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CXCessoR4: Safety and Efficacy Study of Ulocuplumab and Nivolumab in Subjects With Solid Tumors

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Terminated
CT.gov ID
NCT02472977
Collaborator
(none)
61
Enrollment
7
Locations
2
Arms
18.5
Actual Duration (Months)
8.7
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 the combination of Ulocuplumab and Nivolumab is safe and effective in the treatment of pancreatic cancer and small cell lung cancer.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Detailed Description

  • Intervention model: Single group for Stage 1 DLT, then Parallel

  • Data Monitoring Committee: No (Stage 1) Yes (Stage 2 Randomized Ph2)

Study Design

Study Type:
Interventional
Actual Enrollment :
61 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
A Phase 1/2 Study of the Safety and Efficacy of Ulocuplumab Combined With Nivolumab in Subjects With Advanced or Metastatic Solid Tumors
Actual Study Start Date :
Jul 13, 2015
Actual Primary Completion Date :
Jan 27, 2017
Actual Study Completion Date :
Jan 27, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: BMS-936564 (Ulocuplumab) + Nivolumab, Tumor type arm (SCLC)

Small cell lung cancer (SCLC)

Drug: Ulocuplumab
Other Names:
  • BMS-936564

    • Drug: Nivolumab
    Active Comparator: BMS-936564 (Ulocuplumab) + Nivolumab, Tumor type arm (PAC)

    Pancreatic cancer (PAC)

    Drug: Ulocuplumab
    Other Names:
  • BMS-936564

    • Drug: Nivolumab

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Immune-mediated AEs [From first dose until date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2017, approximately 18 months)]

      The number participants who experienced on-study AEs, SAEs, and AEs requiring immune modulating medication is reported.

    2. Objective Response Rate (ORR) Per RECIST 1.1 Criteria [From first dose until disease progression or treatment discontinuation (assessed up to January 2017, approximately 18 months)]

      ORR is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of treated participants. BOR is defined as the best response designation recorded between the first dose date and the date of progression per RECIST 1.1, or the date of subsequent anti-cancer therapy, whichever occurs first. CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD)=At least a 20% increase in the sum of diameters of target lesions, referencing the smallest sum on study, and an absolute increase of at least 5 mm, or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, referencing the smallest sum diameters while on study.

    3. Overall Survival (OS) [From date of randomization to date of death (assessed up to study completion, approximately 18 months)]

      If a Phase 2 comparative study is initiated and, for PAC only: Overall Survival is defined as the time from randomization to date of death due to any cause.

    4. Number of Participants With Laboratory Abnormalities [From first dose until date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2017, approximately 18 months)]

      The number of participants who experienced on-study Grade 3 or 4 laboratory abnormalities (without Grade 3 or 4 abnormality at baseline) was reported for each arm.

    5. Number of Participants With Electrocardiogram Abnormalities [From first dose to date of last dose plus 30 days]

      The number of participants experiencing electrocardiogram abnormalities was reported for each arm

    Secondary Outcome Measures

    1. Progression-Free Survival (PFS) [From first dose to date of progression (assessed up to January 2017, approximately 18 months)]

      Progression-free survival is defined as the time from first dosing date to the date of the first documented tumor progression, as determined by the investigator according to RECIST 1.1 criteria, or death due to any cause, whichever occurs first. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. PFS was not assessed for this study due to the small number of participants.

    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:

    • SCLC or PAC that is advanced or has spread to other parts of the body

    • Treated with at least one other chemotherapy that did not work or where cancer relapsed

    • Minimal limitations on activities of daily living as measured by Eastern Cooperative Oncology Group (ECOG) score of 0-1

    Exclusion Criteria:

    • Patients with cancer that spread to the brain

    • Active, known or suspected autoimmune disease

    • Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Of Colorado Hosp Aurora Colorado United States 80045
    2 Indiana University Health Indianapolis Indiana United States 46202
    3 Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins Baltimore Maryland United States 21287
    4 Columbia University Medical Center (Cumc) New York New York United States 10032
    5 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    6 Huntsman Cancer Institute Salt Lake City Utah United States 84112
    7 Local Institution Helsinki Finland 00029

    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:
    NCT02472977
    Other Study ID Numbers:
    • CA212-115
    • 2015-000136-15
    First Posted:
    Jun 16, 2015
    Last Update Posted:
    Nov 1, 2018
    Last Verified:
    Oct 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasms
    Nivolumab

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail 61 participants were enrolled; 41 participants entered the treatment period.
    Arm/Group Title PAC DL1 (DLT) PAC DL-1 (Tot) SCLC (Tot)
    Arm/Group Description Pancreatic Adenocarcinoma (PAC) Dose level 1, 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W Pancreatic Adenocarcinoma (PAC) Dose level -1, 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W All Small Cell Lung Cancer (SCLC) subjects in study, 1 subject received 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W and 7 subjects received 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
    Period Title: Overall Study
    STARTED 6 27 8
    COMPLETED 0 0 0
    NOT COMPLETED 6 27 8

    Baseline Characteristics

    Arm/Group Title PAC DL1 (DLT) PAC DL-1 (Tot) SCLC (Tot) Total
    Arm/Group Description Pancreatic Adenocarcinoma (PAC) Dose level 1, 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W Pancreatic Adenocarcinoma (PAC) Dose level -1, 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W All Small Cell Lung Cancer (SCLC) subjects in study, 1 subject received 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W and 7 subjects received 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W Total of all reporting groups
    Overall Participants 6 27 8 41
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    63.3
    (5.05)
    61.9
    (7.93)
    60.1
    (14.13)
    61.7
    (8.94)
    Sex: Female, Male (Count of Participants)
    Female
    1
    16.7%
    14
    51.9%
    4
    50%
    19
    46.3%
    Male
    5
    83.3%
    13
    48.1%
    4
    50%
    22
    53.7%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    1
    3.7%
    1
    12.5%
    2
    4.9%
    Not Hispanic or Latino
    6
    100%
    22
    81.5%
    7
    87.5%
    35
    85.4%
    Unknown or Not Reported
    0
    0%
    4
    14.8%
    0
    0%
    4
    9.8%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    0
    0%
    2
    7.4%
    1
    12.5%
    3
    7.3%
    White
    6
    100%
    25
    92.6%
    7
    87.5%
    38
    92.7%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Immune-mediated AEs
    Description The number participants who experienced on-study AEs, SAEs, and AEs requiring immune modulating medication is reported.
    Time Frame From first dose until date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2017, approximately 18 months)

    Outcome Measure Data

    Analysis Population Description
    All treated participants. Participants in the SCLC (Tot) Arm were not evaluated for Immune-mediated AEs
    Arm/Group Title PAC DL1 (DLT) PAC DL-1 (Tot) SCLC (Tot)
    Arm/Group Description Pancreatic Adenocarcinoma (PAC) Dose level 1, 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W Pancreatic Adenocarcinoma (PAC) Dose level -1, 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W All Small Cell Lung Cancer (SCLC) subjects in study, 1 subject received 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W and 7 subjects received 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
    Measure Participants 6 27 8
    Adverse Events
    6
    100%
    27
    100%
    8
    100%
    Serious Adverse Events
    3
    50%
    21
    77.8%
    7
    87.5%
    Immune-mediated AEs
    1
    16.7%
    3
    11.1%
    2. Primary Outcome
    Title Objective Response Rate (ORR) Per RECIST 1.1 Criteria
    Description ORR is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of treated participants. BOR is defined as the best response designation recorded between the first dose date and the date of progression per RECIST 1.1, or the date of subsequent anti-cancer therapy, whichever occurs first. CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD)=At least a 20% increase in the sum of diameters of target lesions, referencing the smallest sum on study, and an absolute increase of at least 5 mm, or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, referencing the smallest sum diameters while on study.
    Time Frame From first dose until disease progression or treatment discontinuation (assessed up to January 2017, approximately 18 months)

    Outcome Measure Data

    Analysis Population Description
    All treated participants in PAC arms. ORR data was not collected for SCLC arm.
    Arm/Group Title PAC DL1 (DLT) PAC DL-1 (Tot) SCLC (Tot)
    Arm/Group Description Pancreatic Adenocarcinoma (PAC) Dose level 1, 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W Pancreatic Adenocarcinoma (PAC) Dose level -1, 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W All Small Cell Lung Cancer (SCLC) subjects in study, 1 subject received 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W and 7 subjects received 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
    Measure Participants 6 27 0
    Number (90% Confidence Interval) [Percentage of participants]
    0
    0%
    0
    0%
    3. Primary Outcome
    Title Overall Survival (OS)
    Description If a Phase 2 comparative study is initiated and, for PAC only: Overall Survival is defined as the time from randomization to date of death due to any cause.
    Time Frame From date of randomization to date of death (assessed up to study completion, approximately 18 months)

    Outcome Measure Data

    Analysis Population Description
    OS data was not collected for any participants
    Arm/Group Title PAC DL1 (DLT) PAC DL-1 (Tot) SCLC (Tot)
    Arm/Group Description Pancreatic Adenocarcinoma (PAC) Dose level 1, 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W Pancreatic Adenocarcinoma (PAC) Dose level -1, 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W All Small Cell Lung Cancer (SCLC) subjects in study, 1 subject received 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W and 7 subjects received 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
    Measure Participants 0 0 0
    4. Primary Outcome
    Title Number of Participants With Laboratory Abnormalities
    Description The number of participants who experienced on-study Grade 3 or 4 laboratory abnormalities (without Grade 3 or 4 abnormality at baseline) was reported for each arm.
    Time Frame From first dose until date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2017, approximately 18 months)

    Outcome Measure Data

    Analysis Population Description
    All treated participants in PAC arms. Lab abnormality data was not collected for SCLC arm.
    Arm/Group Title PAC DL1 (DLT) PAC DL-1 (Tot) SCLC (Tot)
    Arm/Group Description Pancreatic Adenocarcinoma (PAC) Dose level 1, 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W Pancreatic Adenocarcinoma (PAC) Dose level -1, 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W All Small Cell Lung Cancer (SCLC) subjects in study, 1 subject received 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W and 7 subjects received 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
    Measure Participants 6 27 0
    Increased lymphocytes
    1
    16.7%
    2
    7.4%
    Decreased platelet count
    1
    16.7%
    2
    7.4%
    Hemoglobin
    1
    16.7%
    1
    3.7%
    Leukocytes
    0
    0%
    1
    3.7%
    Neutrophils
    0
    0%
    0
    0%
    Platelet Count
    1
    16.7%
    2
    7.4%
    Alanine Aminotransferase
    0
    0%
    3
    11.1%
    Alkaline Phosphatase
    1
    16.7%
    11
    40.7%
    Aspartate Aminotransferase
    0
    0%
    5
    18.5%
    Bilirubin
    0
    0%
    1
    3.7%
    Creatine
    0
    0%
    0
    0%
    Hypernatremia
    0
    0%
    0
    0%
    Hyponatremia
    1
    16.7%
    3
    11.1%
    Hypermagnesemia
    0
    0%
    0
    0%
    Hypomagnesemia
    0
    0%
    0
    0%
    Hypercalcemia
    0
    0%
    0
    0%
    Hypocalcemia
    0
    0%
    0
    0%
    Hyperkalemia
    0
    0%
    1
    3.7%
    Hypokalemia
    0
    0%
    0
    0%
    Amylase
    1
    16.7%
    0
    0%
    Lipase
    1
    16.7%
    1
    3.7%
    5. Secondary Outcome
    Title Progression-Free Survival (PFS)
    Description Progression-free survival is defined as the time from first dosing date to the date of the first documented tumor progression, as determined by the investigator according to RECIST 1.1 criteria, or death due to any cause, whichever occurs first. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. PFS was not assessed for this study due to the small number of participants.
    Time Frame From first dose to date of progression (assessed up to January 2017, approximately 18 months)

    Outcome Measure Data

    Analysis Population Description
    PFS data was not collected for any participants
    Arm/Group Title PAC DL1 (DLT) PAC DL-1 (Tot) SCLC (Tot)
    Arm/Group Description Pancreatic Adenocarcinoma (PAC) Dose level 1, 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W Pancreatic Adenocarcinoma (PAC) Dose level -1, 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W All Small Cell Lung Cancer (SCLC) subjects in study, 1 subject received 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W and 7 subjects received 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
    Measure Participants 0 0 0
    6. Primary Outcome
    Title Number of Participants With Electrocardiogram Abnormalities
    Description The number of participants experiencing electrocardiogram abnormalities was reported for each arm
    Time Frame From first dose to date of last dose plus 30 days

    Outcome Measure Data

    Analysis Population Description
    Electrocardiogram data was not collected for any participants
    Arm/Group Title PAC DL1 (DLT) PAC DL-1 (Tot) SCLC (Tot)
    Arm/Group Description Pancreatic Adenocarcinoma (PAC) Dose level 1, 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W Pancreatic Adenocarcinoma (PAC) Dose level -1, 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W All Small Cell Lung Cancer (SCLC) subjects in study, 1 subject received 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W and 7 subjects received 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
    Measure Participants 0 0 0

    Adverse Events

    Time Frame From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)
    Adverse Event Reporting Description
    Arm/Group Title PAC DL1 (DLT) PAC DL-1 (Tot) SCLC (Tot)
    Arm/Group Description Pancreatic Adenocarcinoma (PAC) Dose level 1, 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W Pancreatic Adenocarcinoma (PAC) Dose level -1, 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W All Small Cell Lung Cancer (SCLC) subjects in study, 1 subject received 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W and 7 subjects received 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
    All Cause Mortality
    PAC DL1 (DLT) PAC DL-1 (Tot) SCLC (Tot)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 3/6 (50%) 16/27 (59.3%) 5/8 (62.5%)
    Serious Adverse Events
    PAC DL1 (DLT) PAC DL-1 (Tot) SCLC (Tot)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 3/6 (50%) 21/27 (77.8%) 7/8 (87.5%)
    Gastrointestinal disorders
    Ascites 0/6 (0%) 1/27 (3.7%) 0/8 (0%)
    Haemorrhoidal haemorrhage 0/6 (0%) 1/27 (3.7%) 0/8 (0%)
    General disorders
    Asthenia 0/6 (0%) 1/27 (3.7%) 0/8 (0%)
    Fatigue 0/6 (0%) 1/27 (3.7%) 0/8 (0%)
    Gait disturbance 0/6 (0%) 1/27 (3.7%) 0/8 (0%)
    Pyrexia 0/6 (0%) 2/27 (7.4%) 0/8 (0%)
    Hepatobiliary disorders
    Bile duct obstruction 0/6 (0%) 1/27 (3.7%) 0/8 (0%)
    Infections and infestations
    Biliary tract infection 0/6 (0%) 1/27 (3.7%) 0/8 (0%)
    Diverticulitis 0/6 (0%) 1/27 (3.7%) 0/8 (0%)
    Infection 0/6 (0%) 1/27 (3.7%) 0/8 (0%)
    Sepsis 0/6 (0%) 1/27 (3.7%) 0/8 (0%)
    Injury, poisoning and procedural complications
    Infusion related reaction 0/6 (0%) 0/27 (0%) 1/8 (12.5%)
    Investigations
    Blood bilirubin increased 0/6 (0%) 1/27 (3.7%) 0/8 (0%)
    C-reactive protein increased 0/6 (0%) 1/27 (3.7%) 0/8 (0%)
    Neutrophil count decreased 0/6 (0%) 1/27 (3.7%) 0/8 (0%)
    Metabolism and nutrition disorders
    Failure to thrive 0/6 (0%) 0/27 (0%) 1/8 (12.5%)
    Hyponatraemia 0/6 (0%) 1/27 (3.7%) 1/8 (12.5%)
    Musculoskeletal and connective tissue disorders
    Musculoskeletal pain 0/6 (0%) 1/27 (3.7%) 0/8 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant neoplasm progression 3/6 (50%) 16/27 (59.3%) 3/8 (37.5%)
    Nervous system disorders
    Cerebrovascular accident 0/6 (0%) 1/27 (3.7%) 0/8 (0%)
    Presyncope 0/6 (0%) 1/27 (3.7%) 0/8 (0%)
    Psychiatric disorders
    Agitation 0/6 (0%) 1/27 (3.7%) 0/8 (0%)
    Mental status changes 0/6 (0%) 1/27 (3.7%) 0/8 (0%)
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 0/6 (0%) 1/27 (3.7%) 1/8 (12.5%)
    Pleural effusion 0/6 (0%) 2/27 (7.4%) 0/8 (0%)
    Pneumonitis 0/6 (0%) 0/27 (0%) 1/8 (12.5%)
    Pulmonary embolism 0/6 (0%) 1/27 (3.7%) 0/8 (0%)
    Respiratory failure 0/6 (0%) 0/27 (0%) 1/8 (12.5%)
    Vascular disorders
    Aortic aneurysm 0/6 (0%) 0/27 (0%) 1/8 (12.5%)
    Embolism 0/6 (0%) 2/27 (7.4%) 0/8 (0%)
    Haematoma 0/6 (0%) 0/27 (0%) 1/8 (12.5%)
    Other (Not Including Serious) Adverse Events
    PAC DL1 (DLT) PAC DL-1 (Tot) SCLC (Tot)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 6/6 (100%) 26/27 (96.3%) 8/8 (100%)
    Blood and lymphatic system disorders
    Anaemia 1/6 (16.7%) 6/27 (22.2%) 1/8 (12.5%)
    Leukocytosis 0/6 (0%) 0/27 (0%) 1/8 (12.5%)
    Thrombocytopenia 3/6 (50%) 7/27 (25.9%) 1/8 (12.5%)
    Cardiac disorders
    Tachycardia 0/6 (0%) 2/27 (7.4%) 0/8 (0%)
    Endocrine disorders
    Hypothyroidism 1/6 (16.7%) 1/27 (3.7%) 0/8 (0%)
    Eye disorders
    Diplopia 1/6 (16.7%) 0/27 (0%) 0/8 (0%)
    Vision blurred 1/6 (16.7%) 0/27 (0%) 0/8 (0%)
    Gastrointestinal disorders
    Abdominal discomfort 1/6 (16.7%) 0/27 (0%) 0/8 (0%)
    Abdominal distension 0/6 (0%) 4/27 (14.8%) 1/8 (12.5%)
    Abdominal pain 1/6 (16.7%) 4/27 (14.8%) 0/8 (0%)
    Ascites 1/6 (16.7%) 3/27 (11.1%) 0/8 (0%)
    Constipation 1/6 (16.7%) 6/27 (22.2%) 2/8 (25%)
    Diarrhoea 1/6 (16.7%) 5/27 (18.5%) 1/8 (12.5%)
    Flatulence 1/6 (16.7%) 1/27 (3.7%) 1/8 (12.5%)
    Gingival pain 0/6 (0%) 0/27 (0%) 1/8 (12.5%)
    Nausea 2/6 (33.3%) 3/27 (11.1%) 1/8 (12.5%)
    Oesophagitis 0/6 (0%) 0/27 (0%) 1/8 (12.5%)
    Vomiting 0/6 (0%) 5/27 (18.5%) 1/8 (12.5%)
    General disorders
    Chills 1/6 (16.7%) 0/27 (0%) 0/8 (0%)
    Fatigue 0/6 (0%) 11/27 (40.7%) 2/8 (25%)
    Pain 0/6 (0%) 2/27 (7.4%) 0/8 (0%)
    Pyrexia 1/6 (16.7%) 5/27 (18.5%) 0/8 (0%)
    Hepatobiliary disorders
    Hyperbilirubinaemia 0/6 (0%) 0/27 (0%) 1/8 (12.5%)
    Portal vein thrombosis 0/6 (0%) 2/27 (7.4%) 0/8 (0%)
    Infections and infestations
    Sepsis 0/6 (0%) 0/27 (0%) 1/8 (12.5%)
    Urinary tract infection 0/6 (0%) 1/27 (3.7%) 1/8 (12.5%)
    Investigations
    Alanine aminotransferase increased 2/6 (33.3%) 6/27 (22.2%) 2/8 (25%)
    Amylase increased 2/6 (33.3%) 0/27 (0%) 2/8 (25%)
    Aspartate aminotransferase increased 2/6 (33.3%) 4/27 (14.8%) 1/8 (12.5%)
    Blood alkaline phosphatase increased 2/6 (33.3%) 6/27 (22.2%) 0/8 (0%)
    Blood bilirubin increased 0/6 (0%) 3/27 (11.1%) 0/8 (0%)
    Blood creatinine increased 0/6 (0%) 2/27 (7.4%) 2/8 (25%)
    C-reactive protein increased 0/6 (0%) 2/27 (7.4%) 0/8 (0%)
    Lipase abnormal 0/6 (0%) 0/27 (0%) 1/8 (12.5%)
    Lipase increased 1/6 (16.7%) 0/27 (0%) 3/8 (37.5%)
    Platelet count decreased 0/6 (0%) 4/27 (14.8%) 0/8 (0%)
    Troponin increased 0/6 (0%) 0/27 (0%) 1/8 (12.5%)
    Weight decreased 0/6 (0%) 3/27 (11.1%) 1/8 (12.5%)
    White blood cell count increased 0/6 (0%) 2/27 (7.4%) 0/8 (0%)
    Metabolism and nutrition disorders
    Decreased appetite 1/6 (16.7%) 3/27 (11.1%) 2/8 (25%)
    Dehydration 1/6 (16.7%) 1/27 (3.7%) 0/8 (0%)
    Hyperglycaemia 0/6 (0%) 4/27 (14.8%) 0/8 (0%)
    Hyperuricaemia 0/6 (0%) 1/27 (3.7%) 1/8 (12.5%)
    Hypoalbuminaemia 0/6 (0%) 3/27 (11.1%) 0/8 (0%)
    Hypocalcaemia 0/6 (0%) 4/27 (14.8%) 0/8 (0%)
    Hypokalaemia 1/6 (16.7%) 2/27 (7.4%) 3/8 (37.5%)
    Hypomagnesaemia 1/6 (16.7%) 0/27 (0%) 0/8 (0%)
    Hyponatraemia 1/6 (16.7%) 2/27 (7.4%) 2/8 (25%)
    Hypophosphataemia 0/6 (0%) 1/27 (3.7%) 2/8 (25%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 1/6 (16.7%) 2/27 (7.4%) 0/8 (0%)
    Back pain 2/6 (33.3%) 3/27 (11.1%) 0/8 (0%)
    Flank pain 0/6 (0%) 2/27 (7.4%) 0/8 (0%)
    Groin pain 1/6 (16.7%) 0/27 (0%) 0/8 (0%)
    Musculoskeletal chest pain 0/6 (0%) 2/27 (7.4%) 0/8 (0%)
    Pain in jaw 0/6 (0%) 0/27 (0%) 2/8 (25%)
    Nervous system disorders
    Dizziness 0/6 (0%) 2/27 (7.4%) 1/8 (12.5%)
    Dysgeusia 0/6 (0%) 0/27 (0%) 1/8 (12.5%)
    Headache 1/6 (16.7%) 2/27 (7.4%) 1/8 (12.5%)
    Neuropathy peripheral 1/6 (16.7%) 1/27 (3.7%) 0/8 (0%)
    Psychiatric disorders
    Anxiety 0/6 (0%) 1/27 (3.7%) 1/8 (12.5%)
    Confusional state 1/6 (16.7%) 0/27 (0%) 0/8 (0%)
    Insomnia 0/6 (0%) 1/27 (3.7%) 1/8 (12.5%)
    Renal and urinary disorders
    Acute kidney injury 0/6 (0%) 2/27 (7.4%) 0/8 (0%)
    Chromaturia 0/6 (0%) 0/27 (0%) 1/8 (12.5%)
    Proteinuria 0/6 (0%) 0/27 (0%) 1/8 (12.5%)
    Reproductive system and breast disorders
    Erectile dysfunction 1/6 (16.7%) 0/27 (0%) 0/8 (0%)
    Respiratory, thoracic and mediastinal disorders
    Cough 0/6 (0%) 3/27 (11.1%) 2/8 (25%)
    Dysphonia 0/6 (0%) 0/27 (0%) 1/8 (12.5%)
    Dyspnoea 0/6 (0%) 4/27 (14.8%) 2/8 (25%)
    Dyspnoea exertional 1/6 (16.7%) 1/27 (3.7%) 1/8 (12.5%)
    Epistaxis 1/6 (16.7%) 0/27 (0%) 1/8 (12.5%)
    Haemoptysis 0/6 (0%) 0/27 (0%) 1/8 (12.5%)
    Hypoxia 0/6 (0%) 1/27 (3.7%) 1/8 (12.5%)
    Pleural effusion 0/6 (0%) 3/27 (11.1%) 0/8 (0%)
    Skin and subcutaneous tissue disorders
    Pruritus 1/6 (16.7%) 1/27 (3.7%) 0/8 (0%)
    Rash 1/6 (16.7%) 2/27 (7.4%) 0/8 (0%)
    Urticaria 0/6 (0%) 0/27 (0%) 1/8 (12.5%)
    Vascular disorders
    Hypertension 0/6 (0%) 1/27 (3.7%) 2/8 (25%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.

    Results Point of Contact

    Name/Title Bristol-Myers Squibb Study Director
    Organization Bristol-Myers Squibb
    Phone Clinical.Trials@bms.com
    Email Clinical.Trials@bms.com
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT02472977
    Other Study ID Numbers:
    • CA212-115
    • 2015-000136-15
    First Posted:
    Jun 16, 2015
    Last Update Posted:
    Nov 1, 2018
    Last Verified:
    Oct 1, 2018