Follow-up of patients with advanced melanoma

Constitution of a National Cohort of Patients With Metastatic Melanoma Resectable Stage II or Stage III or IV or Unresectable Primary With the Objective of Setting up Epidemiological Monitoring and Clinico-biological Database, MELBASE

This study is tracking patients with advanced melanoma to see how different factors affect their treatment outcomes and to understand the costs and side effects of new therapies.

Quick facts

• Study type: Observational
• Enrollment: 6000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (Academic / other)
• Drugs / interventions: pembrolizumab, trametinib
• Locations: 27 sites (Amiens and 26 other locations)
• Trial ID: NCT02828202 on ClinicalTrials.gov

What this trial studies

This observational study aims to follow a national cohort of patients diagnosed with resectable stage II, III, or IV melanoma, as well as those with unresectable primary melanoma. It focuses on collecting clinico-epidemiological and biological data to identify new prognostic and predictive factors related to melanoma. The study will also assess the economic impact of innovative treatments and their associated toxicities. By analyzing various factors, including genomic alterations and individual immunological profiles, the study seeks to improve the prognosis for advanced melanoma patients.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with resectable stage II or III melanoma or those with unresectable stage III or IV melanoma.

Not a fit: Patients with stage I melanoma, choroid melanoma, or those who are not eligible due to guardianship or refusal may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better prognostic tools and treatment strategies for patients with advanced melanoma.

How similar studies have performed: Other studies have shown success in identifying prognostic factors and improving treatment outcomes for melanoma, making this approach both relevant and promising.

Eligibility criteria

1. Cohort Patients with Resectable stage II or III

   Inclusion Criteria:

   Patients diagnosed with resectable stage IIA/IIB/IIC or III melanoma, confirmed by histological exam.

   Naïve of systemic treatment for resectable stage II or III. Whose metastatic tumoral material can be collected by the Biological Resource Centers (optional criteria).

   Aged ≥ 18 years. Consenting to participate (signed informed consent).

   Exclusion Criteria:

   Patients refusal. Choroid melanoma. Resectable stage 1 melanoma. Stage 4, unresectable primitive or unresectable stage 3 melanoma. Patients under guardianship and under trusteeship.
2. Cohort patients with Unresectable stage III or stage IV (resectable or not) or unresectable primary:

Inclusion Criteria:

Patients diagnosed with an advanced melanoma, confirmed by histological exam. Unresectable primitive or unresectable stage III or stage IV (resectable or not) melanoma ; or patients treated by neoadjuvant treatment (exceptional) Naïve of systemic treatment for unresectable primitive or unresectable stage III or stage IV (resectable or not) melanoma, except adjuvant treatment.

Whose metastatic tumoral material can be collected by the Biological Resource Centers (optional criteria).

Aged ≥ 18 years. Consenting to participate (signed informed consent).

Exclusion Criteria:

Resectable stage 1, 2 or 3 melanoma. Patients refusal. Choroid melanoma. Patients under guardianship and under trusteeship.

Where this trial is running

Amiens and 26 other locations

• CHU d'Amiens — Amiens, France (Recruiting)
• CH Annecy Genevois — Annecy, France (Recruiting)
• CHU de Besançon — Besançon, France (Recruiting)
• Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Avicennes — Bobigny, France (Recruiting)
• CHU de Bordeaux Hôpital Haut Levêque — Bordeaux, France (Active_not_recruiting)
• CHU de Bordeaux Hôpital Saint-André — Bordeaux, France (Recruiting)
• Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Ambroise Paré — Boulogne-Billancourt, France (Active_not_recruiting)
• CHU de Brest — Brest, France (Recruiting)
• CHU de Caen — Caen, France (Active_not_recruiting)
• Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Henri Mondor — Créteil, France (Recruiting)
• CHU de Dijon — Dijon, France (Recruiting)
• CHU de Grenoble — Grenoble, France (Recruiting)
• CHRU de Lille — Lille, France (Recruiting)
• Centre Léon Bérard — Lyon, France (Recruiting)
• Hospices Civils de Lyon — Lyon, France (Recruiting)
• AP-HM Hopital de la Timone — Marseille, France (Recruiting)
• CHU de Montpellier — Montpellier, France (Recruiting)
• CHU de Nancy — Nancy, France (Recruiting)
• CHU de Nantes — Nantes, France (Not_yet_recruiting)
• CHU de Nice — Nice, France (Recruiting)
• CHRU de Nîmes — Nîmes, France (Recruiting)
• Assistance Publique - Hôpitaux de Paris (AP-HP), Hopital Saint-Louis, centre d'oncodermatologie — Paris, France (Recruiting)
• Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Bichat — Paris, France (Recruiting)
• Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Cochin — Paris, France (Not_yet_recruiting)
• CHU de Rennes — Rennes, France (Active_not_recruiting)
• CLCC Eugène Marquis — Rennes, France (Active_not_recruiting)
• CHU de Toulouse — Toulouse, France (Recruiting)

Study contacts

• Study coordinator: Celeste Lebbe, MD, PhD

Conditions Malignant Melanoma; Melanoma; Skin; Biobank