Non-squamous Non-Small Cell Lung Cancer Clinical Trial
— CheckMate 169Official 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
| NCT number | NCT02475382 |
| Other study ID # | CA209-169 |
| Secondary ID | |
| Status | No longer available |
| Phase | |
| First received | |
| Last updated |
| Verified date | November 2020 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Expanded Access |
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.
| Status | No longer available |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Local Institution | Barretos | Sao Paulo |
| Brazil | Local Institution | Belo Horizonte | Minas Gerais |
| Brazil | Local Institution | Brasilia | Distrito Federal |
| Brazil | Local Institution | Campinas | Sao Paulo |
| Brazil | Local Institution | Cascavel | Parana |
| Brazil | Local Institution | Curitiba | Parana |
| Brazil | Local Institution | Curitiba | Parana |
| Brazil | Local Institution | Distrito Federal | |
| Brazil | Local Institution | Florianopolis | Santa Catarina |
| Brazil | Local Institution | Fortaleza | Ceara |
| Brazil | Local Institution | Fortaleza | Ceara |
| Brazil | Local Institution | Ijui | RIO Grande DO SUL |
| Brazil | Local Institution | Itajai | Santa Catarina |
| Brazil | Local Institution | Jau | Sao Paulo |
| Brazil | Local Institution | Natal | Rio Grande Do Norte |
| Brazil | Local Institution | Passo Fundo | Rio Grande Do Sul |
| Brazil | Local Institution | Porto Alegre | RIO Grande DO SUL |
| Brazil | Local Institution | Porto Alegre | Rio Grande Do Sul |
| Brazil | Local Institution | Porto Alegre | Rio Grande Do Sul |
| Brazil | Local Institution | Porto Alegre | Rio Grande Do Sul |
| Brazil | Local Institution | Recife | Pernambuco |
| Brazil | Local Institution | Recife | Pernambuco |
| Brazil | Local Institution | Ribeirao Preto | Sao Paulo |
| Brazil | Local Institution | Rio de Janeiro | |
| Brazil | Local Institution | Rio de Janeiro | |
| Brazil | Local Institution | Salvador | |
| Brazil | Local Institution | Salvador | Bahia |
| Brazil | Local Institution | Santo Andre | SAO Paulo |
| Brazil | Local Institution | Sao Paulo | |
| Brazil | Local Institution | Sao Paulo | |
| Brazil | Local Institution | Sao Paulo | |
| Brazil | Local Institution | Sao Paulo | |
| Brazil | Local Institution | Sao Paulo | |
| Brazil | Local Institution | Sao Paulo | |
| Brazil | Local Institution | Sao Paulo | |
| Canada | Local Institution | Burnaby | British Columbia |
| Canada | Local Institution | Chicoutimi | Quebec |
| Canada | Local Institution | Edmonton | Alberta |
| Canada | Local Institution | Greenfield Park | Quebec |
| Canada | Local Institution | Hamilton | Ontario |
| Canada | Local Institution | Kelowna | British Columbia |
| Canada | Local Institution | Moncton | New Brunswick |
| Canada | Local Institution | Montreal | Quebec |
| Canada | Local Institution | Oshawa | Ontario |
| Canada | Local Institution | Richmond | British Columbia |
| Canada | Centre De Sante Et De Services Sociaux Rimouski Neigette | Rimouski | Quebec |
| Canada | Local Institution | Sudbury | Ontario |
| Canada | Local Institution | Thunder Bay | Ontario |
| Canada | Local Institution | Toronto | Ontario |
| Canada | Local Institution | Winnipeg | Manitoba |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
Brazil, Canada,
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