This is a monocentric, prospective, interventional and translational phase II study.
Metastatic melanoma (mMEL) patients who are naive to immune therapy in the metastatic
setting, and for whom an anti-Programmed Cell Death-1 (PD-1) therapy is needed could be
The aim of the study is to identify biological markers which allow to better understand and
predict the tumor response to pembrolizumab treatment, and thus to establish more efficient
treatments for selected patients. Eligible patients will be registered (n=30) and will be
treated with pembrolizumab monotherapy at 200 mg every three weeks for 2 years maximum until
progression, unacceptable toxicity, or withdrawal of consent, whichever happens first.
Patients may be treated for up to one year of additional treatment with pembrolizumab via the
Second Course Phase. Patients will be followed medically and radiographically during
pembrolizumab treatment. Patients will be followed radiographically every 9 weeks (+/- 7
days) until progression and disease evaluation will be assessed by RECIST 1.1 criteria. After
progression, patients will be followed every 6 months for 5 years to collect survival data.
Metastatic Melanoma Naive to Immune Therapy in Metastatic Setting
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.