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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 (Checkmate 171)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02409368
Recruitment Status : Active, not recruiting
First Posted : April 6, 2015
Last Update Posted : June 19, 2020
Sponsor:
Collaborator:
PPD
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE April 1, 2015
First Posted Date  ICMJE April 6, 2015
Last Update Posted Date June 19, 2020
Actual Study Start Date  ICMJE April 23, 2015
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2015)
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 5 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 3, 2015)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2015)
  • Incidence and to characterize the outcome of all high-grade (CTCAE v4.0 Grades 3-4), select adverse events [ Time Frame: Approximately 5 years ]
  • Overall survival (OS) in all treated subject [ Time Frame: Approximately 5 years ]
  • Investigator-assessed objective response rate (ORR) [ Time Frame: Approximately 3 years ]
  • Median time to onset (Grades 3-4) of select adverse events [ Time Frame: Approximately 5 years ]
  • Median time to resolution (Grades 3-4) of select adverse events [ Time Frame: Approximately 5 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2015)
  • Incidence and to characterize the outcome of all high-grade (CTCAE v4.0 Grades 3-4), select adverse events [ Time Frame: Approximately 3 years ]
  • Overall survival (OS) in all treated subject [ Time Frame: Approximately 5 years ]
  • Investigator-assessed objective response rate (ORR) [ Time Frame: Approximately 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Non-Small Cell Lung Cancer
Intervention  ICMJE Drug: Nivolumab
Study Arms  ICMJE Experimental: Cohort A: Treatment - Nivolumab
Nivolumab IV infusion
Intervention: Drug: Nivolumab
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 8, 2015)
800
Original Estimated Enrollment  ICMJE
 (submitted: April 3, 2015)
1482
Estimated Study Completion Date  ICMJE May 31, 2021
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Denmark,   Finland,   Greece,   Hungary,   Ireland,   Poland,   Portugal,   Romania,   Russian Federation,   Spain,   Sweden,   United Kingdom
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT02409368
Other Study ID Numbers  ICMJE CA209-171
2014-001285-10 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE PPD
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP