Studies have shown that the study drug, pembrolizumab, works by helping the immune system. In this way, pembrolizumab may help to slow the growth of melanoma or may cause cancer cells to die. Compared to standard treatments, pembrolizumab seems to lengthen the time patients lived overall and the time without their cancer getting worse.
The main purpose of this study is to find out if a type of CT (computed topography) scan can help to know if pembrolizumab is working. This CT scan (called Texture Analysis) looks at the tumour in fine detail. The use of this type of CT scan has not been studied in patients with metastatic melanoma. Investigators want to see if this CT scan will show if some patients being treated with pembrolizumab respond better than others. One of the other purposes is to compare the costs within this trial to costs of the standard of care.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Kingston Health Sciences Centre
Kingston, Ontario, Canada
London Regional Cancer Program
London, Ontario, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Odette Cancer Centre
Toronto, Ontario, Canada
Measurement of Tumor Texture by CT Scan
To assess whether tumour texture parameters from a CT scan can differentiate patients who do and who do not respond to treatment with pembrolizumab. Trial closed due to slow accrual, analysis was no done for the primary outcome because data were not collected.
Time frame: 12 months
Overall Response Rate Assessed by CT Scan
To determine the overall response rate (complete + partial response)/total number of patients. Response and progression will be evaluated in this study using the revised international criteria (1.1) proposed by the RECIST (Response Evaluation Criteria in Solid Tumours) committee as well as the modified iRECIST guidelines. Response were assessed by CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: 24 months
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Allan Blair Cancer Centre
Regina, Saskatchewan, Canada