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NCT Number: NCT06586593

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

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.

Recruiting

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Key information

Conditions

Melanoma Metastatic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Angers, Angers, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Complete histological response

    Time frame: Day 1

    Histological response rate on histological analysis of the resected specimen

Secondary outcomes

  1. Objectival response rate

    Time frame: Day 1

    Objectival response rate on imaging

  2. Event-free survival

    Time frame: 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.

  3. Disease Free Survival after surgery

    Time frame: Month 12

  4. Overall survival

    Time frame: Month 18

  5. Metastases-free survival

    Time frame: Month 18

  6. Frequency of toxicities

    Time frame: Month 12

    According to Common Terminology Criteria for Adverse Events (CTCAE) v5, grades III and IV

  7. Severity of toxicities

    Time frame: Month 12

    According to CTCAE v5, grades III and IV

Study contacts

Contact information is provided by the study sponsor or research team.

Charlée NARDIN, MD PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Official study title

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

Acronym: NEOMEL

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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