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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)

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ClinicalTrials.gov Identifier: NCT02409368
Recruitment Status : Active, not recruiting
First Posted : April 6, 2015
Last Update Posted : December 13, 2017
Sponsor:
Collaborator:
PPD
Information provided by (Responsible Party):
Bristol-Myers Squibb

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.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Nivolumab Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : April 23, 2015
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : July 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Cohort A: Treatment - Nivolumab
Nivolumab IV infusion
Drug: Nivolumab



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 5 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 5 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 ]
  4. Median time to onset (Grades 3-4) of select adverse events [ Time Frame: Approximately 5 years ]
  5. Median time to resolution (Grades 3-4) of select adverse events [ Time Frame: Approximately 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02409368


  Show 79 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
PPD
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02409368     History of Changes
Other Study ID Numbers: CA209-171
2014-001285-10 ( EudraCT Number )
First Posted: April 6, 2015    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs