Trial record 1 of 8 for:    nivolumab lung cancer phase 3 safety
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A 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 (CheckMate 153)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02066636
First received: February 14, 2014
Last updated: September 10, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Non Small Cell Lung Cancer (NSCLC)
Drug: Nivolumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
    Immune modulating medication (e.g. corticosteroids, Infliximab, Cyclophosphamide, intravenous immune globulin (IVIG), and Mycophenolate Mofetil)


Estimated Enrollment: 780
Study Start Date: February 2014
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  • First line therapy is defined as therapy used to treat advanced disease. Each subsequent line of therapy is 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 progression or recurrent disease during or after Epithelial Growth Factor Receptor (EGFR) or Anaplastic Lymphoma Kinase (ALK) tyrosine kinase inhibitor (TKI) regimen are eligible
  • Experimental therapies when given as separate regimen are considered as separate line of therapy
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02066636

Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

  Show 72 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02066636     History of Changes
Other Study ID Numbers: CA209-153
Study First Received: February 14, 2014
Last Updated: September 10, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 16, 2014