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Study of Nivolumab (BMS-936558) in Patients With Advanced or Metastatic Squamous Cell Nonsmall-cell Lung Cancer Who Have Received At Least 2 Prior Systemic Regimens

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ClinicalTrials.gov Identifier: NCT01721759
Recruitment Status : Active, not recruiting
First Posted : November 6, 2012
Results First Posted : October 22, 2015
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE November 2, 2012
First Posted Date  ICMJE November 6, 2012
Results First Submitted Date  ICMJE September 14, 2015
Results First Posted Date  ICMJE October 22, 2015
Last Update Posted Date March 25, 2020
Actual Study Start Date  ICMJE November 14, 2012
Actual Primary Completion Date January 22, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2016)
  • Objective Response Rate (ORR) as Assessed by Independent Radiology Review Committee (IRC) [ Time Frame: Day 1 of treatment to approximately 19 months ]
    ORR is defined as the number of participants with best overall response (OR) of confirmed complete response (CR) or partial response (PR) divided by the number of participants who received treatment. Participants were evaluated for tumor response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. The IRC-assessed ORR (using RECIST v1.1, to confirm response and based on the IRC global radiology review after incorporation of on-study clinical data) was estimated using a binomial response rate and its corresponding 2-sided 95% exact confidence intervals using the Clopper-Pearson method.
  • Objective Response Rate (ORR) as Assessed by Independent Radiology Review Committee (IRC) [ Time Frame: Day 1 of treatment to approximately 16 months ]
    ORR is defined as the number of participants with best overall response (OR) of confirmed complete response (CR) or partial response (PR) divided by the number of participants who received treatment. Participants were evaluated for tumor response per RECIST v1.1 for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. The IRC-assessed ORR (using RECIST v1.1, to confirm response and based on the IRC global radiology review after incorporation of on-study clinical data) was estimated using a binomial response rate and its corresponding 2-sided 95% exact confidence intervals using the Clopper-Pearson method.
Original Primary Outcome Measures  ICMJE
 (submitted: November 2, 2012)
Primary endpoint of investigator-assessed Objective response rate (ORR) [ Time Frame: 15 Months ]
Defined as the number of subjects with a confirmed best overall response (BOR) of Complete response (CR) or Partial response (PR) divided by the number of treated subjects
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2016)
Objective Response Rate (ORR) as Assessed by Investigator [ Time Frame: Day 1 of treatment to approximately 16 months ]
ORR is defined as the number of participants with best overall response (OR) of confirmed complete response (CR) or partial response (PR) divided by the total number of participants who received treatment. Participants were evaluated for tumor response per RECIST v1.1 for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Best overall response, ORR, duration of response, and time to response as assessed by investigator were summarized using RECIST v1.1, to confirm response.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2012)
The secondary endpoint of ORR as assessed by Independent radiology review committee (IRC) [ Time Frame: 15 Months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Nivolumab (BMS-936558) in Patients With Advanced or Metastatic Squamous Cell Nonsmall-cell Lung Cancer Who Have Received At Least 2 Prior Systemic Regimens
Official Title  ICMJE A Single-Arm Phase 2 Study of Nivolumab (BMS-936558) in Subjects With Advanced or Metastatic Squamous Cell Non-Small Cell Lung Cancer Who Have Received At Least Two Prior Systemic Regimens
Brief Summary The purpose of the study is to assess the objective response rate (change in tumor size from baseline) in patients with advanced or metastatic squamous cell nonsmall-cell lung cancer treated with Nivolumab (BMS-936558) after failure of 2 prior systemic regimens
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: Treatment
Condition  ICMJE Squamous Cell Non-small Cell Lung Cancer
Intervention  ICMJE Drug: Nivolumab
Other Name: BMS-936558
Study Arms  ICMJE Experimental: Nivolumab, 3 mg/kg
Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
Intervention: Drug: Nivolumab
Publications *

*   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
Actual Enrollment  ICMJE
 (submitted: September 23, 2015)
140
Original Estimated Enrollment  ICMJE
 (submitted: November 2, 2012)
100
Estimated Study Completion Date  ICMJE June 14, 2020
Actual Primary Completion Date January 22, 2014   (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:

  • Men and women ≥18 years of age
  • Patients with histologically or cytologically documented squamous cell nonsmall-cell lung cancer 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 chemoradiation for locally advanced disease
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1
  • Disease progression or recurrence after both a platinum doublet-based chemotherapy regimen and at least 1 additional systemic therapy
  • Measurable disease by computed tomography scan/magnetic resonance imaging as per Response Evaluation Criteria in Solid Tumors, volume 1.1

Exclusion Criteria:

  • Untreated central nervous system (CNS) metastases. Metastases have been treated and patients neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to enrollment. In addition, patients must have stopped taking corticosteroids or be taking a stable or decreasing dose of ≤10 mg prednisone daily (or equivalent)
  • Carcinomatous meningitis
  • Active known or suspected autoimmune disease or interstitial lung disease
  • Prior treatment on either arm of study CA209-017 or CA184-104
  • Prior therapy with anti-Programmed death-1 (anti-PD-1), anti-Programmed cell death ligand 1 (anti-PD-L1), anti-Programmed cell death ligand 2 (anti-PD-L2), anti-CD137, or anti-Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways
  • A condition requiring systemic treatment with corticosteroids or other immunosuppressive medications within 14 days of first dose of study drug
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 France,   Germany,   Italy,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01721759
Other Study ID Numbers  ICMJE CA209-063
2012-003965-16 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date March 2020

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