Actively Recruiting
Neoadjuvant Immunotherapy for Operable Metastatic Melanoma in Real-Life Settings (GCC)
Led by Centre Hospitalier Universitaire de Besancon · Updated on 2024-09-19
77
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with operable metastatic melanoma at stage III or IV
- Treated or planned to be treated with neoadjuvant immunotherapy using anti-PD1 alone or combined with anti-CTLA-4
- Efficacy of immunotherapy assessed by histological or radiological methods
- Includes patients whose surgery was cancelled due to disease progression, complete response, or patient refusal
You will not qualify if you...
- Diagnosis of uveal melanoma
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Varies based on treatment plan
Participants receive neoadjuvant immunotherapy with anti-PD1 alone or combined with anti-CTLA-4 before surgery.
Visits as scheduled during immunotherapy treatment
Duration - Up to several weeks depending on recovery
Participants undergo surgery for operable metastatic melanoma and receive immediate post-operative care.
1 surgery visit and several post-operative visits
Duration - Up to 18 months
Participants are monitored after surgery to assess disease status and treatment outcomes.
Regular follow-up visits for up to 18 months
Trial Site Locations
Total: 9 locations
1
CHU Angers
Angers, France
Active, Not Recruiting
2
CHU de Besançon
Besançon, France
Actively Recruiting
3
Hôpital Avicenne
Bobigny, France
Active, Not Recruiting
4
CH de Boulogne-sur-Mer
Boulogne-sur-Mer, France
Active, Not Recruiting
5
CHU Clermont-Ferrand
Clermont-Ferrand, France
Active, Not Recruiting
6
Centre de Lutte Contre le Cancer Léon Bérard
Lyon, France
Active, Not Recruiting
7
ICO René Gauducheau
Saint-Herblain, France
Active, Not Recruiting
8
Institut Universitaire de Cancérologie de Toulouse
Toulouse, France
Active, Not Recruiting
9
CH de Valence
Valence, France
Active, Not Recruiting
Research Team
C
Charlée NARDIN, MD PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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