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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/NCT01721772
Registration number
NCT01721772
Ethics application status
Date submitted
2/11/2012
Date registered
6/11/2012
Date last updated
12/07/2022
Titles & IDs
Public title
Study of Nivolumab (BMS-936558) Compared With Dacarbazine in Untreated, Unresectable, or Metastatic Melanoma
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Scientific title
A Phase 3, Randomized, Double-Blind Study of BMS-936558 vs Dacarbazine in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma
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Secondary ID [1]
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2012-003718-16
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Secondary ID [2]
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CA209-066
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Universal Trial Number (UTN)
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Trial acronym
CheckMate 066
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Melanoma
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Condition category
Condition code
Cancer
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Malignant melanoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - BMS-936558 (Nivolumab)
Other interventions - Placebo matching BMS-936558 (Nivolumab)
Treatment: Drugs - Dacarbazine
Treatment: Drugs - Placebo matching Dacarbazine
Experimental: Nivolumab, 3 mg/kg - Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion. Eligible participants may switch to nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
Active Comparator: Dacarbazine, 1000 mg/m^2 - Participants received dacarbazine, 1000 mg/m^2, solution administered IV every 3 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion. Eligible participants may cross-over to nivolumab open label treatment, either 3 mg/kg every 2 weeks or 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
Other interventions: BMS-936558 (Nivolumab)
Other interventions: Placebo matching BMS-936558 (Nivolumab)
Treatment: Drugs: Dacarbazine
Treatment: Drugs: Placebo matching Dacarbazine
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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)
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Assessment method [1]
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OS is defined as the time between the date of randomization and the date of death or the last date the participant was known to be alive.
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Timepoint [1]
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From date of randomization to date of death. For those without documentation of death, to the last date the participant was known to be alive, assessed up to 17 months.
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Primary outcome [2]
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Overall Survival (OS) Rate
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Assessment method [2]
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OS rate is calculated as the percentage of participants alive at the indicated timepoints
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Timepoint [2]
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From randomization to 6 months and or to 12 months
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Secondary outcome [1]
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Progression-free Survival (PFS)
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Assessment method [1]
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Investigator-assessed PFS is defined as the time from randomization to the date of the first documented progression, as determined by the investigator, or death due to any cause, whichever occurs first. Patients who died without progressing were considered to have progressed on the date of their death. Those who did not progress or die were documented on the date of their last evaluable tumor assessment. Patients who did not have any on-study tumor assessments and did not die were documented on their date of randomization. Those who started any subsequent anticancer therapy without a prior reported progression were documented on the date of their last evaluable tumor assessment prior to initiation of subsequent anticancer therapy.
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Timepoint [1]
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From date of randomization up to date of disease progression or death, up to approximately 84 months
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Secondary outcome [2]
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Progression-free Survival (PFS) Rate
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Assessment method [2]
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The PFS rate at a time point is the estimated percentage of patients who have not progressed and are alive at that time point following randomization and is estimated using the Kaplan-Meier methodology.
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Timepoint [2]
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From randomization to the specified timepoints, up to 84 months
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Secondary outcome [3]
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Objective Response Rate (ORR)
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Assessment method [3]
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ORR is defined as the percentage of participants with a best overall response of Response Evaluation Criteria in Solid Tumors (RECIST) defined complete response (CR) or partial response (PR). RECIST, volume 1.1 for target lesions: CR=disappearance of all target lesions; PR=at least a 30% decrease in the sum of the longest dimension (LD) of target lesions, taking as reference the baseline sum LD; stable disease=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; PD=at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, and the sum LD must have an absolute increase of =5 mm.
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Timepoint [3]
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Tumor assessments beginning at 9 weeks following randomization and continuing every 6 weeks for the first year, then every 12 weeks thereafter until disease progression or death, assessed to 94 months
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Secondary outcome [4]
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Overall Survival by Programmed Cell Death Ligand 1 (PD-L1) Expression Level
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Assessment method [4]
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Overall Survival is defined as the time between the date of randomization and the date of death or the last date the participant was known to be alive. PD-L1 expression level is defined as the percent of tumor cells demonstrating plasma membrane PD-L1-staining in a minimum of 100 evaluable tumor cells per a Dako PD-L1 IHC (immunohistochemistry) assay (referred to as quantifiable PD-L1 expression). Assessment of OS by PD-L1 expression as measured by a validated assay and comparing OS in patients with tumor PD-L1 expression =5% (PD-L1 positive) versus patients with tumor PD-L1 expression <5% (PD-L1 negative). Tumor tissue samples for PD-L1 testing were collected at screening from metastatic or unresectable sites prior to randomization.
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Timepoint [4]
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From date of randomization to date of disease progression or death, up to approximately 94 months
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Secondary outcome [5]
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Change From Baseline in Health-related Quality of Life (HRQoL) Scores
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Assessment method [5]
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HRQoL is evaluated by mean changes from baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) global health status/quality of life composite scale in all randomized patients. The QLQ-30 is a cancer-specific, self-administered questionnaire that contains 30 questions, covering global, functional, and symptom scales. Scores range from 0 to 100. Higher scores on global and functional scales indicate better quality of life (QoL), while higher scores on the symptom scales indicate declining QoL.
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Timepoint [5]
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At baseline and every 6 weeks for 12 months and at follow-up visits 1 and 2, assessed up to 93 months
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Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com
- Men and women =18 years of age
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Untreated and histologically confirmed unresectable Stage III or Stage IV melanoma, as
per the staging system of the American Joint Committee on Cancer
- Measurable disease as per Response Evaluation Criteria in Solid Tumors 1.1
- Tumor tissue from an unresectable or metastatic site of disease must be provided for
biomarker analyses
- Known BRAF wild-type, as per regionally acceptable V600 mutational status testing.
BRAF mutant patients and those with indeterminate or unknown BRAF status are not
permitted to randomize
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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
- Active brain metastases or leptomeningeal metastases
- Ocular melanoma
- Any active, known, or suspected autoimmune disease
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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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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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
18/01/2013
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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
14/05/2021
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Sample size
Target
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Accrual to date
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Final
418
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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 - Camperdown
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Coffs Harbour Health Campus - Coffs Harbour
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Local Institution - 0006 - North Sydney
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Local Institution - Westmead
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Greenslopes Private Hospital - Greenslopes
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Recruitment hospital [6]
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Local Institution - Southport
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [8]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [9]
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Cabrini Hospital - Malvern
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Recruitment postcode(s) [1]
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2050 - Camperdown
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2450 - Coffs Harbour
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Recruitment postcode(s) [3]
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2060 - North Sydney
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Recruitment postcode(s) [4]
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2145 - Westmead
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Recruitment postcode(s) [5]
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4120 - Greenslopes
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Recruitment postcode(s) [6]
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4215 - Southport
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Recruitment postcode(s) [7]
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4102 - Woolloongabba
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Recruitment postcode(s) [8]
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5000 - Adelaide
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Recruitment postcode(s) [9]
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3144 - Malvern
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Recruitment outside Australia
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Argentina
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Distrito Federal
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Argentina
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Buenos Aires
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Argentina
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Cordoba
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Helsinki
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Umea
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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 this study is to compare the clinical benefit, as measured by overall
survival, of nivolumab with that of. dacarbazine in patients with previously untreated,
unresectable, or metastatic melanoma
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01721772
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01721772
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