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

NCT06586593 — Unknown, 77 participants, Centre Hospitalier Universitaire de Besancon

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

RegistryNCT06586593, acronym NEOMEL
StatusUnknown
Study typeObservational
Enrollment77 (Estimated)
SponsorCentre Hospitalier Universitaire de Besancon (Other)
ConditionsMelanoma Metastatic
Datesstart 2023-03-24, primary completion 2025-01-01 (estimated), completion 2025-01-01 (estimated), first posted 2024-09-19, last updated 2024-09-19
Locations9 sites in France

Related Papers Related Patents Related Grants Related Experts
All trials for Melanoma Metastatic

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Operable metastatic melanomaOperable metastatic melanoma

+Outcome measures

Primary outcomes

  • Complete histological response [Day 1]: Histological response rate on histological analysis of the resected specimen

Secondary outcomes

  • 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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (9)

FacilityCityCountryStatus
CHU AngersAngersFranceActive not recruiting
CHU de BesançonBesançonFranceRecruiting
Hôpital AvicenneBobignyFranceActive not recruiting
CH de Boulogne-sur-MerBoulogne-sur-MerFranceActive not recruiting
CHU Clermont-FerrandClermont-FerrandFranceActive not recruiting
Centre de Lutte Contre le Cancer Léon BérardLyonFranceActive not recruiting
ICO René GauducheauSaint-HerblainFranceActive not recruiting
Institut Universitaire de Cancérologie de ToulouseToulouseFranceActive not recruiting
CH de ValenceValenceFranceActive not recruiting