Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC) (CheckMate 017)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01642004
First received: July 9, 2012
Last updated: August 28, 2014
Last verified: July 2014

July 9, 2012
August 28, 2014
June 2012
January 2016   (final data collection date for primary outcome measure)
Overall Survival (OS) of BMS-936558 (Nivolumab) versus Docetaxel in subjects with squamous cell NSCLC after failure of prior-platinum doublet-based chemotherapy [ Time Frame: 38 months ] [ Designated as safety issue: No ]
OS is defined as the time from randomization to the date of death
  • Overall Survival [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
    Overall Survival is defined as the time from randomization to the date of death
  • Objective Response Rate [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
    Objective Response Rate is defined as the number of subjects with a Best overall response (BOR) of CR or PR divided by the number of randomized subjects
Complete list of historical versions of study NCT01642004 on ClinicalTrials.gov Archive Site
  • ORR of BMS-936558 (Nivolumab) versus Docetaxel [ Time Frame: 38 months ] [ Designated as safety issue: No ]
    Objective response rate (ORR) is defined as the number of subjects whose best confirmed objective response is either a complete response (CR) or partial response (PR) divided by the number of randomized subjects
  • PFS of BMS-936558 (Nivolumab) versus Docetaxel [ Time Frame: 38 months ] [ Designated as safety issue: No ]
    Progression-free survival (PFS) is defined as the time from randomization to the date of the first documented tumor progression (per RECIST 1.1) or death due to any cause
  • Potential association between PD-L1 expression and efficacy measures (ORR, OS PFS) will be assessed [ Time Frame: 38 Months ] [ Designated as safety issue: No ]
  • QoL measured by disease-related symptom improvement rate in BMS-936558 (Nivolumab) and Docetaxel groups [ Time Frame: 38 Months ] [ Designated as safety issue: No ]
    Quality of life (QoL) is defined as the proportion of randomized subjects who had a disease-related symptom improvement as measured by the Lung Cancer Symptom Scale (LCSS)
  • The progression-free survival (PFS) of BMS-936558 versus docetaxel [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Clinical benefit in terms of Objective response rate (ORR) and Overall survival (OS) of BMS-936558 versus docetaxel, in PD-L1 + versus PD-L1- protein expression subgroups [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Duration of objective response in BMS-936558 and docetaxel groups [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
    Duration of objective response (DOOR) is defined as the time between the date of first response to the date of the first documented tumor progression or death due to any cause
  • Time to objective response in BMS-936558 and docetaxel groups [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
    Time to objective response (TTOR) is defined as the time from randomization to the date of the first documented Complete response (CR) or Partial response (PR)
  • Proportion of subjects exhibiting disease-related symptom progression, as measured by Lung Cancer Symptom Scale (LCSS), in BMS-936558 and docetaxel groups [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC) (CheckMate 017)
An Open-Label Randomized Phase III Trial of BMS-936558 (Nivolumab) Versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC)

The purpose of the study is to compare the change in tumor size, and overall survival of BMS-936558 as compared with Docetaxel in subjects with squamous cell non-small cell lung cancer (NSCLC), after failure of prior platinum-based chemotherapy.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Squamous Cell Non-small Cell Lung Cancer
  • Biological: Nivolumab
    Other Name: BMS-936558
  • Drug: Docetaxel
    Other Name: Taxotere®
  • Experimental: Arm A: Nivolumab
    Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
    Intervention: Biological: Nivolumab
  • Experimental: Arm B: Docetaxel
    Docetaxel 75 mg/m2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
    Intervention: Drug: Docetaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
264
January 2017
January 2016   (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
  • Subjects with histologically or cytologically-documented squamous cell NSCLC who present with Stage IIIB/IV disease or with recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection or definitive chemoradiation therapy for locally advanced disease)
  • Disease recurrence or progression during/after one prior platinum doublet-based chemotherapy regimen for advanced or metastatic disease
  • Measurable disease by computed tomography (CT)/Magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1
  • An formalin fixed, paraffin-embedded (FFPE) tumor tissue block or unstained slides of tumor sample (archival or recent) must be available for biomarker evaluation. Specimens must be received by the central lab prior to randomization. Biopsy should be excisional, incisional or core needle. Fine needle aspiration is insufficient

Exclusion Criteria:

  • Subjects with untreated central nervous system (CNS) metastases are excluded. Subjects are eligible if CNS metastases are treated and subjects are neurologically returned to baseline for at least 2 weeks prior to enrollment. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of ≤10 mg daily prednisone (or equivalent)
  • Subjects with carcinomatous meningitis
  • Subjects with active, known or suspected autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
  • Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of randomization
  • Prior therapy with anti-Programmed death-1 (PD-1), anti-Programmed cell death ligand 1 (PD-L1), anti-Programmed cell death ligand 2 (PD-L2), anti-CD137, or anti-Cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
  • Prior treatment on the first line study CA184104 first line NSCLC study
  • Prior treatment with Docetaxel
  • Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
  • Treatment with any investigational agent within 14 days of first administration of study treatment
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Austria,   Canada,   Chile,   Czech Republic,   France,   Germany,   Hungary,   Ireland,   Italy,   Mexico,   Netherlands,   Peru,   Poland,   Romania,   Russian Federation,   Spain,   United Kingdom
 
NCT01642004
CA209-017, 2011-004792-36
Yes
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
July 2014

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