Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Metastatic Non-squamous NSCLC (CheckMate 057)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01673867
First received: August 24, 2012
Last updated: September 22, 2014
Last verified: September 2014

August 24, 2012
September 22, 2014
November 2012
May 2015   (final data collection date for primary outcome measure)
  • Overall Survival [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Overall Survival is defined as the time from randomization to the date of death
  • Overall Survival [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Month 18 ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Month 36 ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Month 48 ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Year 5 ] [ Designated as safety issue: No ]
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
Complete list of historical versions of study NCT01673867 on ClinicalTrials.gov Archive Site
  • Objective response rate (ORR) of BMS-936558 (Nivolumab) versus Docetaxel [ Time Frame: 6, 12, 18, 24, 36, 48 months and 5 year ] [ Designated as safety issue: No ]
    ORR is defined as the proportion of all randomized subjects whose best overall response (BOR) from baseline is either a Complete response (CR) or Partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
  • Progression-free survival (PFS) of BMS-936558 (Nivolumab) versus Docetaxel [ Time Frame: 6, 12, 18, 24, 36, 48 months and 5 year ] [ Designated as safety issue: No ]
    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
  • PD-L1 protein expression [ Time Frame: 6, 12, 18, 24, 36, 48 months and 5 year ] [ Designated as safety issue: No ]
    PD-L1 expression is defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay
  • Disease-related symptom improvement rate [ Time Frame: Up to Week 12 ] [ Designated as safety issue: No ]
    Measured by LCSS, in BMS-936558 (nivolumab) and docetaxel treatment groups
  • Objective response rate of BMS-936558 versus Docetaxel [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Objective response rate is defined as the proportion of all randomized subjects whose best overall response (BOR) from baseline is either a Complete response (CR) or Partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
  • Progression-free survival (PFS) of BMS-936558 versus Docetaxel [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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
  • Clinical benefit of BMS-936558 versus Docetaxel, in PD-L1 + versus PD-L1-protein expression subgroups [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • 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 Metastatic Non-squamous NSCLC (CheckMate 057)
An Open-Label Randomized Phase III Trial of BMS-936558 (Nivolumab) Versus Docetaxel in Previously Treated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)

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

CheckMate 057: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 057

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Squamous Cell Non-small Cell Lung Cancer
  • Biological: Nivolumab
    Other Name: BMS-936558 (Anti-PD1)
  • 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
  • Active Comparator: Arm B: Docetaxel
    Docetaxel 75 mg/m² concentrate for solution for intravenous infusion 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
582
May 2016
May 2015   (final data collection date for primary outcome measure)

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Men & women ≥18 years of age
  • Subjects with histologically or cytologically-documented non-squamous cell NSCLC who present with Stage IIIB/IV disease or recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection, or definitive chemoradiation therapy for locally advanced disease) and who will receive study therapy as second or third line of treatment for 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 RECIST 1.1 criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1
  • A 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 asymptomatic or 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 ≤10mg daily prednisone (or equivalent)
  • Subjects with carcinomatous meningitis
  • Subjects with active,or recent history of known or suspected autoimmune disease. Subjects with Type 1 diabetes mellitus, hypothyroidism only requiring skin disorders (vitiligo, psoriasis, or alopecia) not requiring systemic treatment 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 (anti-PD-1), anti programmed cell death ligand 1 (anti-PD-L1), anti programmed cell death ligand 2 (anti-PD-L2), anti-cluster of differentiation 137 (anti-CD137), or anti-Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4) antibody (including Ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
  • Prior treatment with Docetaxel
  • 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
Canada,   United States,   Germany,   Poland,   Switzerland,   Spain,   Singapore,   Russian Federation,   Romania,   Argentina,   Australia,   Austria,   Brazil,   Chile,   Czech Republic,   France,   Hong Kong,   Hungary,   Italy,   Mexico,   Norway,   Peru
 
NCT01673867
CA209-057, 2012-002472-14
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
September 2014

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