Actively Recruiting
Real-World Study of Neoadjuvant Immunotherapy for Treating Operable Metastatic Melanoma
Led by Centre Hospitalier Universitaire de Besancon · Updated on 2024-09-19
77
Participants Needed
9
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and tolerance of neoadjuvant immunotherapy in patients with advanced but operable metastatic melanoma. The study focuses on real-life use of these treatments before surgery and aims to measure the complete histological response as a key indicator. This observational study is sponsored by the Centre Hospitalier Universitaire de Besancon. Participants receive neoadjuvant immunotherapy involving anti-PD1 alone or combined with anti-CTLA-4. The study includes patients with stage III or IV melanoma who are planned for surgery but may have surgery cancelled due to disease progression, complete response, or patient choice. No placebo or comparator group is mentioned. During the study, researchers assess treatment response through histological and radiological exams. They also monitor event-free survival, disease-free survival after surgery, overall survival, metastases-free survival, and track the frequency and severity of any toxicities over 12 to 18 months. Patient involvement includes receiving immunotherapy and undergoing regular follow-up to evaluate outcomes and safety.
CONDITIONS
Brief Title
Neoadjuvant Immunotherapy of Operable Metastatic Melanoma in Real Life (GCC)
Research Team
C
Charlée NARDIN, MD PhD
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