Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-24 @ 10:45 PM
NCT ID:
NCT03534635
Brief Summary:
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 eligible.
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.
Study:
NCT03534635
Study Brief:
Protocol Section:
NCT03534635