Back to resultsAn Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) Monotherapy in Subjects With Advanced or Metastatic Squamous Cell (Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Prior Systemic Regimen for the Treatment of Stage IIIb/IV SqNSCLC (Checkmate 171)
Primary Purpose
Non-Small Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Nivolumab
Sponsored by
About this trial
This is an interventional other trial for Non-Small Cell Lung Cancer
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- ECOG Status: PS 0-1 & PS 2
- Subjects with histologically or cytologically-documented SqNSCLC
- Subjects must have experienced disease progression or recurrence during or after one prior platinum doublet-based chemotherapy regimen
- Subjects must have evaluable disease by CT or MRI per RECIST 1.1 criteria
- Subjects with treated or asymptomatic CNS metastases
- Prior palliative radiotherapy must have been completed at least 14 days prior to study drug administration
- Prior lines of antineoplastic therapy, including hemotherapy, hormonal therapy, immunotherapy, surgical resection of lesions, non-palliative radiation therapy, or standard or investigational agents for treatment of NSCLC, must be completed 28 days prior to the first dose of nivolumab
- Males and Females, ages 18 or older
Exclusion Criteria:
- Subjects with untreated, symptomatic CNS metastases
- Subjects with carcinomatous meningitis
- Subjects with active, known or suspected autoimmune disease.
- Subjects who received prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways) or who have previously taken part in a randomized BMS clinical trial for nivolumab or ipilimumab.
Sites / Locations
- Local Institution - 0002
- Local Institution - 0003
- Local Institution - 0005
- Local Institution - 0173
- Local Institution - 0021
- Local Institution - 0020
- Local Institution - 0022
- Local Institution - 0023
- Local Institution - 0051
- Local Institution - 0052
- Local Institution - 0177
- Local Institution - 0148
- Local Institution - 0147
- Local Institution - 0054
- Local Institution - 0053
- Local Institution - 0347
- Local Institution - 0178
- Local Institution - 0056
- Local Institution - 0058
- Local Institution - 0349
- Local Institution - 0158
- Local Institution - 0184
- Local Institution - 0087
- Local Institution - 0086
- Local Institution - 0088
- Local Institution - 0089
- Local Institution - 0094
- Local Institution - 0093
- Local Institution - 0090
- Local Institution - 0092
- Local Institution - 0091
- Local Institution - 0159
- Local Institution - 0192
- Local Institution - 0098
- Local Institution - 0187
- Local Institution - 0095
- Local Institution - 0096
- Local Institution - 0097
- Local Institution - 0100
- Local Institution - 0160
- Local Institution - 0099
- Local Institution - 0337
- Local Institution - 0109
- Local Institution - 0107
- Local Institution - 0104
- Local Institution - 0119
- Local Institution - 0162
- Local Institution - 0112
- Local Institution - 0111
- Local Institution - 0110
- Local Institution - 0108
- Local Institution - 0103
- Local Institution - 0114
- Local Institution - 0117
- Local Institution - 0116
- Local Institution - 0105
- Local Institution - 0106
- Local Institution - 0113
- Local Institution - 0118
- Local Institution - 0161
- Local Institution - 0102
- Local Institution - 0163
- Local Institution - 0339
- Local Institution - 0346
- Local Institution - 0193
- Local Institution - 0348
- Local Institution - 0342
- Local Institution - 0120
- Local Institution - 0345
- Local Institution - 0127
- Local Institution - 0191
- Local Institution - 0131
- Local Institution - 0128
- Local Institution - 0195
- Local Institution - 0132
- Local Institution - 0167
- Local Institution - 0196
- Local Institution - 0171
- Local Institution - 0340
- Local Institution - 0344
- Local Institution - 0190
- Local Institution - 0133
- Local Institution - 0126
- Local Institution - 0165
- Local Institution - 0169
- Local Institution - 0194
- Local Institution - 0166
- Local Institution - 0124
- Local Institution - 0189
- Local Institution - 0338
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cohort A: Treatment - Nivolumab
Arm Description
Nivolumab IV infusion
Outcomes
Primary Outcome Measures
Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events
The total number of participants with high grade treatment related select adverse events.
Secondary Outcome Measures
Number of Participants With High Grade Select Adverse Events
The total number of participants with high grade select adverse events. High grade is defined as Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Grades 3-4. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. Select AEs include Pulmonary toxicity, Gastrointestinal toxicity (diarrhea or colitis, Endocrinopathies, Hepatotoxicity (including asymptomatic LFT elevations), Renal toxicity, Skin toxicity, and Neurological toxicity.
Median Time to Onset of Any Grade Select Adverse Events
Median Time to onset of any grade select adverse events reported up to 100 days after last dose. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. Select AEs include Pulmonary toxicity, Gastrointestinal toxicity (diarrhea or colitis, Endocrinopathies, Hepatotoxicity (including asymptomatic LFT elevations), Renal toxicity, Skin toxicity, and Neurological toxicity.
Median Time to Resolution of Any Grade Select Adverse Events
Median time to resolution of any grade select adverse events reported up to 100 days after last dose. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. Select AEs include Pulmonary toxicity, Gastrointestinal toxicity (diarrhea or colitis, Endocrinopathies, Hepatotoxicity (including asymptomatic LFT elevations), Renal toxicity, Skin toxicity, and Neurological toxicity.
Overall Survival
Overall Survival (OS) is defined as the time from first dosing date to the date of death. A subject who has not died will be censored at last known date alive. OS will be followed continuously while subjects are on treatment and every 3 months via in-person or phone contact after subjects discontinue the study drug.
Objective Response Rate (ORR)
ORR is defined as the percentage of subjects with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR). CR is defined as the disappearance of all target lesions; PR is defined by at least a 30% decrease in the sum of the longest diameter of target lesions. ORR as assessed by the investigator will be reported.
Full Information
NCT ID
NCT02409368
First Posted
April 1, 2015
Last Updated
October 17, 2022
Sponsor
Bristol-Myers Squibb
Collaborators
PPD
1. Study Identification
Unique Protocol Identification Number
NCT02409368
Brief Title
An Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) Monotherapy in Subjects With Advanced or Metastatic Squamous Cell (Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Prior Systemic Regimen for the Treatment of Stage IIIb/IV SqNSCLC
Acronym
Checkmate 171
Official Title
An Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) Monotherapy in Subjects With Advanced or Metastatic Squamous Cell (Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Prior Systemic Regimen for the Treatment of Stage IIIb/IV SqNSCLC
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
April 29, 2015 (Actual)
Primary Completion Date
March 7, 2018 (Actual)
Study Completion Date
August 27, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
Collaborators
PPD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the study is to determine the occurrence of high-grade (CTCAE v4.0 Grades 3-4), treatment-related, select adverse events in patients with advanced or metastatic Squamous Cell Non-Small Cell Lung Cancer (SqNSCLC) with progression of disease during or after at least 1 systemic therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
812 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort A: Treatment - Nivolumab
Arm Type
Experimental
Arm Description
Nivolumab IV infusion
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Primary Outcome Measure Information:
Title
Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events
Description
The total number of participants with high grade treatment related select adverse events.
Time Frame
From first dose to time of analysis of primary endpoint (approximately up to 34 months)
Secondary Outcome Measure Information:
Title
Number of Participants With High Grade Select Adverse Events
Description
The total number of participants with high grade select adverse events. High grade is defined as Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Grades 3-4. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. Select AEs include Pulmonary toxicity, Gastrointestinal toxicity (diarrhea or colitis, Endocrinopathies, Hepatotoxicity (including asymptomatic LFT elevations), Renal toxicity, Skin toxicity, and Neurological toxicity.
Time Frame
From first dose up to 100 days post last dose (up to 76 months)
Title
Median Time to Onset of Any Grade Select Adverse Events
Description
Median Time to onset of any grade select adverse events reported up to 100 days after last dose. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. Select AEs include Pulmonary toxicity, Gastrointestinal toxicity (diarrhea or colitis, Endocrinopathies, Hepatotoxicity (including asymptomatic LFT elevations), Renal toxicity, Skin toxicity, and Neurological toxicity.
Time Frame
From first dose up to 100 days post last dose (up to approximately 65 months)
Title
Median Time to Resolution of Any Grade Select Adverse Events
Description
Median time to resolution of any grade select adverse events reported up to 100 days after last dose. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. Select AEs include Pulmonary toxicity, Gastrointestinal toxicity (diarrhea or colitis, Endocrinopathies, Hepatotoxicity (including asymptomatic LFT elevations), Renal toxicity, Skin toxicity, and Neurological toxicity.
Time Frame
From first dose to up to 100 days post last dose (up to approximately 45 months)
Title
Overall Survival
Description
Overall Survival (OS) is defined as the time from first dosing date to the date of death. A subject who has not died will be censored at last known date alive. OS will be followed continuously while subjects are on treatment and every 3 months via in-person or phone contact after subjects discontinue the study drug.
Time Frame
From the first dosing up to the date of death (up to approximately 76 months)
Title
Objective Response Rate (ORR)
Description
ORR is defined as the percentage of subjects with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR). CR is defined as the disappearance of all target lesions; PR is defined by at least a 30% decrease in the sum of the longest diameter of target lesions. ORR as assessed by the investigator will be reported.
Time Frame
From first dose up to last dose (up to approximately 76 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
ECOG Status: PS 0-1 & PS 2
Subjects with histologically or cytologically-documented SqNSCLC
Subjects must have experienced disease progression or recurrence during or after one prior platinum doublet-based chemotherapy regimen
Subjects must have evaluable disease by CT or MRI per RECIST 1.1 criteria
Subjects with treated or asymptomatic CNS metastases
Prior palliative radiotherapy must have been completed at least 14 days prior to study drug administration
Prior lines of antineoplastic therapy, including hemotherapy, hormonal therapy, immunotherapy, surgical resection of lesions, non-palliative radiation therapy, or standard or investigational agents for treatment of NSCLC, must be completed 28 days prior to the first dose of nivolumab
Males and Females, ages 18 or older
Exclusion Criteria:
Subjects with untreated, symptomatic CNS metastases
Subjects with carcinomatous meningitis
Subjects with active, known or suspected autoimmune disease.
Subjects who received prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways) or who have previously taken part in a randomized BMS clinical trial for nivolumab or ipilimumab.
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 - 0002
City
Wels
State/Province
Oberösterreich
ZIP/Postal Code
4600
Country
Austria
Facility Name
Local Institution - 0003
City
Salzburg
ZIP/Postal Code
5020
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Austria
Facility Name
Local Institution - 0005
City
Wien
ZIP/Postal Code
1140
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Austria
Facility Name
Local Institution - 0173
City
Odense
State/Province
South Denmark
ZIP/Postal Code
5000
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Denmark
Facility Name
Local Institution - 0021
City
Aalborg
ZIP/Postal Code
9000
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Denmark
Facility Name
Local Institution - 0020
City
Herlev
ZIP/Postal Code
2730
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Denmark
Facility Name
Local Institution - 0022
City
Oulu
State/Province
Pohjois-Pohjanmaa
ZIP/Postal Code
90230
Country
Finland
Facility Name
Local Institution - 0023
City
Pori
ZIP/Postal Code
FI-28500
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Finland
Facility Name
Local Institution - 0051
City
Athens
ZIP/Postal Code
11527
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Greece
Facility Name
Local Institution - 0052
City
Heraklion
ZIP/Postal Code
71110
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Greece
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Local Institution - 0177
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Nea Kifisia Athens
ZIP/Postal Code
14564
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Greece
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Local Institution - 0148
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Patras
ZIP/Postal Code
26504
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Greece
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Thessaloniki
ZIP/Postal Code
57010
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Greece
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Pécs
State/Province
Baranya
ZIP/Postal Code
7624
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Hungary
Facility Name
Local Institution - 0053
City
Budapest
ZIP/Postal Code
1121
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Hungary
Facility Name
Local Institution - 0347
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Budapest
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1125
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Hungary
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Debrecen
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Dublin 8
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Ireland
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Galway
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Ireland
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Tullamore, Offaly
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Gliwice
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Slaskie
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Zabrze
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Slaskie
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Poland
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Poznan
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Poland
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Gdansk
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Lodz
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Local Institution - 0089
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Warszawa
ZIP/Postal Code
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Poland
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Local Institution - 0094
City
Coimbra
ZIP/Postal Code
3000-602
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Portugal
Facility Name
Local Institution - 0093
City
Lisboa
ZIP/Postal Code
1099-023
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Portugal
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Local Institution - 0090
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Lisboa
ZIP/Postal Code
1769-001
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Portugal
Facility Name
Local Institution - 0092
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Porto
ZIP/Postal Code
4099-001
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Portugal
Facility Name
Local Institution - 0091
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Porto
ZIP/Postal Code
4200-072
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Portugal
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Local Institution - 0159
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Porto
ZIP/Postal Code
4200-319
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Portugal
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Local Institution - 0192
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Oradea
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Bihor
ZIP/Postal Code
410469
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Romania
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Local Institution - 0098
City
Cluj-Napoca
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Cluj
ZIP/Postal Code
400058
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Romania
Facility Name
Local Institution - 0187
City
Timisoara
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Timis
ZIP/Postal Code
300167
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Romania
Facility Name
Local Institution - 0095
City
Bucharest
ZIP/Postal Code
022328
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Romania
Facility Name
Local Institution - 0096
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Bucharest
ZIP/Postal Code
030171
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Romania
Facility Name
Local Institution - 0097
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Cluj Napoca
ZIP/Postal Code
400015
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Romania
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Local Institution - 0100
City
Saint Petersburg
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Leningradskaya Oblast
ZIP/Postal Code
197758
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Russian Federation
Facility Name
Local Institution - 0160
City
Moscow
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Moskva
ZIP/Postal Code
115478
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Russian Federation
Facility Name
Local Institution - 0099
City
St. Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Local Institution - 0337
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33006
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Spain
Facility Name
Local Institution - 0109
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Local Institution - 0107
City
La Laguna
State/Province
Santa Cruz De Tenerife
ZIP/Postal Code
38320
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Spain
Facility Name
Local Institution - 0104
City
A Coruna
ZIP/Postal Code
15006
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Spain
Facility Name
Local Institution - 0119
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Alicante
ZIP/Postal Code
03010
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Spain
Facility Name
Local Institution - 0162
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Barcelona
ZIP/Postal Code
08036
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Spain
Facility Name
Local Institution - 0112
City
Barcelona
ZIP/Postal Code
08916
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Spain
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Local Institution - 0111
City
Barcelona
ZIP/Postal Code
8028
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Spain
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Local Institution - 0110
City
Barcelona
ZIP/Postal Code
8035
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Spain
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Local Institution - 0108
City
Burgos
ZIP/Postal Code
09006
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Spain
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Local Institution - 0103
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Granada
ZIP/Postal Code
18014
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Spain
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Local Institution - 0114
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Madrid
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28034
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Spain
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Local Institution - 0117
City
Madrid
ZIP/Postal Code
28040
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Spain
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Madrid
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28041
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Spain
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City
Madrid
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28046
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Spain
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Malaga
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29010
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Spain
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Palma de Mallorca
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07198
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Spain
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Local Institution - 0118
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Seville
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41013
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Spain
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Local Institution - 0161
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Valencia
ZIP/Postal Code
46010
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Spain
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Local Institution - 0102
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Valencia
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46026
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Spain
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Local Institution - 0163
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Zaragoza
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50009
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Spain
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Local Institution - 0339
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Örebro
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Orebro Lan
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SE-70185
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Sweden
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Local Institution - 0346
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Stockholm
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Stockholms Lan
ZIP/Postal Code
17176
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Sweden
Facility Name
Local Institution - 0193
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Goteborg
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Vastra Gotalands Lan
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41345
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Sweden
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Local Institution - 0348
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Linköping
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581 85
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Sweden
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Local Institution - 0342
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Lund
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22185
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Sweden
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Local Institution - 0120
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Stockholm
ZIP/Postal Code
171 76
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Sweden
Facility Name
Local Institution - 0345
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Aberdeen
State/Province
Aberdeen CITY
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
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Local Institution - 0127
City
London
State/Province
Greater London
ZIP/Postal Code
N18 1QX
Country
United Kingdom
Facility Name
Local Institution - 0191
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Local Institution - 0131
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
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Local Institution - 0128
City
Maidstone
State/Province
Kent
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Facility Name
Local Institution - 0195
City
Glasgow
State/Province
Lanarkshire
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Local Institution - 0132
City
Preston
State/Province
Lancashire
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Facility Name
Local Institution - 0167
City
Leicester
State/Province
Leicestershire
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Local Institution - 0196
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Local Institution - 0171
City
Bebington
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
Local Institution - 0340
City
Bodelwyddan, Rhyl
ZIP/Postal Code
LL18 5UJ
Country
United Kingdom
Facility Name
Local Institution - 0344
City
Bradford
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Facility Name
Local Institution - 0190
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Local Institution - 0133
City
Cardiff
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Facility Name
Local Institution - 0126
City
Cottingham
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
Local Institution - 0165
City
London
ZIP/Postal Code
W1T 7HA
Country
United Kingdom
Facility Name
Local Institution - 0169
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
Local Institution - 0194
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Local Institution - 0166
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Local Institution - 0124
City
Sheffield
ZIP/Postal Code
S10 5SJ
Country
United Kingdom
Facility Name
Local Institution - 0189
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Local Institution - 0338
City
West Midlands
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
32028209
Citation
Felip E, Ardizzoni A, Ciuleanu T, Cobo M, Laktionov K, Szilasi M, Califano R, Carcereny E, Griffiths R, Paz-Ares L, Duchnowska R, Garcia MA, Isla D, Jassem J, Appel W, Milanowski J, Van Meerbeeck JP, Wolf J, Li A, Acevedo A, Popat S. CheckMate 171: A phase 2 trial of nivolumab in patients with previously treated advanced squamous non-small cell lung cancer, including ECOG PS 2 and elderly populations. Eur J Cancer. 2020 Mar;127:160-172. doi: 10.1016/j.ejca.2019.11.019. Epub 2020 Feb 3.
Results Reference
derived
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.BMSStudyConnect.com
Description
BMS Clinical Trial Patient Recruiting
Learn more about this trial
An Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) Monotherapy in Subjects With Advanced or Metastatic Squamous Cell (Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Prior Systemic Regimen for the Treatment of Stage IIIb/IV SqNSCLC
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