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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01721759
First received: November 2, 2012
Last updated: September 23, 2015
Last verified: September 2015

November 2, 2012
September 23, 2015
November 2012
January 2014   (final data collection date for primary outcome measure)
  • Objective Response Rate (ORR) as Assessed by Independent Radiology Review Committee (IRC) [ Time Frame: Day 1 of treatment to approximately 19 months ] [ Designated as safety issue: No ]
    ORR is defined as the number of patients with best overall response of confirmed complete response or partial response divided by the number of patients who received treatment. Participants were evaluated for tumor response 8 weeks (+/- 5 days) from start of study and every 6 weeks (+/- 5 days) thereafter. The IRC-assessed ORR (using Response Evaluation Criteria in Solid Tumors, volume 1.1, 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 ] [ Designated as safety issue: No ]
    ORR is defined as the number of patients with best overall response of confirmed complete response or partial response divided by the number of patients who received treatment. Participants were evaluated for tumor response 8 weeks (+/- 5 days) from start of study and every 6 weeks (+/- 5 days) thereafter. The IRC-assessed ORR (using Response Evaluation Criteria in Solid Tumors, volume 1.1, 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.
Primary endpoint of investigator-assessed Objective response rate (ORR) [ Time Frame: 15 Months ] [ Designated as safety issue: No ]
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
Complete list of historical versions of study NCT01721759 on ClinicalTrials.gov Archive Site
Objective Response Rate (ORR) as Assessed by Investigator [ Time Frame: Day 1 of treatment to approximately 16 months ] [ Designated as safety issue: No ]
ORR is defined as the number of patients with best overall response of confirmed complete response or partial response divided by the total number of patients who received treatment. Participants were evaluated for tumor response 8 weeks (+/- 5 days) from start of study and every 6 weeks (+/- 5 days) thereafter. Best overall response, ORR, duration of response, and time to response as assessed by investigator were summarized using Response Evaluation Criteria in Solid Tumors, volume 1.1, to confirm response.
The secondary endpoint of ORR as assessed by Independent radiology review committee (IRC) [ Time Frame: 15 Months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
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
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
Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Squamous Cell Non-small Cell Lung Cancer
Drug: Nivolumab
Other Name: BMS-936558
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
Rizvi NA, Mazières J, Planchard D, Stinchcombe TE, Dy GK, Antonia SJ, Horn L, Lena H, Minenza E, Mennecier B, Otterson GA, Campos LT, Gandara DR, Levy BP, Nair SG, Zalcman G, Wolf J, Souquet PJ, Baldini E, Cappuzzo F, Chouaid C, Dowlati A, Sanborn R, Lopez-Chavez A, Grohe C, Huber RM, Harbison CT, Baudelet C, Lestini BJ, Ramalingam SS. Activity and safety of nivolumab, an anti-PD-1 immune checkpoint inhibitor, for patients with advanced, refractory squamous non-small-cell lung cancer (CheckMate 063): a phase 2, single-arm trial. Lancet Oncol. 2015 Mar;16(3):257-65. doi: 10.1016/S1470-2045(15)70054-9. Epub 2015 Feb 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
140
August 2016
January 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Germany,   Italy
 
NCT01721759
CA209-063, 2012-003965-16
No
Not Provided
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
September 2015

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