Metastatic melanoma

Summary

Metastatic melanoma (MONDO:0005191) is a cancer and 397 clinical trials. Top therapeutic interventions include trametinib, dacarbazine, and relatlimab. A subtype of melanoma — broader associated-gene and molecular evidence is on the parent page (see Disease family below).

At a glance

• Classification: Cancer
• Clinical trials: 397

Clinical features

No curated clinical features (Orphanet) for this disease.

Identifiers

Disease identifiers

Field	Value
Canonical name	metastatic melanoma
Mondo ID	MONDO:0005191
EFO	EFO:0002617
NCIT	C8925
SNOMED CT	443493003
UMLS	C0278883
MedGen	83002
Is cancer (heuristic)	yes

Also known as: metastatic malignant melanoma · metastatic melanoma

Disease family

This is a subtype of melanoma. Genetic, therapeutic, and trial evidence is largely curated at the broader-term level — see the parent page for the associated-gene cohort and molecular evidence.

Classification path: disease › human disease › disease by etiologic mechanism › cancer or benign tumor › neoplastic disease or syndrome › neoplasm › melanocytic neoplasm › melanoma › metastatic melanoma

Related subtypes (14): scrotum melanoma, amelanotic melanoma, epithelioid cell melanoma, malignant breast melanoma, melanomatosis, cutaneous melanoma, non-cutaneous melanoma, ocular melanoma, spindle cell melanoma, mixed epithelioid and spindle cell melanoma, malignant melanoma of the mucosa, familial melanoma, CDK4 linked melanoma, childhood malignant melanoma

Subtypes (1): ovarian melanoma

Genetics & variants

GWAS landscape

No GWAS associations recorded — common-variant (GWAS) studies don’t cover this disease (typical for Mendelian / rare diseases). See the curated gene cohort and Mendelian overlap below.

Variant details and genetic-evidence tiers

No tiered GWAS variants or ClinVar records for this disease.

Genes & proteins

No associated-gene cohort resolved for this disease. Atlas builds the molecular and therapeutic sections — associated genes, protein families, druggability, pathways, interactions, and drug associations — by aggregating over a disease’s associated genes (resolved via GWAS / GenCC / ClinVar / CIViC), and none resolved here. This is expected for antibody-mediated, autoimmune, or otherwise non-gene-defined conditions; the curated evidence for this disease is its clinical features, GWAS susceptibility, and clinical trials (above).

Function

No pathway enrichment — requires an associated-gene cohort.

Therapeutics

Drugs indicated for this disease

10 approved, 22 in late-stage (phase 3) trials. Disease-direct ChEMBL indications, not inferred from the associated-gene cohort below.

Drug	Development status
Aldesleukin	Approved (phase 4)
Binimetinib	Approved (phase 4)
Dacarbazine	Approved (phase 4)
Encorafenib	Approved (phase 4)
Ipilimumab	Approved (phase 4)
Lifileucel	Approved (phase 4)
Nivolumab	Approved (phase 4)
PEGINTERFERON ALFA-2B	Approved (phase 4)
Pembrolizumab	Approved (phase 4)
Vemurafenib	Approved (phase 4)
Aflibercept	Phase 3 (in late-stage trials)
Atezolizumab	Phase 3 (in late-stage trials)
Bempegaldesleukin	Phase 3 (in late-stage trials)
Carboplatin	Phase 3 (in late-stage trials)
Cisplatin	Phase 3 (in late-stage trials)
Cobimetinib	Phase 3 (in late-stage trials)
Dabrafenib	Phase 3 (in late-stage trials)
Fludarabine	Phase 3 (in late-stage trials)
INTERFERON ALFA-2A	Phase 3 (in late-stage trials)
L19IL2	Phase 3 (in late-stage trials)
Masitinib	Phase 3 (in late-stage trials)
Paclitaxel	Phase 3 (in late-stage trials)
Prolgolimab	Phase 3 (in late-stage trials)
Relatlimab	Phase 3 (in late-stage trials)
Sargramostim	Phase 3 (in late-stage trials)
Temozolomide	Phase 3 (in late-stage trials)
Tilsotolimod	Phase 3 (in late-stage trials)
Toripalimab	Phase 3 (in late-stage trials)
Trametinib	Phase 3 (in late-stage trials)
Tremelimumab	Phase 3 (in late-stage trials)
Tyrosinase	Phase 3 (in late-stage trials)
Vinblastine	Phase 3 (in late-stage trials)

Earlier-phase candidates (phase 2, investigational — efficacy not yet established): Azacitidine, Bevacizumab, Cabozantinib, Dasatinib Anhydrous, Decitabine, Disulfiram, Everolimus, Evofosfamide, Fludarabine Phosphate, Ibrutinib, Imatinib, Infliximab, Metformin, Nilotinib, Niraparib, Olaparib, Paclitaxel Docosahexaenoic Acid, Pelareorep, Pexidartinib, Rituximab, Selinexor, Selumetinib, Sunitinib, Tasisulam, Tilsotolimod Sodium, Troriluzole, Veliparib, Vinorelbine.

Clinical trials & evidence

Clinical trials

Clinical trials: 397.

Phase distribution (across all retrieved trials)

Phase	Trials
PHASE2	134
PHASE1	102
PHASE1/PHASE2	69
Not specified	61
PHASE3	15
PHASE4	9
EARLY_PHASE1	6
PHASE2/PHASE3	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT07405086	PHASE4	RECRUITING	Morning Versus Afternoon Administration of Immunotherapy for the Treatment of Advanced or Metastatic Solid Tumors, The Knight SHIFT Study
NCT07459543	PHASE4	NOT_YET_RECRUITING	A Study To Assess the Safety, and Tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) In Untreated, Unresectable or Metastatic Melanoma Participants In India
NCT07504796	PHASE4	RECRUITING	ctDNA-guided Addition of Ipilimumab to Patients Receiving Nivolumab and Relatlimab
NCT00226473	PHASE4	UNKNOWN	Standard Palliative Care Versus Standard Palliative Care Plus Polychemotherapy in Metastasized Malignant Melanoma
NCT00414765	PHASE4	COMPLETED	Aldesleukin in Participants With Metastatic Renal Cell Carcinoma or Metastatic Melanoma
NCT01683188	PHASE4	TERMINATED	HD IL-2 + Vemurafenib in Patients With BRAF Mutation Positive Metastatic Melanoma
NCT01856023	PHASE4	TERMINATED	HD IL-2 + Ipilimumab in Patients With Metastatic Melanoma
NCT02626065	PHASE4	COMPLETED	Immune Modulation Study in Patients With Metastatic Melanoma Treated With Anti-PD1 Monoclonal Antibodies
NCT03673332	PHASE4	TERMINATED	Elderly Cancer PatIents, Safety and qualiTy of Life Under immunOtheraPies
NCT02224781	PHASE3	ACTIVE_NOT_RECRUITING	Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma
NCT02821013	PHASE3	RECRUITING	Duration of Anti-PD-1 Therapy in Metastatic Melanoma
NCT04674683	PHASE3	ACTIVE_NOT_RECRUITING	Study Comparing Investigational Drug HBI-8000 + Nivolumab vs. Placebo + Nivolumab in Patients With Advanced Melanoma
NCT05155254	PHASE3	ACTIVE_NOT_RECRUITING	IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18)
NCT05727904	PHASE3	RECRUITING	Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.
NCT06500455	PHASE3	RECRUITING	Testing Longer Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With Cancer That Has Spread to the Brain
NCT00395070	PHASE3	COMPLETED	A Phase 3 Pivotal Trial Comparing Allovectin-7® Alone vs Chemotherapy Alone in Patients With Stage 3 or Stage 4 Melanoma
NCT01280565	PHASE3	TERMINATED	Masitinib in Non-Resectable or Metastatic Stage 3/4 Melanoma Carrying a Mutation in the Juxta Membrane Domain of c-Kit
NCT01721746	PHASE3	COMPLETED	A Study to Compare BMS-936558 to the Physician’s Choice of Either Dacarbazine or Carboplatin and Paclitaxel in Advanced Melanoma Patients That Have Progressed Following Anti-CTLA-4 Therapy (CheckMate 037)
NCT01844505	PHASE3	COMPLETED	Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma (CheckMate 067)
NCT02278887	PHASE3	COMPLETED	Study Comparing TIL to Standard Ipilimumab in Patients With Metastatic Melanoma
NCT03430297	PHASE3	COMPLETED	A Randomized, Controlled, Multi-center, Phase III Clinical Study to Investigate Recombinant Humanized PD-1 Monoclonal Antibody Injection (JS001) Versus Dacarbazine as the 1st-line Therapy for Unresectable or Metastatic Melanoma
NCT03445533	PHASE3	TERMINATED	A Study of Tilsotolimod in Combo With Ipilimumab vs Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma
NCT04588246	PHASE3	TERMINATED	Comparing Whole Brain Radiotherapy Using a Technique That Avoids the Hippocampus to Stereotactic Radiosurgery in Patients With Cancer That Has Spread to the Brain and Come Back in Other Areas of the Brain After Earlier Stereotactic Radiosurgery
NCT04695977	PHASE2/PHASE3	TERMINATED	CMP-001 in Combination With Nivolumab Compared to Nivolumab Monotherapy in Subjects With Advanced Melanoma
NCT05783882	PHASE3	UNKNOWN	Prolgolimab 250 mg Q3W in Patients With Unresectable or Metastatic Melanoma
NCT00553618	PHASE2	ACTIVE_NOT_RECRUITING	Adjuvant, Combined Interleukin 2 (Proleukin) and DTIC (Dacarbazine) in High-risk Melanoma Patients
NCT01134614	PHASE2	ACTIVE_NOT_RECRUITING	Ipilimumab With or Without Sargramostim in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
NCT01416831	PHASE2	ACTIVE_NOT_RECRUITING	Comparison of High-dose IL-2 and High-dose IL-2 With Radiation Therapy in Patients With Metastatic Melanoma.
NCT01644591	PHASE2	ACTIVE_NOT_RECRUITING	Stereotactic Radiosurgery in Treating Patients With Greater Than 3 Melanoma Brain Metastases
NCT01989585	PHASE1/PHASE2	ACTIVE_NOT_RECRUITING	Testing the Addition of Navitoclax to the Combination of Dabrafenib and Trametinib in People Who Have BRAF Mutant Melanoma
NCT02581930	PHASE2	ACTIVE_NOT_RECRUITING	Ibrutinib in Treating Patients With Refractory Metastatic Cutaneous Melanoma
NCT02650986	PHASE1/PHASE2	ACTIVE_NOT_RECRUITING	Gene-Modified T Cells With or Without Decitabine in Treating Patients With Advanced Malignancies Expressing NY-ESO-1
NCT02713269	PHASE2	ACTIVE_NOT_RECRUITING	Thermal Ablation and Spine Stereotactic Radiosurgery in Treating Patients With Spine Metastases at Risk for Compressing the Spinal Cord
NCT02910700	PHASE2	ACTIVE_NOT_RECRUITING	Nivolumab With Trametinib and Dabrafenib, or Encorafenib and Binimetinib in Treating Patients With BRAF Mutated Metastatic or Unresectable Stage III-IV Melanoma
NCT03122522	PHASE2	ACTIVE_NOT_RECRUITING	A Study to Evaluate Adaptive Dosing of Ipilimumab and Nivolumab Combination Immunotherapy
NCT03131908	PHASE1/PHASE2	ACTIVE_NOT_RECRUITING	Study of the Selective PI3K-Beta Inhibitor GSK2636771 in Combination With Pembrolizumab in Patients With Metastatic Melanoma and PTEN Loss
NCT03149029	PHASE2	ACTIVE_NOT_RECRUITING	Abbreviated MAPK Targeted Therapy Plus Pembrolizumab in Melanoma
NCT03175432	PHASE2	ACTIVE_NOT_RECRUITING	Bevacizumab and Atezolizumab With or Without Cobimetinib in Treating Patients With Untreated Melanoma Brain Metastases
NCT03474497	PHASE1/PHASE2	ACTIVE_NOT_RECRUITING	UCDCC#272: IL-2, Radiotherapy, and Pembrolizumab in Patients Refractory to Checkpoint Blockade
NCT03611868	PHASE1/PHASE2	ACTIVE_NOT_RECRUITING	A Study of APG-115 in as a Monotherapy or Combination With Pembrolizumab in Patients With Metastatic Melanomas or Advanced Solid Tumors

Drugs tested across these trials (top 30)

Molecule	Max phase	Trials referencing
TRAMETINIB	4	9
DACARBAZINE	4	8
RELATLIMAB	4	7
VEMURAFENIB	4	7
IPILIMUMAB	4	6
NIVOLUMAB	4	6
CISPLATIN	4	4
DABRAFENIB MESYLATE	4	3
ALDESLEUKIN	4	2
SUNITINIB	4	2
CALCITRIOL	4	1
FLUDARABINE PHOSPHATE	4	1
MEMANTINE	4	1
RAMUCIRUMAB	4	1
TEMOZOLOMIDE	4	1
VINDESINE	4	1
VINORELBINE	4	1
PACLITAXEL DOCOSAHEXAENOIC ACID	3	2
FLUDARABINE	3	1
MASITINIB	3	1
PROLGOLIMAB	3	1
TASISULAM	3	1
TYROSINASE	3	1
MELANOMA-ASSOCIATED ANTIGEN 3	2	2
RAF-265	2	1
CHEMBL1574179	0	9
CHEMBL3415553	0	7
CHEMBL4209555	0	7
PLX-4720	0	7
CHEMBL4228794	0	1