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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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Frequently asked questions about LXH254

What is LXH254 used for in melanoma?

LXH254 is an investigational small molecule being studied for the treatment of melanoma. It is currently in Phase 2 clinical development for patients with previously treated unresectable or metastatic melanoma. The drug is being evaluated in combination with other agents to assess its efficacy and safety in this patient population.

Who is developing LXH254?

LXH254 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. Novartis is conducting clinical trials to evaluate the drug's potential as a treatment for melanoma.

What phase is LXH254 in?

LXH254 is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 2 trial is studying the drug in combination with other treatments for patients with previously treated unresectable or metastatic melanoma.

What clinical trials is LXH254 in?

LXH254 is being studied in a Phase 2 clinical trial with the identifier NCT04417621. This trial is titled 'Study of Efficacy and Safety of LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma' and is currently active but not recruiting. The trial has an enrollment of 134 participants.

Is LXH254 an approved treatment for melanoma?

No, LXH254 is not an approved treatment for melanoma. It is an investigational drug currently in Phase 2 clinical trials. The drug is being studied for its efficacy and safety in patients with previously treated unresectable or metastatic melanoma, but it has not yet received regulatory approval.

What is the mechanism of action of LXH254?

LXH254 is a small molecule being developed by Novartis for the treatment of melanoma. The specific molecular target of LXH254 has not been disclosed in the available information. The drug is being evaluated in combination with other agents in a Phase 2 clinical trial for patients with previously treated unresectable or metastatic melanoma.