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A Safety Trial of Nivolumab in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed During or After Receiving At Least One Prior Chemotherapy Regimen (CheckMate153)

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ClinicalTrials.gov Identifier: NCT02066636
Recruitment Status : Active, not recruiting
First Posted : February 19, 2014
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to estimate the incidence and characterize the outcome of high grade, select adverse events in subjects with advanced or metastatic NSCLC treated with Nivolumab.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer (NSCLC) Drug: Nivolumab Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IIIb/IV Safety Trial of Nivolumab (BMS-936558) in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed During or After Receiving At Least One Prior Systemic Regimen
Actual Study Start Date : February 28, 2014
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : January 31, 2022

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: Nivolumab
Nivolumab 3 mg/kg solution intravenous infusion over 60 minutes every two weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent
Drug: Nivolumab
Other Name: BMS-936558

Experimental: Cohort B: Nivolumab

Nivolumab 3 mg/kg solution intravenous infusion over 60 minutes every two weeks until 1 year (52 weeks).

Discontinue treatment and at progression, retreatment allowed

Drug: Nivolumab
Other Name: BMS-936558




Primary Outcome Measures :
  1. Incidence for high grade (Grade 3-4 and Grade 5) treatment related select adverse events (AEs) [ Time Frame: Up to 100 days after last dose date (approximately up to 6.5 years) ]

Secondary Outcome Measures :
  1. Incidence for high grade (Grade 3-4 and Grade 5) select AEs [ Time Frame: Up to 100 days after last dose date (approximately up to 6.5 years) ]
  2. Median time to onset and median time to resolution (Grade 3-4) [ Time Frame: Up to 100 days after last dose date (approximately up to 6.5 years) ]
  3. Percentage of subjects who received immune modulating medication or hormonal replacement therapy, percentage of subjects who received ≥40 mg Prednisone equivalents, total duration of all immune modulating medications given for select event [ Time Frame: Up to 100 days after last dose date (approximately up to 6.5 years) ]
    Immune modulating medication (e.g. corticosteroids, Infliximab, Cyclophosphamide, intravenous immune globulin (IVIG), and Mycophenolate Mofetil)



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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:

1. Target Population

  • Subjects with histologically-or cytologically-documented NSCLC [squamous (SQ) or nonsquamous (NSQ)] who present with Stage IIIB/Stage IV disease (according to version 7 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology), or with recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection or definitive chemoradiotherapy for locally advanced disease)
  • Subjects must have experienced disease progression or recurrence during or after at least one systemic therapy for advanced or metastatic disease
  • Each subsequent line of therapy must be preceded by disease progression. A switch of an agent within a regimen in order to manage toxicity does not define the start of a new line of therapy
  • Maintenance therapy following platinum doublet-based chemotherapy is not considered as a separate regimen of therapy
  • Subjects who received platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, and developed recurrent (local or metastatic) disease within 6 months of completing therapy are eligible
  • Subjects with recurrent disease >6 months after platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, who also subsequently progressed during or after a platinum doublet-based regimen given to treat the recurrence are eligible
  • Subjects with non-squamous histology must be tested for Epithelial Growth Factor Receptor (EGFR) mutations (including, but not limited to, deletions in exon 19 and exon 21 [L858R] substitution) and Anaplastic Lymphoma Kinase (ALK) rearrangement if tests have not been previously performed. Subjects with progressive disease during or after EGFR or ALK tyrosine kinase inhibitor (TKI) regimens are eligible. Subjects are eligible if genetic test results are indeterminate or if no tumor tissue is available or accessible for testing as long as they have received one prior systemic therapy
  • Experimental therapies when given as separate regimen are considered as separate line of therapy
  • Subjects must have measurable disease by CT or MRI per RECIST 1.1 criteria (radiographic tumor assessment performed within 28 days of first dose of study drug) or clinically apparent disease that the investigator can follow for response per RECIST 1.1
  • Eastern Cooperative Oncology Arm (ECOG) performance status (PS)
  • PS 0 to 1
  • PS 2

Exclusion Criteria:

  1. Target Disease Exceptions

    • Subjects with active central nervous system (CNS) metastases are excluded
    • Subjects with carcinomatous meningitis
  2. Medical History and Concurrent Diseases

    • Subjects with a history of interstitial lung disease
    • Subjects with active, known or suspected autoimmune disease
    • Subject whom participated in either arm of the following clinical trials CA209-017, CA209-057, CA209-026, and CA184-104 or received prior treatment with anti-programmed death 1 (PD-1) or anti-programmed death-ligand 1 (PDL1) experimental agents
  3. Prohibited Treatments and/or Restricted Therapies

    • Ongoing or planned administration of anti-cancer therapies other than those specified in this study
    • Use of corticosteroids or other immunosuppressive medications

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): NCT02066636


  Show 133 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02066636     History of Changes
Other Study ID Numbers: CA209-153
First Posted: February 19, 2014    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018

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