A Comparative Study in Chinese Subjects With Chemotherapy Naïve Stage IV Melanoma Receiving Ipilimumab (3 mg/kg) vs. Dacarbazine

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT02545075
Collaborator
(none)
182
Enrollment
8
Locations
2
Arms
41.6
Actual Duration (Months)
22.8
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether Ipilimumab will extend the life of chinese patients with Chemotherapy Naive Stage IV Melanoma more than Dacarbazine as well as to examine safety in this patient population.

Condition or DiseaseIntervention/TreatmentPhase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
182 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Open-Label, Two-arm, Comparative Study in Chinese Subjects With Chemotherapy Naïve Stage IV Melanoma Receiving Ipilimumab (3 mg/kg) vs. Dacarbazine
Actual Study Start Date :
Oct 31, 2015
Actual Primary Completion Date :
Apr 19, 2019
Actual Study Completion Date :
Apr 19, 2019

Arms and Interventions

ArmIntervention/Treatment
Experimental: Ipilimumab

Intravenously (IV) 3 mg/kg every 3 weeks (at week 1,4,7,10) and thereafter (q3w/4 doses) at the time of progression

Drug: Ipilimumab
Other Names:
  • MDX-010
  • Experimental: Dacarbazine

    IV solution 250 mg/m2 (Day 1-5, every 3weeks/at week 1, 4, 7, 10,13,16,19,22)

    Drug: Dacarbazine
    Other Names:
  • DTIC
  • Outcome Measures

    Primary Outcome Measures

    1. Two-Years Survival Rate [24 months]

      Two-year survival rate is defined as the probability that a subject is alive at 2 years following the randomization date and will be estimated via the Kaplan-Meier (KM) method.

    Secondary Outcome Measures

    1. One-Year Survival Rate [Approximately 43 months]

      Survival rate at 1 year is defined as the probability that a subject is alive at 1 year following the randomization date and will be estimated via the Kaplan-Meier (KM) method.

    2. Overall Survival (OS) [Approximately 43 months]

      OS is defined for each subject as the time between randomization date and the date of death (of any cause).

    3. Progression Free Survival ( PFS) [Approximately 43 months]

      PFS is defined for each subject as the time between randomization date and the date of progression or death, whichever occurs first.

    4. Disease Control Rate ( DCR ) [Approximately 43 months]

      Primary DCR is defined as the number of subjects in the arm with Best Overall Response (BOR) of complete response (CR), partial response (PR), or stable disease (SD), divided by the total number of randomized subjects in the arm.

    5. Best Overall Response Rate ( BORR ) [Approximately 43 months]

      BORR definition is defined as the number of subjects in the arm with a BOR of CR or PR, divided by the total number of randomized subjects in the arm.

    6. Duration of Response ( DoR) [Approximately 43 months]

      DoR definition for the response evaluable subjects whose BOR is CR or PR is defined as the time between the date of response of CR or PR (whichever occurs first) and the first date of progressive disease (PD) or the date of death (whichever occurs first).

    7. Duration of Stable Disease ( DoSD ) [Approximately 43 months]

      Primary duration of stable disease (DoSD) definition for the randomized subjects whose BOR is SD is defined as the time between the randomization date and the first date of PD or the date of death (whichever occurs first)."

    Eligibility Criteria

    Criteria

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

    For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

    Inclusion Criteria:
    • Chinese males and females ≥ 18 years of age

    • Histologic diagnosis of malignant melanoma

    • Chemotherapy naive Stage IV melanoma (AJCC 2010)

    • Life expectancy of ≥ 16 weeks

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

    Exclusion Criteria:
    • Evidence of brain metastases on brain imaging

    • Primary ocular or mucosal melanoma

    • Any other malignancy from which the patient has been disease-free for less than 5 years

    • BRAF status cannot be determined by Screening test

    • Human Immunodeficiency Virus (HIV) positive or hepatitis B surface antigen (HBsAg) positive, or active Hepatitis C infection

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Local InstitutionNanjingJiangsuChina210000
    2Local InstitutionChangchunJilinChina130021
    3Local InstitutionXi'anShanxiChina710038
    4Local InstitutionTianjingTianjinChina300060
    5Local InstitutionHanghzouZhejiangChina
    6Local InstitutionBeijingChina100142
    7Local InstitutionKunmingChina
    8Local InstitutionShanghaiChina200032

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT02545075
    Other Study ID Numbers:
    • CA184-248
    First Posted:
    Sep 9, 2015
    Last Update Posted:
    May 19, 2020
    Last Verified:
    May 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail182 participants were enrolled, 68 were not randomized, reasons for not being randomized:3 participants withdrew consent and 65 no longer meet study criteria.
    Arm/Group TitleIpilimumab (3 mg/kg)Dacarbazine (250 mg/m2)
    Arm/Group DescriptionIpilimumab 3 mg/kg to be administered via intravenous infusion over 90 minutes at Weeks 1, 4, 7 and 10, for a total of four doses in Induction (and Re-Induction for those randomized to the ipilimumab arm who qualify)DTIC 250 mg/m2 - Day 1 - 5, to be administered via intravenous infusion at Weeks 1, 4, 7, 10, 13, 16,19, and 22.
    Period Title: Randomization
    STARTED12260
    COMPLETED12253
    NOT COMPLETED07
    Period Title: Randomization
    STARTED12253
    COMPLETED00
    NOT COMPLETED12253

    Baseline Characteristics

    Arm/Group TitleIpilimumab (3 mg/kg)Dacarbazine (250 mg/m2)Total
    Arm/Group DescriptionIpilimumab 3 mg/kg to be administered via intravenous infusion over 90 minutes at Weeks 1, 4, 7 and 10, for a total of four doses in Induction (and Re-Induction for those randomized to the ipilimumab arm who qualify)DTIC 250 mg/m2 - Day 1 - 5, to be administered via intravenous infusion at Weeks 1, 4, 7, 10, 13, 16,19, and 22.Total of all reporting groups
    Overall Participants12260182
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    53.6
    (13.69)
    54.3
    (13.39)
    53.8
    (13.56)
    Sex: Female, Male (Count of Participants)
    Female
    53
    43.4%
    26
    43.3%
    79
    43.4%
    Male
    69
    56.6%
    34
    56.7%
    103
    56.6%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    0
    0%
    0
    0%
    Not Hispanic or Latino
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    122
    100%
    60
    100%
    182
    100%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    122
    100%
    60
    100%
    182
    100%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    0
    0%
    0
    0%
    0
    0%
    White
    0
    0%
    0
    0%
    0
    0%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%

    Outcome Measures

    1. Primary Outcome
    TitleTwo-Years Survival Rate
    DescriptionTwo-year survival rate is defined as the probability that a subject is alive at 2 years following the randomization date and will be estimated via the Kaplan-Meier (KM) method.
    Time Frame24 months

    Outcome Measure Data

    Analysis Population Description
    All randomized participants
    Arm/Group TitleIpilimumab (3 mg/kg)Dacarbazine (250 mg/m2)
    Arm/Group DescriptionIpilimumab 3 mg/kg to be administered via intravenous infusion over 90 minutes at Weeks 1, 4, 7 and 10, for a total of four doses in Induction (and Re-Induction for those randomized to the ipilimumab arm who qualify)DTIC 250 mg/m2 - Day 1 - 5, to be administered via intravenous infusion at Weeks 1, 4, 7, 10, 13, 16,19, and 22.
    Measure Participants12260
    Number (80% Confidence Interval) [Percentage of Participants]
    33.98
    27.9%
    34.09
    56.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Ipilimumab (3 mg/kg), Dacarbazine (250 mg/m2)
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesisp-Value0.5059
    Comments
    MethodChi-squared
    CommentsOne-sided p-value based on unstratified chi-square test
    2. Secondary Outcome
    TitleOne-Year Survival Rate
    DescriptionSurvival rate at 1 year is defined as the probability that a subject is alive at 1 year following the randomization date and will be estimated via the Kaplan-Meier (KM) method.
    Time FrameApproximately 43 months

    Outcome Measure Data

    Analysis Population Description
    All randomized participants
    Arm/Group TitleIpilimumab (3 mg/kg)Dacarbazine (250 mg/m2)
    Arm/Group DescriptionIpilimumab 3 mg/kg to be administered via intravenous infusion over 90 minutes at Weeks 1, 4, 7 and 10, for a total of four doses in Induction (and Re-Induction for those randomized to the ipilimumab arm who qualify)DTIC 250 mg/m2 - Day 1 - 5, to be administered via intravenous infusion at Weeks 1, 4, 7, 10, 13, 16,19, and 22.
    Measure Participants12260
    Number (80% Confidence Interval) [Percentage of Participants]
    61.68
    50.6%
    64.11
    106.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Ipilimumab (3 mg/kg), Dacarbazine (250 mg/m2)
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesisp-Value0.6202
    Comments
    MethodChi-squared
    CommentsOne-sided unstratified chi-square
    3. Secondary Outcome
    TitleOverall Survival (OS)
    DescriptionOS is defined for each subject as the time between randomization date and the date of death (of any cause).
    Time FrameApproximately 43 months

    Outcome Measure Data

    Analysis Population Description
    All randomized participants
    Arm/Group TitleIpilimumab (3 mg/kg)Dacarbazine (250 mg/m2)
    Arm/Group DescriptionIpilimumab 3 mg/kg to be administered via intravenous infusion over 90 minutes at Weeks 1, 4, 7 and 10, for a total of four doses in Induction (and Re-Induction for those randomized to the ipilimumab arm who qualify)DTIC 250 mg/m2 - Day 1 - 5, to be administered via intravenous infusion at Weeks 1, 4, 7, 10, 13, 16,19, and 22.
    Measure Participants12260
    Median (80% Confidence Interval) [Months]
    15.08
    14.55
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Ipilimumab (3 mg/kg), Dacarbazine (250 mg/m2)
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesisp-Value0.7267
    Comments
    MethodLog Rank
    CommentsOne-sided p-value from Log-rank Test stratified by M substage (M1a+M1b vs. M1c)
    Method of EstimationEstimation ParameterStratified cox proportional hazard model
    Estimated Value1.13
    Confidence Interval (2-Sided) 80%
    0.87 to 1.45
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Secondary Outcome
    TitleProgression Free Survival ( PFS)
    DescriptionPFS is defined for each subject as the time between randomization date and the date of progression or death, whichever occurs first.
    Time FrameApproximately 43 months

    Outcome Measure Data

    Analysis Population Description
    All randomized participants
    Arm/Group TitleIpilimumab (3 mg/kg)Dacarbazine (250 mg/m2)
    Arm/Group DescriptionIpilimumab 3 mg/kg to be administered via intravenous infusion over 90 minutes at Weeks 1, 4, 7 and 10, for a total of four doses in Induction (and Re-Induction for those randomized to the ipilimumab arm who qualify)DTIC 250 mg/m2 - Day 1 - 5, to be administered via intravenous infusion at Weeks 1, 4, 7, 10, 13, 16,19, and 22.
    Measure Participants12260
    Median (80% Confidence Interval) [Months]
    2.60
    1.84
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Ipilimumab (3 mg/kg), Dacarbazine (250 mg/m2)
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesisp-Value0.2503
    Comments
    MethodLog Rank
    CommentsOne-sided p-value from Log-rank Test stratified by M substage (M1a+M1b vs. M1c) and BRAF mutation status as entered into the IVRS
    Method of EstimationEstimation ParameterStratified Cox proportional hazard
    Estimated Value0.90
    Confidence Interval (2-Sided) 80%
    0.71 to 1.15
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    5. Secondary Outcome
    TitleDisease Control Rate ( DCR )
    DescriptionPrimary DCR is defined as the number of subjects in the arm with Best Overall Response (BOR) of complete response (CR), partial response (PR), or stable disease (SD), divided by the total number of randomized subjects in the arm.
    Time FrameApproximately 43 months

    Outcome Measure Data

    Analysis Population Description
    All randomized participants
    Arm/Group TitleIpilimumab (3 mg/kg)Dacarbazine (250 mg/m2)
    Arm/Group DescriptionIpilimumab 3 mg/kg to be administered via intravenous infusion over 90 minutes at Weeks 1, 4, 7 and 10, for a total of four doses in Induction (and Re-Induction for those randomized to the ipilimumab arm who qualify)DTIC 250 mg/m2 - Day 1 - 5, to be administered via intravenous infusion at Weeks 1, 4, 7, 10, 13, 16,19, and 22.
    Measure Participants12260
    Number (80% Confidence Interval) [Percentage of participants]
    32
    26.2%
    31.7
    52.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Ipilimumab (3 mg/kg), Dacarbazine (250 mg/m2)
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesisp-Value0.9932
    Comments
    MethodCochran-Mantel-Haenszel
    Comments
    Method of EstimationEstimation ParameterOdds Ratio (OR)
    Estimated Value1.00
    Confidence Interval (2-Sided) 80%
    0.64 to 1.55
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    6. Secondary Outcome
    TitleBest Overall Response Rate ( BORR )
    DescriptionBORR definition is defined as the number of subjects in the arm with a BOR of CR or PR, divided by the total number of randomized subjects in the arm.
    Time FrameApproximately 43 months

    Outcome Measure Data

    Analysis Population Description
    All randomized participants
    Arm/Group TitleIpilimumab (3 mg/kg)Dacarbazine (250 mg/m2)
    Arm/Group DescriptionIpilimumab 3 mg/kg to be administered via intravenous infusion over 90 minutes at Weeks 1, 4, 7 and 10, for a total of four doses in Induction (and Re-Induction for those randomized to the ipilimumab arm who qualify)DTIC 250 mg/m2 - Day 1 - 5, to be administered via intravenous infusion at Weeks 1, 4, 7, 10, 13, 16,19, and 22.
    Measure Participants12260
    Number (80% Confidence Interval) [Percentage of participants]
    8.2
    6.7%
    8.3
    13.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Ipilimumab (3 mg/kg), Dacarbazine (250 mg/m2)
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesisp-Value0.9738
    Comments
    MethodCochran-Mantel-Haenszel
    Comments
    Method of EstimationEstimation ParameterOdds Ratio (OR)
    Estimated Value0.98
    Confidence Interval (2-Sided) 80%
    0.48 to 2.03
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    7. Secondary Outcome
    TitleDuration of Response ( DoR)
    DescriptionDoR definition for the response evaluable subjects whose BOR is CR or PR is defined as the time between the date of response of CR or PR (whichever occurs first) and the first date of progressive disease (PD) or the date of death (whichever occurs first).
    Time FrameApproximately 43 months

    Outcome Measure Data

    Analysis Population Description
    All randomized participants with response
    Arm/Group TitleIpilimumab (3 mg/kg)Dacarbazine (250 mg/m2)
    Arm/Group DescriptionIpilimumab 3 mg/kg to be administered via intravenous infusion over 90 minutes at Weeks 1, 4, 7 and 10, for a total of four doses in Induction (and Re-Induction for those randomized to the ipilimumab arm who qualify)DTIC 250 mg/m2 - Day 1 - 5, to be administered via intravenous infusion at Weeks 1, 4, 7, 10, 13, 16,19, and 22.
    Measure Participants105
    Median (80% Confidence Interval) [Months]
    8.99
    7.98
    8. Secondary Outcome
    TitleDuration of Stable Disease ( DoSD )
    DescriptionPrimary duration of stable disease (DoSD) definition for the randomized subjects whose BOR is SD is defined as the time between the randomization date and the first date of PD or the date of death (whichever occurs first)."
    Time FrameApproximately 43 months

    Outcome Measure Data

    Analysis Population Description
    All randomized participants with BOR as stable disease
    Arm/Group TitleIpilimumab (3 mg/kg)Dacarbazine (250 mg/m2)
    Arm/Group DescriptionIpilimumab 3 mg/kg to be administered via intravenous infusion over 90 minutes at Weeks 1, 4, 7 and 10, for a total of four doses in Induction (and Re-Induction for those randomized to the ipilimumab arm who qualify)DTIC 250 mg/m2 - Day 1 - 5, to be administered via intravenous infusion at Weeks 1, 4, 7, 10, 13, 16,19, and 22.
    Measure Participants2914
    Median (80% Confidence Interval) [Months]
    6.83
    9.40

    Adverse Events

    Time FrameApproximately 43 months
    Adverse Event Reporting Description Adverse events are reported between first dose and 90 days after last dose of study therapy.
    Arm/Group TitleIpilimumabDacarbazine
    Arm/Group DescriptionIpilimumab 3 mg/kg to be administered via intravenous infusion over 90 minutes at Weeks 1, 4, 7 and 10, for a total of four doses in Induction (and Re-Induction for those randomized to the ipilimumab arm who qualify)DTIC 250 mg/m2 - Day 1 - 5, to be administered via intravenous infusion at Weeks 1, 4, 7, 10, 13, 16,19, and 22.
    All Cause Mortality
    IpilimumabDacarbazine
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total93/122 (76.2%) 39/53 (73.6%)
    Serious Adverse Events
    IpilimumabDacarbazine
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total34/122 (27.9%) 12/53 (22.6%)
    Blood and lymphatic system disorders
    Anaemia1/122 (0.8%) 1/53 (1.9%)
    Bone marrow failure0/122 (0%) 1/53 (1.9%)
    Endocrine disorders
    Hypophysitis1/122 (0.8%) 0/53 (0%)
    Hypopituitarism1/122 (0.8%) 0/53 (0%)
    Gastrointestinal disorders
    Abdominal pain2/122 (1.6%) 0/53 (0%)
    Ascites1/122 (0.8%) 0/53 (0%)
    Diarrhoea2/122 (1.6%) 0/53 (0%)
    Gastrointestinal haemorrhage1/122 (0.8%) 0/53 (0%)
    Haematemesis0/122 (0%) 1/53 (1.9%)
    General disorders
    Oedema peripheral1/122 (0.8%) 0/53 (0%)
    Pyrexia1/122 (0.8%) 0/53 (0%)
    Sudden death1/122 (0.8%) 0/53 (0%)
    Hepatobiliary disorders
    Cholecystitis acute1/122 (0.8%) 0/53 (0%)
    Immune system disorders
    Hypersensitivity1/122 (0.8%) 0/53 (0%)
    Infections and infestations
    Cellulitis1/122 (0.8%) 0/53 (0%)
    Skin infection0/122 (0%) 1/53 (1.9%)
    Injury, poisoning and procedural complications
    Overdose0/122 (0%) 1/53 (1.9%)
    Wrist fracture1/122 (0.8%) 0/53 (0%)
    Investigations
    Blood bilirubin increased1/122 (0.8%) 0/53 (0%)
    Metabolism and nutrition disorders
    Electrolyte imbalance0/122 (0%) 1/53 (1.9%)
    Hypoproteinaemia0/122 (0%) 1/53 (1.9%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant neoplasm progression16/122 (13.1%) 7/53 (13.2%)
    Nervous system disorders
    Cerebral infarction1/122 (0.8%) 0/53 (0%)
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome1/122 (0.8%) 0/53 (0%)
    Dyspnoea1/122 (0.8%) 0/53 (0%)
    Interstitial lung disease1/122 (0.8%) 0/53 (0%)
    Pleural effusion1/122 (0.8%) 0/53 (0%)
    Pulmonary embolism0/122 (0%) 1/53 (1.9%)
    Skin and subcutaneous tissue disorders
    Erythema1/122 (0.8%) 0/53 (0%)
    Rash2/122 (1.6%) 1/53 (1.9%)
    Vascular disorders
    Pelvic venous thrombosis1/122 (0.8%) 0/53 (0%)
    Other (Not Including Serious) Adverse Events
    IpilimumabDacarbazine
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total118/122 (96.7%) 48/53 (90.6%)
    Blood and lymphatic system disorders
    Anaemia8/122 (6.6%) 3/53 (5.7%)
    Bone marrow failure0/122 (0%) 4/53 (7.5%)
    Leukopenia0/122 (0%) 4/53 (7.5%)
    Neutropenia1/122 (0.8%) 3/53 (5.7%)
    Cardiac disorders
    Sinus bradycardia4/122 (3.3%) 3/53 (5.7%)
    Supraventricular tachycardia8/122 (6.6%) 0/53 (0%)
    Gastrointestinal disorders
    Abdominal distension5/122 (4.1%) 4/53 (7.5%)
    Constipation14/122 (11.5%) 14/53 (26.4%)
    Diarrhoea7/122 (5.7%) 4/53 (7.5%)
    Gastrointestinal disorder4/122 (3.3%) 8/53 (15.1%)
    Nausea18/122 (14.8%) 22/53 (41.5%)
    Vomiting14/122 (11.5%) 5/53 (9.4%)
    General disorders
    Asthenia12/122 (9.8%) 8/53 (15.1%)
    Fatigue11/122 (9%) 6/53 (11.3%)
    Oedema peripheral7/122 (5.7%) 2/53 (3.8%)
    Pain15/122 (12.3%) 6/53 (11.3%)
    Pyrexia23/122 (18.9%) 10/53 (18.9%)
    Hepatobiliary disorders
    Liver injury1/122 (0.8%) 5/53 (9.4%)
    Investigations
    Alanine aminotransferase increased31/122 (25.4%) 19/53 (35.8%)
    Aspartate aminotransferase increased22/122 (18%) 17/53 (32.1%)
    Bilirubin conjugated increased9/122 (7.4%) 5/53 (9.4%)
    Blood albumin decreased15/122 (12.3%) 5/53 (9.4%)
    Blood alkaline phosphatase increased6/122 (4.9%) 4/53 (7.5%)
    Blood bilirubin increased14/122 (11.5%) 5/53 (9.4%)
    Blood bilirubin unconjugated increased7/122 (5.7%) 1/53 (1.9%)
    Blood chloride decreased7/122 (5.7%) 5/53 (9.4%)
    Blood cholesterol increased6/122 (4.9%) 4/53 (7.5%)
    Blood glucose increased10/122 (8.2%) 5/53 (9.4%)
    Blood lactate dehydrogenase increased28/122 (23%) 3/53 (5.7%)
    Blood potassium decreased1/122 (0.8%) 3/53 (5.7%)
    Blood sodium decreased9/122 (7.4%) 6/53 (11.3%)
    Blood thyroid stimulating hormone decreased11/122 (9%) 0/53 (0%)
    Blood thyroid stimulating hormone increased27/122 (22.1%) 4/53 (7.5%)
    Blood triglycerides increased15/122 (12.3%) 5/53 (9.4%)
    Blood uric acid increased7/122 (5.7%) 3/53 (5.7%)
    Blood urine present2/122 (1.6%) 3/53 (5.7%)
    C-reactive protein increased25/122 (20.5%) 4/53 (7.5%)
    Electrocardiogram T wave abnormal8/122 (6.6%) 3/53 (5.7%)
    Gamma-glutamyltransferase increased17/122 (13.9%) 11/53 (20.8%)
    Haemoglobin decreased22/122 (18%) 6/53 (11.3%)
    Lymphocyte count decreased2/122 (1.6%) 3/53 (5.7%)
    Neutrophil count decreased6/122 (4.9%) 8/53 (15.1%)
    Neutrophil count increased16/122 (13.1%) 2/53 (3.8%)
    Neutrophil percentage decreased7/122 (5.7%) 1/53 (1.9%)
    Neutrophil percentage increased11/122 (9%) 0/53 (0%)
    Platelet count decreased3/122 (2.5%) 5/53 (9.4%)
    Platelet count increased13/122 (10.7%) 1/53 (1.9%)
    Protein urine present4/122 (3.3%) 4/53 (7.5%)
    Thyroxine free decreased7/122 (5.7%) 1/53 (1.9%)
    Thyroxine free increased8/122 (6.6%) 0/53 (0%)
    Tri-iodothyronine decreased7/122 (5.7%) 0/53 (0%)
    Tri-iodothyronine free decreased9/122 (7.4%) 0/53 (0%)
    Tri-iodothyronine free increased7/122 (5.7%) 0/53 (0%)
    Weight decreased18/122 (14.8%) 3/53 (5.7%)
    White blood cell count decreased7/122 (5.7%) 15/53 (28.3%)
    White blood cell count increased21/122 (17.2%) 6/53 (11.3%)
    White blood cells urine positive10/122 (8.2%) 2/53 (3.8%)
    Metabolism and nutrition disorders
    Decreased appetite27/122 (22.1%) 17/53 (32.1%)
    Hypokalaemia6/122 (4.9%) 5/53 (9.4%)
    Hyponatraemia6/122 (4.9%) 4/53 (7.5%)
    Musculoskeletal and connective tissue disorders
    Back pain6/122 (4.9%) 3/53 (5.7%)
    Pain in extremity8/122 (6.6%) 1/53 (1.9%)
    Nervous system disorders
    Dizziness4/122 (3.3%) 5/53 (9.4%)
    Headache8/122 (6.6%) 0/53 (0%)
    Psychiatric disorders
    Insomnia8/122 (6.6%) 1/53 (1.9%)
    Respiratory, thoracic and mediastinal disorders
    Cough13/122 (10.7%) 4/53 (7.5%)
    Skin and subcutaneous tissue disorders
    Pruritus27/122 (22.1%) 2/53 (3.8%)
    Rash33/122 (27%) 3/53 (5.7%)
    Vascular disorders
    Hypertension7/122 (5.7%) 0/53 (0%)

    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/TitleBristol-Myers Squibb Study Director
    OrganizationBristol-Myers Squibb
    PhonePlease email
    EmailClinical.Trials@bms.com
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT02545075
    Other Study ID Numbers:
    • CA184-248
    First Posted:
    Sep 9, 2015
    Last Update Posted:
    May 19, 2020
    Last Verified:
    May 1, 2020