ClinicalTrials.gov
History of Changes for Study: NCT02409368
A 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 Two Prior Systemic Regimens for the Treatment of Stage IIIb/IV SqNSCLC (Checkmate 171)
Latest version (submitted October 17, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 3, 2015 None (earliest Version on record)
2 April 6, 2015 Study Status
3 May 28, 2015 Recruitment Status, Study Status, Contacts/Locations, Study Design and Oversight
4 June 3, 2015 Contacts/Locations, Study Design and Study Status
5 June 22, 2015 Contacts/Locations and Study Status
6 July 2, 2015 Contacts/Locations, Study Status and Study Design
7 September 8, 2015 Study Status, Contacts/Locations and Study Design
8 September 16, 2015 Contacts/Locations and Study Status
9 September 23, 2015 Outcome Measures, Study Status, Arms and Interventions, Study Design, Study Identification, Eligibility and Study Description
10 October 1, 2015 Study Status and Contacts/Locations
11 October 15, 2015 Contacts/Locations and Study Status
12 November 4, 2015 Contacts/Locations and Study Status
13 November 18, 2015 Contacts/Locations and Study Status
14 December 8, 2015 Contacts/Locations and Study Status
15 December 21, 2015 Contacts/Locations and Study Status
16 January 6, 2016 Study Status
17 January 21, 2016 Study Status
18 January 26, 2016 Contacts/Locations and Study Status
19 February 10, 2016 Study Status
20 February 25, 2016 Study Status
21 March 11, 2016 Study Status
22 March 28, 2016 Study Status
23 April 12, 2016 Contacts/Locations and Study Status
24 April 25, 2016 Study Status
25 May 6, 2016 Study Status
26 May 10, 2016 Study Status
27 May 25, 2016 Study Status
28 June 9, 2016 Study Status
29 June 24, 2016 Study Status
30 July 11, 2016 Study Status
31 July 26, 2016 Study Status
32 August 8, 2016 Recruitment Status, Contacts/Locations and Study Status
33 August 23, 2016 Study Status
34 September 7, 2016 Study Status
35 September 23, 2016 Study Status
36 October 7, 2016 Study Status
37 October 26, 2016 Study Status
38 November 8, 2016 Study Status
39 November 30, 2016 Study Status
40 December 6, 2016 Contacts/Locations and Study Status
41 December 23, 2016 Study Status
42 January 5, 2017 Study Status
43 January 23, 2017 Study Design and Study Status
44 January 27, 2017 Study Status
45 February 16, 2017 Study Status
46 March 3, 2017 Study Status
47 March 29, 2017 Study Status
48 April 17, 2017 Contacts/Locations and Study Status
49 June 1, 2017 Study Status, Contacts/Locations and References
50 August 7, 2017 Contacts/Locations and Study Status
51 August 30, 2017 Contacts/Locations and Study Status
52 September 14, 2017 Study Status and Contacts/Locations
53 October 17, 2017 Contacts/Locations and Study Status
54 November 6, 2017 Contacts/Locations and Study Status
55 November 21, 2017 Study Status
56 December 11, 2017 Contacts/Locations and Study Status
57 October 1, 2018 Contacts/Locations, Study Status and References
58 October 25, 2019 Study Status and Sponsor/Collaborators
59 June 17, 2020 Contacts/Locations, Study Status and Sponsor/Collaborators
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Results Submission Events
60 July 9, 2021 Study Status, Outcome Measures, Contacts/Locations, Study Design, Document Section and Results
61 September 17, 2021 Recruitment Status and Study Status
62 December 9, 2021 Oversight, Study Status and References
63 October 17, 2022 Adverse Events, Outcome Measures, Participant Flow, Baseline Characteristics, Contacts/Locations, More Information, References, Study Status and Study Design
Comparison Format:
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Study NCT02409368
Submitted Date:  April 3, 2015 (v1)
Open or close this module Study Identification
Unique Protocol ID: CA209-171
Brief Title: A 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 Two Prior Systemic Regimens for the Treatment of Stage IIIb/IV SqNSCLC (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 Two Prior Systemic Regimens for the Treatment of Stage IIIb/IV SqNSCLC
Secondary IDs: 2014-001285-10 [EudraCT Number]
Open or close this module Study Status
Record Verification: April 2015
Overall Status: Not yet recruiting
Study Start: May 2015
Primary Completion: March 2021 [Anticipated]
Study Completion: March 2021 [Anticipated]
First Submitted: April 1, 2015
First Submitted that
Met QC Criteria:		 April 3, 2015
First Posted: April 6, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:		 April 3, 2015
Last Update Posted: April 6, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Bristol-Myers Squibb
Responsible Party: Sponsor
Collaborators: PPD
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module 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 2 systemic therapies.
Detailed Description:
Open or close this module Conditions
Conditions: Non-Small Cell Lung Cancer
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Other
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 1482 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Cohort A: Treatment - Nivolumab
Nivolumab IV infusion
 Drug: Nivolumab
Experimental: Cohort: B: Discontinue treatment and Re-treatment - Nivolumab
Nivolumab IV infusion
 Drug: Nivolumab
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Incidence of high-grade (CTCAE v4.0 Grades 3-4), treatment-related, select adverse events in subjects with advanced or metastatic SqNSCLC
[ Time Frame: Approximately 3 years ]
Secondary Outcome Measures:
1. Incidence and to characterize the outcome of all high-grade (CTCAE v4.0 Grades 3-4), select adverse events
[ Time Frame: Approximately 3 years ]
2. Overall survival (OS) in all treated subject
[ Time Frame: Approximately 5 years ]
3. Investigator-assessed objective response rate (ORR)
[ Time Frame: Approximately 3 years ]
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Easter Cooperative Oncology Group (ECOG) Status: Performance status (PS) 0-1 & PS 2
  • Subjects with histologically or cytologically-documented SqNSCLC
  • Subjects must have experienced disease progression or recurrence during or after both a platinum doublet-based chemotherapy regimen and at least 1 additional systemic therapy
  • Subjects must have evaluable disease by CT or MRI per Response Evaluation Criteria in Solid Tumors (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
  • 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
Open or close this module Contacts/Locations
Central Contact Person: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:
Email: Clinical.Trials@bms.com
Central Contact Backup: First line of the email MUST contain NCT# and Site #.
Study Officials: Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links: Description: BMS clinical trial educational resource
Available IPD/Information:
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