%) 0
    Renal and urinary disorders
    Acute kidney injury2/278 (0.7%) 21/251 (0.4%) 1
    Cystitis haemorrhagic0/278 (0%) 01/251 (0.4%) 1
    Nephrolithiasis1/278 (0.4%) 10/251 (0%) 0
    Oliguria0/278 (0%) 01/251 (0.4%) 1
    Renal failure1/278 (0.4%) 10/251 (0%) 0
    Urinary tract obstruction0/278 (0%) 01/251 (0.4%) 1
    Reproductive system and breast disorders
    Prostatic obstruction1/144 (0.7%) 10/134 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome1/278 (0.4%) 10/251 (0%) 0
    Asthma1/278 (0.4%) 10/251 (0%) 0
    Chronic obstructive pulmonary disease0/278 (0%) 01/251 (0.4%) 1
    Pleural effusion2/278 (0.7%) 21/251 (0.4%) 1
    Pneumonitis2/278 (0.7%) 20/251 (0%) 0
    Pulmonary embolism2/278 (0.7%) 23/251 (1.2%) 3
    Respiratory acidosis1/278 (0.4%) 10/251 (0%) 0
    Skin and subcutaneous tissue disorders
    Rash maculo-papular1/278 (0.4%) 10/251 (0%) 0
    Vascular disorders
    Aortic embolus0/278 (0%) 01/251 (0.4%) 1
    Deep vein thrombosis1/278 (0.4%) 21/251 (0.4%) 1
    Embolism2/278 (0.7%) 22/251 (0.8%) 2
    Internal haemorrhage1/278 (0.4%) 10/251 (0%) 0
    Peripheral coldness0/278 (0%) 01/251 (0.4%) 1
    Other (Not Including Serious) Adverse Events
    Pegilodecakin + FOLFOXFOLFOX
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total271/278 (97.5%) 240/251 (95.6%)
    Blood and lymphatic system disorders
    Anaemia107/278 (38.5%) 20438/251 (15.1%) 56
    Neutropenia58/278 (20.9%) 11841/251 (16.3%) 65
    Thrombocytopenia99/278 (35.6%) 29628/251 (11.2%) 42
    Gastrointestinal disorders
    Abdominal distension18/278 (6.5%) 2214/251 (5.6%) 15
    Abdominal pain82/278 (29.5%) 11458/251 (23.1%) 82
    Abdominal pain upper20/278 (7.2%) 3414/251 (5.6%) 17
    Ascites28/278 (10.1%) 3519/251 (7.6%) 20
    Constipation79/278 (28.4%) 9359/251 (23.5%) 70
    Diarrhoea70/278 (25.2%) 10471/251 (28.3%) 101
    Dyspepsia21/278 (7.6%) 2314/251 (5.6%) 16
    Flatulence14/278 (5%) 154/251 (1.6%) 6
    Nausea126/278 (45.3%) 217106/251 (42.2%) 160
    Stomatitis27/278 (9.7%) 3740/251 (15.9%) 48
    Vomiting80/278 (28.8%) 12269/251 (27.5%) 106
    General disorders
    Asthenia76/278 (27.3%) 15145/251 (17.9%) 105
    Fatigue105/278 (37.8%) 18174/251 (29.5%) 108
    Injection site erythema18/278 (6.5%) 180/251 (0%) 0
    Oedema peripheral41/278 (14.7%) 4922/251 (8.8%) 25
    Pyrexia56/278 (20.1%) 8236/251 (14.3%) 51
    Investigations
    Aspartate aminotransferase increased12/278 (4.3%) 1714/251 (5.6%) 22
    Blood alkaline phosphatase increased21/278 (7.6%) 2815/251 (6%) 20
    Blood bilirubin increased19/278 (6.8%) 2810/251 (4%) 12
    Neutrophil count decreased47/278 (16.9%) 8430/251 (12%) 51
    Platelet count decreased59/278 (21.2%) 16326/251 (10.4%) 51
    Weight decreased14/278 (5%) 1725/251 (10%) 34
    Metabolism and nutrition disorders
    Decreased appetite97/278 (34.9%) 13277/251 (30.7%) 100
    Dehydration12/278 (4.3%) 2214/251 (5.6%) 19
    Hyperglycaemia14/278 (5%) 2010/251 (4%) 11
    Hypoalbuminaemia20/278 (7.2%) 2810/251 (4%) 11
    Hypokalaemia21/278 (7.6%) 3729/251 (11.6%) 39
    Hyponatraemia11/278 (4%) 1516/251 (6.4%) 21
    Musculoskeletal and connective tissue disorders
    Back pain37/278 (13.3%) 4432/251 (12.7%) 39
    Nervous system disorders
    Dizziness19/278 (6.8%) 238/251 (3.2%) 9
    Dysgeusia19/278 (6.8%) 229/251 (3.6%) 11
    Headache18/278 (6.5%) 2417/251 (6.8%) 20
    Neuropathy peripheral40/278 (14.4%) 5038/251 (15.1%) 62
    Neurotoxicity13/278 (4.7%) 2515/251 (6%) 30
    Paraesthesia24/278 (8.6%) 3417/251 (6.8%) 44
    Peripheral sensory neuropathy31/278 (11.2%) 4829/251 (11.6%) 35
    Polyneuropathy9/278 (3.2%) 1314/251 (5.6%) 25
    Psychiatric disorders
    Insomnia14/278 (5%) 1413/251 (5.2%) 13
    Respiratory, thoracic and mediastinal disorders
    Cough17/278 (6.1%) 2219/251 (7.6%) 22
    Dyspnoea30/278 (10.8%) 4115/251 (6%) 17
    Skin and subcutaneous tissue disorders
    Pruritus15/278 (5.4%) 248/251 (3.2%) 11
    Rash23/278 (8.3%) 349/251 (3.6%) 10

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/TitleChief Medical Officer
    OrganizationEli Lilly and Company
    Phone800-545-5979
    EmailClinicalTrials.gov@lilly.com
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT02923921
    Other Study ID Numbers:
    • 17158
    • J1L-AM-JZGB
    • AM0010-301
    • 2016-003858-33
    First Posted:
    Oct 5, 2016
    Last Update Posted:
    Oct 19, 2020
    Last Verified:
    Apr 15, 2020