비흑색종 피부암(BCC / cSCC): 국가별 치료 선택지

임상시험 진행 중

• Cemiplimab-rwlc (Libtayo); pembrolizumab (Keytruda); surgery; radiation therapy; clinical trials임상시험임상시험InvestigationalUnited States · No biomarker requirement stated in fetched sources; PD-1 inhibitor class is treatment mechanism; Recurrent or metastatic cSCC not amenable to curative surgery or radiation; locally advanced cSCC not amenable to curative surgery; adjuvant treatment after surgery and radiation for high-risk recurrence. · NCI PDQ is an evidence summary, not a payer source. FDA approval notices do not determine eligibility, toxicity suitability, or reimbursement. Adjuvant cemiplimab applies only to the high-risk post-surgery/radiation context described by FDA. Confidence/conflicts: High for U.S. evidence summary and approval notices; payer and sequencing details remain unverified. U.S. Food and Drug Administration (FDA) — regulator approval notice
• Cemiplimab; pembrolizumab plus berahyaluronidase alfa; INCB099280; AZD6750 plus rilvegostomig임상시험 · NCT03969004임상시험Trial only (registry)Japan · No biomarker requirement stated for the cSCC-specific Japan records; broad solid-tumor studies may have protocol-specific requirements; High-risk cSCC after surgery and radiation; recurrent/metastatic cSCC; locally advanced unresectable cSCC; advanced/metastatic solid-tumor cohorts including skin SCC. · Registry records do not establish PMDA approval, reimbursement, routine access, or individual eligibility. Some studies are active-not-recruiting or completed. Broad solid-tumor cohorts do not prove cSCC-specific enrollment at every site. Confidence/conflicts: High for Japan registry-listed cSCC activity; PMDA/routine access unverified. ClinicalTrials.gov — clinical-trial registry
• Er:YAG ablative fractional laser-assisted photodynamic therapy; MAL-PDT; MDNA11 plus pembrolizumab임상시험 · NCT02018679임상시험Trial only (registry)Korea · MSI-H, dMMR, or high tumor mutational burden may apply to some broad IL-2 study cohorts; no mutation biomarker required by fetched nodular BCC PDT record; Nodular BCC local therapy study; advanced/unresectable solid tumor cohort including BCC. · Registry records do not establish MFDS approval, reimbursement, routine access, or individual eligibility. The MDNA11 record is broad and does not prove BCC-specific enrollment at every South Korea site. Confidence/conflicts: Medium-high for Korea registry-listed BCC activity; regulator/access unverified. ClinicalTrials.gov — clinical-trial registry
• INCB099280; HMBD-001 plus cetuximab with or without docetaxel; sigvotatug vedotin with pembrolizumab and platinum chemotherapy; AZD6750 plus rilvegostomig; TBio-6517 plus pembrolizumab; TransCon TLR7/8 agonist with or without pembrolizumab임상시험 · NCT05888844임상시험Trial only (registry)Korea · No biomarker requirement stated for cSCC-specific INCB099280 and HMBD-001 records; broad cohorts may have protocol-specific criteria; Advanced cSCC; advanced/metastatic squamous cancer including cSCC; advanced solid tumors including cSCC; neoadjuvant cSCC context in a terminated study. · Registry records do not establish MFDS approval, reimbursement, routine access, or individual eligibility. Some studies are terminated or active-not-recruiting, and broad cohort studies require confirmation that the cSCC cohort is open locally. Confidence/conflicts: High for Korea registry-listed cSCC study activity; regulator/access status unverified. ClinicalTrials.gov — clinical-trial registry
• Pucotenlimab plus becotatug vedotin; camrelizumab plus albumin-bound paclitaxel; HLX07; IBI318; camrelizumab plus cisplatin임상시험 · NCT07394244임상시험Trial only (registry)China · No biomarker requirement stated in fetched China cSCC registry records; Advanced cSCC; locally advanced or metastatic cSCC; squamous cell carcinoma of skin. · Registry records do not establish NMPA approval, reimbursement, routine access, or individual eligibility. Several China records have unknown or not-yet-recruiting status despite listed site status; IBI318 record is terminated. Confidence/conflicts: High for China registry-listed cSCC study activity; NMPA/access unverified. ClinicalTrials.gov — clinical-trial registry
• Sonidegib phosphate capsules; ZSP1602; ivonescimab / ivocizumab임상시험 · NCT06880848임상시험Trial only (registry)China · Hedgehog pathway inhibitor context for sonidegib; no mutation biomarker required by fetched China records; Adult locally advanced BCC; advanced solid tumor/BCC cohort; rare tumor cohort including BCC. · Registry records do not establish NMPA approval, reimbursement, routine access, or individual eligibility. The ZSP1602 and ivonescimab studies are broad cohorts and require protocol confirmation for BCC-specific access. Confidence/conflicts: High for China registry-listed BCC study activity; NMPA/access unverified. ClinicalTrials.gov — clinical-trial registry
• Vismodegib; placebo comparator임상시험 · NCT01815840임상시험Trial only (registry)Russia · Hedgehog pathway inhibitor context; no mutation biomarker required by fetched Russia registry records; Multiple BCC; locally advanced or metastatic BCC. · Registry records do not establish Russian regulator approval, reimbursement, routine access, or current availability. Both studies are completed. Confidence/conflicts: High for historical Russia registry-listed vismodegib activity; current local access unverified. ClinicalTrials.gov — clinical-trial registry
• Cosibelimab (CK-301); cemiplimab; pembrolizumab; CV8102 with or without anti-PD-1 therapy임상시험 · NCT03212404임상시험Trial only (registry)Thailand · No biomarker requirement stated in fetched Thailand/Russia cSCC records; Advanced cancers including cSCC; high-risk cSCC after surgery and radiation; locally advanced cSCC after surgery and radiation; intratumoral therapy context in skin SCC. · Thailand evidence is a broad advanced-cancer record and does not establish cSCC-specific enrollment at each Thai site. Russian records are registry/trial records only and do not establish Russian regulator approval, reimbursement, current enrollment, or routine access. Confidence/conflicts: Medium-high for Thailand/Russia registry activity; country approvals and active access unverified. ClinicalTrials.gov — clinical-trial registry