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
130
2
36.1
4.4
0.1

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 Disease Intervention/Treatment Phase
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

Arm Intervention/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

    Site City State Country Postal Code
    1 Banner MD Anderson Cancer Center Gilbert Arizona United States 85234
    2 Cancer Treatment Centers of America Goodyear Arizona United States 85338
    3 University of Arizona Cancer Center Phoenix Arizona United States 85004
    4 Comprehensive Blood and Cancer Center Bakersfield California United States 93309
    5 St. Joseph Heritage Healthcare Fullerton California United States 92935
    6 USC Norris Cancer Hospital Los Angeles California United States 90033
    7 TRIO - Translational Research in Oncology-US, Inc. Los Angeles California United States 90095
    8 UCLA Medical Center Los Angeles California United States 90095
    9 Cancer Care Associates Medical Group Redondo Beach California United States 90277
    10 Central Coast Medical Oncology Corporation Santa Maria California United States 93454
    11 Rocky Mountain Cancer Center Denver Colorado United States 80218
    12 Georgetown University Medical Center Washington District of Columbia United States 20007
    13 Lynn Cancer Institute Ctr for Hem-Onc Boca Raton Florida United States 33486
    14 Memorial Regional Hospital/Joe Dimaggio Childrens Hospital Hollywood Florida United States 33021
    15 Baptist Cancer Institute Jacksonville Florida United States 32207
    16 Watson Clinic Lakeland Florida United States 33805
    17 Florida Hospital Cancer Institute Orlando Florida United States 32804
    18 UF Health Cancer Center- Orlando Health Orlando Florida United States 32806
    19 Northeast Georgia Cancer Care, LLC Athens Georgia United States 30607
    20 Southeastern Regional Medical Center Newnan Georgia United States 30265
    21 Saint Alphonsus Regional Medical Center Caldwell Idaho United States 83605
    22 Decatur Memorial Hospital Decatur Illinois United States 62526
    23 Fort Wayne Oncology & Hematology Fort Wayne Indiana United States 46815
    24 St. Elizabeth Medical Center Edgewood Kentucky United States 41017
    25 Norton Cancer Institute Louisville Kentucky United States 40202
    26 Hematology Oncology Clinic Baton Rouge Louisiana United States 70808
    27 New England Cancer Specialists - Scarborough Scarborough Maine United States 04074
    28 Committee on Clinical Investigations (CCI)- Beth Isreal Deaconess Medical Center IRB Boston Massachusetts United States 02215
    29 University of Massachusetts Medical Center Worcester Massachusetts United States 01655
    30 Virginia Piper Cancer Institute Minneapolis Minnesota United States 55407
    31 St Louis Cancer Care Bridgeton Missouri United States 63044
    32 Summit Medical Group Summit New Jersey United States 07902
    33 North Shore Hematology Oncology Associates East Setauket New York United States 11733
    34 Winthrop University Hospital Mineola New York United States 11501
    35 Duke University Medical Center Durham North Carolina United States 27710
    36 Novant Health, Oncology Research Institute Winston-Salem North Carolina United States 27103
    37 Gabrail Cancer Center Canton Ohio United States 44718
    38 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73190
    39 Oregon Health and Science University Portland Oregon United States 97239
    40 Gettysburg Cancer Center Gettysburg Pennsylvania United States 17325
    41 Eastern Regional Medical Center Philadelphia Pennsylvania United States 19124
    42 UPMC Hillman Cancer Center Pittsburgh Pennsylvania United States 15232-1305
    43 Sarah Cannon Research Institute SCRI Nashville Tennessee United States 37203
    44 Tennessee Oncology PLLC Nashville Tennessee United States 37203
    45 Texas Oncology-Austin Midtown Austin Texas United States 78705
    46 Texas Oncology-Plano East Plano Texas United States 75075
    47 Texas Oncology - San Antonio Medical Center San Antonio Texas United States 78240
    48 US Oncology The Woodlands Texas United States 77380
    49 Hope Cancer Center of East Texas Tyler Texas United States 75701
    50 Texas Oncology - Tyler Tyler Texas United States 75702
    51 Texas Oncology-Wichital Falls Texoma Cancer Center Wichita Falls Texas United States 76310
    52 University of Utah School of Medicine Salt Lake City Utah United States 84132
    53 Virginia Cancer Institute Richmond Virginia United States 23230
    54 Medical Oncology Associates, PS Spokane Washington United States 99208
    55 MultiCare Regional Cancer Center - Auburn Tacoma Washington United States 98002
    56 Aurora West Allis Medical Center Green Bay Wisconsin United States 54308
    57 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    58 St Vincent's Hospital Sydney New South Wales Australia 2010
    59 Warringal Private Hospital Heidelberg Victoria Australia 3084
    60 Cabrini Hospital Malvern Malvern Victoria Australia 3144
    61 St John of God Murdoch Hospital Murdoch Western Australia Australia 6150
    62 KH der Barmherzigen Schwestern Linz BetriebsGesmbH Linz Oberösterreich Austria 4010
    63 Universitätsklinikum Graz Graz Steiermark Austria 8036
    64 Universitätsklinikum Salzburg Salzburg Austria 5020
    65 Imeldaziekenhuis Bonheiden Belgium 2820
    66 Hospital Universitaire Erasme Brussel Brussel Belgium 1070
    67 Universitair Ziekenhuis Brussel Brussel Belgium 1090
    68 Grand Hopital de Charleroi-Site Notre-Dame Charleroi Belgium 6000
    69 Universitair Ziekenhuis Antwerpen Edegem Belgium 2650
    70 Universitair Ziekenhuis Gent Gent Belgium 9000
    71 AZ Groeninge Kortrijk Belgium 8500
    72 Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg Leuven Belgium 3000
    73 Clinique St Elisabeth Namur Namur Belgium 5000
    74 CHU Dinant Godinne - UCL Namur Yvoir Belgium 5530
    75 Toronto Sunnybrook Regional Cancer Center Toronto Ontario Canada M4N 3M5
    76 McGill University Montreal Quebec Canada H3A 1A1
    77 CHU de Besancon Hopital Jean Minjoz Besancon Cedex France 25030
    78 Hopital de la Pitie Salpetriere Paris CEDEX 13 France 75651
    79 CHU la Miletrie Poitiers France 86021
    80 Hôpital Nord Franche-Comté Trevenans France 90400
    81 Städtisches Klinikum München München Bayern Germany 81737
    82 Kliniken Essen-Mitte Ev. Huyssens-Stiftung Essen Nordrhein-Westfalen Germany 45136
    83 Universitätsklinikum Carl Gustav Carus Dresden Sachsen Germany 01307
    84 Charité Universitätsmedizin Berlin Berlin Germany 13353
    85 St Josef-Hospital Bochum Bochum Germany
    86 Universitätsklinikum Freiburg Freiburg Germany
    87 Asklepios Klinik Altona Hamburg Germany 22763
    88 Istituto Scientifico Romagnolo - Studio e la Cura dei Tumori Meldola Forli Italy 47014
    89 Fondazione Piemonte l'Oncologia-Istituto Ricerca Cura Cancro Candiolo Torino Italy
    90 Ospedale le Torrette Ancona Italy 60100
    91 Azienda Ospedaliera Universitaria Ospedale San Martino di Genova Genova Italy 16132
    92 IRCCS Ospedale San Raffaele Milano Italy 20132
    93 Ospedale Niguarda Ca Granda Milano Italy 20162
    94 AOU dell'Università degli Studi della Campania Luigi Vanvitelli Naples Italy
    95 Istituto Oncologico Veneto Padova Italy 35128
    96 Policlinico San Matteo Pavia Italy 27100
    97 Arcispedale Santa Maria Nuova Azienda Ospedaliera di Reggio Emilia Reggio Emilia Italy 42123
    98 Universita Campus Biomedico Roma Italy 00155
    99 Dong-A University Medical Center Busan Busan Gwang'yeogsi Korea, Republic of 49201
    100 Chonnam National University Hwasun Hospital Hwasun-gun Jeonnam Korea, Republic of 519-809
    101 Severance Hospital Yonsei University Health System Seoul Korea Korea, Republic of 03722
    102 Samsung Medical Center Seoul Korea Korea, Republic of 06351
    103 Seoul St. Mary's Hospital Seoul Korea Korea, Republic of 06591
    104 Asan Medical Center Seoul Korea, Republic of 05505
    105 Uniwersyteckie Centrum Kliniczne Gdansk Poland 80-952
    106 Szp.Kliniczny Przemienienia Panskiego UM im.K.Marcinkowskieg Poznan Poland 60-569
    107 Centrum Medyczne Medyk Rzeszow Poland 35-025
    108 Wojewodzki Szpital Zespolony Torun Poland 87-100
    109 Hospital Duran I Reynals Hospitaled DE Llobre Barcelona Spain 08907
    110 Hospital Clinico Universitario de Santiago Santiago de Compostela La Coruna Spain 15706
    111 Hospital General Universitario Alicante Alicante Spain 03010
    112 Hospital de la Santa Creu i Sant Pau Barcelona Spain 08025
    113 Hospital Universitari Vall d'Hebron Barcelona Spain 08035
    114 Hospital Universitario Germans Trias i Pujol Barcelona Spain
    115 Hospital General Yague Burgos Spain 9005
    116 C.H. Regional Reina Sofia Córdoba Spain 14001
    117 Hospital General Universitario Gregorio Marañon Madrid Spain 28007
    118 Hospital Universitario Ramon y Cajal Madrid Spain 28034
    119 Hospital Universitario 12 de Octubre Madrid Spain 28041
    120 Hospital Madrid Norte Sanchinarro Madrid Spain 28050
    121 Regional University Hospital in Malaga Malaga Spain 29011
    122 Hospital Universitario Virgen del Rocio Sevilla Spain 41013
    123 Tri-Service General Hospital Neihu Taipei Taiwan 11490
    124 National Cheng Kung University Hospital Tainan Taiwan 704
    125 Taipei Veterans General Hospital Taipei Taiwan 11217
    126 Addenbrookes Hospital Cambridge Cambridgeshire United Kingdom CB2 0QQ
    127 Hammersmith Hospital Acton London United Kingdom W12 0HS
    128 Velindre Hospital Cardiff South Glamorgan United Kingdom CF14 2TL
    129 University College London Hospital Foundation Trust London Surrey United Kingdom NW1 2BU
    130 Guys/St. Thomas Hospital London Surrey United Kingdom SE1 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 Detail In 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 Title Pegilodecakin + FOLFOX FOLFOX
    Arm/Group Description Pegilodecakin 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
    STARTED 283 284
    Received at Least 1 Dose of Study Drug 278 251
    Safety Population 278 251
    COMPLETED 230 227
    NOT COMPLETED 53 57

    Baseline Characteristics

    Arm/Group Title Pegilodecakin + FOLFOX FOLFOX Total
    Arm/Group Description Pegilodecakin 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 Participants 283 284 567
    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
    Title Overall Survival
    Description 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.
    Time Frame Randomization 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 Title Pegilodecakin + FOLFOX FOLFOX
    Arm/Group Description Pegilodecakin 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 Participants 283 284
    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 Hypothesis p-Value 0.6565
    Comments
    Method Log Rank
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 1.045
    Confidence Interval (2-Sided) 95%
    0.863 to 1.265
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title Progression Free Survival
    Description 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.
    Time Frame Randomization 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 Title Pegilodecakin + FOLFOX FOLFOX
    Arm/Group Description Pegilodecakin 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 Participants 283 284
    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 Hypothesis p-Value 0.8144
    Comments
    Method Log Rank
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.981
    Confidence Interval (2-Sided) 95%
    0.808 to 1.190
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Secondary Outcome
    Title Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] That Assessed by Investigator
    Description 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.
    Time Frame Randomization to PD (Up To 30 Months)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants.
    Arm/Group Title Pegilodecakin + FOLFOX FOLFOX
    Arm/Group Description Pegilodecakin 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 Participants 283 284
    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 Hypothesis p-Value 0.7044
    Comments P-value is calculated by Exact Cochran-Mantel-Haenszel test stratified by the randomization strata Prior Therapy - interactive voice response system (IVRS), Geographic Region - IVRS.
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.8
    Confidence Interval (2-Sided) 95%
    0.4 to 1.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Secondary Outcome
    Title Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD): Disease Control Rate (DCR)
    Description 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.
    Time Frame Randomization 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 Title Pegilodecakin + FOLFOX FOLFOX
    Arm/Group Description Pegilodecakin 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 Participants 283 284
    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 Hypothesis p-Value 0.1463
    Comments P-value is calculated by Exact Cochran-Mantel-Haenszel test stratified by the randomization strata Prior Therapy - interactive voice response system (IVRS), Geographic Region - IVRS.
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.3
    Confidence Interval (2-Sided) 95%
    0.9 to 1.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    5. Secondary Outcome
    Title Duration of Response (DOR)
    Description 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.
    Time Frame Randomization 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 Title Pegilodecakin + FOLFOX FOLFOX
    Arm/Group Description Pegilodecakin 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 Participants 13 16
    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 Hypothesis p-Value 0.9952
    Comments
    Method Log Rank
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 1.008
    Confidence Interval (2-Sided) 95%
    0.370 to 2.741
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    6. Secondary Outcome
    Title Percentage of Participants Alive at 1 Year (12-Month Survival Rate)
    Description The 12-month survival rate is defined as the percentage of participants who have not died 12 months after the date of randomization.
    Time Frame From 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 Title Pegilodecakin + FOLFOX FOLFOX
    Arm/Group Description Pegilodecakin 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 Participants 283 284
    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 Hypothesis p-Value 0.2298
    Comments
    Method Log Rank
    Comments
    Method of Estimation Estimation Parameter Mean 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 Frame Baseline 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 Title Pegilodecakin + FOLFOX FOLFOX
    Arm/Group Description Pegilodecakin 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 + FOLFOX FOLFOX
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 217/278 (78.1%) 188/251 (74.9%)
    Serious Adverse Events
    Pegilodecakin + FOLFOX FOLFOX
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 123/278 (44.2%) 95/251 (37.8%)
    Blood and lymphatic system disorders
    Anaemia 3/278 (1.1%) 5 1/251 (0.4%) 2
    Febrile neutropenia 3/278 (1.1%) 3 1/251 (0.4%) 1
    Neutropenia 2/278 (0.7%) 3 3/251 (1.2%) 4
    Thrombocytopenia 1/278 (0.4%) 1 0/251 (0%) 0
    Cardiac disorders
    Acute myocardial infarction 0/278 (0%) 0 1/251 (0.4%) 1
    Angina pectoris 2/278 (0.7%) 2 0/251 (0%) 0
    Atrial fibrillation 0/278 (0%) 0 2/251 (0.8%) 2
    Cardiac arrest 1/278 (0.4%) 1 1/251 (0.4%) 1
    Cardiac failure acute 0/278 (0%) 0 1/251 (0.4%) 1
    Gastrointestinal disorders
    Abdominal distension 3/278 (1.1%) 3 0/251 (0%) 0
    Abdominal pain 11/278 (4%) 14 3/251 (1.2%) 3
    Abdominal pain lower 0/278 (0%) 0 1/251 (0.4%) 1
    Abdominal pain upper 1/278 (0.4%) 1 1/251 (0.4%) 1
    Ascites 2/278 (0.7%) 2 1/251 (0.4%) 1
    Colitis 2/278 (0.7%) 2 1/251 (0.4%) 1
    Constipation 2/278 (0.7%) 2 1/251 (0.4%) 1
    Diarrhoea 2/278 (0.7%) 3 5/251 (2%) 5
    Duodenal obstruction 1/278 (0.4%) 1 1/251 (0.4%) 1
    Duodenal stenosis 1/278 (0.4%) 1 0/251 (0%) 0
    Duodenal ulcer haemorrhage 1/278 (0.4%) 1 0/251 (0%) 0
    Dyspepsia 0/278 (0%) 0 1/251 (0.4%) 1
    Gastric haemorrhage 1/278 (0.4%) 1 0/251 (0%) 0
    Gastritis 0/278 (0%) 0 1/251 (0.4%) 1
    Gastroduodenal ulcer 1/278 (0.4%) 1 0/251 (0%) 0
    Gastrointestinal haemorrhage 2/278 (0.7%) 2 1/251 (0.4%) 1
    Gastrointestinal stenosis 0/278 (0%) 0 1/251 (0.4%) 1
    Haematemesis 0/278 (0%) 0 2/251 (0.8%) 2
    Ileal perforation 1/278 (0.4%) 1 0/251 (0%) 0
    Intestinal obstruction 1/278 (0.4%) 1 3/251 (1.2%) 3
    Large intestinal obstruction 0/278 (0%) 0 1/251 (0.4%) 1
    Nausea 3/278 (1.1%) 4 0/251 (0%) 0
    Obstruction gastric 0/278 (0%) 0 1/251 (0.4%) 1
    Oesophageal stenosis 0/278 (0%) 0 1/251 (0.4%) 1
    Pancreatitis acute 1/278 (0.4%) 1 0/251 (0%) 0
    Small intestinal haemorrhage 0/278 (0%) 0 1/251 (0.4%) 1
    Small intestinal obstruction 3/278 (1.1%) 3 2/251 (0.8%) 2
    Stomatitis 1/278 (0.4%) 1 0/251 (0%) 0
    Upper gastrointestinal haemorrhage 1/278 (0.4%) 1 1/251 (0.4%) 1
    Vomiting 7/278 (2.5%) 8 5/251 (2%) 5
    General disorders
    Asthenia 2/278 (0.7%) 2 1/251 (0.4%) 1
    Euthanasia 1/278 (0.4%) 1 0/251 (0%) 0
    Fatigue 1/278 (0.4%) 2 2/251 (0.8%) 2
    General physical health deterioration 3/278 (1.1%) 3 2/251 (0.8%) 3
    Generalised oedema 1/278 (0.4%) 1 0/251 (0%) 0
    Hyperpyrexia 0/278 (0%) 0 1/251 (0.4%) 1
    Malaise 1/278 (0.4%) 1 0/251 (0%) 0
    Mucosal inflammation 0/278 (0%) 0 1/251 (0.4%) 1
    Multiple organ dysfunction syndrome 1/278 (0.4%) 1 1/251 (0.4%) 1
    Oedema peripheral 1/278 (0.4%) 1 0/251 (0%) 0
    Pyrexia 13/278 (4.7%) 15 7/251 (2.8%) 7
    Hepatobiliary disorders
    Bile duct obstruction 1/278 (0.4%) 1 1/251 (0.4%) 1
    Bile duct stenosis 1/278 (0.4%) 1 0/251 (0%) 0
    Cholangitis 6/278 (2.2%) 8 2/251 (0.8%) 2
    Cholangitis acute 2/278 (0.7%) 3 0/251 (0%) 0
    Cholecystitis 1/278 (0.4%) 1 0/251 (0%) 0
    Cholecystitis acute 1/278 (0.4%) 1 0/251 (0%) 0
    Hepatic cirrhosis 1/278 (0.4%) 1 0/251 (0%) 0
    Hepatic function abnormal 1/278 (0.4%) 1 0/251 (0%) 0
    Hepatic pain 0/278 (0%) 0 1/251 (0.4%) 1
    Jaundice cholestatic 3/278 (1.1%) 3 3/251 (1.2%) 3
    Immune system disorders
    Anaphylactic reaction 1/278 (0.4%) 1 0/251 (0%) 0
    Infections and infestations
    Abdominal sepsis 1/278 (0.4%) 1 0/251 (0%) 0
    Bacteraemia 3/278 (1.1%) 3 1/251 (0.4%) 1
    Bacterial disease carrier 0/278 (0%) 0 1/251 (0.4%) 1
    Biliary sepsis 0/278 (0%) 0 2/251 (0.8%) 2
    Biliary tract infection 3/278 (1.1%) 3 1/251 (0.4%) 4
    Cellulitis 1/278 (0.4%) 2 0/251 (0%) 0
    Cholangitis infective 0/278 (0%) 0 1/251 (0.4%) 1
    Clostridium difficile colitis 2/278 (0.7%) 2 0/251 (0%) 0
    Device related infection 4/278 (1.4%) 5 0/251 (0%) 0
    Device related sepsis 0/278 (0%) 0 1/251 (0.4%) 1
    Diverticulitis 0/278 (0%) 0 1/251 (0.4%) 1
    Enterobacter sepsis 0/278 (0%) 0 1/251 (0.4%) 1
    Enterocolitis infectious 1/278 (0.4%) 1 0/251 (0%) 0
    Escherichia sepsis 1/278 (0.4%) 1 1/251 (0.4%) 1
    Gastroenteritis 1/278 (0.4%) 1 0/251 (0%) 0
    Gastroenteritis norovirus 1/278 (0.4%) 1 0/251 (0%) 0
    Klebsiella sepsis 0/278 (0%) 0 1/251 (0.4%) 1
    Liver abscess 1/278 (0.4%) 1 1/251 (0.4%) 1
    Lower respiratory tract infection 0/278 (0%) 0 1/251 (0.4%) 1
    Peritonsillar abscess 0/278 (0%) 0 1/251 (0.4%) 1
    Pneumococcal sepsis 0/278 (0%) 0 1/251 (0.4%) 1
    Pneumocystis jirovecii pneumonia 1/278 (0.4%) 1 0/251 (0%) 0
    Pneumonia 7/278 (2.5%) 8 4/251 (1.6%) 4
    Pneumonia cryptococcal 0/278 (0%) 0 1/251 (0.4%) 1
    Respiratory tract infection 1/278 (0.4%) 1 0/251 (0%) 0
    Sepsis 10/278 (3.6%) 10 4/251 (1.6%) 4
    Septic shock 4/278 (1.4%) 7 0/251 (0%) 0
    Urinary tract infection 1/278 (0.4%) 1 1/251 (0.4%) 1
    Urosepsis 0/278 (0%) 0 1/251 (0.4%) 1
    Viral infection 1/278 (0.4%) 1 0/251 (0%) 0
    Injury, poisoning and procedural complications
    Craniocerebral injury 0/278 (0%) 0 1/251 (0.4%) 1
    Fibula fracture 1/278 (0.4%) 1 0/251 (0%) 0
    Hip fracture 2/278 (0.7%) 2 1/251 (0.4%) 1
    Infusion related reaction 1/278 (0.4%) 1 0/251 (0%) 0
    Overdose 1/278 (0.4%) 1 0/251 (0%) 0
    Tibia fracture 1/278 (0.4%) 1 0/251 (0%) 0
    Investigations
    Blood bilirubin increased 3/278 (1.1%) 4 4/251 (1.6%) 6
    Neutrophil count decreased 1/278 (0.4%) 1 1/251 (0.4%) 1
    Platelet count decreased 2/278 (0.7%) 3 0/251 (0%) 0
    Metabolism and nutrition disorders
    Adult failure to thrive 1/278 (0.4%) 1 0/251 (0%) 0
    Cachexia 1/278 (0.4%) 1 0/251 (0%) 0
    Decreased appetite 1/278 (0.4%) 1 1/251 (0.4%) 1
    Dehydration 3/278 (1.1%) 3 1/251 (0.4%) 1
    Diabetes mellitus 0/278 (0%) 0 1/251 (0.4%) 1
    Diabetic ketoacidosis 1/278 (0.4%) 1 0/251 (0%) 0
    Diabetic metabolic decompensation 0/278 (0%) 0 1/251 (0.4%) 1
    Failure to thrive 1/278 (0.4%) 1 0/251 (0%) 0
    Hypercalcaemia 1/278 (0.4%) 1 0/251 (0%) 0
    Hyperglycaemia 1/278 (0.4%) 1 0/251 (0%) 0
    Hypokalaemia 1/278 (0.4%) 1 1/251 (0.4%) 1
    Hyponatraemia 2/278 (0.7%) 2 1/251 (0.4%) 1
    Lactic acidosis 1/278 (0.4%) 1 0/251 (0%) 0
    Musculoskeletal and connective tissue disorders
    Back pain 0/278 (0%) 0 3/251 (1.2%) 3
    Bursitis 1/278 (0.4%) 1 0/251 (0%) 0
    Flank pain 0/278 (0%) 0 1/251 (0.4%) 1
    Muscular weakness 0/278 (0%) 0 1/251 (0.4%) 1
    Musculoskeletal pain 1/278 (0.4%) 1 1/251 (0.4%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia 1/278 (0.4%) 1 0/251 (0%) 0
    Tumour pain 1/278 (0.4%) 2 1/251 (0.4%) 1
    Nervous system disorders
    Cerebral ischaemia 0/278 (0%) 0 1/251 (0.4%) 1
    Cerebrovascular accident 1/278 (0.4%) 1 0/251 (0%) 0
    Ischaemic stroke 1/278 (0.4%) 1 1/251 (0.4%) 1
    Lethargy 1/278 (0.4%) 1 0/251 (0%) 0
    Metabolic encephalopathy 1/278 (0.4%) 1 0/251 (0%) 0
    Neuropathy peripheral 0/278 (0%) 0 1/251 (0.4%) 1
    Sciatica 0/278 (0%) 0 1/251 (0.4%) 1
    Transient ischaemic attack 0/278 (0%) 0 1/251 (0.4%) 1
    Product Issues
    Device breakage 0/278 (0%) 0 1/251 (0.4%) 1
    Device failure 1/278 (0.4%) 1 0/251 (0%) 0
    Device occlusion 3/278 (1.1%) 3 0/251 (0%) 0
    Psychiatric disorders
    Completed suicide 0/278 (0%) 0 1/251 (0.4%) 1
    Mental status changes 1/278 (0.4%) 1 0/251 (0%) 0
    Suicide attempt 1/278 (0.4%) 1 0/251 (0%) 0
    Renal and urinary disorders
    Acute kidney injury 2/278 (0.7%) 2 1/251 (0.4%) 1
    Cystitis haemorrhagic 0/278 (0%) 0 1/251 (0.4%) 1
    Nephrolithiasis 1/278 (0.4%) 1 0/251 (0%) 0
    Oliguria 0/278 (0%) 0 1/251 (0.4%) 1
    Renal failure 1/278 (0.4%) 1 0/251 (0%) 0
    Urinary tract obstruction 0/278 (0%) 0 1/251 (0.4%) 1
    Reproductive system and breast disorders
    Prostatic obstruction 1/144 (0.7%) 1 0/134 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome 1/278 (0.4%) 1 0/251 (0%) 0
    Asthma 1/278 (0.4%) 1 0/251 (0%) 0
    Chronic obstructive pulmonary disease 0/278 (0%) 0 1/251 (0.4%) 1
    Pleural effusion 2/278 (0.7%) 2 1/251 (0.4%) 1
    Pneumonitis 2/278 (0.7%) 2 0/251 (0%) 0
    Pulmonary embolism 2/278 (0.7%) 2 3/251 (1.2%) 3
    Respiratory acidosis 1/278 (0.4%) 1 0/251 (0%) 0
    Skin and subcutaneous tissue disorders
    Rash maculo-papular 1/278 (0.4%) 1 0/251 (0%) 0
    Vascular disorders
    Aortic embolus 0/278 (0%) 0 1/251 (0.4%) 1
    Deep vein thrombosis 1/278 (0.4%) 2 1/251 (0.4%) 1
    Embolism 2/278 (0.7%) 2 2/251 (0.8%) 2
    Internal haemorrhage 1/278 (0.4%) 1 0/251 (0%) 0
    Peripheral coldness 0/278 (0%) 0 1/251 (0.4%) 1
    Other (Not Including Serious) Adverse Events
    Pegilodecakin + FOLFOX FOLFOX
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 271/278 (97.5%) 240/251 (95.6%)
    Blood and lymphatic system disorders
    Anaemia 107/278 (38.5%) 204 38/251 (15.1%) 56
    Neutropenia 58/278 (20.9%) 118 41/251 (16.3%) 65
    Thrombocytopenia 99/278 (35.6%) 296 28/251 (11.2%) 42
    Gastrointestinal disorders
    Abdominal distension 18/278 (6.5%) 22 14/251 (5.6%) 15
    Abdominal pain 82/278 (29.5%) 114 58/251 (23.1%) 82
    Abdominal pain upper 20/278 (7.2%) 34 14/251 (5.6%) 17
    Ascites 28/278 (10.1%) 35 19/251 (7.6%) 20
    Constipation 79/278 (28.4%) 93 59/251 (23.5%) 70
    Diarrhoea 70/278 (25.2%) 104 71/251 (28.3%) 101
    Dyspepsia 21/278 (7.6%) 23 14/251 (5.6%) 16
    Flatulence 14/278 (5%) 15 4/251 (1.6%) 6
    Nausea 126/278 (45.3%) 217 106/251 (42.2%) 160
    Stomatitis 27/278 (9.7%) 37 40/251 (15.9%) 48
    Vomiting 80/278 (28.8%) 122 69/251 (27.5%) 106
    General disorders
    Asthenia 76/278 (27.3%) 151 45/251 (17.9%) 105
    Fatigue 105/278 (37.8%) 181 74/251 (29.5%) 108
    Injection site erythema 18/278 (6.5%) 18 0/251 (0%) 0
    Oedema peripheral 41/278 (14.7%) 49 22/251 (8.8%) 25
    Pyrexia 56/278 (20.1%) 82 36/251 (14.3%) 51
    Investigations
    Aspartate aminotransferase increased 12/278 (4.3%) 17 14/251 (5.6%) 22
    Blood alkaline phosphatase increased 21/278 (7.6%) 28 15/251 (6%) 20
    Blood bilirubin increased 19/278 (6.8%) 28 10/251 (4%) 12
    Neutrophil count decreased 47/278 (16.9%) 84 30/251 (12%) 51
    Platelet count decreased 59/278 (21.2%) 163 26/251 (10.4%) 51
    Weight decreased 14/278 (5%) 17 25/251 (10%) 34
    Metabolism and nutrition disorders
    Decreased appetite 97/278 (34.9%) 132 77/251 (30.7%) 100
    Dehydration 12/278 (4.3%) 22 14/251 (5.6%) 19
    Hyperglycaemia 14/278 (5%) 20 10/251 (4%) 11
    Hypoalbuminaemia 20/278 (7.2%) 28 10/251 (4%) 11
    Hypokalaemia 21/278 (7.6%) 37 29/251 (11.6%) 39
    Hyponatraemia 11/278 (4%) 15 16/251 (6.4%) 21
    Musculoskeletal and connective tissue disorders
    Back pain 37/278 (13.3%) 44 32/251 (12.7%) 39
    Nervous system disorders
    Dizziness 19/278 (6.8%) 23 8/251 (3.2%) 9
    Dysgeusia 19/278 (6.8%) 22 9/251 (3.6%) 11
    Headache 18/278 (6.5%) 24 17/251 (6.8%) 20
    Neuropathy peripheral 40/278 (14.4%) 50 38/251 (15.1%) 62
    Neurotoxicity 13/278 (4.7%) 25 15/251 (6%) 30
    Paraesthesia 24/278 (8.6%) 34 17/251 (6.8%) 44
    Peripheral sensory neuropathy 31/278 (11.2%) 48 29/251 (11.6%) 35
    Polyneuropathy 9/278 (3.2%) 13 14/251 (5.6%) 25
    Psychiatric disorders
    Insomnia 14/278 (5%) 14 13/251 (5.2%) 13
    Respiratory, thoracic and mediastinal disorders
    Cough 17/278 (6.1%) 22 19/251 (7.6%) 22
    Dyspnoea 30/278 (10.8%) 41 15/251 (6%) 17
    Skin and subcutaneous tissue disorders
    Pruritus 15/278 (5.4%) 24 8/251 (3.2%) 11
    Rash 23/278 (8.3%) 34 9/251 (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/Title Chief Medical Officer
    Organization Eli Lilly and Company
    Phone 800-545-5979
    Email ClinicalTrials.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