Clincosm LogoSign in Get a demo

CheckMate 169: Expanded Access Program With Nivolumab Therapy for Treatment of Advanced/Metastatic SqNSCLC or Non-SqNSCLC After One Prior Systemic Regimen

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
No longer available
CT.gov ID
NCT02475382
Collaborator
(none)
50
Locations

Study Details

Study Description

Brief Summary

The purpose of this study is to provide treatment with nivolumab, a fully human monoclonal antibody, to subjects who have relapsed after treatment with a minimum of 1 prior systemic treatment for advanced or metastatic squamous (Sq) or non-squamous (non-Sq) non-small cell lung cancer (NSCLC) , Stage IIIB/IV and whose physicians believe that nivolumab treatment is appropriate.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Expanded Access
Official Title:
Expanded Access Program With Nivolumab Monotherapy in Subjects With Advanced or Metastatic Squamous (Sq) or Non-Squamous (Non-Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Prior Systemic Regimens for the Treatment of Stage IIIb/IV SqNSCLC

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All

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

    Inclusion Criteria:

    • Sq or Non-Sq NSCLC, Stage IIIb/IV (histologically or cytologically confirmed)

    • Relapsed after 1 prior platinum-based systemic treatment

    • Eastern Cooperative Oncology Group (ECOG) Performance Status < 2

    • CNS metastasis must be treated and returned to baseline at least 2 weeks before first dose of nivolumab and off steroids or using stable or decreasing dose of < 10 mg prednisone or equivalent

    • Prior chemotherapy, Tyrosine Kinase Inhibitor (TKI) therapy or Immunotherapy (tumor vaccine, cytokine or growth factor to control cancer) must be completed at least 2 weeks before first nivolumab dose

    Exclusion Criteria:

    • CNS metastases (untreated and/or symptomatic)

    • Carcinomatous meningitis

    • ECOG Performance status > 3

    • Corticosteroids > 10 mg prednisolone/day (or equivalent)

    • Prior treatment with anti-PD-1, anti-PD-L-1, anti-PDL2, anti-CT137 or anti-CTLA antibody, including ipilimumab or any other drugs specifically targeting T cell costimulation or checkpoint pathways

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution Salvador Bahia Brazil 41950
    2 Local Institution Fortaleza Ceara Brazil 60130
    3 Local Institution Fortaleza Ceara Brazil 60336
    4 Local Institution Brasilia Distrito Federal Brazil 70200
    5 Local Institution Belo Horizonte Minas Gerais Brazil 30430
    6 Local Institution Cascavel Parana Brazil 85806
    7 Local Institution Curitiba Parana Brazil 80530
    8 Local Institution Curitiba Parana Brazil
    9 Local Institution Recife Pernambuco Brazil 50070
    10 Local Institution Recife Pernambuco Brazil 52010
    11 Local Institution Natal Rio Grande Do Norte Brazil 59062
    12 Local Institution Ijui RIO Grande DO SUL Brazil
    13 Local Institution Passo Fundo Rio Grande Do Sul Brazil 99010
    14 Local Institution Porto Alegre RIO Grande DO SUL Brazil 90020
    15 Local Institution Porto Alegre Rio Grande Do Sul Brazil 90035
    16 Local Institution Porto Alegre Rio Grande Do Sul Brazil 90470
    17 Local Institution Porto Alegre Rio Grande Do Sul Brazil
    18 Local Institution Florianopolis Santa Catarina Brazil 88034
    19 Local Institution Itajai Santa Catarina Brazil 88301
    20 Local Institution Barretos Sao Paulo Brazil 14784
    21 Local Institution Campinas Sao Paulo Brazil 13092
    22 Local Institution Jau Sao Paulo Brazil 17210
    23 Local Institution Ribeirao Preto Sao Paulo Brazil 14025
    24 Local Institution Santo Andre SAO Paulo Brazil 09060
    25 Local Institution Distrito Federal Brazil 72025
    26 Local Institution Rio de Janeiro Brazil 22793
    27 Local Institution Rio de Janeiro Brazil
    28 Local Institution Salvador Brazil 40170
    29 Local Institution Sao Paulo Brazil 01308
    30 Local Institution Sao Paulo Brazil 01321
    31 Local Institution Sao Paulo Brazil 01406
    32 Local Institution Sao Paulo Brazil 01525
    33 Local Institution Sao Paulo Brazil 03102
    34 Local Institution Sao Paulo Brazil 04538
    35 Local Institution Sao Paulo Brazil 05651
    36 Local Institution Edmonton Alberta Canada T6G 1Z2
    37 Local Institution Burnaby British Columbia Canada V5G 2X6
    38 Local Institution Kelowna British Columbia Canada V1Y 5L3
    39 Local Institution Richmond British Columbia Canada V6X 1A2
    40 Local Institution Winnipeg Manitoba Canada R3E 0V9
    41 Local Institution Moncton New Brunswick Canada E1C 2Z3
    42 Local Institution Hamilton Ontario Canada
    43 Local Institution Oshawa Ontario Canada L1G 2B9
    44 Local Institution Sudbury Ontario Canada P3E 5J1
    45 Local Institution Thunder Bay Ontario Canada P7B 6V4
    46 Local Institution Toronto Ontario Canada M4N 3M5
    47 Local Institution Chicoutimi Quebec Canada G7H 2A4
    48 Local Institution Greenfield Park Quebec Canada J4V 2H1
    49 Local Institution Montreal Quebec Canada H3A 1A1
    50 Centre De Sante Et De Services Sociaux Rimouski Neigette Rimouski Quebec Canada G5L 5T1

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT02475382
    Other Study ID Numbers:
    • CA209-169
    First Posted:
    Jun 18, 2015
    Last Update Posted:
    Nov 27, 2020
    Last Verified:
    Nov 1, 2020
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Nivolumab

    Study Results

    No Results Posted as of Nov 27, 2020