Recruiting NCT06586593
Neoadjuvant Immunotherapy of Operable Metastatic Melanoma in Real Life (GCC)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Melanoma Metastatic. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
ETUDE NEOMEL: TRAITEMENT NEOADJUVANT PAR IMMUNOTHERAPIE DU MELANOME METASTATIQUE OPERABLE EN VIE REELLE (GCC)
Overview
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.
Primary outcome measures
- Complete histological response [Time frame: Day 1]
Secondary outcome measures (7)
- Objectival response rate [Time frame: Day 1]
- Event-free survival [Time frame: Month 12]
- Disease Free Survival after surgery [Time frame: Month 12]
- Overall survival [Time frame: Month 18]
- Metastases-free survival [Time frame: Month 18]
- Frequency of toxicities [Time frame: Month 12]
- Severity of toxicities [Time frame: Month 12]
Eligibility criteria
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
Exclusion criteria
- Uveal melanoma
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
France · 9 centers
- CHU Angers — Angers
- CHU de Besançon — Besançon
- Hôpital Avicenne — Bobigny
- CH de Boulogne-sur-Mer — Boulogne-sur-Mer
- CHU Clermont-Ferrand — Clermont-Ferrand
- Centre de Lutte Contre le Cancer Léon Bérard — Lyon
- ICO René Gauducheau — Saint-Herblain
- Institut Universitaire de Cancérologie de Toulouse — Toulouse
- … and 1 more center
Identifiers
NCT: NCT06586593 · 2023/758