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

Primary Purpose

Squamous Non-Small Cell Lung Cancer, Non-squamous Non-Small Cell Lung Cancer

Status
No longer available
Phase
Locations
International
Study Type
Expanded Access
Intervention
Nivolumab
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Squamous Non-Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

Sites / Locations

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  • Centre De Sante Et De Services Sociaux Rimouski Neigette

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 16, 2015
Last Updated
November 25, 2020
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT02475382
Brief Title
Expanded Access Program With Nivolumab Therapy for Treatment of Advanced/Metastatic SqNSCLC or Non-SqNSCLC After One Prior Systemic Regimen
Acronym
CheckMate 169
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
Study Type
Expanded Access

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Non-Small Cell Lung Cancer, Non-squamous Non-Small Cell Lung Cancer

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Nivolumab
Intervention Description
Specified dose on specified days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Salvador
State/Province
Bahia
ZIP/Postal Code
41950
Country
Brazil
Facility Name
Local Institution
City
Fortaleza
State/Province
Ceara
ZIP/Postal Code
60130
Country
Brazil
Facility Name
Local Institution
City
Fortaleza
State/Province
Ceara
ZIP/Postal Code
60336
Country
Brazil
Facility Name
Local Institution
City
Brasilia
State/Province
Distrito Federal
ZIP/Postal Code
70200
Country
Brazil
Facility Name
Local Institution
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30430
Country
Brazil
Facility Name
Local Institution
City
Cascavel
State/Province
Parana
ZIP/Postal Code
85806
Country
Brazil
Facility Name
Local Institution
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80530
Country
Brazil
Facility Name
Local Institution
City
Curitiba
State/Province
Parana
Country
Brazil
Facility Name
Local Institution
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50070
Country
Brazil
Facility Name
Local Institution
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
52010
Country
Brazil
Facility Name
Local Institution
City
Natal
State/Province
Rio Grande Do Norte
ZIP/Postal Code
59062
Country
Brazil
Facility Name
Local Institution
City
Ijui
State/Province
RIO Grande DO SUL
Country
Brazil
Facility Name
Local Institution
City
Passo Fundo
State/Province
Rio Grande Do Sul
ZIP/Postal Code
99010
Country
Brazil
Facility Name
Local Institution
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
90020
Country
Brazil
Facility Name
Local Institution
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035
Country
Brazil
Facility Name
Local Institution
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90470
Country
Brazil
Facility Name
Local Institution
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil
Facility Name
Local Institution
City
Florianopolis
State/Province
Santa Catarina
ZIP/Postal Code
88034
Country
Brazil
Facility Name
Local Institution
City
Itajai
State/Province
Santa Catarina
ZIP/Postal Code
88301
Country
Brazil
Facility Name
Local Institution
City
Barretos
State/Province
Sao Paulo
ZIP/Postal Code
14784
Country
Brazil
Facility Name
Local Institution
City
Campinas
State/Province
Sao Paulo
ZIP/Postal Code
13092
Country
Brazil
Facility Name
Local Institution
City
Jau
State/Province
Sao Paulo
ZIP/Postal Code
17210
Country
Brazil
Facility Name
Local Institution
City
Ribeirao Preto
State/Province
Sao Paulo
ZIP/Postal Code
14025
Country
Brazil
Facility Name
Local Institution
City
Santo Andre
State/Province
SAO Paulo
ZIP/Postal Code
09060
Country
Brazil
Facility Name
Local Institution
City
Distrito Federal
ZIP/Postal Code
72025
Country
Brazil
Facility Name
Local Institution
City
Rio de Janeiro
ZIP/Postal Code
22793
Country
Brazil
Facility Name
Local Institution
City
Rio de Janeiro
Country
Brazil
Facility Name
Local Institution
City
Salvador
ZIP/Postal Code
40170
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
01308
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
01321
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
01406
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
01525
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
03102
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
04538
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
05651
Country
Brazil
Facility Name
Local Institution
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Local Institution
City
Burnaby
State/Province
British Columbia
ZIP/Postal Code
V5G 2X6
Country
Canada
Facility Name
Local Institution
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 5L3
Country
Canada
Facility Name
Local Institution
City
Richmond
State/Province
British Columbia
ZIP/Postal Code
V6X 1A2
Country
Canada
Facility Name
Local Institution
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Local Institution
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 2Z3
Country
Canada
Facility Name
Local Institution
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Local Institution
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
Local Institution
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 5J1
Country
Canada
Facility Name
Local Institution
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7B 6V4
Country
Canada
Facility Name
Local Institution
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Local Institution
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 2A4
Country
Canada
Facility Name
Local Institution
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Name
Centre De Sante Et De Services Sociaux Rimouski Neigette
City
Rimouski
State/Province
Quebec
ZIP/Postal Code
G5L 5T1
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource
URL
http://bms.com/studyconnect/Pages/home.aspx
Description
BMS Clinical Trial Patient Recruiting
URL
http://www.bms.com/clinical_trials/investigator_sponsored_research/Pages/expanded-access-program.aspx
Description
EAP Investigator Requests

Learn more about this trial

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

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