Melanoma
Recent clinical, regulatory, research and industry developments relating to this disease.
Innate Immune Cells in Melanoma: Implications for Immunotherapy.
Circadian tumor infiltration and function of CD8<sup>+</sup> T cells dictate immunotherapy efficacy.
What's happening now
An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.
- 3 clinical trials expected to report results, the earliest in Q1 2027.
- Active recent publication activity, including 1 notable finding.
- 7 industry developments reported.
- Q1 2027IDE196 (Darovasertib) in Combination With Crizotinib Versus Investigator's Choice of Treatment as First-line Therapy in HLA-A2 Negative Metastatic Uveal Melanoma (DAR-UM-2)
- Q2 2028A Randomized, Open-label Phase III Study in Patients With Previously Treated Unresectable or Metastatic NRAS Mutant Cutaneous Melanoma Comparing the Combination of Naporafenib + Trametinib to Physician's Choice of Therapy (Dacarbazine, Temozolomide or Trametinib Monotherapy) With a Dose Optimization lead-in [SEACRAFT-2]
- Q4 2029A Phase 3, Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With High-Risk Stage II-IV Melanoma (INTerpath-001)
Research HighlightsViewHide
Clinical MilestonesView all 12Hide
- 2026-02-11A Phase 2 Study of Nivolumab + BMS-986016 (Relatlimab) in Patients With Metastatic Uveal MelanomaResults posted
- 2025-10-15A Phase 3, Randomized, Double-blind, Active-Comparator-Controlled Clinical Study of Adjuvant MK-7684A (Vibostolimab With Pembrolizumab) Versus Adjuvant Pembrolizumab in Participants With High-risk Stage II-IV Melanoma (KEYVIBE-010)Results posted
- 2026-02-27A Randomized, Open-label Phase III Study in Patients With Previously Treated Unresectable or Metastatic NRAS Mutant Cutaneous Melanoma Comparing the Combination of Naporafenib + Trametinib to Physician's Choice of Therapy (Dacarbazine, Temozolomide or Trametinib Monotherapy) With a Dose Optimization lead-in [SEACRAFT-2]Results expected Q2 2028
- 2026-02-17IDE196 (Darovasertib) in Combination With Crizotinib Versus Investigator's Choice of Treatment as First-line Therapy in HLA-A2 Negative Metastatic Uveal Melanoma (DAR-UM-2)Results expected Q1 2027
- 2025-09-24A Phase 3, Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With High-Risk Stage II-IV Melanoma (INTerpath-001)Results expected Q4 2029
- 2026-03-12A Phase 3 Trial of Fianlimab (REGN3767, Anti-LAG-3) + Cemiplimab Versus Pembrolizumab in Patients With Previously Untreated Unresectable Locally Advanced or Metastatic MelanomaPrimary completion
- 2025-12-11A Randomized, Placebo-controlled, Double-blind, Phase II Chemoprevention Clinical Trial of Topical Diclofenac and DFMO in Subjects With a History of Skin CancerCompleted
- 2025-10-31A Randomized, Double-blind Study Evaluating Pharmacokinetic Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Resected Stage III or Stage IV Melanoma Subjects in the Adjuvant SettingCompleted
- 2036-05-01A Multicentre, Open Label, Phase II Study to Determine the Response to Neoadjuvant Pembrolizumab and Lenvatinib Followed by Adjuvant Treatment With Pembrolizumab and Lenvatinib in Mucosal MelanomaWithdrawn
- 2031-07-01Randomized Double-Blind Placebo Controlled Phase II Study of a Galectin Inhibitor (GR-MD-02) and Pembrolizumab Versus Pembrolizumab and Placebo in Patients With Metastatic Melanoma and Head and Neck Squamous Cell CarcinomaWithdrawn
- 2030-08-01Surgical or Radiotherapeutic Intervention Concerning Large Singular Stable to Progressive Metastases in Patients With BRAFV600-mutated Melanoma Receiving Treatment With Encorafenib + BinimetinibWithdrawn
- 2026-01-23A Randomized, Double-blind, Parallel-group Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of JPB898 (Proposed Nivolumab Biosimilar) and US-licensed and EU-authorized Opdivo® in Combination With Yervoy® in Participants With Untreated Advanced (Unresectable/Metastatic) MelanomaTerminated
Industry & MarketView all 7Hide
- 2026-07-30Replimune’s twice-rejected melanoma drug prevails in FDA adcommRegulatory news · Fierce Biotech
- 2026-07-30Replimune’s RP-1 for melanoma wins over FDA adcomRegulatory news · BioWorld Gene Therapy
- 2026-07-30STAT+: Tracking the FDA expert review of Replimune’s melanoma treatmentRegulatory news · STAT News
- 2026-07-22Brown bullhead catfish melanoma represents a novel transmissible cancerIndustry · Nature News
- 2026-07-01Melanoma's secret to cheating death has finally been revealedIndustry · Science Daily
- 2036-05-01ClinicalA Multicentre, Open Label, Phase II Study to Determine the Response to Neoadjuvant Pembrolizumab and Lenvatinib Followed by Adjuvant Treatment With Pembrolizumab and Lenvatinib in Mucosal MelanomaWithdrawn
- 2031-07-01ClinicalRandomized Double-Blind Placebo Controlled Phase II Study of a Galectin Inhibitor (GR-MD-02) and Pembrolizumab Versus Pembrolizumab and Placebo in Patients With Metastatic Melanoma and Head and Neck Squamous Cell CarcinomaWithdrawn
- 2030-08-01ClinicalSurgical or Radiotherapeutic Intervention Concerning Large Singular Stable to Progressive Metastases in Patients With BRAFV600-mutated Melanoma Receiving Treatment With Encorafenib + BinimetinibWithdrawn
- 2026-07-31IndustrySTAT+: Pharmalittle: We’re reading about a Novo setback, support for Replimune’s melanoma drug, and moreIndustry · STAT News
- 2026-07-30IndustryReplimune’s twice-rejected melanoma drug prevails in FDA adcommRegulatory news · Fierce Biotech
- 2026-07-30IndustryReplimune’s RP-1 for melanoma wins over FDA adcomRegulatory news · BioWorld Gene Therapy
- 2026-07-30IndustrySTAT+: Tracking the FDA expert review of Replimune’s melanoma treatmentRegulatory news · STAT News
- 2026-07-22IndustryBrown bullhead catfish melanoma represents a novel transmissible cancerIndustry · Nature News
- 2026-07-01IndustryMelanoma's secret to cheating death has finally been revealedIndustry · Science Daily
- 2026-03-12ClinicalA Phase 3 Trial of Fianlimab (REGN3767, Anti-LAG-3) + Cemiplimab Versus Pembrolizumab in Patients With Previously Untreated Unresectable Locally Advanced or Metastatic MelanomaPrimary completion
Therapeutic landscape
Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.
Approval — Kimmtrak is indicated as monotherapy for the treatment of human leukocyte antigen (HLA)-A… (2022)
Approval — MelanomaBinimetinib in combination with encorafenib is indicated for the treatment of adu… (2018)
Approval — MelanomaEncorafenib in combination with binimetinib is indicated for the treatment of adu… (2018)
Approval — Melanoma Keytruda as monotherapy is indicated for the treatment of adults and adolescents… (2015)
Approval — Imlygic is indicated for the treatment of adults with unresectable melanoma that is regio… (2015)
Approval — Melanoma Trametinib as monotherapy or in combination with dabrafenib is indicat… (2014)
Approval — Melanoma Dabrafenib as monotherapy or in combination with trametinib is indicated for the… (2013)
Approval — Vemurafenib is indicated in monotherapy for the treatment of adult patients with BRAF-V60… (2012)
Clinical trials
The current development programme across all trial phases.
Regulatory timeline
Drug regulatory events matched to this condition by indication — EMA.
European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.
Research activity
Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.
Major themes8
- Melanoma69
- Skin Neoplasms17
- Immune Checkpoint Inhibitors15
- Lung Neoplasms10
- Immunotherapy8
- Tumor Microenvironment5
- Neoplasms4
- Uveal Neoplasms4
Leading journals6
- The New England journal of medicine20
- Nature communications11
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology10
- Frontiers in immunology7
- Journal for immunotherapy of cancer7
- International journal of molecular sciences4
Leading researchers8
- Schadendorf D19
- Robert C17
- Ascierto PA15
- Long GV14
- Rutkowski P14
- Dummer R12
- Ribas A12
- Grob JJ11
Affiliations (unnormalised)6
- Melanoma Institute Australia8
- Memorial Sloan Kettering Cancer Center8
- The University of Texas MD Anderson Cancer Center8
- Dana-Farber Cancer Institute7
- University Hospital Essen7
- Netherlands Cancer Institute5
Disease biology
Key proteins & gene products studied in this disease. Number shows shared papers.
Related conditions
Diseases frequently studied alongside this one. Number shows shared papers.
Disease profile
A grounded synthesis of the condition — overview, causes, mechanism, risk factors and current standard of care.
Melanoma is a malignant tumor arising from pigment-producing cells that can occur in the skin, eye, and more rarely mucous membranes. It usually affects adults and may develop de novo or from a pigmented nevus or malignant lentigo. It is a highly metastatic cancer, with spread commonly involving regional lymph nodes, liver, lungs, and brain.
The grounding supports melanoma as arising from melanocytic cells and notes that it may originate de novo or from a pigmented nevus or malignant lentigo. It also indicates that genomic alterations in signaling pathways such as MAPK and PI3K contribute to melanoma development and progression. No single external cause is established in the supplied material.
Melanoma progression is linked to dysregulated signaling, especially the RAS/RAF/MAPK cascade and the PI3K pathway, through genomic alterations in pathway components. The disease also involves interactions with the tumor microenvironment and the immune system, including tumor-infiltrating lymphocytes and immune checkpoint pathways. These mechanisms contribute to proliferation, survival, invasion, metastasis, and treatment resistance.
The supplied grounding identifies adult age as the typical demographic and notes that melanoma incidence is rising worldwide. It also indicates that melanoma can arise from a pigmented nevus or malignant lentigo, which are associated precursor lesions. No additional risk factors are supported by the grounding.
Localized early-stage melanoma is generally treated with surgery, and the literature notes that surgery alone can be sufficient in early disease. For advanced or metastatic melanoma, treatment categories include immune checkpoint inhibitors, cytokine therapy such as IL-2, chemotherapy, targeted therapy against the MAPK pathway, and adjuvant therapy in selected settings. The grounding also mentions cancer vaccines and clinical trial enrollment as part of management discussions for higher-risk disease.
AI-generated summary grounded in MeSH and 6 peer-reviewed sources. Informational only — not medical advice. Generated 2026-07-06.
Reference
Authoritative identity, definition & identifiers.
A malignant neoplasm derived from cells that are capable of forming melanin, which may occur in the skin of any part of the body, in the eye, or, rarely, in the mucous membranes of the genitalia, anus, oral cavity, or other sites. It occurs mostly in adults and may originate de novo or from a pigmented nevus or malignant lentigo. Melanomas frequently metastasize widely, and the regional lymph nodes, liver, lungs, and brain are likely to be involved. The incidence of malignant skin melanomas is rising rapidly in all parts of the world. (Stedman, 25th ed; from Rook et al., Textbook of Dermatology, 4th ed, p2445)
- Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
- Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
- Research activity — Europe PMC (EMBL-EBI) + OpenAlex-derived paper links
- Related entities are derived from literature co-mention (studied together) — associative, not causal.