Expanded Access Program With Nivolumab Therapy for Treatment of Advanced/Metastatic SqNSCLC or Non-SqNSCLC After One Prior Systemic Regimen
CheckMate 169
1 other identifier
expanded_access
N/A
2 countries
50
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2015
CompletedFirst Posted
Study publicly available on registry
June 18, 2015
CompletedNovember 27, 2020
November 1, 2020
June 16, 2015
November 25, 2020
Conditions
Interventions
Specified dose on specified days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (50)
Local Institution
Fortaleza, Ceará, 60130, Brazil
Local Institution
Fortaleza, Ceará, 60336, Brazil
Local Institution
Salvador, Estado de Bahia, 41950, Brazil
Local Institution
Brasília, Federal District, 70200, Brazil
Local Institution
Distrito Federal, Federal District, 72025, Brazil
Local Institution
Belo Horizonte, Minas Gerais, 30430, Brazil
Local Institution
Cascavel, Paraná, 85806, Brazil
Local Institution
Curitiba, Paraná, 80530, Brazil
Local Institution
Curitiba, Paraná, Brazil
Local Institution
Recife, Pernambuco, 50070, Brazil
Local Institution
Recife, Pernambuco, 52010, Brazil
Local Institution
Natal, Rio Grande do Norte, 59062, Brazil
Local Institution
Ijuí, Rio Grande do Sul, Brazil
Local Institution
Passo Fundo, Rio Grande do Sul, 99010, Brazil
Local Institution
Porto Alegre, Rio Grande do Sul, 90020, Brazil
Local Institution
Porto Alegre, Rio Grande do Sul, 90035, Brazil
Local Institution
Porto Alegre, Rio Grande do Sul, 90470, Brazil
Local Institution
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution
Florianópolis, Santa Catarina, 88034, Brazil
Local Institution
Itajaí, Santa Catarina, 88301, Brazil
Local Institution
Barretos, São Paulo, 14784, Brazil
Local Institution
Campinas, São Paulo, 13092, Brazil
Local Institution
Jaú, São Paulo, 17210, Brazil
Local Institution
Ribeirão Preto, São Paulo, 14025, Brazil
Local Institution
Santo André, São Paulo, 09060, Brazil
Local Institution
Rio de Janeiro, 22793, Brazil
Local Institution
Rio de Janeiro, Brazil
Local Institution
Salvador, 40170, Brazil
Local Institution
São Paulo, 01308, Brazil
Local Institution
São Paulo, 01321, Brazil
Local Institution
São Paulo, 01406, Brazil
Local Institution
São Paulo, 01525, Brazil
Local Institution
São Paulo, 03102, Brazil
Local Institution
São Paulo, 04538, Brazil
Local Institution
São Paulo, 05651, Brazil
Local Institution
Edmonton, Alberta, T6G 1Z2, Canada
Local Institution
Burnaby, British Columbia, V5G 2X6, Canada
Local Institution
Kelowna, British Columbia, V1Y 5L3, Canada
Local Institution
Richmond, British Columbia, V6X 1A2, Canada
Local Institution
Winnipeg, Manitoba, R3E 0V9, Canada
Local Institution
Moncton, New Brunswick, E1C 2Z3, Canada
Local Institution
Greater Sudbury, Ontario, P3E 5J1, Canada
Local Institution
Hamilton, Ontario, Canada
Local Institution
Oshawa, Ontario, L1G 2B9, Canada
Local Institution
Thunder Bay, Ontario, P7B 6V4, Canada
Local Institution
Toronto, Ontario, M4N 3M5, Canada
Local Institution
Chicoutimi, Quebec, G7H 2A4, Canada
Local Institution
Greenfield Park, Quebec, J4V 2H1, Canada
Local Institution
Montreal, Quebec, H3A 1A1, Canada
Centre De Sante Et De Services Sociaux Rimouski Neigette
Rimouski, Quebec, G5L 5T1, Canada
Related Publications (1)
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.
PMID: 39485534DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb