Cypress 2: Study of Pegilodecakin (LY3500518) With Nivolumab Compared to Nivolumab Alone Second-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Terminated
CT.gov ID
NCT03382912
Collaborator
ARMO BioSciences (Industry)
52
35
2
23.4
1.5
0.1

Study Details

Study Description

Brief Summary

To compare the efficacy of pegilodecakin in combination with nivolumab versus nivolumab alone in participants with metastatic non-small cell lung cancer as measured by objective response rate.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

This is an open-label, multi-center, randomized, Phase 2 study designed to compare the efficacy and safety of pegilodecakin in combination with nivolumab versus nivolumab alone in participants with stage IV / metastatic wild type non-small cell lung cancer and tumors with low tumor expression of PD-L1 (0-49%).

Study Design

Study Type:
Interventional
Actual Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Phase 2 Trial of AM0010 in Combination With Nivolumab vs. Nivolumab Alone as Second-Line Therapy in Subjects With Stage IV / Metastatic Wild Type Non-Small Cell Lung Cancer and Low Tumor Expression of PD-L1
Actual Study Start Date :
Mar 22, 2018
Actual Primary Completion Date :
Aug 28, 2019
Actual Study Completion Date :
Mar 3, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pegilodecakin+Nivolumab

Participants received Pegilodecakin subcutaneously at 0.8 milligrams (mg) (≤80 kilograms (kg) body weight) or 1.6 mg (>80 kg body weight) once daily (QD) in the abdomen, thigh or back of upper arm. Nivolumab administered on day 1 of each 14 or 28 day cycle over approximately 30 minutes intravenous (IV) infusion at 240 mg every 2 weeks (Q2W), or 480 mg every 4 weeks (Q4W).

Biological: Pegilodecakin
Pegilodecakin plus Nivolumab
Other Names:
  • LY3500518
  • AM0010
  • Drug: Nivolumab
    Nivolumab Alone

    Active Comparator: Nivolumab

    Participants received Nivolumab on day 1 of each 14- or 28- day cycle over approximately 30 minutes intravenous (IV) infusion at 240 mg every two weeks (Q2W), or 480 mg every 4 weeks (Q4W).

    Drug: Nivolumab
    Nivolumab Alone

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] [From Date of Randomization to Progressive Disease, Death from Any cause (Up to 6 months after the last participant randomized)]

      Objective response rate is the best overall tumor response of complete response (CR) or partial response (PR) as classified by the independent central review according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.

    Secondary Outcome Measures

    1. Overall Survival (OS) [From Date of Randomization to Death Due to Any Cause (Up to 6 months after the last participant randomized)]

      OS is defined as the time from first day of therapy to the date of death from any cause. Participants who were alive at the end of the follow-up period or were lost to follow-up, OS was censored on the last date the participant was known to be alive.

    2. Progression Free Survival (PFS) [From Date of Randomization to Progressive Disease or Death Due to Any Cause (Up to 6 months after the last participant randomized)]

      PFS is defined as the time from the day of randomization to the first evidence of progression as defined by Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) criteria or death from any cause. Progressive Disease (PD) is a 20% increase over the smallest sum of target lesions or new lesions. Participants who died without a reported prior disease progression were considered to have progressed on the day of their death. Participants who did not progress and were subsequently lost to follow-up had their data censored at the day of last tumor assessment.

    3. Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) [From Date of Randomization to Objective Progressive Disease or Start of New Anti-Cancer Therapy (Up to 6 Months after the last participant randomization)]

      Disease control rate (DCR) is the percentage of participants with a best overall response of CR, PR or SD as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as 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 [From Date of Randomization to Death Due to Any Cause (Up to 6 months after the last participant randomized)]

      Duration of response is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1, or the date of death from any cause in the absence of objectively determined disease progression or recurrence. Participants known to be alive and without disease progression will be censored at the time of the last adequate tumor assessment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Participants must have histologically or cytologically confirmed Wild Type NSCLC that is stage IV / metastatic or recurrent

    2. Participants must have received at least one prior systemic therapy that was not an anti-PD-1, anti-PD-L1 and/or anti-CTLA-4 treatment for the advanced stage of the disease

    3. Participants with tumor tissue low expression of PD-L1 as defined by Tumor Proportion Score (TPS) 0% - 49%

    4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

    5. Participants with measurable disease by spiral computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumor (RECIST) v.1.1 criteria

    6. Participants that have completed prior radiotherapy or radiosurgery at least 2 weeks prior to randomization

    Exclusion Criteria:
    1. Participants with active central nervous system (CNS) metastases or carcinomatous meningitis

    2. Participants with any serious or uncontrolled medical disorder or active infection with the hepatitis virus or the human immunodeficiency virus (HIV)

    3. Participants with Grade 1 (NCI-CTCAE v.4.03) toxicities attributed to prior anti-cancer therapy (other than alopecia and fatigue) prior to randomization

    4. Participants that have received nivolumab

    5. Participants that have received therapy with anti-tumor vaccines or other immuno-stimulatory antitumor agents

    6. Participants with a history of severe hypersensitivity reactions to monoclonal antibodies

    7. Participants that have received therapy with anti-PD-1, anti-PD-L1, anti-PD-L-2, anti-CD-137, and/or anti CTLA-4 antibodies

    8. Participants receiving any investigational agent within 28 days of first administration of trial treatment

    9. Pregnant or lactating women

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arizona Oncology Associates, P.C. Tempe Arizona United States 85284
    2 Beverly Hills Cancer Center Beverly Hills California United States 90211
    3 Glendale Adventist Medical Center Los Angeles California United States 90017
    4 Redwood Regional Oncology Center Santa Rosa California United States 95403
    5 The Oncology Institute of Hope and Innovation Whittier California United States 90602
    6 Rocky Mountain Cancer Center Lone Tree Colorado United States 80124
    7 John B. Amos Cancer Center Columbus Georgia United States 31904
    8 Covenant Clinic Waterloo Iowa United States 50702
    9 Baptist Health Medical Group Lexington Kentucky United States 40503
    10 MedStar Health Research Institute Baltimore Maryland United States 21237
    11 Maryland Oncology Hematology, P.A. Columbia Maryland United States 21044
    12 Frederick Memorial Hospital Frederick Maryland United States 21701
    13 Sparrow Health System Lansing Michigan United States 48912
    14 Hattiesburg Clinic Hattiesburg Mississippi United States 39401
    15 The Valley Hospital - Luckow Pavilion Westwood New Jersey United States 07675
    16 Broome Oncology LLC Johnson City New York United States 13790
    17 Winthrop University Hospital Mineola New York United States 11501
    18 Clinical Research Alliance, Inc. New Hyde Park New York United States 11042
    19 Stony Brook University Medical Center Stony Brook New York United States 11794
    20 Gabrail Cancer Center Canton Ohio United States 44718
    21 Christ Hospital Cincinnati Ohio United States 45219
    22 University of Toledo Medical Center Toledo Ohio United States 43614-2598
    23 Charleston Hematology Oncology Associates Charleston South Carolina United States 29414
    24 Mamie McFaddin Ward Cancer Center Beaumont Texas United States 77702
    25 Texas Oncology - Dallas Presbyterian Hospital Dallas Texas United States 75231
    26 Texas Oncology-Baylor Charles A. Sammons Cancer Center Dallas Texas United States 75246
    27 Texas Oncology-Memorial City Houston Texas United States 77024
    28 Millennium Oncology Houston Texas United States 77090
    29 Joe Arrington Cancer Center Lubbock Texas United States 79410
    30 Texas Oncology - Midland Allison Cancer Center Midland Texas United States 79701
    31 US Oncology The Woodlands Texas United States 77380
    32 Texas Oncology - Tyler Tyler Texas United States 75702
    33 Fairfax Northern Virginia Hematology Oncology, PC Fairfax Virginia United States 22031
    34 Oncology and Hematology Associates of Southwest Virginia Inc Roanoke Virginia United States 24014
    35 MultiCare Regional Cancer Center - Auburn Tacoma Washington United States 98002

    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:
    NCT03382912
    Other Study ID Numbers:
    • 17161
    • J1L-AM-JZGD
    • AM0010-202
    First Posted:
    Dec 26, 2017
    Last Update Posted:
    Sep 11, 2020
    Last Verified:
    Jun 1, 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 Completer's included participants who had progression free survival events (Progressive Disease (PD) or death).
    Arm/Group Title Pegilodecakin+Nivolumab Nivolumab
    Arm/Group Description Participants received Pegilodecakin subcutaneously at 0.8 milligrams (mg) (≤80 kilograms (kg) body weight) or 1.6 mg (>80 kg body weight) once daily (QD) in the abdomen, thigh or back of upper arm. Nivolumab administered on day 1 of each 14 or 28 day cycle over approximately 30 minutes intravenous (IV) infusion at 240 mg every 2 weeks (Q2W), or 480 mg every 4 weeks (Q4W). Participants received Nivolumab on day 1 of each 14- or 28- day cycle over approximately 30 minutes intravenous (IV) infusion at 240 mg every two weeks (Q2W), or 480 mg every 4 weeks (Q4W).
    Period Title: Overall Study
    STARTED 27 25
    Received at Least 1 Dose of Study Drug 27 24
    COMPLETED 21 13
    NOT COMPLETED 6 12

    Baseline Characteristics

    Arm/Group Title Pegilodecakin + Nivolumab Nivolumab Total
    Arm/Group Description Participants received Pegilodecakin subcutaneously at 0.8 mg (≤80 kg body weight) or 1.6 mg (>80 kg body weight) once daily in the abdomen, thigh or back of upper arm. Nivolumab administered on day 1 of each 14 or 28 day cycle over approximately 30 minutes IV infusion at 240 mg Q2W, or 480 mg Q4W. Participants received Nivolumab on day 1 of each 14 or 28 day cycle over approximately 30 minutes IV infusion at 240 mg Q2W, or 480 mg Q4W. Total of all reporting groups
    Overall Participants 27 25 52
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    68.4
    (8.2)
    65.9
    (10.4)
    67.2
    (9.3)
    Sex: Female, Male (Count of Participants)
    Female
    10
    37%
    11
    44%
    21
    40.4%
    Male
    17
    63%
    14
    56%
    31
    59.6%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    2
    8%
    2
    3.8%
    Not Hispanic or Latino
    24
    88.9%
    20
    80%
    44
    84.6%
    Unknown or Not Reported
    3
    11.1%
    3
    12%
    6
    11.5%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    1
    3.7%
    0
    0%
    1
    1.9%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    1
    3.7%
    3
    12%
    4
    7.7%
    White
    23
    85.2%
    20
    80%
    43
    82.7%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    2
    7.4%
    2
    8%
    4
    7.7%
    Region of Enrollment (Count of Participants)
    United States
    27
    100%
    25
    100%
    52
    100%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
    Description Objective response rate is the best overall tumor response of complete response (CR) or partial response (PR) as classified by the independent central review according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.
    Time Frame From Date of Randomization to Progressive Disease, Death from Any cause (Up to 6 months after the last participant randomized)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants.
    Arm/Group Title Pegilodecakin + Nivolumab Nivolumab
    Arm/Group Description Participants received Pegilodecakin subcutaneously at 0.8 mg (≤80 kg body weight) or 1.6 mg (>80 kg body weight) once daily in the abdomen, thigh or back of upper arm. Nivolumab administered on day 1 of each 14 or 28 day cycle over approximately 30 minutes IV infusion at 240 mg Q2W or 480 mg Q4W. Participants received Nivolumab on day 1 of each 14 or 28 day cycle over approximately 30 minutes IV infusion at 240 mg Q2W or 480 mg Q4W.
    Measure Participants 27 25
    Number (95% Confidence Interval) [Percentage of participants]
    14.8
    54.8%
    12.0
    48%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Pegilodecakin + Nivolumab, Nivolumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.2
    Confidence Interval (2-Sided) 95%
    0.3 to 5.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments Odds Ratio stratified based on tumor histology at randomization (interactive web response system (IWRS)), smoking status (IWRS). Confidence intervals were based on the Clopper-Pearson method.
    2. Secondary Outcome
    Title Overall Survival (OS)
    Description OS is defined as the time from first day of therapy to the date of death from any cause. Participants who were alive at the end of the follow-up period or were lost to follow-up, OS was censored on the last date the participant was known to be alive.
    Time Frame From Date of Randomization to Death Due to Any Cause (Up to 6 months after the last participant randomized)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants. Participants censored: Pegilodecakin + Nivolumab = 6 and Nivolumab = 5.
    Arm/Group Title Pegilodecakin + Nivolumab Nivolumab
    Arm/Group Description Participants received Pegilodecakin subcutaneously at 0.8 mg (≤80 kg body weight) or 1.6 mg (>80 kg body weight) once daily in the abdomen, thigh or back of upper arm. Nivolumab administered on day 1 of each 14 or 28 day cycle over approximately 30 minutes IV infusion at 240 mg Q2W or 480 mg Q4W. Participants received Nivolumab on day 1 of each 14 or 28 day cycle over approximately 30 minutes IV infusion at 240 mg Q2W or 480 mg Q4W.
    Measure Participants 27 25
    Median (95% Confidence Interval) [Months]
    1.87
    1.94
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Pegilodecakin + Nivolumab, Nivolumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 1.006
    Confidence Interval (2-Sided) 95%
    0.519 to 1.951
    Parameter Dispersion Type:
    Value:
    Estimation Comments The estimate of the hazard ration (HR) stratified based on tumor histology at randomization (interactive web response system (IWRS)) and smoking status (IWRS).
    3. Secondary Outcome
    Title Progression Free Survival (PFS)
    Description PFS is defined as the time from the day of randomization to the first evidence of progression as defined by Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) criteria or death from any cause. Progressive Disease (PD) is a 20% increase over the smallest sum of target lesions or new lesions. Participants who died without a reported prior disease progression were considered to have progressed on the day of their death. Participants who did not progress and were subsequently lost to follow-up had their data censored at the day of last tumor assessment.
    Time Frame From Date of Randomization to Progressive Disease or Death Due to Any Cause (Up to 6 months after the last participant randomized)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants. Participants censored: Pegilodecakin + Nivolumab = 12 and Nivolumab = 16.
    Arm/Group Title Pegilodecakin + Nivolumab Nivolumab
    Arm/Group Description Participants received Pegilodecakin subcutaneously at 0.8 mg (≤80 kg body weight) or 1.6 mg (>80 kg body weight) once daily in the abdomen, thigh or back of upper arm. Nivolumab administered on day 1 of each 14 or 28 day cycle over approximately 30 minutes IV infusion at 240 mg Q2W or 480 mg Q4W. Participants received Nivolumab on day 1 of each 14 or 28 day cycle over approximately 30 minutes IV infusion at 240 mg Q2W or 480 mg Q4W.
    Measure Participants 27 25
    Median (95% Confidence Interval) [Months]
    6.70
    10.74
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Pegilodecakin + Nivolumab, Nivolumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 1.871
    Confidence Interval (2-Sided) 95%
    0.772 to 4.532
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Other Statistical Analysis The estimate of the hazard ration (HR) stratified based on tumor histology at randomization (IWRS) and smoking status (IWRS).
    4. Secondary Outcome
    Title Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD)
    Description Disease control rate (DCR) is the percentage of participants with a best overall response of CR, PR or SD as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as 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 From Date of Randomization to Objective Progressive Disease or Start of New Anti-Cancer Therapy (Up to 6 Months after the last participant randomization)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants.
    Arm/Group Title Pegilodecakin + Nivolumab Nivolumab
    Arm/Group Description Participants received Pegilodecakin subcutaneously at 0.8 mg (≤80 kg body weight) or 1.6 mg (>80 kg body weight) once daily in the abdomen, thigh or back of upper arm. Nivolumab administered on day 1 of each 14 or 28 day cycle over approximately 30 minutes IV infusion at 240 mg Q2W or 480 mg Q4W. Participants received Nivolumab on day 1 of each 14 or 28 day cycle over approximately 30 minutes IV infusion at 240 mg Q2W or 480 mg Q4W.
    Measure Participants 27 25
    Number (95% Confidence Interval) [Percentage of participants]
    37.0
    137%
    28.0
    112%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Pegilodecakin + Nivolumab, Nivolumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.3
    Confidence Interval (2-Sided) 95%
    0.4 to 4.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments Odds Ratio stratified based on tumor histology at randomization (IWRS) and smoking status (IWRS). Confidence intervals were based on the Clopper-Pearson method.
    5. Secondary Outcome
    Title Duration of Response
    Description Duration of response is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1, or the date of death from any cause in the absence of objectively determined disease progression or recurrence. Participants known to be alive and without disease progression will be censored at the time of the last adequate tumor assessment.
    Time Frame From Date of Randomization to Death Due to Any Cause (Up to 6 months after the last participant randomized)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of study drug and had CR or PR responses. Participants censored: Pegilodecakin + Nivolumab = 3 and Nivolumab = 1.
    Arm/Group Title Pegilodecakin + Nivolumab Nivolumab
    Arm/Group Description Participants received Pegilodecakin subcutaneously at 0.8 mg (≤80 kg body weight) or 1.6 mg (>80 kg body weight) once daily in the abdomen, thigh or back of upper arm. Nivolumab administered on day 1 of each 14 or 28 day cycle over approximately 30 minutes IV infusion at 240 mg Q2W or 480 mg Q4W. Participants received Nivolumab on day 1 of each 14 or 28 day cycle over approximately 30 minutes IV infusion at 240 mg Q2W or 480 mg Q4W.
    Measure Participants 4 3
    Median (95% Confidence Interval) [Months]
    NA
    3.06

    Adverse Events

    Time Frame Up to 23 Months
    Adverse Event Reporting Description All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
    Arm/Group Title Pegilodecakin + Nivolumab Nivolumab
    Arm/Group Description Participants received Pegilodecakin subcutaneously at 0.8 mg (≤80 kg body weight) or 1.6 mg (>80 kg body weight) once daily in the abdomen, thigh or back of upper arm. Nivolumab administered on day 1 of each 14 or 28 day cycle over approximately 30 minutes IV infusion at 240 mg Q2W or 480 mg Q4W. Participants received Nivolumab on day 1 of each 14 or 28 day cycle over approximately 30 minutes IV infusion at 240 mg Q2W or 480 mg Q4W.
    All Cause Mortality
    Pegilodecakin + Nivolumab Nivolumab
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 15/27 (55.6%) 12/24 (50%)
    Serious Adverse Events
    Pegilodecakin + Nivolumab Nivolumab
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 13/27 (48.1%) 9/24 (37.5%)
    Blood and lymphatic system disorders
    Anaemia 4/27 (14.8%) 4 1/24 (4.2%) 1
    Haemolysis 1/27 (3.7%) 1 0/24 (0%) 0
    Thrombocytopenia 1/27 (3.7%) 1 0/24 (0%) 0
    Cardiac disorders
    Cardiac arrest 0/27 (0%) 0 1/24 (4.2%) 1
    Cardio-respiratory arrest 0/27 (0%) 0 1/24 (4.2%) 1
    Cardiomyopathy 1/27 (3.7%) 1 0/24 (0%) 0
    Tachycardia 0/27 (0%) 0 1/24 (4.2%) 2
    Gastrointestinal disorders
    Bezoar 1/27 (3.7%) 1 0/24 (0%) 0
    General disorders
    Asthenia 1/27 (3.7%) 1 0/24 (0%) 0
    Pyrexia 1/27 (3.7%) 1 0/24 (0%) 0
    Infections and infestations
    Pleural infection 0/27 (0%) 0 1/24 (4.2%) 1
    Pneumonia 1/27 (3.7%) 1 3/24 (12.5%) 3
    Rhinovirus infection 0/27 (0%) 0 1/24 (4.2%) 1
    Sepsis 1/27 (3.7%) 1 1/24 (4.2%) 1
    Streptococcal bacteraemia 0/27 (0%) 0 1/24 (4.2%) 1
    Injury, poisoning and procedural complications
    Fall 2/27 (7.4%) 2 0/24 (0%) 0
    Spinal fracture 1/27 (3.7%) 1 0/24 (0%) 0
    Metabolism and nutrition disorders
    Dehydration 1/27 (3.7%) 1 1/24 (4.2%) 1
    Hyperkalaemia 1/27 (3.7%) 1 0/24 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bone neoplasm 1/27 (3.7%) 1 0/24 (0%) 0
    Malignant pleural effusion 0/27 (0%) 0 1/24 (4.2%) 1
    Tumour pain 1/27 (3.7%) 1 0/24 (0%) 0
    Nervous system disorders
    Metabolic encephalopathy 0/27 (0%) 0 1/24 (4.2%) 1
    Syncope 0/27 (0%) 0 1/24 (4.2%) 1
    Psychiatric disorders
    Mental status changes 0/27 (0%) 0 1/24 (4.2%) 1
    Renal and urinary disorders
    Acute kidney injury 1/27 (3.7%) 1 0/24 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure 2/27 (7.4%) 2 0/24 (0%) 0
    Bronchospasm 0/27 (0%) 0 1/24 (4.2%) 1
    Dyspnoea 1/27 (3.7%) 1 2/24 (8.3%) 4
    Hypoxia 0/27 (0%) 0 2/24 (8.3%) 2
    Pleural effusion 0/27 (0%) 0 1/24 (4.2%) 2
    Respiratory failure 1/27 (3.7%) 1 0/24 (0%) 0
    Vascular disorders
    Hypotension 0/27 (0%) 0 1/24 (4.2%) 1
    Superior vena cava syndrome 1/27 (3.7%) 1 0/24 (0%) 0
    Other (Not Including Serious) Adverse Events
    Pegilodecakin + Nivolumab Nivolumab
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 27/27 (100%) 22/24 (91.7%)
    Blood and lymphatic system disorders
    Anaemia 14/27 (51.9%) 37 5/24 (20.8%) 24
    Thrombocytopenia 5/27 (18.5%) 15 2/24 (8.3%) 3
    Cardiac disorders
    Atrial fibrillation 1/27 (3.7%) 1 4/24 (16.7%) 5
    Ear and labyrinth disorders
    Ear discomfort 0/27 (0%) 0 2/24 (8.3%) 2
    Endocrine disorders
    Hypothyroidism 3/27 (11.1%) 3 3/24 (12.5%) 3
    Gastrointestinal disorders
    Abdominal pain 2/27 (7.4%) 2 1/24 (4.2%) 2
    Constipation 7/27 (25.9%) 8 5/24 (20.8%) 5
    Diarrhoea 2/27 (7.4%) 3 3/24 (12.5%) 4
    Dyspepsia 2/27 (7.4%) 2 1/24 (4.2%) 1
    Gastrooesophageal reflux disease 0/27 (0%) 0 2/24 (8.3%) 2
    Nausea 4/27 (14.8%) 5 4/24 (16.7%) 7
    Vomiting 6/27 (22.2%) 6 2/24 (8.3%) 2
    General disorders
    Asthenia 4/27 (14.8%) 9 1/24 (4.2%) 1
    Chills 3/27 (11.1%) 3 0/24 (0%) 0
    Fatigue 17/27 (63%) 35 10/24 (41.7%) 18
    Gait disturbance 3/27 (11.1%) 3 0/24 (0%) 0
    Influenza like illness 2/27 (7.4%) 2 0/24 (0%) 0
    Injection site rash 5/27 (18.5%) 5 0/24 (0%) 0
    Oedema peripheral 4/27 (14.8%) 11 3/24 (12.5%) 3
    Pain 1/27 (3.7%) 1 2/24 (8.3%) 2
    Pyrexia 8/27 (29.6%) 14 4/24 (16.7%) 4
    Infections and infestations
    Pneumonia 2/27 (7.4%) 3 2/24 (8.3%) 2
    Upper respiratory tract infection 1/27 (3.7%) 2 2/24 (8.3%) 3
    Urinary tract infection 2/27 (7.4%) 2 3/24 (12.5%) 5
    Vaginal infection 0/10 (0%) 0 1/11 (9.1%) 1
    Injury, poisoning and procedural complications
    Fall 1/27 (3.7%) 1 3/24 (12.5%) 5
    Investigations
    Alanine aminotransferase increased 1/27 (3.7%) 1 2/24 (8.3%) 4
    Aspartate aminotransferase increased 2/27 (7.4%) 2 3/24 (12.5%) 6
    Blood alkaline phosphatase increased 3/27 (11.1%) 3 2/24 (8.3%) 4
    Blood bilirubin increased 2/27 (7.4%) 2 1/24 (4.2%) 1
    Blood creatinine increased 2/27 (7.4%) 3 0/24 (0%) 0
    Blood thyroid stimulating hormone increased 2/27 (7.4%) 2 1/24 (4.2%) 1
    Platelet count decreased 4/27 (14.8%) 5 0/24 (0%) 0
    Troponin increased 2/27 (7.4%) 2 0/24 (0%) 0
    Weight decreased 5/27 (18.5%) 6 5/24 (20.8%) 6
    Metabolism and nutrition disorders
    Decreased appetite 11/27 (40.7%) 12 7/24 (29.2%) 9
    Dehydration 6/27 (22.2%) 8 3/24 (12.5%) 5
    Hyperglycaemia 2/27 (7.4%) 8 1/24 (4.2%) 2
    Hypoalbuminaemia 2/27 (7.4%) 4 0/24 (0%) 0
    Hypocalcaemia 2/27 (7.4%) 2 1/24 (4.2%) 1
    Hypokalaemia 4/27 (14.8%) 7 4/24 (16.7%) 7
    Hypomagnesaemia 2/27 (7.4%) 2 3/24 (12.5%) 4
    Hypophosphataemia 0/27 (0%) 0 2/24 (8.3%) 3
    Musculoskeletal and connective tissue disorders
    Arthralgia 3/27 (11.1%) 3 5/24 (20.8%) 7
    Back pain 3/27 (11.1%) 3 2/24 (8.3%) 2
    Groin pain 2/27 (7.4%) 4 0/24 (0%) 0
    Muscular weakness 1/27 (3.7%) 1 3/24 (12.5%) 3
    Musculoskeletal chest pain 1/27 (3.7%) 1 3/24 (12.5%) 5
    Musculoskeletal pain 2/27 (7.4%) 2 0/24 (0%) 0
    Pain in extremity 2/27 (7.4%) 2 1/24 (4.2%) 1
    Nervous system disorders
    Dizziness 7/27 (25.9%) 10 4/24 (16.7%) 4
    Dysgeusia 2/27 (7.4%) 3 0/24 (0%) 0
    Headache 2/27 (7.4%) 3 2/24 (8.3%) 2
    Psychiatric disorders
    Anxiety 3/27 (11.1%) 4 2/24 (8.3%) 2
    Depression 0/27 (0%) 0 3/24 (12.5%) 3
    Insomnia 4/27 (14.8%) 4 3/24 (12.5%) 3
    Renal and urinary disorders
    Pollakiuria 0/27 (0%) 0 3/24 (12.5%) 3
    Reproductive system and breast disorders
    Erectile dysfunction 1/17 (5.9%) 1 0/14 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease 2/27 (7.4%) 2 3/24 (12.5%) 3
    Cough 8/27 (29.6%) 9 4/24 (16.7%) 5
    Dysphonia 2/27 (7.4%) 2 1/24 (4.2%) 1
    Dyspnoea 14/27 (51.9%) 18 10/24 (41.7%) 16
    Haemoptysis 2/27 (7.4%) 3 1/24 (4.2%) 1
    Hypoxia 2/27 (7.4%) 2 3/24 (12.5%) 4
    Nasal congestion 0/27 (0%) 0 2/24 (8.3%) 2
    Oropharyngeal pain 2/27 (7.4%) 2 1/24 (4.2%) 1
    Pleural effusion 2/27 (7.4%) 2 1/24 (4.2%) 1
    Wheezing 1/27 (3.7%) 1 2/24 (8.3%) 3
    Skin and subcutaneous tissue disorders
    Alopecia 0/27 (0%) 0 2/24 (8.3%) 2
    Decubitus ulcer 2/27 (7.4%) 3 0/24 (0%) 0
    Pruritus 4/27 (14.8%) 7 5/24 (20.8%) 6
    Rash 5/27 (18.5%) 5 1/24 (4.2%) 2
    Rash maculo-papular 2/27 (7.4%) 3 1/24 (4.2%) 1
    Rash pruritic 2/27 (7.4%) 3 0/24 (0%) 0
    Vascular disorders
    Hypotension 7/27 (25.9%) 9 6/24 (25%) 7

    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 more than 60 days but less than or equal to 180 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:
    NCT03382912
    Other Study ID Numbers:
    • 17161
    • J1L-AM-JZGD
    • AM0010-202
    First Posted:
    Dec 26, 2017
    Last Update Posted:
    Sep 11, 2020
    Last Verified:
    Jun 1, 2020