NCT06586593

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
77

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 24, 2023

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1.8 years

First QC Date

September 4, 2024

Last Update Submit

September 6, 2024

Conditions

Melanoma Metastatic

Outcome Measures

Primary Outcomes (1)

  • Complete histological response

    Histological response rate on histological analysis of the resected specimen

    Day 1

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (1)

Operable metastatic melanoma

Operable metastatic melanoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with operable metastatic melanoma (stade III or IV of AJCC) treated with neoadjuvant immunotherapy (anti-PD1 or anti-PD1 + anti-CTLA-4)

You may qualify if:

  • 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

You may not qualify if:

  • Uveal melanoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

CHU Angers

Angers, France

ACTIVE NOT RECRUITING

CHU de Besançon

Besançon, France

RECRUITING

Hôpital Avicenne

Bobigny, France

ACTIVE NOT RECRUITING

CH de Boulogne-sur-Mer

Boulogne-sur-Mer, France

ACTIVE NOT RECRUITING

CHU Clermont-Ferrand

Clermont-Ferrand, France

ACTIVE NOT RECRUITING

Centre de Lutte Contre le Cancer Léon Bérard

Lyon, France

ACTIVE NOT RECRUITING

ICO René Gauducheau

Saint-Herblain, France

ACTIVE NOT RECRUITING

Institut Universitaire de Cancérologie de Toulouse

Toulouse, France

ACTIVE NOT RECRUITING

CH de Valence

Valence, France

ACTIVE NOT RECRUITING

Central Study Contacts

Charlée NARDIN, MD PhD

CONTACT

cnardin@chu-besancon.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2024

First Posted

September 19, 2024

Study Start

March 24, 2023

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(9)