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Oncology›Condition·Updated Jul 11, 2026·v1

Melanoma

Melanoma is a highly aggressive skin cancer with rising incidence, especially of thick tumors. Management has been revolutionized by immune checkpoint inhibitors and targeted therapies, yielding long-term survival rates >40% in advanced disease. Accurate staging (AJCC 8th), BRAF mutation testing, and sentinel lymph node biopsy guide treatment decisions. Neoadjuvant immunotherapy is now preferred for resectable stage III, while nivolumab plus ipilimumab is first-line for most advanced patients. BRAF/MEK inhibitors offer rapid disease control but are less durable. Early detection through total-body skin examination remains crucial. Special considerations include pregnancy, uveal melanoma, and brain metastases.

High Evidence862 references·2,485 words·10 min read·v1
melanomacutaneous melanomaBRAFimmune checkpoint inhibitorsskin canceroncologyneoadjuvant therapy

Quick Reference

RxDrug of choiceNivolumab + ipilimumab (first-line for advanced melanoma regardless of BRAF status); neoadjuvant ipilimumab + nivolumab for resectable stage III
AltAlternativesPembrolizumab monotherapy; nivolumab + relatlimab; dabrafenib + trametinib (BRAF-mutant); encorafenib + binimetinib (BRAF-mutant); TIL therapy (lifileucel) for anti-PD-1-refractory; tebentafusp (uveal melanoma, HLA-A*02:01+)
⊘AvoidCytotoxic chemotherapy as first-line; BRAF inhibitor monotherapy (must combine with MEK inhibitor); whole-brain radiotherapy for asymptomatic brain metastases if systemic therapy available; high-dose corticosteroids (≥10 mg prednisone equivalent/day) without managing irAE, may blunt immunotherapy efficacy
DxTest of choiceExcisional biopsy with 1-3 mm margins (diagnosis and microstaging); BRAF V600 mutation testing (stage III/IV); PET-CT (staging stage IIC+); brain MRI (stage IV); sentinel lymph node biopsy (T1b-T3)
ScKey scoreAJCC 8th edition staging (TNM); Breslow thickness; sentinel lymph node status; serum LDH; diagnosis-specific GPA for brain metastases; ctDNA detection (post-surgery landmark)
→When to referSuspicious lesion → dermatology for biopsy; stage I+ → surgical oncology for wide excision and SLNB; stage III+ → medical oncology for systemic therapy; brain metastases → radiation oncology and/or neurosurgery; genetic counseling for familial cases (≥3 primaries, family history, early onset); pregnancy-associated melanoma → maternal-fetal medicine
Early detection through total-body skin examination in high-risk individuals is critical. For advanced melanoma, combination immunotherapy (nivolumab + ipilimumab) yields the highest long-term survival (10-year OS 43%). For resectable stage III, neoadjuvant ipilimumab + nivolumab is the new standard (12-month EFS 83.7%). BRAF/MEK inhibitors offer rapid disease control but less durable benefit; sequencing immunotherapy first is preferred for BRAF-mutant patients. Adjuvant therapy with anti-PD-1 or targeted therapy significantly improves RFS in high-risk resected disease. Avoid cytotoxic chemotherapy and unnecessary corticosteroids in patients receiving immunotherapy.
Melanoma is a malignant neoplasm of melanocytes, the deadliest skin cancer, with rising incidence of thick tumors. Key subtypes include cutaneous, acral lentiginous, mucosal, and uveal. Management has been transformed by immune checkpoint inhibitors (nivolumab + ipilimumab) and targeted therapy (BRAF/MEK inhibitors). Prognosis depends on stage, molecular profile, and treatment response, with 10-year OS now ~43% for advanced disease.

Overview and Recommendations

Background

  • •Melanoma is a malignant neoplasm of melanocytes, the pigment-producing cells of the skin, mucosa, uveal tract, and leptomeninges, and is the deadliest form of skin cancer, accounting for the vast majority of skin-cancer deaths. Incidence has risen steadily in fair-skinned populations; in the United States, the lifetime risk is now approximately 1 in 68, and the incidence of thickest tumors (T4, >4.0 mm) increased 3.32% per year from 2010 to 2018, signaling a shift toward later detection rather than overdiagnosis.
  • •Cutaneous melanoma is the most common subtype (~90%), but distinct variants include acral lentiginous melanoma (palms, soles, nailbeds; not UV-related, KIT mutations), mucosal melanoma (sinonasal, anogenital; aggressive, low mutational burden), and uveal melanoma (primary intraocular; GNAQ/GNA11 mutations, 15-GEP/PRAME stratifies metastasis risk). Superficial spreading melanoma (~70%) and nodular melanoma (~15%) are the major histologic patterns within cutaneous disease.
  • •Approximately 40-50% of cutaneous melanomas harbor an activating BRAF V600 mutation (most commonly V600E), which drives constitutive MAPK pathway signaling and is targetable with BRAF/MEK inhibitor combinations. NRAS mutations occur in 15-20%, KIT mutations in acral/mucosal subtypes, and NF1 loss in ~15%, these are generally mutually exclusive. UV-induced mutagenesis (C→T transitions) is the dominant environmental etiology, but acral and mucosal melanomas arise through UV-independent mechanisms.
  • •Melanoma has the highest propensity for brain metastasis among solid tumors: in stage III disease, the cumulative incidence of CNS metastasis is 15.8% at 5 years. Untreated metastatic melanoma historically carried a 5-year survival <10%, but modern immunotherapy (nivolumab + ipilimumab) now achieves a median overall survival of 71.9 months and a 10-year survival rate of 43% (CheckMate 067). For resected stage III, adjuvant nivolumab yields a median recurrence-free survival of 61.1 months at 9-year follow-up.
  • •Host risk factors include fair skin, high nevus count (>50 nevi confers 2- to 4-fold risk), atypical (dysplastic) nevi, family history, and immunosuppression. The attributable risk from seven easily obtained clinical features (including nevus count, freckling, and sunburn history) is 86% for men and 89% for women, underscoring that the vast majority of melanomas arise from identifiable, potentially modifiable factors.

Evaluation

  • •Suspect melanoma in any patient presenting with a changing pigmented lesion, apply the ABCDE criteria (Asymmetry, Border irregularity, Color variation, Diameter >6 mm, Evolution) and the “ugly duckling” sign (a lesion that looks different from the patient’s other nevi). Nodular melanomas may grow rapidly (weeks) and can be amelanotic (pink, red, flesh-colored), leading to frequent misdiagnosis as basal cell carcinoma or pyogenic granuloma.
  • •Ask about prior sun exposure history, blistering sunburns (especially in childhood), indoor tanning bed use, personal or family history of melanoma or pancreatic cancer, and immunosuppression (transplant, HIV, CLL). In women, inquire about pregnancy status, postpartum diagnosis is associated with increased mortality (aHR 1.84).
  • •Examine the total skin surface, including scalp, nails, interdigital web spaces, palms, soles, and mucosal surfaces. Document the lesion’s size, color variegation, ulceration, bleeding, and surrounding satellites. Palpate the regional lymph node basins (axillary, inguinal, cervical) for adenopathy. Dermoscopy by a trained clinician increases diagnostic accuracy by 10-30% over naked-eye examination.
  • •Perform an excisional biopsy with 1-3 mm peripheral margins, extending to the subcutaneous fat, to obtain a full-thickness specimen for accurate microstaging. Avoid shave biopsy for suspicious lesions, incomplete sampling can underestimate Breslow thickness and preclude sentinel lymph node biopsy (SLNB) eligibility. If shave is unavoidable, a deep saucerization is preferred over superficial shave.
  • •The pathologist must report Breslow thickness (to nearest 0.1 mm), ulceration (present/absent), dermal mitotic rate (mitoses/mm²), and peripheral/deep margin status. Additional features, tumor-infiltrating lymphocytes (TILs), regression, lymphovascular invasion, microsatellitosis, inform prognosis and SLNB decision-making. For melanoma in situ, Mohs micrographic surgery with immunohistochemistry (Melan-A, SOX10) is recommended.
  • •Order BRAF V600 mutation testing on all patients with stage III or IV cutaneous melanoma using a validated assay (NGS, PCR, or immunohistochemistry). Also consider KIT mutation testing for acral and mucosal subtypes, and NTRK fusion testing for rare cases. PD-L1 immunohistochemistry provides predictive information but is neither necessary nor sufficient for checkpoint inhibitor benefit.
  • •Stage all patients according to AJCC 8th edition: T category combines Breslow thickness and ulceration (e.g., T1a: <0.8 mm nonulcerated; T1b: 0.8-1.0 mm or <0.8 mm with ulceration). N category integrates number of positive nodes, microscopic vs. macroscopic involvement, and in-transit/satellite metastases. M category depends on distant site and serum LDH level (normal vs. elevated). Sentinel lymph node biopsy is the most important staging procedure for clinically node-negative patients, recommended for T2-T3 (>1.0-4.0 mm) and considered for T1b (0.8-1.0 mm or <0.8 mm with ulceration); not recommended for T1a.
  • •Routine imaging is not indicated for stage 0-IIA (asymptomatic). For stage IIC, III (any N), and IV, obtain chest/abdomen/pelvis CT with IV contrast; PET-CT is more sensitive for distant metastases and is preferred when surgical resection of oligometastatic disease is planned. Brain MRI with contrast is mandatory for stage IV and should be considered for stage III, especially with neurological symptoms. Be aware of the ~5.8% false-positive rate of PET-CT.
  • •Consider circulating tumor DNA (ctDNA) testing at the postoperative landmark (≤12 weeks after resection) for stage III disease, detectable ctDNA confers a 3.42-fold increased risk of relapse and may guide intensified surveillance or adjuvant therapy decisions. Tumor-informed bespoke assays can detect molecular residual disease a median 128 days before radiographic relapse.
  • •Genetic counseling and germline testing should be offered to patients with ≥3 primary melanomas, families with ≥3 cases of melanoma or pancreatic cancer, or personal history of multiple atypical nevi. High-penetrance genes include CDKN2A (20-40% of familial cases; also confers ~50-fold increased risk of pancreatic cancer) and BAP1 (associated with uveal melanoma and mesothelioma). Cascade testing of at-risk relatives is essential.

Management

  • •For primary melanoma without nodal involvement (stage 0-II), perform wide local excision with margins based on Breslow thickness: melanoma in situ - 0.5-1.0 cm; ≤1 mm - 1 cm; 1.01-2 mm - 1-2 cm; >2 mm - 2 cm. For T1b-T3 melanomas, offer sentinel lymph node biopsy (SLNB) after discussion of risks and benefits. Completion lymph node dissection after positive SLNB improves regional control but does not improve melanoma-specific survival; nodal observation with serial ultrasound is an acceptable alternative for low-volume micrometastatic disease.
  • •For resectable macroscopic stage III melanoma (clinically palpable nodes or in-transit metastases), prefer neoadjuvant therapy: administer two cycles of ipilimumab 1 mg/kg plus nivolumab 3 mg/kg every 3 weeks, followed by surgical resection 4-6 weeks after cycle 2. Then, based on pathologic response: if major pathologic response (≤10% viable tumor) - continue adjuvant nivolumab (480 mg q4w) for up to 12 months; if no major response - consider dabrafenib + trametinib (if BRAF-mutant) or alternative. This regimen (NADINA trial) achieved 83.7% 12-month event-free survival vs. 57.2% with adjuvant nivolumab alone (HR 0.32). An alternative is neoadjuvant pembrolizumab 200 mg q3w for 3 doses before surgery, then 15 doses adjuvant (SWOG S1801).
  • •For patients with resected stage IIB-IV melanoma who did not receive neoadjuvant therapy, offer adjuvant immunotherapy: nivolumab 240 mg q2w (or 480 mg q4w) or pembrolizumab 200 mg q3w (or 400 mg q6w) for up to 12 months (category 1). In KEYNOTE-716, adjuvant pembrolizumab improved 36-month distant metastasis-free survival to 84.4% vs. 74.7% (HR 0.59). For BRAF V600-mutant stage III melanoma, adjuvant dabrafenib 150 mg BID plus trametinib 2 mg daily for 12 months is also category 1 (COMBI-AD: 10-year RFS HR 0.52; OS HR 0.80, not significant). Adjuvant therapy for stage IIIA (AJCC v8) is controversial, retrospective data show no clear benefit over observation; shared decision-making is essential.
  • •First-line therapy for advanced (unresectable stage III or IV) melanoma is determined by BRAF status, performance status, and patient preference. For most fit patients, regardless of BRAF status, initiate ipilimumab 3 mg/kg plus nivolumab 1 mg/kg every 3 weeks for 4 doses, followed by nivolumab maintenance (240 mg q2w or 480 mg q4w). CheckMate 067 reported median OS 71.9 months for the combination; 10-year OS 43%. Grade 3-4 immune-related adverse events (irAEs) occur in 55-59%, requires proactive toxicity monitoring and management with corticosteroids, TNF inhibitors, or other immunosuppressants per established algorithms.
  • •For patients with contraindications to high-dose corticosteroids, autoimmune disease, or those who prefer lower toxicity, alternatives include: (1) nivolumab 240 mg q2w or pembrolizumab 200 mg q3w monotherapy (10-year OS ~34-37%, grade 3-4 irAEs 13-16%); (2) nivolumab 480 mg plus relatlimab 160 mg fixed-dose combination q4w (median PFS 10.1 vs. 4.6 months for nivolumab alone; grade 3-4 18.9%). Pembrolizumab is also available as 400 mg q6w for convenience.
  • •For patients with BRAF V600-mutant advanced melanoma, the preferred first-line strategy is immunotherapy (nivolumab + ipilimumab) based on DREAMseq (2-year OS 71.8% with immunotherapy-first vs. 51.5% with targeted therapy-first). BRAF/MEK inhibitors are a category 1 alternative for rapid disease control: dabrafenib 150 mg BID + trametinib 2 mg daily (median PFS 11.0 months; grade 3-4 32%), encorafenib 450 mg daily + binimetinib 45 mg BID (median PFS 14.9 months; grade 3-4 40%), or vemurafenib 960 mg BID + cobimetinib 60 mg daily (21 days on/7 off; median PFS 12.3 months; grade 3-4 39%). Reserve targeted therapy for patients with high tumor burden, symptomatic disease, or contraindications to immunotherapy.
  • •For patients whose disease progresses on anti-PD-1 therapy, options include: (1) ipilimumab 3 mg/kg plus pembrolizumab 2 mg/kg (ORR 29%; median OS 24.7 months); (2) TIL therapy (lifileucel) - FDA-approved for anti-PD-1-refractory melanoma, ORR 31.5% with median duration of response not reached at 5 years; (3) oncolytic virus RP1 plus nivolumab (ORR 32.9%; 2-year OS 63.3%). Ipilimumab monotherapy is no longer recommended after anti-PD-1 failure if combination is feasible.
  • •For melanoma brain metastases: in asymptomatic patients, initiate systemic therapy first, nivolumab + ipilimumab achieved intracranial clinical benefit rate of ~80% with 3-year OS 71.9% (CheckMate 204). For BRAF-mutant disease, dabrafenib + trametinib produced intracranial responses in 58% (COMBI-MB). Reserve stereotactic radiosurgery (SRS) for symptomatic or progressing lesions; avoid whole-brain radiotherapy (WBRT) as it does not improve OS and impairs neurocognition. If leptomeningeal disease develops, consider intrathecal therapy or clinical trials.
  • •For metastatic uveal melanoma: if HLA-A*02:01-positive, treat with tebentafusp 20-68-68 mcg weekly infusion (bispecific T-cell engager targeting gp100×CD3). The IMCgp100-202 trial improved 3-year OS to 27% vs. 18% with investigator’s choice (HR 0.68). Checkpoint inhibitors have limited activity in uveal melanoma and are not recommended as first-line.
  • •What NOT to do: Do not use cytotoxic chemotherapy (dacarbazine, temozolomide, platinum/taxanes) as first-line therapy, response rates <15% and no survival benefit in the immunotherapy era. Do not administer BRAF inhibitor monotherapy without a MEK inhibitor (increased toxicity, lower efficacy). Do not routinely start corticosteroids (e.g., dexamethasone) for asymptomatic brain metastases unless symptom control is needed, corticosteroids may impair immunotherapy efficacy. Do not delay systemic therapy for asymptomatic brain metastases in favor of immediate radiation, deferring SRS until progression is safe and preserves quality of life.

Board Review — High Yield

  • •ABCDE criteria, Asymmetry, Border irregularity, Color variegation, Diameter >6 mm, Evolution, classic warning signs for melanoma on skin exam.
  • •Breslow thickness, Most important prognostic factor in primary melanoma; measured to nearest 0.1 mm; T1a = <0.8 mm nonulcerated, T1b = 0.8-1.0 mm or <0.8 mm with ulceration.
  • •Sentinel lymph node biopsy (SLNB), Recommended for T1b-T3 melanomas (0.8-4.0 mm); most powerful independent predictor of recurrence and survival in early-stage disease.
  • •BRAF V600 mutation, Present in 40-50% of cutaneous melanomas; targetable with dabrafenib + trametinib, encorafenib + binimetinib, or vemurafenib + cobimetinib; testing mandatory for stage III/IV.
  • •CheckMate 067, Landmark trial: nivolumab + ipilimumab achieved median OS 71.9 months (10-year OS 43%) vs. 36.9 months (37%) for nivolumab alone vs. 19.9 months (19%) for ipilimumab alone in advanced melanoma.
  • •NADINA trial, Neoadjuvant ipilimumab + nivolumab (2 cycles) before surgery in resectable stage III melanoma improved 12-month event-free survival to 83.7% vs. 57.2% with adjuvant nivolumab alone (HR 0.32).
  • •DREAMseq (EA6134), For BRAF-mutant advanced melanoma, initial immunotherapy (nivolumab + ipilimumab) followed by dabrafenib + trametinib at progression is superior to the reverse sequence (2-year OS 71.8% vs. 51.5%; P=0.010).
  • •Uveal melanoma, Distinct biology: GNAQ/GNA11 mutations in 80-90%; 15-GEP/PRAME classifier stratifies metastasis risk; treat HLA-A*02:01+ patients with tebentafusp (bispecific T-cell engager).
  • •ctDNA biomarker, Postoperative detection of circulating tumor DNA confers a 3.42-fold increased risk of relapse (HR 3.42) and can detect molecular recurrence a median 128 days before radiographic progression.
  • •Lactate dehydrogenase (LDH), Elevated serum LDH (>ULN) is an independent negative prognostic factor in stage IV melanoma and shifts M1a-M1c to a higher-risk substage; also incorporated into the Lung Immune Prognostic Index (LIPI).

Deep Dive — Evidence Details

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