Mucosal Melanoma

P1/2, N=55, Recruiting, University of Chicago | Not yet recruiting --> Recruiting

Multidisciplinary team approaches are essential for individualized care. Future progress depends on biomarker-driven trials, integration of novel strategies such as Chimeric Antigen Receptor T-Cell (CAR-T) therapy, and stronger international collaborative research to improve outcomes in this challenging malignancy.

This study is the first to characterize cultured TILs established from a series of Japanese melanoma patients. These findings suggest that the expansion of tumor-reactive TILs from Japanese melanoma tissues is feasible and may provide a basis for the development of TIL therapy in Japan.

P2, N=101, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting

P=N/A, N=50, Recruiting, Yana Najjar | Trial completion date: Mar 2027 --> Mar 2029 | Trial primary completion date: Mar 2027 --> Mar 2029

Despite treatment with pembrolizumab, the disease progressed rapidly both locally and distantly, necessitating palliative care. This case highlights the persistent challenges in diagnosing oral mucosal melanoma due to its atypical clinical and pathological features, emphasizes the critical role of immunohistochemistry in achieving an accurate diagnosis, and underscores the generally poor prognosis despite current therapeutic options. It also reinforces the importance of early detection and timely multidisciplinary management.

P2, N=25, Recruiting, Eye & ENT Hospital of Fudan University

Primary melanoma subtypes present significant differences in their immune and genomic landscapes, as well as their interactions. Distinct measures of pTMB carry added value compared to standard TMB for identification of tumour-immune associations across primary melanoma subtypes. Our findings indicate that pTMB is a relevant neoantigenicity marker in primary melanoma with the potential to modulate immune infiltration, leading to more aggressive disease.

Only tumor extension was independently associated with disease-free survival (HR: 7.325, 95%CI: 1.316-40.779) but a trend was seen for tumor size (p = 0.078). Our data shows that for primary anal canal melanoma, the anal cancer staging system in combination with the extent of tumor invasion is more adequate for patient stratification.

Patients with germline PVs were more likely to have two or more affected first-degree relatives (49.0% vs. 29.1%, p = 0.019). These findings highlight a meaningful germline contribution to MM risk and support the incorporation of genetic testing in this population.

Responders exhibited higher prevalence of persistent TCR clonotypes and tighter spatial proximity between activated CD4⁺ and CD8⁺ T cells. Although the pre-specified primary endpoint was not met, our findings identify activated CD4+/CD8+ T cell states and TCR persistence as key outcome-associated features, supporting immune-informed optimization of peri-operative therapy in mucosal melanoma.

P2, N=150, Active, not recruiting, ECOG-ACRIN Cancer Research Group | Trial completion date: Aug 2026 --> Sep 2030 | Trial primary completion date: Aug 2026 --> Jan 2027