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Mucosal Melanoma
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Related cancers:
1d
Pembrolizumab and Hypofractionated Radiation Therapy for the Treatment of Mucosal Melanoma (clinicaltrials.gov)
P2, N=16, Recruiting, Washington University School of Medicine | Trial completion date: Jul 2030 --> Mar 2026 | Trial primary completion date: Jul 2027 --> Mar 2024
Trial completion date • Trial primary completion date
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Keytruda (pembrolizumab)
16d
The Roles of Vitamin D Receptor (VDR) and CD8+ T-Lymphocytes in Acral and Mucosal Melanoma Invasion Depth. (PubMed, J Cutan Pathol)
The role of VDR and CD8+ T-lymphocytes are inversely associated with melanoma depth in acral melanoma, while only VDR is associated with melanoma depth in mucosal melanoma.
Journal
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CD8 (cluster of differentiation 8) • VDR (Vitamin D Receptor)
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CD8 expression
16d
Oral Decitabine/Cedazuridine (DEC-C) in Combination With Nivolumab for Patients With Mucosal Melanoma (clinicaltrials.gov)
P1/2, N=8, Active, not recruiting, University of Colorado, Denver | Recruiting --> Active, not recruiting | N=30 --> 8
Enrollment closed • Enrollment change • Combination therapy • Checkpoint inhibition • IO biomarker • Checkpoint block • Metastases
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CD4 (CD4 Molecule)
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Opdivo (nivolumab) • Inqovi (decitabine/cedazuridine)
17d
SWOG S1801: A Study to Compare the Administration of Pembrolizumab After Surgery Versus Administration Both Before and After Surgery for High-Risk Melanoma (clinicaltrials.gov)
P2, N=313, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Sep 2024 --> Oct 2025
Trial completion date • Surgery
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CD4 (CD4 Molecule)
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Keytruda (pembrolizumab)
1m
Genetic Characteristics of Cutaneous, Acral, and Mucosal Melanoma in Japan. (PubMed, Cancer Med)
This study highlights distinct genetic abnormalities and actionable alterations in Japanese melanoma patients. This suggests a lower tumor mutational burden in East Asian cutaneous melanoma, which may affect the efficacy of immune checkpoint inhibitors. The heterogeneity of driver mutations across and within individuals highlights the need for personalized treatment approaches.
Journal • Tumor mutational burden • IO biomarker
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KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • TMB (Tumor Mutational Burden) • NRAS (Neuroblastoma RAS viral oncogene homolog) • PTEN (Phosphatase and tensin homolog) • NF1 (Neurofibromin 1) • GNAQ (G Protein Subunit Alpha Q)
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BRAF V600E • KRAS mutation • NRAS mutation • BRAF V600 • PTEN mutation • BRAF V600K • TMB-L • NF1 mutation
1m
Diversity of the immune microenvironment and response to checkpoint inhibitor immunotherapy in mucosal melanoma. (PubMed, JCI Insight)
Our data show organ region-specific differences in immune infiltration and IFN-γ signature levels in MucM, with H&N MucM displaying the most favorable immune profile. Our study might offer a starting point for developing more personalized treatment strategies for this disease.
Journal • Checkpoint inhibition
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CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • TGFB1 (Transforming Growth Factor Beta 1)
1m
Enhancer of Zeste Homolog 2 Protects Mucosal Melanoma from Ferroptosis via the KLF14-SLC7A11 Signaling Pathway. (PubMed, Cancers (Basel))
Our findings not only establish EZH2 as a biomarker for MM prognosis but also highlight the EZH2-KLF14-SLC7A11 axis as a potential target for MM treatment.
Journal
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SLC7A11 (Solute Carrier Family 7 Member 11) • KLF14 (KLF Transcription Factor 14)
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SLC7A11 expression
1m
Mutational Signature Comparison of Different Melanomas: Cutaneous versus Non-cutaneous (AMP 2024)
In summary, targeted sequencing of a large NGS panel can detect predicted ultraviolet radiation mutational signatures in skin cancer with >99% specificity. This preliminary result warrants a potential application of mutational signature characterization in routine tumor profiling testing. Further investigation with larger data sets will follow up to determine the overall sensitivity and specificity for detection.
TruSight Oncology 500 Assay
1m
A retrospective study of the correlation between tumor depth of invasion and the prognosis of oral mucosal malignant melanoma (ChiCTR2400089885)
P=N/A, N=200, Not yet recruiting, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine; Shanghai Ninth People's Hospital, Shanghai Jiaotong University Scho
New trial
2ms
Sinonasal Mucosal Melanoma: A Contemporary Review. (PubMed, Surg Pathol Clin)
The histopathologic features of SNMM are quite variable and immunohistochemical analysis is usually necessary for diagnosis. Mucosal melanomas lack ultraviolet signature, have low somatic mutational burden, and are reported to have more genomic instability manifested as structural variants, deletions, and amplifications.
Review • Journal • Tumor mutational burden
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TMB (Tumor Mutational Burden)
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TMB-L
2ms
MC1R-targeted Alpha-particle Monotherapy and Combination Therapy Trial With Nivolumab in Adults With Advanced Melanoma (clinicaltrials.gov)
P1/2, N=264, Recruiting, Perspective Therapeutics | Trial completion date: Jun 2027 --> Dec 2029 | Trial primary completion date: Jun 2025 --> Dec 2027
Trial completion date • Trial primary completion date • Combination therapy • Metastases
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BRAF (B-raf proto-oncogene)
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Opdivo (nivolumab) • VMT-01
2ms
R3767-ONC-2011: Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma (clinicaltrials.gov)
P3, N=1535, Recruiting, Regeneron Pharmaceuticals | Trial completion date: Aug 2032 --> Jun 2031 | Trial primary completion date: Mar 2026 --> Jun 2025
Trial completion date • Trial primary completion date • Combination therapy • Metastases
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Keytruda (pembrolizumab) • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
2ms
NCI-2018-01211: Intravenous and Intrathecal Nivolumab in Treating Patients with Leptomeningeal Disease (clinicaltrials.gov)
P1, N=70, Recruiting, M.D. Anderson Cancer Center | Active, not recruiting --> Recruiting | N=50 --> 70
Enrollment open • Enrollment change
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BRAF (B-raf proto-oncogene) • IL2 (Interleukin 2)
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Opdivo (nivolumab)
2ms
Stromal Expression Profiling Reveals Immune-Driven Adaption to Malignancy in Canine Melanoma Subtypes. (PubMed, Vet Comp Oncol)
Finally, we identify an immune-suppressive stromal signature in a subset of CMM characterised by the downregulation of key immune checkpoints and pathways. Together, these findings provide a solid foundation for understanding the role of CAS in canine melanoma, specific to cutaneous and mucosal subtypes.
Journal • IO biomarker • Stroma
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CD20 (Membrane Spanning 4-Domains A1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • CD68 (CD68 Molecule)
2ms
Identification of mutations in canine oral mucosal melanomas by exome sequencing and comparison with human melanomas. (PubMed, Sci Rep)
These mutations were categorized based on the gene functions. The identification of these mutations provides critical insights that can pave the way for the development of novel therapeutic strategies for both canine and human OMM, offering hope for more effective treatments in the future.
Clinical • Journal
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NOTCH1 (Notch 1) • LRP1B (LDL Receptor Related Protein 1B) • EP300 (E1A binding protein p300) • JAK3 (Janus Kinase 3) • NCOR1 (Nuclear Receptor Corepressor 1) • FAT4 (FAT Atypical Cadherin 4)
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JAK3 mutation
3ms
Toripalimab in combination with HBM4003, an anti-CTLA-4 heavy chain-only antibody, in advanced melanoma and other solid tumors: an open-label phase I trial. (PubMed, J Immunother Cancer)
HBM4003 0.3 mg/kg plus toripalimab 240 mg every 3 week demonstrated manageable safety in solid tumors and no new safety signal. Limited data demonstrated promising antitumor activity, especially in PD-1 treatment-naïve mucosal melanoma.
P1 data • Journal • Combination therapy • PD(L)-1 Biomarker • IO biomarker • Metastases
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CD4 (CD4 Molecule)
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Loqtorzi (toripalimab-tpzi) • porustobart (HBM4003)
3ms
Genetic analysis of metastatic versus nonmetastatic conjunctival melanoma using a cutaneous melanoma gene expression panel. (PubMed, Can J Ophthalmol)
In assessing if a CM gene expression panel could aid in the risk stratification of patients with CJM, we found that the uveal melanoma-relevant gene, BAP1, may be important. Additional studies with larger sample sizes are needed to determine the relevance of this and other differentially expressed genes in CJM prognostication.
Journal • Metastases
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BAP1 (BRCA1 Associated Protein 1)
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DecisionDx®-Melanoma
3ms
LUMINOS-102: Lerapolturev With or Without Immune Checkpoint Blockade in Advanced PD-1 Refractory Melanoma (clinicaltrials.gov)
P2, N=56, Active, not recruiting, Istari Oncology, Inc. | Trial primary completion date: Jun 2024 --> Oct 2024
Trial primary completion date • Checkpoint inhibition • IO biomarker • Checkpoint block • Metastases
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PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • CD8 (cluster of differentiation 8)
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PD-L1 expression • BRAF mutation • BRAF wild-type
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lerapolturev (PVS-RIPO)
3ms
MC1R-targeted Alpha-particle Monotherapy and Combination Therapy Trial With Nivolumab in Adults With Advanced Melanoma (clinicaltrials.gov)
P1/2, N=264, Recruiting, Perspective Therapeutics | N=52 --> 264
Enrollment change • Combination therapy • Metastases
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BRAF (B-raf proto-oncogene)
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Opdivo (nivolumab) • VMT-01
3ms
High-resolution RNA-sequencing reveals TRIM33::CSDE1 gene fusion in metastasizing vulvar melanoma. (PubMed, Melanoma Res)
Vulvar melanoma is the third tumor to have been reported to harbor TRIM33::CSDE1 fusion. Detecting fusions may have a clinically significant impact in patients with advanced mucosal melanoma who have failed front-line immunotherapy.
Journal • Metastases
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TRIM33 (Tripartite Motif Containing 33)
3ms
An assessment of "neuroendocrine differentiation" in malignant melanomas of the sinonasal and oral region. (PubMed, Ann Diagn Pathol)
The results of our study suggest that neuroendocrine differentiation is not uncommon in oral and sinonasal melanomas. Knowing that malignant melanomas can show neuroendocrine differentiation will prevent diagnostic pitfalls.
Journal
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NCAM1 (Neural cell adhesion molecule 1) • SYP (Synaptophysin)
3ms
Genomic landscape of cutaneous, acral, mucosal, and uveal melanoma in Japan: analysis of clinical comprehensive genomic profiling data. (PubMed, Int J Clin Oncol)
The distinct genomic profiling in Japanese patients, including lower TMB, compared to Caucasians, is associated with poorer treatment outcomes. This result underscores the need for more effective therapeutic agents.
Journal • Tumor mutational burden • MSi-H Biomarker • IO biomarker
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BRAF (B-raf proto-oncogene) • TMB (Tumor Mutational Burden) • NRAS (Neuroblastoma RAS viral oncogene homolog) • MSI (Microsatellite instability) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • NF1 (Neurofibromin 1) • GNAQ (G Protein Subunit Alpha Q) • SF3B1 (Splicing Factor 3b Subunit 1) • CCND1 (Cyclin D1) • BAP1 (BRCA1 Associated Protein 1) • GNA11 (G Protein Subunit Alpha 11) • CDK4 (Cyclin-dependent kinase 4) • CDKN2B (Cyclin Dependent Kinase Inhibitor 2B)
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BRAF V600E • MSI-H/dMMR • NRAS mutation • BRAF V600 • BRAF V600K • NF1 mutation • SF3B1 mutation • GNA11 mutation • BAP1 mutation • NRAS G13
3ms
Multi-regional genomic and transcriptomic characterization of a melanoma-associated oral cavity cancer provide evidence for CASP8 alteration-mediated field cancerization. (PubMed, Hum Genomics)
CASP8 alterations are the earliest driving events in oral field carcinogenesis, whereas additional somatic mutational, copy number and transcriptomic alterations ultimately lead to OSCC tumour formation and progression.
Journal
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CD8 (cluster of differentiation 8) • CASP8 (Caspase 8)
4ms
A Retrospective Analysis of the Prognostic Factors and Adverse Events in the Treatment of Mucosal Melanoma in a Single Centre. (PubMed, J Clin Med)
However, an elevated LDH is a reliable, independent negative prognostic marker. Inter-disciplinary management remains essential in order to develop optimal treatment strategies.
Retrospective data • Journal • Adverse events • IO biomarker
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NRAS (Neuroblastoma RAS viral oncogene homolog)
4ms
Morphological and Immunohistochemical Aspects with Prognostic Implications and Therapeutic Targets of Primary Sinonasal Mucosal Melanoma: A Retrospective Study. (PubMed, Cancers (Basel))
This study identifies eosinophils, macrophages, natural killer cells and plasma cells as favorable prognostic factors. Therefore, a CD8:CD4 ratio of more than 3 is correlated with a good response to PD-1 inhibitor therapy.
Retrospective data • Journal
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CD4 (CD4 Molecule)
4ms
MELMUQ: Molecular Characterization of Primary Mucosal Melanoma (clinicaltrials.gov)
P=N/A, N=65, Completed, CHU de Reims | Unknown status --> Completed
Trial completion
4ms
A Study to Investigate the Antitumor Activity, Safety, Tolerability, and Pharmacokinetics of BGB-A445 in Combination With Tislelizumab in Participants With Select Advanced Solid Tumors. (clinicaltrials.gov)
P1/2, N=202, Recruiting, BeiGene | Trial completion date: Aug 2025 --> Sep 2026 | Trial primary completion date: Sep 2024 --> Apr 2026
Trial completion date • Trial primary completion date • Combination therapy • Metastases
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cisplatin • Tevimbra (tislelizumab-jsgr) • BGB-A445
4ms
Camu-Camu Prebiotic and Immune Checkpoint Inhibition in Patients With Non-small Cell Lung Cancer and Melanoma (clinicaltrials.gov)
P1, N=45, Recruiting, Centre hospitalier de l'Université de Montréal (CHUM) | Trial primary completion date: Apr 2024 --> Apr 2025
Trial primary completion date • Checkpoint inhibition
|
PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene)
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Keytruda (pembrolizumab) • Opdivo (nivolumab)
5ms
Nab-Paclitaxel and Bevacizumab in Treating Patients With Unresectable Stage IV Melanoma or Gynecological Cancers (clinicaltrials.gov)
P1, N=43, Completed, Mayo Clinic | N=73 --> 43
Enrollment change • Metastases
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MUC16 (Mucin 16, Cell Surface Associated)
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Avastin (bevacizumab) • albumin-bound paclitaxel
5ms
Phase 1b/2 Study of the Combination of IMCgp100 With Durvalumab and/or Tremelimumab in Advanced Cutaneous Melanoma (clinicaltrials.gov)
P1/2, N=0, Withdrawn, Immunocore Ltd | N=113 --> 0 | Completed --> Withdrawn
Enrollment change • Trial withdrawal • Combination therapy • IO biomarker • Metastases
|
BRAF (B-raf proto-oncogene) • HLA-A (Major Histocompatibility Complex, Class I, A)
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Imfinzi (durvalumab) • Imjudo (tremelimumab) • Kimmtrak (tebentafusp-tebn)
5ms
Nab-Paclitaxel and Bevacizumab in Treating Patients With Unresectable Stage IV Melanoma or Gynecological Cancers (clinicaltrials.gov)
P1, N=73, Completed, Mayo Clinic | Active, not recruiting --> Completed | Trial completion date: Jun 2025 --> Jul 2024
Trial completion • Trial completion date • Metastases
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MUC16 (Mucin 16, Cell Surface Associated)
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Avastin (bevacizumab) • albumin-bound paclitaxel
5ms
Personalized Neo-Antigen Peptide Vaccine for the Treatment of Stage IIIC-IV Melanoma or Hormone Receptor Positive Her2 Negative Metastatic Refractory Breast Cancer (clinicaltrials.gov)
P1, N=20, Recruiting, Fred Hutchinson Cancer Center | Trial completion date: Nov 2025 --> Nov 2026 | Trial primary completion date: Nov 2024 --> Nov 2025
Trial completion date • Trial primary completion date • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • ER (Estrogen receptor) • PGR (Progesterone receptor)
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Opdivo (nivolumab) • Hiltonol (poly-ICLC) • PNV21 vaccine
5ms
Proteogenomic insights into the biology and treatment of pan-melanoma. (PubMed, Cell Discov)
In contrast, PRKDC may reduce the sensitivity of melanoma patients to immunotherapy by promoting DNA repair in melanoma cells. These results emphasize the clinical value of multi-omics data and have the potential to improve the understanding of melanoma treatment.
Journal • PD(L)-1 Biomarker • IO biomarker
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PRKDC (Protein Kinase, DNA-Activated, Catalytic Subunit)
5ms
iPREDICT: Study of Zirconium Zr 89 Crefmirlimab Berdoxam PET/CT in Subjects With Advanced or Metastatic Malignancies (clinicaltrials.gov)
P2, N=70, Active, not recruiting, ImaginAb, Inc. | Recruiting --> Active, not recruiting
Enrollment closed • IO biomarker • Metastases
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PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1)
5ms
Detection of human papillomavirus (HPV) in malignant melanoma. (PubMed, Ann Diagn Pathol)
The most common genetic abnormalities detected in this study occurred in the TERT promoter (TERTp) (n = 5), a finding that has been reported to be associated with aggressive disease. Our data shows that while HPV+ melanoma is rare, identifying this disease entity could help guide therapy given the demonstrated genomic alterations.
Journal
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BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog) • NF1 (Neurofibromin 1)
5ms
Primary malignant melanoma of the gastroesophageal junction with KIT gene exon 11 mutation. (PubMed, J Pak Med Assoc)
Although the clinicians emphasised the necessity of systemic chemotherapy and immunotherapy with the patient and his family, the patient did not receive any adjuvant therapy and died 36 months after surgery. Primary malignant melanoma of GEJ should be considered in a differential diagnosis for gastrointestinal malignancies, especially after excluding the source of metastasis through a systemic examination.
Journal • IO biomarker
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KIT (KIT proto-oncogene, receptor tyrosine kinase)
5ms
Expression of immune checkpoint molecules TIGIT and TIM-3 by tumor-infiltrating lymphocytes predicts poor outcome in sinonasal mucosal melanoma. (PubMed, Pathol Res Pract)
We identified high densities of TIM-3+ and TIGIT+ TILs as strong negative prognostic biomarkers in SNMM. This suggests that TIM-3 and TIGIT contribute to immunosuppression in SNMM and provides a rationale for novel treatment strategies based on this next generation of immune checkpoint inhibitors. Prospective studies with larger case numbers are warranted to confirm our findings and their implications for immunotherapy.
Journal • Tumor-infiltrating lymphocyte • IO biomarker
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LAG3 (Lymphocyte Activating 3) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
5ms
Shortened progression free and overall survival to immune-checkpoint inhibitors in BRAF-, RAS- and NF1- ("Triple") wild type melanomas. (PubMed, Eur J Cancer)
While known prognostic factors such as TERT promoter mutations and TMB were equally distributed among patients who received either anti-CTLA4 plus anti-PD1 combination therapy or anti-PD1 monotherapy as first line therapy, we did not find a prolonged mPFS or mOS in either of those. For both therapy concepts, mPFS and mOS were considerably shorter than reported for melanomas with known oncogene mutations.
Clinical • Journal • Checkpoint inhibition • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
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BRAF (B-raf proto-oncogene) • TMB (Tumor Mutational Burden) • NRAS (Neuroblastoma RAS viral oncogene homolog) • NF1 (Neurofibromin 1) • TERT (Telomerase Reverse Transcriptase)
5ms
ClearMe: Clear Me: Interception Trial to Detect and Clear Molecular Residual Disease in Patients With High-risk Melanoma (clinicaltrials.gov)
P2, N=54, Recruiting, University Health Network, Toronto | Initiation date: May 2024 --> Jul 2024
Trial initiation date
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Opdivo (nivolumab) • Opdualag (nivolumab/relatlimab-rmbw)
5ms
DIONE-01: A Study to Assess a PI3Kδ Inhibitor (IOA-244) in Patients With Metastatic Cancers (clinicaltrials.gov)
P1; Trial completion date: Apr 2024 --> Mar 2025 | Trial primary completion date: Sep 2023 --> Mar 2025
Combination therapy • Trial completion date • Trial primary completion date • Metastases
|
PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay
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cisplatin • Bavencio (avelumab) • Jakafi (ruxolitinib) • pemetrexed • roginolisib (IOA-244)
5ms
REFCORbirth: Study on the Occurrence of Head and Neck Cancers During Pregnancy (clinicaltrials.gov)
P=N/A, N=14, Active, not recruiting, Centre Francois Baclesse | Recruiting --> Active, not recruiting | N=50 --> 14 | Trial completion date: Nov 2028 --> May 2027 | Trial primary completion date: Nov 2028 --> May 2027
Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
5ms
SHR6390 in Treating Patients with Recurrent and/or Metastatic Mucosal Melanoma of Head and Neck Harboring CDK4 Amplification (ChiCTR2000031608)
P=N/A, N=17, Completed, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine; Shanghai Ninth People's Hospital, Shanghai Jiaotong University Scho | Recruiting --> Completed
Trial completion
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CDK4 (Cyclin-dependent kinase 4)
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AiRuiKang (dalpiciclib)
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