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
Enrollment
35
Locations
2
Arms
23.4
Actual Duration (Months)
1.5
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 nivolumab versus nivolumab alone in participants with metastatic non-small cell lung cancer as measured by objective response rate.

Condition or DiseaseIntervention/TreatmentPhase
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

ArmIntervention/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

    SiteCityStateCountryPostal Code
    1Arizona Oncology Associates, P.C.TempeArizonaUnited States85284
    2Beverly Hills Cancer CenterBeverly HillsCaliforniaUnited States90211
    3Glendale Adventist Medical CenterLos AngelesCaliforniaUnited States90017
    4Redwood Regional Oncology CenterSanta RosaCaliforniaUnited States95403
    5The Oncology Institute of Hope and InnovationWhittierCaliforniaUnited States90602
    6Rocky Mountain Cancer CenterLone TreeColoradoUnited States80124
    7John B. Amos Cancer CenterColumbusGeorgiaUnited States31904
    8Covenant ClinicWaterlooIowaUnited States50702
    9Baptist Health Medical GroupLexingtonKentuckyUnited States40503
    10MedStar Health Research InstituteBaltimoreMarylandUnited States21237
    11Maryland Oncology Hematology, P.A.ColumbiaMarylandUnited States21044
    12Frederick Memorial HospitalFrederickMarylandUnited States21701
    13Sparrow Health SystemLansingMichiganUnited States48912
    14Hattiesburg ClinicHattiesburgMississippiUnited States39401
    15The Valley Hospital - Luckow PavilionWestwoodNew JerseyUnited States07675
    16Broome Oncology LLCJohnson CityNew YorkUnited States13790
    17Winthrop University HospitalMineolaNew YorkUnited States11501
    18Clinical Research Alliance, Inc.New Hyde ParkNew YorkUnited States11042
    19Stony Brook University Medical CenterStony BrookNew YorkUnited States11794
    20Gabrail Cancer CenterCantonOhioUnited States44718
    21Christ HospitalCincinnatiOhioUnited States45219
    22University of Toledo Medical CenterToledoOhioUnited States43614-2598
    23Charleston Hematology Oncology AssociatesCharlestonSouth CarolinaUnited States29414
    24Mamie McFaddin Ward Cancer CenterBeaumontTexasUnited States77702
    25Texas Oncology - Dallas Presbyterian HospitalDallasTexasUnited States75231
    26Texas Oncology-Baylor Charles A. Sammons Cancer CenterDallasTexasUnited States75246
    27Texas Oncology-Memorial CityHoustonTexasUnited States77024
    28Millennium OncologyHoustonTexasUnited States77090
    29Joe Arrington Cancer CenterLubbockTexasUnited States79410
    30Texas Oncology - Midland Allison Cancer CenterMidlandTexasUnited States79701
    31US OncologyThe WoodlandsTexasUnited States77380
    32Texas Oncology - TylerTylerTexasUnited States75702
    33Fairfax Northern Virginia Hematology Oncology, PCFairfaxVirginiaUnited States22031
    34Oncology and Hematology Associates of Southwest Virginia IncRoanokeVirginiaUnited States24014
    35MultiCare Regional Cancer Center - AuburnTacomaWashingtonUnited States98002

    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 DetailCompleter's included participants who had progression free survival events (Progressive Disease (PD) or death).
    Arm/Group TitlePegilodecakin+NivolumabNivolumab
    Arm/Group DescriptionParticipants 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
    STARTED2725
    Received at Least 1 Dose of Study Drug2724
    COMPLETED2113
    NOT COMPLETED612

    Baseline Characteristics

    Arm/Group TitlePegilodecakin + NivolumabNivolumabTotal
    Arm/Group DescriptionParticipants 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 Participants272552
    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
    TitlePercentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
    DescriptionObjective 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 FrameFrom 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 TitlePegilodecakin + NivolumabNivolumab
    Arm/Group DescriptionParticipants 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 Participants2725
    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 Hypothesisp-Value
    Comments
    Method
    Comments
    Method of EstimationEstimation ParameterOdds Ratio (OR)
    Estimated Value1.2
    Confidence Interval (2-Sided) 95%
    0.3 to 5.9
    Parameter Dispersion Type:
    Value:
    Estimation CommentsOdds 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
    TitleOverall Survival (OS)
    DescriptionOS 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 FrameFrom 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 TitlePegilodecakin + NivolumabNivolumab
    Arm/Group DescriptionParticipants 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 Participants2725
    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 Hypothesisp-Value
    Comments
    Method
    Comments
    Method of EstimationEstimation ParameterHazard Ratio (HR)
    Estimated Value1.006
    Confidence Interval (2-Sided) 95%
    0.519 to 1.951
    Parameter Dispersion Type:
    Value:
    Estimation CommentsThe 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
    TitleProgression Free Survival (PFS)
    DescriptionPFS 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 FrameFrom 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 TitlePegilodecakin + NivolumabNivolumab
    Arm/Group DescriptionParticipants 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 Participants2725
    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 Hypothesisp-Value
    Comments
    Method
    Comments
    Method of EstimationEstimation ParameterHazard Ratio (HR)
    Estimated Value1.871
    Confidence Interval (2-Sided) 95%
    0.772 to 4.532
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Other Statistical AnalysisThe estimate of the hazard ration (HR) stratified based on tumor histology at randomization (IWRS) and smoking status (IWRS).
    4. Secondary Outcome
    TitleDisease Control Rate (DCR): Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD)
    DescriptionDisease 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 FrameFrom 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 TitlePegilodecakin + NivolumabNivolumab
    Arm/Group DescriptionParticipants 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 Participants2725
    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 Hypothesisp-Value
    Comments
    Method
    Comments
    Method of EstimationEstimation ParameterOdds Ratio (OR)
    Estimated Value1.3
    Confidence Interval (2-Sided) 95%
    0.4 to 4.1
    Parameter Dispersion Type:
    Value:
    Estimation CommentsOdds 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
    TitleDuration of Response
    DescriptionDuration 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 FrameFrom 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 TitlePegilodecakin + NivolumabNivolumab
    Arm/Group DescriptionParticipants 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 Participants43
    Median (95% Confidence Interval) [Months]
    NA
    3.06

    Adverse Events

    Time FrameUp 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 TitlePegilodecakin + NivolumabNivolumab
    Arm/Group DescriptionParticipants 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 + NivolumabNivolumab
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total15/27 (55.6%) 12/24 (50%)
    Serious Adverse Events
    Pegilodecakin + NivolumabNivolumab
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total13/27 (48.1%) 9/24 (37.5%)
    Blood and lymphatic system disorders
    Anaemia4/27 (14.8%) 41/24 (4.2%) 1
    Haemolysis1/27 (3.7%) 10/24 (0%) 0
    Thrombocytopenia1/27 (3.7%) 10/24 (0%) 0
    Cardiac disorders
    Cardiac arrest0/27 (0%) 01/24 (4.2%) 1
    Cardio-respiratory arrest0/27 (0%) 01/24 (4.2%) 1
    Cardiomyopathy1/27 (3.7%) 10/24 (0%) 0
    Tachycardia0/27 (0%) 01/24 (4.2%) 2
    Gastrointestinal disorders
    Bezoar1/27 (3.7%) 10/24 (0%) 0
    General disorders
    Asthenia1/27 (3.7%) 10/24 (0%) 0
    Pyrexia1/27 (3.7%) 10/24 (0%) 0
    Infections and infestations
    Pleural infection0/27 (0%) 01/24 (4.2%) 1
    Pneumonia1/27 (3.7%) 13/24 (12.5%) 3
    Rhinovirus infection0/27 (0%) 01/24 (4.2%) 1
    Sepsis1/27 (3.7%) 11/24 (4.2%) 1
    Streptococcal bacteraemia0/27 (0%) 01/24 (4.2%) 1
    Injury, poisoning and procedural complications
    Fall2/27 (7.4%) 20/24 (0%) 0
    Spinal fracture1/27 (3.7%) 10/24 (0%) 0
    Metabolism and nutrition disorders
    Dehydration1/27 (3.7%) 11/24 (4.2%) 1
    Hyperkalaemia1/27 (3.7%) 10/24 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bone neoplasm1/27 (3.7%) 10/24 (0%) 0
    Malignant pleural effusion0/27 (0%) 01/24 (4.2%) 1
    Tumour pain1/27 (3.7%) 10/24 (0%) 0
    Nervous system disorders
    Metabolic encephalopathy0/27 (0%) 01/24 (4.2%) 1
    Syncope0/27 (0%) 01/24 (4.2%) 1
    Psychiatric disorders
    Mental status changes0/27 (0%) 01/24 (4.2%) 1
    Renal and urinary disorders
    Acute kidney injury1/27 (3.7%) 10/24 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure2/27 (7.4%) 20/24 (0%) 0
    Bronchospasm0/27 (0%) 01/24 (4.2%) 1
    Dyspnoea1/27 (3.7%) 12/24 (8.3%) 4
    Hypoxia0/27 (0%) 02/24 (8.3%) 2
    Pleural effusion0/27 (0%) 01/24 (4.2%) 2
    Respiratory failure1/27 (3.7%) 10/24 (0%) 0
    Vascular disorders
    Hypotension0/27 (0%) 01/24 (4.2%) 1
    Superior vena cava syndrome1/27 (3.7%) 10/24 (0%) 0
    Other (Not Including Serious) Adverse Events
    Pegilodecakin + NivolumabNivolumab
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total27/27 (100%) 22/24 (91.7%)
    Blood and lymphatic system disorders
    Anaemia14/27 (51.9%) 375/24 (20.8%) 24
    Thrombocytopenia5/27 (18.5%) 152/24 (8.3%) 3
    Cardiac disorders
    Atrial fibrillation1/27 (3.7%) 14/24 (16.7%) 5
    Ear and labyrinth disorders
    Ear discomfort0/27 (0%) 02/24 (8.3%) 2
    Endocrine disorders
    Hypothyroidism3/27 (11.1%) 33/24 (12.5%) 3
    Gastrointestinal disorders
    Abdominal pain2/27 (7.4%) 21/24 (4.2%) 2
    Constipation7/27 (25.9%) 85/24 (20.8%) 5
    Diarrhoea2/27 (7.4%) 33/24 (12.5%) 4
    Dyspepsia2/27 (7.4%) 21/24 (4.2%) 1
    Gastrooesophageal reflux disease0/27 (0%) 02/24 (8.3%) 2
    Nausea4/27 (14.8%) 54/24 (16.7%) 7
    Vomiting6/27 (22.2%) 62/24 (8.3%) 2
    General disorders
    Asthenia4/27 (14.8%) 91/24 (4.2%) 1
    Chills3/27 (11.1%) 30/24 (0%) 0
    Fatigue17/27 (63%) 3510/24 (41.7%) 18
    Gait disturbance3/27 (11.1%) 30/24 (0%) 0
    Influenza like illness2/27 (7.4%) 20/24 (0%) 0
    Injection site rash5/27 (18.5%) 50/24 (0%) 0
    Oedema peripheral4/27 (14.8%) 113/24 (12.5%) 3
    Pain1/27 (3.7%) 12/24 (8.3%) 2
    Pyrexia8/27 (29.6%) 144/24 (16.7%) 4
    Infections and infestations
    Pneumonia2/27 (7.4%) 32/24 (8.3%) 2
    Upper respiratory tract infection1/27 (3.7%) 22/24 (8.3%) 3
    Urinary tract infection2/27 (7.4%) 23/24 (12.5%) 5
    Vaginal infection0/10 (0%) 01/11 (9.1%) 1
    Injury, poisoning and procedural complications
    Fall1/27 (3.7%) 13/24 (12.5%) 5
    Investigations
    Alanine aminotransferase increased1/27 (3.7%) 12/24 (8.3%) 4
    Aspartate aminotransferase increased2/27 (7.4%) 23/24 (12.5%) 6
    Blood alkaline phosphatase increased3/27 (11.1%) 32/24 (8.3%) 4
    Blood bilirubin increased2/27 (7.4%) 21/24 (4.2%) 1
    Blood creatinine increased2/27 (7.4%) 30/24 (0%) 0
    Blood thyroid stimulating hormone increased2/27 (7.4%) 21/24 (4.2%) 1
    Platelet count decreased4/27 (14.8%) 50/24 (0%) 0
    Troponin increased2/27 (7.4%) 20/24 (0%) 0
    Weight decreased5/27 (18.5%) 65/24 (20.8%) 6
    Metabolism and nutrition disorders
    Decreased appetite11/27 (40.7%) 127/24 (29.2%) 9
    Dehydration6/27 (22.2%) 83/24 (12.5%) 5
    Hyperglycaemia2/27 (7.4%) 81/24 (4.2%) 2
    Hypoalbuminaemia2/27 (7.4%) 40/24 (0%) 0
    Hypocalcaemia2/27 (7.4%) 21/24 (4.2%) 1
    Hypokalaemia4/27 (14.8%) 74/24 (16.7%) 7
    Hypomagnesaemia2/27 (7.4%) 23/24 (12.5%) 4
    Hypophosphataemia0/27 (0%) 02/24 (8.3%) 3
    Musculoskeletal and connective tissue disorders
    Arthralgia3/27 (11.1%) 35/24 (20.8%) 7
    Back pain3/27 (11.1%) 32/24 (8.3%) 2
    Groin pain2/27 (7.4%) 40/24 (0%) 0
    Muscular weakness1/27 (3.7%) 13/24 (12.5%) 3
    Musculoskeletal chest pain1/27 (3.7%) 13/24 (12.5%) 5
    Musculoskeletal pain2/27 (7.4%) 20/24 (0%) 0
    Pain in extremity2/27 (7.4%) 21/24 (4.2%) 1
    Nervous system disorders
    Dizziness7/27 (25.9%) 104/24 (16.7%) 4
    Dysgeusia2/27 (7.4%) 30/24 (0%) 0
    Headache2/27 (7.4%) 32/24 (8.3%) 2
    Psychiatric disorders
    Anxiety3/27 (11.1%) 42/24 (8.3%) 2
    Depression0/27 (0%) 03/24 (12.5%) 3
    Insomnia4/27 (14.8%) 43/24 (12.5%) 3
    Renal and urinary disorders
    Pollakiuria0/27 (0%) 03/24 (12.5%) 3
    Reproductive system and breast disorders
    Erectile dysfunction1/17 (5.9%) 10/14 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease2/27 (7.4%) 23/24 (12.5%) 3
    Cough8/27 (29.6%) 94/24 (16.7%) 5
    Dysphonia2/27 (7.4%) 21/24 (4.2%) 1
    Dyspnoea14/27 (51.9%) 1810/24 (41.7%) 16
    Haemoptysis2/27 (7.4%) 31/24 (4.2%) 1
    Hypoxia2/27 (7.4%) 23/24 (12.5%) 4
    Nasal congestion0/27 (0%) 02/24 (8.3%) 2
    Oropharyngeal pain2/27 (7.4%) 21/24 (4.2%) 1
    Pleural effusion2/27 (7.4%) 21/24 (4.2%) 1
    Wheezing1/27 (3.7%) 12/24 (8.3%) 3
    Skin and subcutaneous tissue disorders
    Alopecia0/27 (0%) 02/24 (8.3%) 2
    Decubitus ulcer2/27 (7.4%) 30/24 (0%) 0
    Pruritus4/27 (14.8%) 75/24 (20.8%) 6
    Rash5/27 (18.5%) 51/24 (4.2%) 2
    Rash maculo-papular2/27 (7.4%) 31/24 (4.2%) 1
    Rash pruritic2/27 (7.4%) 30/24 (0%) 0
    Vascular disorders
    Hypotension7/27 (25.9%) 96/24 (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/TitleChief Medical Officer
    OrganizationEli Lilly and Company
    Phone800-545-5979
    EmailClinicalTrials.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