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

Strong agreement: it is recommended to perform systematic regional and remote extension assessment at diagnosis; PET-CT is the gold standard for remote assessment; isolated radiotherapy is not recommended for curative treatment; given the major risk of metastasis and the poor prognosis, alternatives to heavy destructive surgery should be considered in the rare cancer multidisciplinary tumor board; it is recommended to screen for NRAS, BRAF and KIT mutations, to identify possible treatment targets; reference imaging should be performed 3 months after end of treatment, using sinonasal and brain MRI and PET-CT; due to the risk of early recurrence, close follow-up is recommended during the first 2 years, then at least every 6 months up to 5 years postoperatively. Relative agreement: operable sinonasal mucosal melanoma should be treated by total macroscopic resection with negative margins followed by radiotherapy on the tumor bed; postoperative radiotherapy is recommended, to improve local control; neoadjuvant or adjuvant chemotherapy, other than immunotherapy or targeted therapy, is not recommended; for non-resectable and/or metastatic sinonasal mucosal melanoma, immunotherapy is the systematic first-line treatment; prophylactic lymph-node treatment is not recommended in N0 sinonasal mucosal melanoma; lymph-node surgery is recommended in N+ cases without remote metastasis, including cases of regional recurrence.

P2, N=50, Not yet recruiting, Fred Hutchinson Cancer Center

Integrated spatial proteomics and metabolomics reveal response-associated tumor-immune neighborhood architecture, stromal contexts linked to immune exclusion, and altered indole/tryptophan metabolism in the microenvironment. These spatial features nominate biomarkers and therapeutic hypotheses to improve immunotherapy for MuM.

However, the sample size is relatively small and needs to be increased for further research. https://clinicaltrials.gov/study/NCT03986515, identifier NCT03986515.

P1/2, N=67, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Apr 2026 --> Apr 2027 | Trial primary completion date: Apr 2026 --> Apr 2027

Despite thrombectomy with iliac vein stenting, percutaneous nephrostomy tube placement, arterial embolization, and multidisciplinary oncologic management, the patient experienced progressive metastatic disease and ultimately transitioned to hospice care. This case highlights the aggressive nature of anorectal melanoma and illustrates how advanced pelvic malignancy may produce complex multisystem complications requiring multidisciplinary management.

P1/2, N=980, Recruiting, BioNTech SE | N=329 --> 980

This review briefly outlines the epidemiology and unique clinical characteristics of melanoma in East Asian patients; summarizes existing immunotherapy approvals, treatment landscape, and unmet needs; and aims to enable clinicians to make more informed treatment decisions for patients. Further research is urgently needed into novel immunotherapeutic combinations, and biomarkers of response, to fully unlock the potential of immunotherapy for East Asian AM and MM and guide future therapeutic strategies.

P2, N=72, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Mar 2026 --> Mar 2027

Vulvar and vaginal melanoma present unique diagnostic and therapeutic challenges in gynecologic oncology. Site-specific prognosis and distinct response patterns to immunotherapy underscore the importance of individualized management strategies and multidisciplinary coordination in this rare population.

Network analysis recommended regimens: gemcitabine/cisplatin for TNBC (SUCRA = 95.7%), oxaliplatin/capecitabine for G/GEJ cancer (ORR = 60.0% vs. irinotecan 27.6%, HR = 0.45). The integrated model classified high-benefit (≥ 3 points; ORR 78.2%) and low-benefit (≤ 0 points; ORR 28.3%) groups, plus high-risk (≤ -2 points; grade ≥ 3 irAEs 41.2%) and low-risk (≥ 1 point; irAEs 3.5%) groups, validated by decision curve analysis. This defines precise application scenarios and provides an extensible analytical paradigm.