Neoadjuvant Immunotherapy of Operable Metastatic Melanoma in Real Life (GCC)

Recruiting

• Conditions: Melanoma Metastatic

• Registration Number: NCT06586593
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief Summary

This study aims to evaluate efficacy and tolerance of real life neoadjuvant immunotherapy in advanced yet operable melanoma.

The complete histological response will be assessed.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2023-03-24
• Status Verified: 2024-09
• Study First Submitted: 2024-09-04
• Study First Submitted QC: 2024-09-05
• Study First Posted: 2024-09-06
• Last Update Submitted: 2024-09-06
• Last Update Posted: 2024-09-12
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

• Patients with operable metastatic melanoma (stage III or IV of American Joint Committee on Cancer [AJCC] Stages CLassification) treated with neoadjuvant immunotherapy (anti-PD1 or anti-PD1 + anti-CTLA-4), even if surgery cancelled due to disease progression or complete response or patient's refusal to be operated.
• Efficacy of the neoadjuvant immunotherapy histologically of radiologically assessed

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Exclusion Criteria

• Uveal melanoma

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete histological response	Day 1	Histological response rate on histological analysis of the resected specimen

Secondary Outcome Measures

Name	Time	Method
Objectival response rate	Day 1	Objectival response rate on imaging
Event-free survival	Month 12	An event is defined by progression of the disease or toxicity making surgery impossible, the impossibility of starting adjuvant treatment within 84 days following surgery, recurrence of melanoma after surgery or death.
Disease Free Survival after surgery	Month 12
Overall survival	Month 18
Metastases-free survival	Month 18
Frequency of toxicities	Month 12	According to Common Terminology Criteria for Adverse Events (CTCAE) v5, grades III and IV
Severity of toxicities	Month 12	According to CTCAE v5, grades III and IV

Trial Locations

Locations (9)

CHU Angers; 🇫🇷 Angers, France

CHU de Besançon; 🇫🇷 Besançon, France

Hôpital Avicenne; 🇫🇷 Bobigny, France

CH de Boulogne-sur-Mer; 🇫🇷 Boulogne-sur-Mer, France

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

Centre de Lutte Contre le Cancer Léon Bérard; 🇫🇷 Lyon, France

ICO René Gauducheau; 🇫🇷 Saint-Herblain, France

Institut Universitaire de Cancérologie de Toulouse; 🇫🇷 Toulouse, France

CH de Valence; 🇫🇷 Valence, France