Response to Pembrolizumab in Metastatic Melanoma: Computed Tomography Texture Analysis as a Predi… (NCT02740920) | Clinical Trial Compass
TerminatedPhase 2
Response to Pembrolizumab in Metastatic Melanoma: Computed Tomography Texture Analysis as a Predictive Biomarker
Canada9 participantsStarted 2017-01-10
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically confirmed melanoma that is recurrent/metastatic and not amenable to potentially curative surgery.
* Presence of clinically and/or radiologically documented disease based on RECIST 1.1. At least one site of disease must be unidimensionally measurable by contrast-enhanced CT scan as follows:
CT scan (with slice thickness of ≤ 5 mm) ≥ 10 mm --\> longest diameter Lymph nodes by CT scan ≥ 15 mm --\> measured in short axis
* Age ≥ 18 years.
* ECOG Performance Status of 0 to 1.
* Previous Therapy
Surgery:
Previous surgery is permitted provided that it has been at least 21 days prior to patient registration and that wound healing has occurred.
Systemic Therapy:
Patients may not have received any prior systemic therapy for metastatic melanoma.
Radiation:
Palliative radiation is permitted provided \> 7 days has elapsed between last dose and enrollment on the trial.
* Laboratory Requirements Absolute neutrophils ≥ 1.5 x 10\^9/L Platelets ≥ 100 x 10\^9/L Hemoglobin ≥ 90 g/L or ≥ 5.6 mmol/L (without transfusion or EPO dependency) Serum creatinine or measured or calculated creatinine: ≤1.5 x ULN or ≥ 60 mL/min for subject with creatinine clearance levels \> 1.5 x ULN Serum Total Bilirubin ≤ 1.5 x ULN or Direct bilirubin ≤ ULN for subjects with total bilirubin levels \> 1.5 x ULN AST and ALT ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver mets) Albumin ≥ 25 g/L
* Women/men of childbearing potential must have agreed to use a highly effective cont…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.