Mucosal Melanoma

P1, N=210, Active, not recruiting, iOnctura | Trial completion date: Mar 2025 --> Mar 2027

P1, N=10, Active, not recruiting, Dana-Farber Cancer Institute | Recruiting --> Active, not recruiting | N=30 --> 10 | Trial primary completion date: Dec 2026 --> Dec 2027

Notably, a distinct "TME phenotype" (CD3low/CD20high/CD68high) is linked with unfavorable features - such as LVI and advanced pT4a/pT4b staging - as well as the need for more aggressive therapies. We also observed discordant TME and molecular results in consecutive samples from a subset of patients, suggesting heterogeneity that may potentially affect prognosis and therapeutic strategies.

SOX10 and PRAME are nuclear staining markers that can be used for diagnostic purposes and as adjunct markers for the diagnosis of VM and benign melanocytic lesions. PRAME immunostaining shows high specificity for melanoma and melanoma in situ.

P1, N=25, Recruiting, Fred Hutchinson Cancer Center | Trial primary completion date: Nov 2026 --> Nov 2027 | Trial completion date: Nov 2027 --> Nov 2028

Prognosis is poor, with median survival often below one year in more severe cases. Early detection and novel treatments, including cancer vaccines, immunotherapy combinations, and personalized medicine approaches, are promising to improve survival and quality of life.

SN-MM displays an immune-desert phenotype yet retains intrinsic immunogenicity. Most tumors preserve functional IFN-γ signaling, while poorly differentiated cells show resistance to IFN-γ-mediated effects. These findings underscore heterogeneity in immune responsiveness and support functional immune profiling to refine immunotherapy strategies in MM.

This study evaluated a novel combination of DNV3 (anti-LAG-3), toripalimab (anti-PD-1), and chemotherapy (nab-paclitaxel/cisplatin) in 27 Asian patients with unresectable or metastatic melanoma (77.8% [21/27] previously treated with anti-PD-[L]1 and 22.2% [6/27] treatment-naïve mucosal melanoma; subtypes: 13 mucosal, 6 acral, 5 cutaneous, and 3 of unknown primary origin). Therefore, the combination of LAG-3/PD-1 blockade and chemotherapy demonstrated promising efficacy, notably in treatment-naïve mucosal melanoma with liver metastases. (Chinese Clinical Trial Registry number, ChiCTR2400079543).

P1/2, N=55, Not yet recruiting, University of Chicago | Initiation date: Jan 2026 --> Dec 2026

P1/2, N=20, Recruiting, Erasmus Medical Center | Not yet recruiting --> Recruiting

[18F]PFPN PET outperforms [18F]FDG PET in lesion detection and clinical staging in mucosal melanoma, especially for liver and bone metastases. Its association with melanin differentiation markers may support its use in personalized imaging strategies.

P3, N=1301, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jan 2026 --> Jan 2027