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Disease

Melanoma

Late-stage therapeutic developmentExtensively researchedCooling momentum
139
Publications
24
Clinical trials
12
Related conditions
8
Related treatments
10
Related proteins
2026
Latest publication
Current focus
Antibodies biologyIpilimumab biologyTherapeutic developmentInflammation & immunity
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this disease.

Innate Immune Cells in Melanoma: Implications for Immunotherapy.

Research2024-08-05International journal of molecular sciences

Cancer statistics, 2024.

Research2024-01-17CA: a cancer journal for clinicians

What's happening now

An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.

Major developments
Research Highlights2View
Clinical Milestones12View all 12
+4 more in the activity timeline below
Industry & Market7View all 7
+2 more in the activity timeline below
Activity timeline21

Therapeutic landscape

Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.

Approved & established therapies
Tebentafuspapproved

Approval — Kimmtrak is indicated as monotherapy for the treatment of human leukocyte antigen (HLA)-A… (2022)

Binimetinibapproved

Approval — MelanomaBinimetinib in combination with encorafenib is indicated for the treatment of adu… (2018)

Encorafenibapproved

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)

Trametinibapproved

Approval — Melanoma Trametinib as monotherapy or in combination with dabrafenib is indicat… (2014)

Dabrafenibapproved

Approval — Melanoma Dabrafenib as monotherapy or in combination with trametinib is indicated for the… (2013)

Vemurafenibapproved

Approval — Vemurafenib is indicated in monotherapy for the treatment of adult patients with BRAF-V60… (2012)

Research-associated treatments

Clinical trials

16 sponsors · 0 new · 4 completed in the last 12 months (net -1)

The current development programme across all trial phases.

Clinical programme
24
All trials
6
Active
14
Late-stage
6
Completed
Late-stage studies
Recently completed

Regulatory timeline

Drug regulatory events matched to this condition by indication — EMA.

First approvals
2022emaApprovalTebentafusp· Kimmtrak is indicated as monotherapy for the treatment of human leukocyte antigen (HLA)-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma. source ↗
2018emaApprovalBinimetinib· MelanomaBinimetinib in combination with encorafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.Non-small cell lung cancer (NSCLC)Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation. source ↗
2018emaApprovalEncorafenib· MelanomaEncorafenib in combination with binimetinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.Colorectal cancer (CRC)Encorafenib in combination with cetuximab is indicated for the treatment of adult patients with metastatic colorectal cancer (CRC)  with a BRAF V600E mutation, who have received prior systemic therapy. Encorafenib in combination with cetuximab and FOLFOX is indicated for the first line treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation.  Non-small cell lung cancer (NSCLC)Encorafenib in combination with binimetinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation. source ↗
2015emaApprovalTalimogene laherparepvec· Imlygic is indicated for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease. source ↗
2015emaApprovalPembrolizumab· Melanoma Keytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. Keytruda as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage IIB, IIC, or with Stage III melanoma and lymph node involvement who have undergone complete resection. Non small cell lung carcinoma (NSCLC) Keytruda, in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment, is indicated for the treatment of resectable non small cell lung carcinoma at high risk of recurrence in adults Keytruda as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum based chemotherapy (for selection criteria, see section 5.1). Keytruda as monotherapy is indicated for the first line treatment of metastatic non small cell lung carcinoma in adults whose tumours express PD L1 with a ≥ 50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations. Keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non squamous non small cell lung carcinoma in adults whose tumours have no EGFR or ALK positive mutations. Keytruda, in combination with carboplatin and either paclitaxel or nab paclitaxel, is indicated for the first line treatment of metastatic squamous non small cell lung carcinoma in adults. Keytruda  as monotherapy is indicated for the treatment of locally advanced or metastatic non small cell lung carcinoma in adults whose tumours express PD L1 with a ≥ 1% TPS and who have received at least one prior chemotherapy regimen. Patients with EGFR or ALK positive tumour mutations should also have received targeted therapy before receiving KEYTRUDA. Malignant pleural mesothelioma (MPM) Keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first‑line treatment of adults with unresectable non-epithelioid malignant pleural mesothelioma. Classical Hodgkin lymphoma (cHL) Keytruda as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT is not a treatment option. Urothelial carcinoma Keytruda, in combination with enfortumab vedotin, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, is indicated for the treatment of adults with resectable muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin‑containing chemotherapy. Keytruda, in combination with enfortumab vedotin, is indicated for the first-line treatment of unresectable or metastatic urothelial carcinoma in adults. Keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum containing chemotherapy.Keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin containing chemotherapy and whose tumours express PD L1 with a combined positive score (CPS) ≥ 10. Head and neck squamous cell carcinoma (HNSCC) Keytruda as monotherapy is indicated for the treatment of resectable locally advanced head and neck squamous cell carcinoma as neoadjuvant treatment, continued as adjuvant treatment in combination with radiation therapy with or without concomitant cisplatin and then as monotherapy in adults whose tumours express PD-L1 with a CPS ≥ 1. Keytruda, as monotherapy or in combination with platinum and 5 fluorouracil (5 FU) chemotherapy, is indicated for the first line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express PD L1 with a CPS ≥ 1. Keytruda as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express PD L1 with a ? 50% TPS and progressing on or after platinum containing chemotherapy. Renal cell carcinoma (RCC) Keytruda, in combination with axitinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults. Keytruda, in combination with lenvatinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults. Keytruda as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (for selection criteria, please see section 5.1). Microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) cancers Colorectal cancer (CRC)Keytruda as monotherapy is indicated for theadults with MSI-H or dMMR colorectal cancer in the following settings: first line treatment of metastatic microsatellite instability high (MSI H) or mismatch repair deficient (dMMR) colorectal cancer in adults; treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy.  Non-colorectal cancersKeytruda as monotherapy is indicated for the treatment of the following MSI H or dMMR tumours in adults with: advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation; unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. Oesophageal carcinoma Keytruda, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus in adults whose tumours express PD L1 with a CPS ≥ 10. Triple negative breast cancer (TNBC) Keytruda, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. Keytruda, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express PD L1 with a CPS ≥ 10 and who have not received prior chemotherapy for metastatic disease. Endometrial carcinoma (EC) Keytruda, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of primary advanced or recurrent endometrial carcinoma in adults who are candidates for systemic therapy.  Keytruda, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. Cervical cancer Keytruda, in combination with chemoradiotherapy (external beam radiation therapy followed by brachytherapy), is indicated for the treatment of FIGO 2014 Stage III - IVA locally advanced cervical cancer in adults who have not received prior definitive therapy.  Keytruda, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express PD L1 with a CPS ≥ 1. Gastric or gastro-oesophageal junction (GEJ) adenocarcinoma Keytruda, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1. Keytruda, in combination with fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD L1 with a CPS ≥ 1 (see section 5.1). Biliary tract carcinoma (BTC) Keytruda, in combination with gemcitabine and cisplatin, is indicated for the first-line treatment of locally advanced unresectable or metastatic biliary tract carcinoma in adults. Ovarian Cancer Keytruda, in combination with paclitaxel, with or without bevacizumab, is indicated for the treatment of platinum‑resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma in adults whose tumours express PD‑L1 with a CPS ≥ 1 and who have received one or two prior systemic treatment regimens. source ↗
2014emaApprovalTrametinib· Melanoma Trametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adults and adolescents aged 12 years and older with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1). Trametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior BRAF inhibitor therapy (see section 5.1). Adjuvant treatment of melanoma Trametinib in combination with dabrafenib is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage III melanoma with a BRAF V600 mutation, following complete resection. Non-small cell lung cancer (NSCLC) Trametinib in combination with dabrafenib is indicated for the treatment of adults with advanced non-small cell lung cancer with a BRAF V600 mutation. Differentiated thyroid cancer (DTC) Trametinib in combination with dabrafenib is indicated for the treatment of adult patients with locally advanced or metastatic differentiated thyroid cancer with a BRAF V600E mutation, refractory to or not eligible for radioactive iodine (RAI) who have progressed during or after prior systemic therapy (for biomarker-based patient selection, see section 4.2). source ↗
2013emaApprovalDabrafenib· Melanoma Dabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adults and adolescents aged 12 years and older with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1). Adjuvant treatment of melanoma Dabrafenib in combination with trametinib is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage III melanoma with a BRAF V600 mutation, following complete resection. Non-small cell lung cancer (NSCLC) Dabrafenib in combination with trametinib is indicated for the treatment of adults with advanced non-small cell lung cancer with a BRAF V600 mutation. Differentiated thyroid cancer (DTC) Dabrafenib in combination with trametinib is indicated for the treatment of adult patients with locally advanced or metastatic differentiated thyroid cancer with a BRAF V600E mutation, refractory to or not eligible for radioactive iodine (RAI) who have progressed during or after prior systemic therapy (for biomarker-based patient selection, see section 4.2). source ↗
2012emaApprovalVemurafenib· Vemurafenib is indicated in monotherapy for the treatment of adult patients with BRAF-V600-mutation-positive unresectable or metastatic melanoma. source ↗

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

139 papers

Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.

Publications over time
20152026
Most influential

Cancer statistics, 2023.

CA: a cancer journal for clinicians · 2023 · 12,757 cites

Improved survival with ipilimumab in patients with metastatic melanoma.

The New England journal of medicine · 2010 · 11,354 cites

Safety, activity, and immune correlates of anti-PD-1 antibody in cancer.

The New England journal of medicine · 2012 · 9,851 cites

Cancer statistics, 2024.

CA: a cancer journal for clinicians · 2024 · 8,001 cites

Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma.

The New England journal of medicine · 2015 · 5,963 cites

Improved survival with vemurafenib in melanoma with BRAF V600E mutation.

The New England journal of medicine · 2011 · 5,684 cites
Recent publications
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

10 matches

Key proteins & gene products studied in this disease. Number shows shared papers.

Related conditions

12 matches

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.

Overview

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.

Causes

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.

Pathophysiology

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.

Risk factors

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.

Current standard of care

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.

Defined in MeSH

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)

Identifiers
References & data sources
  • 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.