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Melanoma (cutaneous)

United States

  • lifileucel (Amtagvi)[1]FDA-approved (accelerated approval)unresectable or metastatic melanoma, adults, after prior PD-1 blockade; if BRAF V600-positive, after a BRAF inhibitor with or without a MEK inhibitor · Accelerated approval; prescribing information includes a boxed warning. Not indicated for untreated melanoma.
  • encorafenib (Braftovi) + binimetinib (Mektovi)[2]FDA-approvedunresectable or metastatic melanoma with a BRAF V600E or V600K mutation detected by an FDA-approved test · Not indicated for wild-type BRAF melanoma; confirm BRAF V600E/V600K mutation before initiation.
  • dabrafenib (Tafinlar) plus trametinib (Mekinist)[13]FDA-approvedBRAF V600E or BRAF V600K mutation, detected by an FDA-approved test; BRAF V600E/V600K unresectable or metastatic melanoma; adjuvant treatment after complete resection when nodal involvement is present. · The Tafinlar label says to confirm BRAF mutation status before treatment and notes the medicine is not indicated for wild-type BRAF tumors. This entry does not establish sequencing versus immunotherapy or payer coverage. Confidence/conflicts: High for U.S. label indication and biomarker requirement. No conflict identified.
  • entrectinib (Rozlytrek)[14]FDA-approvedNTRK gene fusion; Metastatic or unresectable NTRK fusion-positive melanoma after standard treatment and with no other effective option; pediatric scope later expanded by FDA per the NCI update note. · This is an NCI summary of FDA approval rather than a full label page. The approval is tumor-agnostic, not melanoma-labeled, so melanoma use still depends on confirmed NTRK fusion and case-specific eligibility. Confidence/conflicts: High for the summarized U.S. approval scope and later pediatric expansion note. No conflict found; melanoma applicability is inferred from the tissue-agnostic approval.
  • larotrectinib (Vitrakvi)[15]FDA accelerated approvalNTRK gene fusion without a known acquired resistance mutation; Metastatic or surgery-morbid NTRK fusion-positive melanoma in adults or children when no satisfactory alternative treatment exists or after progression following treatment. · The FDA notice is tissue-agnostic rather than melanoma-specific and describes accelerated approval. The source does not imply that unselected melanoma qualifies; confirmed NTRK fusion status and clinical fit are required. Confidence/conflicts: High for U.S. approval scope and criteria. No conflict found; melanoma applicability is an inference from the tissue-agnostic label plus confirmed NTRK fusion.
  • nivolumab (Opdivo)[16]Approvednot biomarker-selected in the fetched label; Unresectable or metastatic melanoma; adjuvant treatment after complete resection of Stage IIB, IIC, III, or IV melanoma. · The label establishes U.S. indication scope only. It does not establish payer coverage, sequencing after prior PD-1 treatment, or suitability for an individual case. Confidence/conflicts: High for U.S. label indication. No conflict identified.
  • nivolumab + relatlimab-rmbw (Opdualag)[17]FDA-approvedunresectable or metastatic melanoma; FDA page describes RELATIVITY-047 in previously untreated metastatic or unresectable Stage III or IV melanoma. · FDA page states RELATIVITY-047 excluded patients with active autoimmune disease, certain systemic immunosuppression needs, uveal melanoma, and active or untreated brain or leptomeningeal metastases.
  • nivolumab and hyaluronidase-nvhy (Opdivo Qvantig)[18]Approvednot biomarker-selected in the fetched label; Subcutaneous formulation context for unresectable/metastatic melanoma and adjuvant melanoma; label includes monotherapy or post-intravenous nivolumab/ipilimumab contexts rather than combination use with ipilimumab. · This entry records formulation/route availability and label limits, not a recommendation to switch formulation. The label does not establish insurance coverage or infusion-center policies. Confidence/conflicts: High for U.S. label formulation and limitation language. No conflict identified.
  • pembrolizumab (Keytruda)[19]Approvednot biomarker-selected in the fetched label; Unresectable or metastatic melanoma; adjuvant treatment after complete resection of Stage IIB, IIC, or III melanoma. · The label confirms U.S. indication scope only. It does not imply that pembrolizumab is preferred over other PD-1 or checkpoint options, and it does not establish coverage. Confidence/conflicts: High for U.S. label indication. No conflict identified.
  • repotrectinib (Augtyro)[20]FDA accelerated approvalNTRK gene fusion; Adult and pediatric age 12+ locally advanced, metastatic, or surgery-morbid NTRK fusion-positive melanoma after progression or when no satisfactory alternative therapy exists. · This is an accelerated approval and not a melanoma-specific label. The trial summary on the FDA page excluded patients with symptomatic brain metastases, so the source should not be over-read as addressing every melanoma CNS scenario. Confidence/conflicts: High for U.S. approval scope and age criteria. No conflict found; melanoma applicability is inferred from the tissue-agnostic approval.
  • talimogene laherparepvec (Imlygic)[21]FDA-approvednot biomarker-selected in the fetched label; Local treatment of unresectable cutaneous, subcutaneous, and nodal melanoma lesions recurrent after initial surgery. · DailyMed states limitations of use: Imlygic has not been shown to improve overall survival or have an effect on visceral metastases. The entry should not be generalized to visceral metastatic melanoma. Confidence/conflicts: High for U.S. approval and label limits. No conflict identified.

European Union

  • nivolumab + relatlimab (Opdualag)[6]EMA-authorised (central marketing authorisation)first-line advanced unresectable or metastatic melanoma, adults and adolescents 12 years and older, tumour-cell PD-L1 expression less than 1% · Central EU authorisation only (under additional monitoring); member-state reimbursement (e.g. Germany/France) not verified.
  • binimetinib (Mektovi) + encorafenib (Braftovi)[7]EMA-authorised (central marketing authorisation)unresectable or metastatic melanoma with a BRAF V600 mutation, adults · Central EU authorisation only; member-state reimbursement (e.g. Germany/France) not verified.
  • lifileucel (Amtagvi)[8]EMA: not authorised (marketing authorisation application withdrawn 2025-07-22)intended use was unresectable or metastatic melanoma in adults after prior PD-1 blockade (and, if BRAF V600-mutated, a BRAF inhibitor with or without a MEK inhibitor) · Application withdrawn by Iovance Biotherapeutics B.V.; EMA's provisional opinion was that Amtagvi could not have been authorised. Not an available EU treatment option.
  • Dabrafenib (Tafinlar) plus trametinib (Mekinist)[22]ApprovedBRAF V600 mutation-positive melanoma; Adjuvant treatment of adult stage III BRAF V600 mutation-positive melanoma after complete resection. · Source is French HAS material and should receive human-language review before patient-facing reuse. It documents reimbursement opinion/clinical benefit, not individual eligibility. Confidence/conflicts: High for HAS reimbursement context; no conflict found. French-language source requires human review. Primary source not in English. English summary pending human review — confirm exact wording with your care team.
  • Dabrafenib (Tafinlar) plus trametinib (Mekinist)[23]ApprovedBRAF V600 mutation-positive melanoma; Adjuvant treatment of adult stage III BRAF V600 mutation-positive melanoma after complete resection. · IQWiG is assessment context, not a full prescribing or reimbursement implementation source. Final G-BA decision documents and current local payer rules remain source-pending. Confidence/conflicts: Medium-high for IQWiG assessment context; final G-BA decision extraction remains source-pending. No conflict found.
  • Dabrafenib (Tafinlar) with trametinib (Mekinist)[24]ApprovedBRAF V600 mutation-positive melanoma; Adult unresectable or metastatic melanoma with BRAF V600 mutation. · Source is German G-BA material and should receive human-language review before patient-facing reuse. G-BA benefit assessment does not by itself specify an individual patient’s coverage or center access. Confidence/conflicts: High for G-BA procedure and indication context; German-language source requires human review. No conflict found. Primary source not in English. English summary pending human review — confirm exact wording with your care team.
  • Encorafenib (Braftovi) plus binimetinib (Mektovi)[25]ApprovedBRAF V600 mutation-positive melanoma; Adult unresectable or metastatic melanoma with BRAF V600 mutation. · HAS source is French/English mixed and should receive human-language review before patient-facing reuse. The entry does not establish sequencing or superiority for an individual case. Confidence/conflicts: High for HAS reimbursement context; French-language source requires human review. No conflict found. Primary source not in English. English summary pending human review — confirm exact wording with your care team.
  • entrectinib (Rozlytrek)[26]EMA authorisedNTRK gene fusion; Metastatic or surgery-morbid NTRK fusion-positive melanoma, including pediatric age scope from 1 month, when prior same-class treatment has not been given and other treatments are not suitable. · The source is tumor-agnostic and conditional, not melanoma-specific. It also includes a prior same-class-treatment restriction that differs from other TRK inhibitor pages and should be checked carefully against the treating-country context. Confidence/conflicts: High for EU tumour-agnostic authorisation scope and prior-NTRK-inhibitor caveat. No conflict found; melanoma applicability is inferred from the tissue-agnostic EMA indication.
  • larotrectinib (Vitrakvi)[27]EMA authorisedNTRK gene fusion; Advanced, metastatic, or non-surgically-manageable NTRK fusion-positive melanoma with no satisfactory alternative treatment. · EMA's authorisation is tumor-agnostic and conditional, not melanoma-specific. The source does not establish member-state reimbursement or national access for melanoma. Confidence/conflicts: High for EU tumour-agnostic authorisation scope. No conflict found; melanoma applicability is inferred from the tissue-agnostic EMA indication.
  • nivolumab plus relatlimab (Opdualag)[28]Approvedtumour-cell PD-L1 expression below 1%; no active brain metastasis in the reimbursed HAS population; First-line advanced unresectable or metastatic melanoma in the HAS-defined PD-L1 below 1%, ECOG 0-1, no-active-brain-metastasis population. · Source is in French; human-language review is needed before patient-facing reuse. The HAS page notes that the place of Opdualag relative to nivolumab-ipilimumab and pembrolizumab monotherapy cannot be specified because of lack of comparative data. Confidence/conflicts: High for France HAS reimbursement-perimeter claim; language review required. No conflict identified. Primary source not in English. English summary pending human review — confirm exact wording with your care team.
  • nivolumab plus relatlimab (Opdualag)[29]Approvedtumour-cell PD-L1 expression below 1%; BRAF V600 status affects comparator options listed by G-BA; First-line advanced unresectable or metastatic melanoma, PD-L1 below 1%, age 12 years and older; G-BA assessment in progress. · Source is in German; human-language review is needed before patient-facing reuse. The G-BA page records an assessment process and product-information indication; it does not provide a final 2026 added-benefit decision yet. Confidence/conflicts: Medium-high for G-BA process and indication scope; final benefit decision pending and language review required. No conflict identified. Primary source not in English. English summary pending human review — confirm exact wording with your care team.

United Kingdom

  • nivolumab + relatlimab (Opdualag)[3]NICE-recommended on the NHS (England and Wales)untreated advanced unresectable or metastatic melanoma, people 12 years and over · Recommended only with a 2-year stopping rule (or earlier on progression) and under the commercial arrangement; NHS England/Wales context, not a universal UK availability statement.
  • nivolumab (Opdivo) + ipilimumab (Yervoy)[4]NICE-recommended on the NHS (England and Wales)advanced unresectable or metastatic melanoma, adults · Recommended within marketing authorisation, conditional on the agreed patient access scheme discount for ipilimumab.
  • encorafenib (Braftovi) + binimetinib (Mektovi)[5]NICE-recommended on the NHS (England and Wales)unresectable or metastatic BRAF V600 mutation-positive melanoma, adults · Recommended within marketing authorisation, only if both medicines are provided under the commercial arrangements.
  • encorafenib (Braftovi) + binimetinib (Mektovi)[30]ApprovedBRAF V600 mutation-positive; unresectable or metastatic BRAF V600 mutation-positive melanoma in adults. · Recommendation is conditional on commercial arrangements. NICE identifies current comparators including dabrafenib with trametinib and BRAF inhibitor monotherapy but does not replace individualized clinical decision-making.
  • nivolumab (Opdivo) + ipilimumab (Yervoy)[31]Approvedadvanced unresectable or metastatic melanoma in adults. · Recommendation is conditional on marketing authorisation and the patient access scheme discount; the source is a NICE appraisal rather than a dosing guide.
  • nivolumab + relatlimab (Opdualag)[32]NICE recommendeduntreated advanced unresectable or metastatic melanoma. · NICE recommendation includes a 2-year stopping rule or earlier stop if progression occurs, plus commercial arrangement requirement. NICE notes uncertainty in clinical-effectiveness evidence and indirect comparisons.

Japan

  • Dabrafenib (Tafinlar) plus trametinib (Mekinist)[33]PMDA-approved (Japan)BRAF mutation-positive melanoma; PMDA report states BRAF mutation confirmation should be performed by experienced pathology/testing laboratory using an approved in vitro diagnostic or equivalent.; Malignant melanoma with BRAF mutations; PMDA review discusses unresectable malignant melanoma and adjuvant treatment following complete resection. · This is approval-context PMDA review material, not a reimbursement or current package-insert extraction. BRAF testing requirements and local access should be confirmed with the treating institution. Confidence/conflicts: Medium-high for PMDA approval context; live reimbursement/source details remain a gap. No conflict found.
  • Encorafenib (Braftovi) plus binimetinib (Mektovi)[34]PMDA-approved (Japan)BRAF gene mutation, with PMDA discussion referencing BRAF V600E or V600K mutation in the pivotal global phase 3 study context.; Unresectable malignant melanoma with BRAF gene mutation; PMDA review references treatment-naive BRAF V600E or V600K population in the pivotal study context. · This is PMDA review-report evidence and does not provide current reimbursement or all live package-insert restrictions. Eye, cardiac, hepatic, muscle, skin-malignancy, hypertension, bleeding, and hand-foot syndrome safety monitoring were flagged for post-marketing attention in the review. Confidence/conflicts: Medium-high for PMDA approval context; current reimbursement and label details remain source-pending. No conflict found.
  • Nivolumab (Opdivo)[35]PMDA-approved (Japan)Not biomarker-selected in the fetched PMDA nivolumab melanoma indication context.; Unresectable malignant melanoma; later PMDA review material references unresectable malignant melanoma as an approved indication. · This is a PMDA review-report approval-context source, not a live Japanese package-insert or reimbursement rule. Current label wording, reimbursement, and local sequencing should be confirmed from Japanese-language official sources before patient-facing use. Confidence/conflicts: Medium-high for Japan approval history; current-label and reimbursement details remain source-pending. No conflict found.
  • Pembrolizumab (Keytruda)[36]PMDA-approved (Japan)Not biomarker-selected in the fetched PMDA pembrolizumab melanoma context.; Adult unresectable or metastatic melanoma and adjuvant treatment of adult patients with melanoma, as reflected in the fetched PMDA-hosted Keytruda document; PMDA review also discusses resected malignant melanoma after Study 054. · The fetched PMDA-hosted material includes dosing tables that are not reproduced here as patient guidance. Current Japanese package insert, reimbursement, and specialist criteria should be confirmed locally. Confidence/conflicts: Medium-high for PMDA approval context; current reimbursement and exact live label require confirmation. No conflict found.

China

  • tunlametinib (科露平 / HL-085)[9]NMPA: conditionally approved (priority review)advanced NRAS-mutant melanoma after anti–PD-1/PD-L1 treatment failure · Conditional (accelerated) approval, China only; a selective MEK1/2 inhibitor. Availability outside China should not be assumed.
  • Pembrolizumab (Keytruda)[37]ApprovedNot biomarker-selected in the fetched China approval notice.; Adult unresectable or metastatic melanoma after one prior systemic line, as stated in the fetched company approval notice. · Source is a manufacturer announcement, not a primary NMPA label. Current NMPA label, reimbursement, and hospital access should be confirmed from official Chinese sources before patient-facing reuse. Confidence/conflicts: Medium; manufacturer source directly states CNDA approval but primary NMPA label remains source-pending. No conflict found.
  • Toripalimab (Tuoyi; JS001)[38]NMPA-approved (China)Not biomarker-selected in the fetched Junshi first-line approval notice.; First-line systemic treatment for unresectable or metastatic melanoma, as stated in the Junshi NMPA approval announcement. · Approval statement is from the manufacturer, supported by a fetched registry record for the pivotal China study; current official NMPA label and reimbursement details remain source-pending. Confidence/conflicts: Medium-high for manufacturer-announced NMPA approval plus registry support; primary label and reimbursement source-pending. No conflict found.
  • Tunlametinib (HL-085)임상시험 · NCT05217303[39]NMPA-approved (China)NRAS-mutated advanced melanoma after prior anti-PD-1/PD-L1 therapy; Advanced NRAS-mutated melanoma after anti-PD-1/PD-L1 therapy, as stated by the fetched news source. · Approval source is oncology news referencing developer/NMPA approval, not the primary NMPA label. Current official label, commercial availability, and reimbursement in China remain source-pending. Confidence/conflicts: Medium; trial registry supports the studied population but primary NMPA label remains source-pending. No conflict found.

Russia

  • prolgolimab (Forteca; Prolgo in trial publication)[40]EMA authorisedfirst-line unresectable or metastatic melanoma, as reported in the Frontiers article. · Approval statement is attributed to a peer-reviewed article and company news release, not a fetched Russian regulator page. Frontiers also describes FLAT as a study supporting a fixed-dose regimen, not as a substitute for regulator label review. Confidence/conflicts: medium-high for reported Russian approval and setting; no conflict found. Confidence is not high because Russian regulator primary-source verification was not obtained this cycle. A secondary/company source is present; the cited primary source is the regulator/HTA/official record. Availability/reimbursement outside the approving regulator not established.

Uveal melanoma

United States

  • Surgery (resection and enucleation)[12]NCI PDQ: listed among standard treatment optionsprimary intraocular/uveal melanoma; enucleation described when vision cannot be saved and the tumor is large, has spread to the optic nerve, or causes high intraocular pressure · PDQ is an information summary, not a patient-specific eligibility rule; choice depends on tumor size and extent.
  • Radiation therapy (plaque radiation therapy; external-beam charged-particle radiation therapy)[12]NCI PDQ: listed among standard treatment optionslocal treatment for intraocular/uveal melanoma, including medium-sized choroidal melanoma · Charged-particle radiation is offered at specialized referral centers; options differ by tumor extent and clinical factors.

European Union

  • tebentafusp (Kimmtrak)[10]EMA-authorised (central marketing authorisation)uveal melanoma that cannot be removed by surgery or has spread, adults · Central EU authorisation only; must be given where cytokine release syndrome can be managed; member-state reimbursement (e.g. Germany/France) not verified.

United Kingdom

  • tebentafusp (Kimmtrak)[11]NICE-recommended on the NHS (England and Wales)HLA-A*02:01-positive unresectable or metastatic uveal melanoma, adults · Recommended within marketing authorisation, only under the commercial arrangement; NHS access appraisal, not a universal UK availability statement.

출처

  1. FDA — accelerated approval notice (lifileucel) · FDA regulator approval notice
  2. FDA — Braftovi (encorafenib) drug label · FDA official drug label
  3. NICE TA950 · NICE health technology appraisal
  4. NICE TA400 · NICE health technology appraisal
  5. NICE TA562 · NICE health technology appraisal
  6. EMA EPAR — Opdualag · EMA EPAR
  7. EMA EPAR — Mektovi · EMA EPAR
  8. EMA EPAR — Amtagvi (withdrawn application) · EMA EPAR (withdrawn application)
  9. NMPA — Tunlametinib Capsules approved with conditions · NMPA regulator approval notice
  10. EMA EPAR — Kimmtrak · EMA EPAR
  11. NICE TA1027 · NICE health technology appraisal
  12. NCI PDQ — Intraocular (Uveal) Melanoma Treatment · NCI PDQ
  13. DailyMed / U.S. National Library of Medicine — official U.S. drug label · official U.S. drug label
  14. National Cancer Institute — national cancer agency FDA approval summary · national cancer agency FDA approval summary
  15. U.S. Food and Drug Administration — regulator approval notice · regulator approval notice
  16. DailyMed / U.S. National Library of Medicine — official U.S. drug label · official U.S. drug label
  17. U.S. Food and Drug Administration — regulator approval notice · regulator approval notice
  18. DailyMed / U.S. National Library of Medicine — official U.S. drug label · official U.S. drug label
  19. DailyMed / U.S. National Library of Medicine — official U.S. drug label · official U.S. drug label
  20. U.S. Food and Drug Administration — regulator approval notice · regulator approval notice
  21. DailyMed / U.S. National Library of Medicine — official U.S. drug label · official U.S. drug label
  22. Haute Autorite de Sante (HAS) — HTA reimbursement opinion · HTA reimbursement opinion
  23. Institute for Quality and Efficiency in Health Care (IQWiG) — benefit assessment project page · benefit assessment project page
  24. Gemeinsamer Bundesausschuss (G-BA) — AMNOG benefit-assessment procedure page · AMNOG benefit-assessment procedure page
  25. Haute Autorite de Sante (HAS) — HTA reimbursement history / medicine page · HTA reimbursement history / medicine page
  26. European Medicines Agency — regulator product page / EPAR · regulator product page / EPAR
  27. European Medicines Agency — regulator product page / EPAR · regulator product page / EPAR
  28. Haute Autorite de Sante (HAS) — HTA reimbursement opinion · HTA reimbursement opinion
  29. Gemeinsamer Bundesausschuss (G-BA) — AMNOG benefit-assessment procedure page · AMNOG benefit-assessment procedure page
  30. National Institute for Health and Care Excellence (NICE) — health technology appraisal / guideline · health technology appraisal / guideline
  31. National Institute for Health and Care Excellence (NICE) — health technology appraisal / guideline · health technology appraisal / guideline
  32. National Institute for Health and Care Excellence (NICE) — health technology appraisal / guideline · health technology appraisal / guideline
  33. Pharmaceuticals and Medical Devices Agency (PMDA) — regulator review report · regulator review report
  34. Pharmaceuticals and Medical Devices Agency (PMDA) — regulator review report · regulator review report
  35. Pharmaceuticals and Medical Devices Agency (PMDA) — regulator review report · regulator review report
  36. Pharmaceuticals and Medical Devices Agency (PMDA) — PMDA-hosted product information / review material · PMDA-hosted product information / review material
  37. Merck/MSD — manufacturer regulatory approval announcement · manufacturer regulatory approval announcement
  38. Junshi Biosciences — manufacturer NMPA approval announcement · manufacturer NMPA approval announcement
  39. ClinicalTrials.gov — clinical-trial registry · clinical-trial registry
  40. Frontiers in Oncology — peer-reviewed literature · peer-reviewed literature

위 내용은 공식 규제·접근 상태일 뿐, 의학적 조언이나 추천이 아니고, 적격성을 판단하지도 않습니다. 어떤 선택지가 적합한지는 환자의 상황과 종양내과 팀에 달려 있습니다. 규제 상태는 바뀔 수 있으니 표시된 출처에서 확인하세요. 일부 선택지는 신속·조건부 승인 상태로, 적응증이 축소되거나 철회될 수 있습니다. 임상 세부 내용은 영문이 정본입니다. 최종 확인 2026.06.

승인된 치료 너머

임상시험 및 신흥 선택지

환자가 거주하는 국가에서 아직 승인된 표준 치료가 아닌 선택지입니다 — 연구, 임상시험, 허가 외 사용, 담당 종양내과 의사가 먼저 언급하지 않을 수 있는 초기 근거입니다. 각 항목은 근거의 강도에 따라 구분됩니다. 여기에 실린 항목은 조사하고 의료진과 상의할 정보일 뿐, 효과가 입증되었거나 안전하거나 현재 이용 가능하다는 의미가 아닙니다. 임상 세부 내용은 영문이 정본입니다.

임상시험 진행 중

  • belvarafenib + cobimetinib임상시험 · NCT07449754임상시험Phase II trial (NCT07449754)Korea · locally advanced or metastatic NRAS-mutant melanoma · Recruiting Phase 2; investigational, not an approval. ClinicalTrials.gov — NCT07449754
  • naporafenib (ERAS-254) + trametinib임상시험 · NCT06346067임상시험Phase III trial (NCT06346067)advanced/metastatic NRAS-mutant melanoma after anti-PD-1/PD-L1 (SEACRAFT-2) · Active, not recruiting; multinational Phase 3. ClinicalTrials.gov — NCT06346067
  • binimetinib + imatinib임상시험 · NCT04598009임상시험Phase II trial (NCT04598009)United States · unresectable stage III-IV KIT-mutant melanoma · Recruiting Phase 2 (UCSF); investigational combination. ClinicalTrials.gov — NCT04598009
  • IMA203 (ACTengine TCR-T cell therapy)임상시험 · NCT06743126임상시험Phase III trial (NCT06743126)previously treated unresectable/metastatic cutaneous melanoma (SUPRAME) · Recruiting Phase 3; investigational cell therapy vs investigator choice. ClinicalTrials.gov — NCT06743126
  • Belvarafenib alone, belvarafenib plus cobimetinib, or belvarafenib plus cobimetinib plus nivolumab임상시험 · NCT04835805임상시험Trial only (NCT04835805)United States · NRAS-mutant advanced melanoma after anti-PD-1/PD-L1 therapy; NRAS-mutant advanced melanoma after anti-PD-1/PD-L1 therapy. · Active-not-recruiting means this is not currently a new-enrollment option in the registry; it is included for landscape awareness and possible site/team discussion only. It is not a regulatory approval or routine access claim. Confidence/conflicts: High for registry status and geography; caveat that the study is active but not recruiting. No conflict found. ClinicalTrials.gov — clinical-trial registry
  • Binimetinib (Mektovi) plus imatinib (Gleevec or generic imatinib)임상시험 · NCT04598009임상시험Trial only (NCT04598009)United States · KIT-mutant melanoma; Unresectable stage III-IV KIT-mutant melanoma. · Trial-only access; the combination should not be treated as routine approval for KIT-mutant melanoma. The registry does not establish that every KIT alteration is eligible or sensitive to treatment. Confidence/conflicts: High for registry status and KIT-mutant melanoma scope. No conflict found. ClinicalTrials.gov — clinical-trial registry
  • Defactinib plus avutometinib, with or without encorafenib임상시험 · NCT06194929임상시험Trial only (NCT06194929)United States · RAS, BRAF, or NF1 mutation, or triple-wildtype status; BRAF V600E/K cohort for encorafenib-containing arm; Advanced cutaneous melanoma with radiographically confirmed brain metastases after at least one line of prior systemic immunotherapy; registry cohorts include RAS/BRAF/NF1/triple-wildtype and BRAF V600E/K settings. · Investigational trial listing only. Registry eligibility includes lesion and prior-therapy requirements; it does not imply individual eligibility or routine access. Confidence/conflicts: High for registry status and U.S. locations; no conflict found. ClinicalTrials.gov — clinical-trial registry
  • IMA203 ACTengine cell therapy versus investigator's choice treatment임상시험 · NCT06743126임상시험Trial only (NCT06743126)United States · PRAME-targeted cell-therapy context implied by IMA203/ACTengine platform; exact antigen eligibility requires trial confirmation.; Previously treated unresectable or metastatic cutaneous melanoma. · This is investigational cell-therapy trial access and not routine approval. Comparator options listed in the registry reflect investigator's choice within the trial, not a country-by-country availability statement. Confidence/conflicts: High for recruiting status and geography; antigen/testing details require trial-team confirmation. No conflict found. ClinicalTrials.gov — clinical-trial registry
  • KIN-2787, alone or with binimetinib임상시험 · NCT04913285임상시험Trial only (NCT04913285)United States · BRAF class I/II/III alteration or NRAS-mutated melanoma; Metastatic or advanced solid tumor with known BRAF alteration, or melanoma with NRAS mutation, as confirmed by genomic analysis of tumor tissue or ctDNA. · Active-not-recruiting registry listing only; it does not establish routine access or approval. The trial includes solid tumors beyond melanoma, so melanoma relevance is biomarker-defined rather than melanoma-exclusive. Confidence/conflicts: High for registry status and country list; no conflict found. ClinicalTrials.gov — clinical-trial registry
  • Mirdametinib임상시험 · NCT07237100임상시험Trial only (NCT07237100)United States · NF1 mutation; Advanced NF1-mutant melanoma whose disease has progressed while on or after previous immunotherapy; registry eligibility requires prior anti-PD-1/PD-L1 and anti-CTLA-4 and/or anti-LAG3 unless standard checkpoint inhibitors are not clinically indicated or suitable. · Investigational registry listing only; it does not establish routine access, approval, benefit, or eligibility for any individual. Confidence/conflicts: High for registry status and setting; no conflict found. ClinicalTrials.gov — clinical-trial registry
  • Naporafenib (ERAS-254) plus trametinib versus physician's choice of dacarbazine, temozolomide, or trametinib monotherapy임상시험 · NCT06346067임상시험Trial only (NCT06346067)United States · NRAS mutation; Previously treated unresectable or metastatic NRAS-mutant cutaneous melanoma after anti-PD-1/L1-based therapy with documented progression as described in registry eligibility. · Active-not-recruiting status means the registry does not indicate new enrollment. Trial comparator options do not establish preferred routine treatment in any country. Confidence/conflicts: High for registry status and country list; no conflict found. ClinicalTrials.gov — clinical-trial registry
  • RLY-8161임상시험 · NCT07584226임상시험Trial only (NCT07584226)United States · NRAS mutations including G12D, G13R, G13D, G12V, Q61R, Q61K, Q61L, and Q61H listed in the registry conditions; Advanced NRAS-mutant melanoma and other advanced NRAS-mutant solid tumors. · First-in-human investigational trial; no routine access or efficacy claim is implied. Mutation subtype, prior therapy, performance status, and other trial criteria require direct study-team confirmation. Confidence/conflicts: High for registry status, intervention, biomarker, and U.S. recruiting geography. No conflict found. ClinicalTrials.gov — clinical-trial registry
  • AZD6750, a CD8-guided IL-2 agent, alone or with other anticancer agents including rilvegostomig임상시험 · NCT07115043임상시험Trial only (NCT07115043)Japan · Locally advanced or metastatic selected solid tumors, including melanoma, after adequate standard of care as described in the registry module. · Early-phase investigational trial listing only; melanoma-specific cohort details and routine country access are not established by this registry cell. Confidence/conflicts: High for registry status and country list; medium for melanoma-specific applicability because this is a multi-tumor study. ClinicalTrials.gov — clinical-trial registry
  • HBI-8000 plus nivolumab versus placebo plus nivolumab임상시험 · NCT04674683임상시험Trial only (NCT04674683)Japan · BRAF V600 status and PD-L1 expression collected for registry stratification/testing; Non-uveal stage III unresectable or stage IV melanoma not previously treated with PD-1 or PD-L1 inhibitors; registry also describes a separate open-label cohort for new/progressive brain metastasis or adolescents. · Active-not-recruiting trial listing only; it does not establish routine access or approval for HBI-8000 in Japan, South Korea, or other listed countries. Confidence/conflicts: High for registry status and country list; no conflict found. ClinicalTrials.gov — clinical-trial registry
  • OX40 agonist PF-04518600 alone or with 4-1BB agonist PF-05082566임상시험 · NCT02315066임상시험Trial only (NCT02315066)Japan · Selected locally advanced or metastatic cancers; melanoma cohort language includes ocular melanoma with advanced/metastatic disease and cutaneous/acral melanoma after checkpoint inhibitor context. · Completed early-phase trial only; it does not establish approved availability of PF-04518600 or PF-05082566 in Japan or elsewhere. Confidence/conflicts: Medium-high for registry trial cell; no conflict found. Completed status limits current access relevance. ClinicalTrials.gov — clinical-trial registry
  • Pembrolizumab plus lenvatinib; boron neutron capture therapy (BNCT) using CICS-1 and SPM-011임상시험 · NCT06673628임상시험Trial only (NCT06673628)Japan · No biomarker required by fetched records; Unresectable cutaneous angiosarcoma for pembrolizumab/lenvatinib; unresectable angiosarcoma or malignant melanoma/angiosarcoma BNCT context. · Registry records do not establish PMDA approval, reimbursement, routine access, active enrollment beyond stated status, or individual eligibility. Confidence/conflicts: High for registry facts; no local approval claim made. ClinicalTrials.gov — clinical-trial registry
  • Belvarafenib plus cobimetinib임상시험 · NCT07449754임상시험Trial only (NCT07449754)Korea · NRAS mutation-positive melanoma; Locally advanced or metastatic NRAS-mutant melanoma. · Trial-only access; belvarafenib is investigational in this context. Site-level recruiting status varies and must be confirmed with the trial team. This is not a regulator approval or reimbursement finding. Confidence/conflicts: High for registry status, biomarker, intervention, and South Korea geography. No conflict found. ClinicalTrials.gov — clinical-trial registry
  • Dabrafenib (Tafinlar) plus trametinib (Mekinist)임상시험 · NCT02083354임상시험Trial only (NCT02083354)China · BRAF V600 mutation-positive melanoma; BRAF V600 mutation-positive unresectable or metastatic acral lentiginous or cutaneous melanoma. · Completed trial evidence does not establish current access, approval, or reimbursement in any listed country. It is included for East Asia evidence/geography context and should be paired with current regulator/payer sources before surfaced as an available option. Confidence/conflicts: High for completed registry geography and trial population; current access not established. No conflict found. ClinicalTrials.gov — clinical-trial registry
  • EB-DTKN-401 allogeneic dual-target CSPG4/GD2 CAR-NK cells after lymphodepleting chemotherapy with fludarabine and cyclophosphamide임상시험 · NCT07627698임상시험Trial only (NCT07627698)China · CSPG4 and/or GD2 expression by central testing; Disease progressed after standard therapy, intolerance to standard therapy, or no remaining standard option expected to provide meaningful benefit; uveal melanoma registry eligibility references prior tebentafusp if HLA-A*02:01-positive and eligible, or documented unsuitability/unavailability plus at least one prior systemic therapy. · Investigational cell-therapy registry listing only; it does not establish NMPA approval, routine access, efficacy, or individual eligibility. Confidence/conflicts: High for registry status and China site; no conflict found. ClinicalTrials.gov — clinical-trial registry
  • FCN-159임상시험 · NCT03932253임상시험Trial only (NCT03932253)China · NRAS aberration or NRAS mutation or NF1 mutation; Histologically or cytologically diagnosed advanced melanoma that cannot be surgically resected, stage III or IV, after failed or rejected standard treatment, with NRAS aberrant, NRAS mutation, or NF1 mutation report as specified by the registry. · The study status is suspended and the registry does not establish current enrollment, approval, routine availability, or individual eligibility. China access outside this trial remains source-pending. Confidence/conflicts: High for registry status; no conflict found. ClinicalTrials.gov — clinical-trial registry
  • BCD-100임상시험 · NCT03269565임상시험Trial only (NCT03269565)Russia · Not biomarker-selected in the fetched registry summary.; Unresectable/metastatic melanoma. · Unknown registry status and last update in 2020 mean this should be treated as historical/landscape evidence unless a current Russian source confirms access. It is not a routine approval claim. Confidence/conflicts: Medium; registry verifies the historical trial cell but not current access. No conflict found. ClinicalTrials.gov — clinical-trial registry
  • BCD-263 compared with Opdivo (nivolumab)임상시험 · NCT06640530임상시험Trial only (NCT06640530)Russia · Not biomarker-selected in the fetched registry summary.; Advanced unresectable or metastatic melanoma of the skin. · Active-not-recruiting means this should not be presented as a new-enrollment option. It is registry evidence of an ongoing study landscape, not routine access or regulator approval. The registry does not establish BCD-263 interchangeability or availability outside the study. Confidence/conflicts: High for registry status and geography; routine access remains unverified. No conflict found. ClinicalTrials.gov — clinical-trial registry
  • BCD-263; nivolumab (Opdivo)임상시험 · NCT06112808임상시험Trial only (registry)Russia · advanced melanoma of the skin. · Overall status is ACTIVE_NOT_RECRUITING. Russian locations include Chelyabinsk, Saint Petersburg, Pyatigorsk, Arkhangelsk, Barnaul, Kaliningrad, Kaluga, and other sites in the full registry record. The registry record does not establish current access outside the study. Confidence/conflicts: high for trial record and Russian locations; no source conflict identified. Confidence low for routine Russia availability because the source is a trial registry, not a Russian regulator. ClinicalTrials.gov — clinical-trial registry
  • Prolgolimab임상시험 · NCT05783882임상시험Trial only (NCT05783882)Russia · Not biomarker-selected in the fetched registry summary.; Unresectable or metastatic melanoma. · Registry status is unknown, so this is not a current recruiting option. Russian regulator approval and routine access for prolgolimab were not confirmed from a primary regulator source in this cycle. Confidence/conflicts: Medium; registry verifies study design and Russian geography but status is unknown and regulator confirmation is source-pending. No conflict found. ClinicalTrials.gov — clinical-trial registry
  • prolgolimab임상시험 · NCT05783882임상시험Trial only (registry)Russia · unresectable or metastatic melanoma. · Overall status is UNKNOWN, with estimated completion in 2023 in the fetched record. Russian locations include Arkhangelsk, Chelyabinsk, Moscow, and Saint Petersburg oncology centers. The registry record does not establish current access outside the study. Confidence/conflicts: high for trial record and Russian locations; no source conflict identified. Confidence limited by UNKNOWN registry status and lack of regulator confirmation. ClinicalTrials.gov — clinical-trial registry
  • ABP 206 compared with FDA-licensed nivolumab (Opdivo) and EU-authorized nivolumab임상시험 · NCT05907122임상시험Trial only (NCT05907122)Thailand · Completely surgically removed advanced melanoma in an adjuvant setting; registry excludes ocular or uveal melanoma. · Completed biosimilar trial geography does not establish Thai, Japanese, or Korean regulatory approval, substitution policy, reimbursement, or routine access for ABP 206. Confidence/conflicts: High for registry country list and completed status; no conflict found. ClinicalTrials.gov — clinical-trial registry
  • ABP 206; FDA-licensed nivolumab (Opdivo); EU-authorized nivolumab (Opdivo)임상시험 · NCT05907122임상시험Trial only (registry)Thailand · resected melanoma. · Overall status is COMPLETED. Thai sites listed include Khon Kaen University/Srinagarind Hospital, Prince of Songkla University, King Chulalongkorn Memorial Hospital, and Siriraj Hospital. The registry record does not establish current access outside the study. Confidence/conflicts: high for trial existence and Thai locations; no source conflict identified. Confidence low for routine Thailand availability because the source is a trial registry, not a Thai regulator. ClinicalTrials.gov — clinical-trial registry
  • ABP 206; nivolumab (Opdivo)임상시험 · NCT06054555임상시험Trial only (registry)Thailand · unresectable or metastatic melanoma. · Overall status is ACTIVE_NOT_RECRUITING. Thai sites listed include Khon Kaen University/Srinagarind Hospital, Prince of Songkla University, Maharaj Nakorn Chiangmai Hospital, King Chulalongkorn Memorial Hospital, Siriraj Hospital, and Ramathibodi Hospital. The registry record does not establish current access outside the study. Confidence/conflicts: high for trial existence and Thai locations; no source conflict identified. Confidence low for routine Thailand availability because the source is a trial registry, not a Thai regulator. ClinicalTrials.gov — clinical-trial registry
  • dabrafenib (Tafinlar) + trametinib (Mekinist)임상시험 · NCT02083354임상시험Trial only (registry)Thailand · BRAF V600 mutation-positive; BRAF V600 mutation-positive melanoma; objective response-rate study. · Overall status is COMPLETED. Thai locations listed include Novartis investigative sites in Bangkok and Songkhla. The registry record does not establish current access outside the study. Confidence/conflicts: high for trial existence, BRAF V600 study population, and Thai locations; no source conflict identified. Confidence low for routine Thailand availability because the source is a trial registry, not a Thai regulator. ClinicalTrials.gov — clinical-trial registry

신흥 / 초기 근거

임상시험이나 초기 보고에 실렸다는 것은 해당 선택지가 연구되고 있다는 의미일 뿐, 효과가 있거나 특정 환자에게 안전하거나 현재 등록 가능하다는 뜻은 아닙니다. 어떤 선택지가 적합한지는 담당 종양내과 팀과 임상시험 팀이 함께 상의할 문제입니다. 최종 확인 2026.06.