Expanded Access Program With Nivolumab Therapy for Treatment of Advanced/Metastatic SqNSCLC or Non-SqNSCLC After One Prior Systemic Regimen
NCT ID: NCT02475382
Last Updated: 2020-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NO_LONGER_AVAILABLE
EXPANDED_ACCESS
Brief Summary
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Detailed Description
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Conditions
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Interventions
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Nivolumab
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Fortaleza, Ceará, Brazil
Local Institution
Fortaleza, Ceará, Brazil
Local Institution
Salvador, Estado de Bahia, Brazil
Local Institution
Brasília, Federal District, Brazil
Local Institution
Distrito Federal, Federal District, Brazil
Local Institution
Belo Horizonte, Minas Gerais, Brazil
Local Institution
Cascavel, Paraná, Brazil
Local Institution
Curitiba, Paraná, Brazil
Local Institution
Curitiba, Paraná, Brazil
Local Institution
Recife, Pernambuco, Brazil
Local Institution
Recife, Pernambuco, Brazil
Local Institution
Natal, Rio Grande do Norte, Brazil
Local Institution
Ijuí, Rio Grande do Sul, 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
Florianópolis, Santa Catarina, Brazil
Local Institution
Itajaí, Santa Catarina, Brazil
Local Institution
Barretos, São Paulo, Brazil
Local Institution
Campinas, São Paulo, Brazil
Local Institution
Jaú, São Paulo, Brazil
Local Institution
Ribeirão Preto, São Paulo, Brazil
Local Institution
Santo André, São Paulo, Brazil
Local Institution
Rio de Janeiro, , Brazil
Local Institution
Rio de Janeiro, , Brazil
Local Institution
Salvador, , Brazil
Local Institution
São Paulo, , Brazil
Local Institution
São Paulo, , Brazil
Local Institution
São Paulo, , Brazil
Local Institution
São Paulo, , Brazil
Local Institution
São Paulo, , Brazil
Local Institution
São Paulo, , Brazil
Local Institution
São Paulo, , Brazil
Local Institution
Edmonton, Alberta, Canada
Local Institution
Burnaby, British Columbia, Canada
Local Institution
Kelowna, British Columbia, Canada
Local Institution
Richmond, British Columbia, Canada
Local Institution
Winnipeg, Manitoba, Canada
Local Institution
Moncton, New Brunswick, Canada
Local Institution
Greater Sudbury, Ontario, Canada
Local Institution
Hamilton, Ontario, Canada
Local Institution
Oshawa, Ontario, Canada
Local Institution
Thunder Bay, Ontario, Canada
Local Institution
Toronto, Ontario, Canada
Local Institution
Chicoutimi, Quebec, Canada
Local Institution
Greenfield Park, Quebec, Canada
Local Institution
Montreal, Quebec, Canada
Centre De Sante Et De Services Sociaux Rimouski Neigette
Rimouski, Quebec, Canada
Countries
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References
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Parodi D, Dighero E, Biddau G, D'Amico F, Bauckneht M, Marini C, Garbarino S, Campi C, Piana M, Sambuceti G. Localized FDG loss in lung cancer lesions. EJNMMI Res. 2024 Nov 1;14(1):102. doi: 10.1186/s13550-024-01161-y.
Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
BMS Clinical Trial Patient Recruiting
EAP Investigator Requests
Other Identifiers
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CA209-169
Identifier Type: -
Identifier Source: org_study_id