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LXH254

Phase 2

Melanoma | Small molecule | Oncology |Novartis AG|Last Updated: Mar 12, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment134
FDA Designations
No designations recorded
Clinical trial landscape

LXH254 · 1 trial · 1 indication

Phase 2 1
NCT04417621Study of Efficacy and Safety of LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic MelanomaMelanoma
ACTIVE NOT_RECRUITING134 Analytics
PHASE2ACTIVE NOT_RECRUITING
Study of Efficacy and Safety of LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma
MelanomaUnlock trial analytics
Study Endpoints
Primary Endpoints
Overall Response Rate
35 months

Confirmed ORR using RECIST v1.1, per local assessment

Secondary Endpoints
Duration of Reposnse (DOR)
4 years
Progression Free Survival (PFS)
4 years
Disease Control Rate (DCR)
3 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LXH254 + LTT462EXPERIMENTAL -
LXH254 + trametinibEXPERIMENTAL -
LXH254 + ribociclibEXPERIMENTAL -
Interventions
NameTypeDescription
LXH254DRUGLXH254 will be supplied as tablet for oral use.
LTT462DRUGLTT462 will be supplied as hard gelatin capsule for oral use.
TrametinibDRUGTrametinib will be supplied as film-coated tablet for oral use
RibociclibDRUGRibociclib will be supplied in tablets and hard gelatin capsules.
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Eligibility Criteria
Age Range12 Years to 120 Years
SexALL
Healthy VolunteersNo
Study Sites36

Inclusion Criteria: Male or female must be ≥ 12 years For adolescents only (12-17 years): body weight \> 40kg Histologically confirmed unresectable or metastatic cutaneous melanoma Previously treated for unresectable or metastatic melanoma: * Participants with NRAS mutation: * Participants must h...

Countries:United StatesArgentinaAustraliaBelgiumFranceGermanyIsraelItalyNetherlandsNorwaySwitzerlandUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT04417621primaryCompletionDate: changed
LOWMay 24, 2026NCT04417621studyFirstPostDate: changed