Metastatic melanoma
Also known as metastatic malignant melanoma.
Recent clinical, regulatory, research and industry developments relating to this disease.
What's happening now
An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.
- 5 clinical trials expected to report results, the earliest in Q4 2027.
- Q4 2027A Randomized Phase III Trial of the Duration of Anti-PD-1 Therapy in Metastatic Melanoma
- Q1 2028A Phase 3, Multicenter, Randomized, Open-label, Parallel Group, Treatment Study to Assess the Efficacy and Safety of the Lifileucel (LN-144, Autologous Tumor Infiltrating Lymphocytes [TIL]) Regimen in Combination With Pembrolizumab Compared With Pembrolizumab Monotherapy in Participants With Untreated, Unresectable or Metastatic Melanoma
- Q2 2028A Phase II Study to Evaluate the Safety and Efficacy of Rigosertib (ON 01910) Plus Pembrolizumab in Patients With Metastatic Melanoma Refractory to Immune Checkpoint Blockade
- Q2 2029A Multi-center Trial Evaluating the ctDNA-guided Addition of Ipilimumab to Patients Receiving Nivolumab and Relatlimab for Advanced Melanoma
- Q3 2029A Phase 2, Multicenter, Single-Arm Study of Belvarafenib (HM95573) in Combination With Cobimetinib in Patients With Locally Advanced or Metastatic NRAS-Mutant Melanoma
Clinical MilestonesView all 9Hide
- 2026-06-26A Phase 3, Multicenter, Randomized, Open-label, Parallel Group, Treatment Study to Assess the Efficacy and Safety of the Lifileucel (LN-144, Autologous Tumor Infiltrating Lymphocytes [TIL]) Regimen in Combination With Pembrolizumab Compared With Pembrolizumab Monotherapy in Participants With Untreated, Unresectable or Metastatic MelanomaResults expected Q1 2028
- 2026-06-09A Randomized Phase III Trial of the Duration of Anti-PD-1 Therapy in Metastatic MelanomaResults expected Q4 2027
- 2026-04-27A Phase II Study to Evaluate the Safety and Efficacy of Rigosertib (ON 01910) Plus Pembrolizumab in Patients With Metastatic Melanoma Refractory to Immune Checkpoint BlockadeResults expected Q2 2028
- 2026-04-21A Multi-center Trial Evaluating the ctDNA-guided Addition of Ipilimumab to Patients Receiving Nivolumab and Relatlimab for Advanced MelanomaResults expected Q2 2029
- 2026-03-04A Phase 2, Multicenter, Single-Arm Study of Belvarafenib (HM95573) in Combination With Cobimetinib in Patients With Locally Advanced or Metastatic NRAS-Mutant MelanomaResults expected Q3 2029
- 2026-07-01A Multicenter, Randomized, Double-Blind Phase 3 Study of HBI-8000 Combined With Nivolumab Versus Placebo With Nivolumab in Patients With Unresectable or Metastatic Melanoma Not Previously Treated With PD-1 or PD-L1 InhibitorsPrimary completion
- 2026-03-19Phase II Study of Oral Azacitidine (CC-486) in Combination With Pembrolizumab (MK-3475) in Patients With Metastatic MelanomaCompleted
- 2027-05-01ClinicalPilot Trial of Olaparib in Patients With Unresectable or Metastatic Melanoma With Mutations in BRCA1/2 GenesWithdrawn
- 2026-07-01ClinicalA Multicenter, Randomized, Double-Blind Phase 3 Study of HBI-8000 Combined With Nivolumab Versus Placebo With Nivolumab in Patients With Unresectable or Metastatic Melanoma Not Previously Treated With PD-1 or PD-L1 InhibitorsPrimary completion
- 2026-06-26ClinicalA Phase 3, Multicenter, Randomized, Open-label, Parallel Group, Treatment Study to Assess the Efficacy and Safety of the Lifileucel (LN-144, Autologous Tumor Infiltrating Lymphocytes [TIL]) Regimen in Combination With Pembrolizumab Compared With Pembrolizumab Monotherapy in Participants With Untreated, Unresectable or Metastatic MelanomaResults expected Q1 2028
- 2026-06-09ClinicalA Randomized Phase III Trial of the Duration of Anti-PD-1 Therapy in Metastatic MelanomaResults expected Q4 2027
- 2026-04-27ClinicalA Phase II Study to Evaluate the Safety and Efficacy of Rigosertib (ON 01910) Plus Pembrolizumab in Patients With Metastatic Melanoma Refractory to Immune Checkpoint BlockadeResults expected Q2 2028
- 2026-04-21ClinicalA Multi-center Trial Evaluating the ctDNA-guided Addition of Ipilimumab to Patients Receiving Nivolumab and Relatlimab for Advanced MelanomaResults expected Q2 2029
- 2026-03-19ClinicalPhase II Study of Oral Azacitidine (CC-486) in Combination With Pembrolizumab (MK-3475) in Patients With Metastatic MelanomaCompleted
- 2026-03-04ClinicalA Phase 2, Multicenter, Single-Arm Study of Belvarafenib (HM95573) in Combination With Cobimetinib in Patients With Locally Advanced or Metastatic NRAS-Mutant MelanomaResults expected Q3 2029
- 2026-01-09ClinicalA Phase II Study of Open Label Low Dose Ipilimumab in Combination With Pembrolizumab in Metastatic Melanoma Patients With Brain MetastasesResults posted
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 Opdivo as monotherapy or in combination with ipilimumab is indicated for the tr… (2015)
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)
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.
Associated genes
Genes associated with this disease in the canonical knowledge graph (Open Targets evidence). Number shows the association score.
Disease biology
Proteins whose encoding gene is associated with this disease, reached through the canonical gene→disease graph. Number shows the gene's association score.
Reference
Authoritative identity, definition & identifiers.
metastatic malignant melanoma
- Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
- Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
- Related entities are derived from literature co-mention (studied together) — associative, not causal.