Where melanoma treatment is heading

About 100,000 people in the US are diagnosed with invasive melanoma each year. Most are cured by surgery. For advanced melanoma, immunotherapy turned a disease that killed within a year into one with long-term survivors. The newest step: treatment before surgery, and the first personalized mRNA vaccine to succeed in a phase 3 trial.

• 817studies open or running
• 67phase 3 trials
• 3,900papers published this year
• 40NIH-funded projects

1. Now

   Nov 2026

   A personalized mRNA vaccine worksHappened 42% lower recurrence risk

   Adding intismeran to pembrolizumab after surgery lowered the risk of recurrence or death by 42%.

   42%: lower risk of recurrence or death.

   • INTerpath-001 trial
   • KEYNOTE-942 5-year update

   Immunotherapy before surgeryHappened 83.7% event-free at 1 year

   For stage III, two doses before surgery: 83.7% event-free at a year vs 57.2% with surgery first.

   83.7%: event-free at 12 months, vs 57.2% with surgery first.

   • NADINA trial

   Ten-year survivors of advanced melanomaHappened 71.9 mo median survival

   Nivolumab plus ipilimumab: median survival 71.9 months, and 37% alive at 10 years.

   71.9 mo: median survival with nivolumab plus ipilimumab.

   • CheckMate 067 10-year results

   A tumor-killing virus after immunotherapy failsHappened 32.9% tumors shrank

   RP1 plus nivolumab shrank tumors in 32.9% of people whose melanoma had grown on immunotherapy.

   32.9%: of tumors shrank.

   • IGNYTE trial

2. 6 months

   by May 2027

   Vaccine filingLikely 42% lower recurrence risk

   Full INTerpath-001 data are going to regulators; an FDA decision could follow in 2027.

   42%: lower risk of recurrence or death.

   • INTerpath-001 trial

   A new immunotherapy pairPossible

   Regeneron's fianlimab plus cemiplimab vs pembrolizumab (1,546 people) finished in 2026; results expected.

   • Fianlimab phase 3

3. 12 months

   by Nov 2027

   Targeted pills after surgery for stage IIPossible

   COLUMBUS-AD (815 people) tests encorafenib plus binimetinib for BRAF-mutated stage II melanoma; due March 2027.

   • COLUMBUS-AD

4. 3 years

   by late 2029

   A new kind of immune engagerPossible

   Immunocore's brenetafusp, which targets the PRAME protein, is in a 680-person phase 3 as first treatment; due October 2027.

   • PRISM-MEL-301

5. 5 years

   by late 2031

   Less surgery for lymph nodesLong shot

   An ECOG-ACRIN trial tests whether less invasive procedures can replace standard lymph node surgery; due 2031.

   • ECOG-ACRIN trial

The research paths

Open to join now

• Advanced, untreated, HLA-A*02:01

  Brenetafusp regimen

  Phase 3 · 211 sites

  Locations and eligibility →

• Stage III

  Less invasive lymph node procedures

  Phase 3 · 181 sites

  Locations and eligibility →

See every recruiting Melanoma trial →

When the trials finish

Completion dates the trials registered. Results usually follow 3 to 12 months later.

What just happened

Standard treatment today

• Early (stage I-II)Wide excision, sometimes sentinel lymph node biopsy; pembrolizumab or nivolumab after surgery for high-risk stage IIB-C.
• Stage III, removableImmunotherapy before surgery is increasingly favored; otherwise surgery then a year of immunotherapy (or BRAF/MEK pills).
• AdvancedNivolumab plus ipilimumab or relatlimab, or pembrolizumab; BRAF/MEK pills for BRAF-mutated tumors.
• After immunotherapy failsTIL cell therapy (lifileucel), BRAF/MEK pills, or a clinical trial.

See Melanoma trials recruiting now →