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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01673867
Registration number
NCT01673867
Ethics application status
Date submitted
24/08/2012
Date registered
28/08/2012
Date last updated
8/02/2023
Titles & IDs
Public title
Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Metastatic Non-squamous NSCLC
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Scientific title
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)
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Secondary ID [1]
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2012-002472-14
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Secondary ID [2]
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CA209-057
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Universal Trial Number (UTN)
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Trial acronym
CheckMate057
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-Squamous Cell Non-small Cell Lung Cancer
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Other interventions - Nivolumab
Treatment: Drugs - Docetaxel
Experimental: Arm A: Nivolumab - Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
Active Comparator: Arm B: Docetaxel - Docetaxel 75 mg/m^2 concentrate for solution for intravenous infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
Other interventions: Nivolumab
Treatment: Drugs: Docetaxel
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint
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Assessment method [1]
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Overall survival was defined as the time from randomization to the date of death. A participant who has not died will be censored at last known date alive. OS will be followed continuously while participants are on the study drug and every 3 months via in-person or phone contact after participants discontinue the study drug. Median and hazard ratio computed using Kaplan-Meier method.
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Timepoint [1]
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Randomization until 413 deaths, up to March 2015 (approximately 29 months)
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Secondary outcome [1]
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Objective Response Rate (ORR)
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Assessment method [1]
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ORR was defined as the percentage of participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). BOR was defined as the best investigator-assessed response designation, recorded between the date of randomization and the date of objectively documented progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or the date of subsequent anti-cancer therapy (excluding on-treatment palliative radiotherapy of non-target bone lesions or Central Nervous System (CNS) lesions), whichever occurred first. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CR+PR, confidence interval based on the Clopper and Pearson method.
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Timepoint [1]
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From randomization to date of objectively documented progression (up to approximately 110 months)
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Secondary outcome [2]
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Time To Objective Response (TTOR)
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Assessment method [2]
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Time to Objective Response for participants demonstrating a response (either CR or PR) was defined as the time from the date of randomization to the date of the first confirmed response. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters.
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Timepoint [2]
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From randomization to the date of first confirmed response (up to approximately 110 months)
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Secondary outcome [3]
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Duration of Objective Response (DOOR)
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Assessment method [3]
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DOR was defined as the time from the date of first confirmed response to the date of the first documented tumor progression (per RECIST v1.1), as determined by the investigator, or death due to any cause, whichever occurred first. DOR was evaluated only for confirmed responders (i.e. participants with confirmed CR or PR). CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. Participants who neither progressed nor died were censored on the date of their last evaluable tumor assessment. Median computed using Kaplan-Meier method.
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Timepoint [3]
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From randomization to date of first documented tumor progression or death due to any cause, whichever occurred first (up to approximately 110 months)
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Secondary outcome [4]
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Progression-Free Survival (PFS)
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Assessment method [4]
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PFS was 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. Participants who died without a reported prior progression were considered to have progressed on the date of their death. Progression will be assessed every 6 weeks (from the first on-study radiographic assessment) until disease progression is noted. Progressive disease was defined as least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. Median computed using the Kaplan-Meier method.
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Timepoint [4]
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From randomization to first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurred first (up to approximately 110 months)
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Secondary outcome [5]
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Percentage of Participants Experiencing Disease-Related Symptom Improvement by Week 12
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Assessment method [5]
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Disease-related symptom improvement rate by Week 12 was defined as the percentage of randomized participants who had a 10 point or greater decrease from baseline in average symptom burden index score at any time between randomization and Week 12. The participant portion of the Lung Cancer Symptom Scale (LCSS) consisted of 6 symptom-specific questions that addressed cough, dyspnea, fatigue, pain, hemoptysis, and anorexia, plus 3 summary items on symptom distress, interference with activity level, and global health-related Quality of Life (QoL). The scores range from 0 to 100, with 0 representing the best possible score and 100 being the worst possible score. The average symptom burden index score at each assessment was defined as the mean of the 6 symptom-specific questions of the LCSS. 95% CIs were computed using Clopper-Pearson Method.
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Timepoint [5]
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Randomization to Week 12
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Secondary outcome [6]
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Overall Survival (OS) by PD-L1 Expression at Baseline
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Assessment method [6]
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Overall survival was defined as the time from randomization to the date of death. A participant who has not died will be censored at last known date alive. Overall Survival time was measured in months for all randomized participants grouped by their baseline PD-L1 expression level. PD-L1 expression in participants was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay. Median computed using the Kaplan-Meier method.
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Timepoint [6]
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From randomization to the date of death or last known date alive (up to approximately 110 months)
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Secondary outcome [7]
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Objective Response Rate (ORR) by PD-L1 Expression at Baseline
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Assessment method [7]
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ORR was defined as the percentage of all randomized participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CR+PR, confidence interval based on the Clopper and Pearson method. ORR was reported for all randomized participants grouped by their baseline PD-L1 expression level. PD-L1 expression in participants was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay.
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Timepoint [7]
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From randomization to date of objectively documented progression (up to approximately 110 months)
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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 hormone
replacement, or 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
Other protocol-defined inclusion/exclusion criteria apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/11/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
17/12/2021
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Sample size
Target
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Accrual to date
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Final
582
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Local Institution - Tweed Heads
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Local Institution - Melbourne
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2485 - Tweed Heads
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4102 - Woolloongabba
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5000 - Adelaide
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5037 - Kurralta Park
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3199 - Frankston
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Recruitment postcode(s) [6]
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3065 - Melbourne
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Chur
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
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
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01673867
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01673867
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