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Clinical Trials/NCT06586593
NCT06586593
Recruiting
Not Applicable

ETUDE NEOMEL: TRAITEMENT NEOADJUVANT PAR IMMUNOTHERAPIE DU MELANOME METASTATIQUE OPERABLE EN VIE REELLE (GCC)

Centre Hospitalier Universitaire de Besancon9 sites in 1 country77 target enrollmentMarch 24, 2023
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ConditionsMelanoma Metastatic

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Melanoma Metastatic
Sponsor
Centre Hospitalier Universitaire de Besancon
Enrollment
77
Locations
9
Primary Endpoint
Complete histological response
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 24, 2023
End Date
January 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Complete histological response

Time Frame: Day 1

Histological response rate on histological analysis of the resected specimen

Secondary Outcomes

  • Objectival response rate(Day 1)
  • Event-free survival(Month 12)
  • Disease Free Survival after surgery(Month 12)
  • Overall survival(Month 18)
  • Metastases-free survival(Month 18)
  • Frequency of toxicities(Month 12)
  • Severity of toxicities(Month 12)

Study Sites (9)

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