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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06586593
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Centre Hospitalier Universitaire de Besancon
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Melanoma Metastatic
Arms & Interventions

Arms

: Operable metastatic melanoma

Operable metastatic melanoma

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CHU Angers, Angers, France

Status

Active, not recruiting

Address

CHU Angers

Angers, ,

Site Contact

[email protected]

CHU de Besançon, Besançon, France

Status

Recruiting

Address

CHU de Besançon

Besançon, ,

Site Contact

Charlée NARDIN, MD PhD

[email protected]

Hôpital Avicenne, Bobigny, France

Status

Active, not recruiting

Address

Hôpital Avicenne

Bobigny, ,

Site Contact

[email protected]

CH de Boulogne-sur-Mer, Boulogne-sur-Mer, France

Status

Active, not recruiting

Address

CH de Boulogne-sur-Mer

Boulogne-sur-Mer, ,

Site Contact

[email protected]

CHU Clermont-Ferrand, Clermont-Ferrand, France

Status

Active, not recruiting

Address

CHU Clermont-Ferrand

Clermont-Ferrand, ,

Site Contact

[email protected]

Lyon, France

Status

Active, not recruiting

Address

Centre de Lutte Contre le Cancer Léon Bérard

Lyon, ,

Site Contact

[email protected]

ICO René Gauducheau, Saint-Herblain, France

Status

Active, not recruiting

Address

ICO René Gauducheau

Saint-Herblain, ,

Site Contact

[email protected]

Toulouse, France

Status

Active, not recruiting

Address

Institut Universitaire de Cancérologie de Toulouse

Toulouse, ,

Site Contact

[email protected]

CH de Valence, Valence, France

Status

Active, not recruiting

Address

CH de Valence

Valence, ,

Site Contact

[email protected]

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