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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
418
Overall Survival (OS)
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.
Time frame: 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.
Overall Survival (OS) Rate
OS rate is calculated as the percentage of participants alive at the indicated timepoints
Time frame: From randomization to 6 months and or to 12 months
Progression-free Survival (PFS)
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.
Time frame: From date of randomization up to date of disease progression or death, up to approximately 84 months
Progression-free Survival (PFS) Rate
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.
Time frame: From randomization to the specified timepoints, up to 84 months
Objective Response Rate (ORR)
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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Fundacion Cidea
Buenos Aires, Distrito Federal, Argentina
Instituto Medico Especialazado Alexander Fleming
Buenos Aires, Argentina
Instituto Oncologico De Cordoba
Córdoba, Argentina
Local Institution
Camperdown, New South Wales, Australia
Coffs Harbour Health Campus
Coffs Harbour, New South Wales, Australia
Local Institution - 0006
North Sydney, New South Wales, Australia
Local Institution
Westmead, New South Wales, Australia
Greenslopes Private Hospital
Greenslopes, Queensland, Australia
Local Institution
Southport, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
...and 65 more locations
Time frame: 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
Overall Survival by Programmed Cell Death Ligand 1 (PD-L1) Expression Level
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.
Time frame: From date of randomization to date of disease progression or death, up to approximately 94 months
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
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.
Time frame: At baseline and every 6 weeks for 12 months and at follow-up visits 1 and 2, assessed up to 93 months