Melanoma Metastatic
Conditions
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.
Interventions
None listed
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete histological response | Day 1 | Histological response rate on histological analysis of the resected specimen |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Objectival response rate | Day 1 | Objectival response rate on imaging |
| 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 |
| Metastases-free survival | Month 18 | — |
Countries
France
Contacts
Primary ContactCharlée NARDIN, MD PhD
Outcome results
None listed