Evaluating neoadjuvant immunotherapy for operable metastatic melanoma
ETUDE NEOMEL: TRAITEMENT NEOADJUVANT PAR IMMUNOTHERAPIE DU MELANOME METASTATIQUE OPERABLE EN VIE REELLE (GCC)
This study is testing if a new type of immunotherapy can help people with advanced melanoma before surgery and see how well they tolerate the treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 77 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Besancon Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 9 sites (Angers and 8 other locations) |
| Trial ID | NCT06586593 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the efficacy and tolerance of neoadjuvant immunotherapy in patients with advanced yet operable melanoma. Participants will receive treatment with anti-PD1 or a combination of anti-PD1 and anti-CTLA-4, and their histological responses will be evaluated. The study will include patients whose surgeries may be canceled due to disease progression or complete response. The focus is on real-life applications of immunotherapy in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with operable metastatic melanoma (stage III or IV) who are eligible for neoadjuvant immunotherapy.
Not a fit: Patients with uveal melanoma will not benefit from this study as they are excluded from participation.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes for patients with operable metastatic melanoma by providing insights into effective neoadjuvant therapies.
How similar studies have performed: Other studies have shown promise with neoadjuvant immunotherapy approaches in melanoma, suggesting potential for success in this study.
Eligibility criteria
Show full 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
Where this trial is running
Angers and 8 other locations
- 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)
Study contacts
- Study coordinator: Charlée NARDIN, MD PhD
- Email: cnardin@chu-besancon.fr
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.