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Study of Efficacy and Safety of LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma | Clinical Trials | Clareo Health

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Study of Efficacy and Safety of LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma

A Randomized, Open-label, Multi-arm, Two-part, Phase II Study to Assess Efficacy and Safety of Multiple LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic BRAFV600 or NRAS Mutant Melanoma

NCT04417621•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

The primary purpose of this study is to evaluate the efficacy of LXH254 combinations in previously treated unresectable or metastatic melanoma

Eligibility

Age

12 - 120 years

Sex

ALL

Healthy Volunteers

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 have received prior systemic therapy for unresectable or metastatic melanoma with checkpoint inhibitors (CPI), either an anti-PD-1/PD-L1 as a single agent or in combination with anti-CTLA-4, investigational agents, chemotherapy or locally directed anti-neoplastic agents.
•A maximum of two prior lines of systemic CPI-containing immunotherapy for unresectable or metastatic melanoma are allowed. Additional agents administered with CPI are permitted.
•To rule out pseudo-progression, participants must have documented confirmed progressive disease as per RECIST v1.1 while on/after treatment with checkpoint inhibitor therapy. Confirmation is not required for patients who remained on treatment for \>6 months.
•Participants with BRAFV600 mutant disease:
•Participants must have received prior systemic therapy for unresectable or metastatic melanoma with checkpoint inhibitors (CPI), either an anti-PD-1/PD-L1 as a single agent or in combination with anti-CTLA-4, investigational agents, chemotherapy or locally directed anti-neoplastic agents. Additionally, participants must have received targeted therapy with a RAFi as a single agent or in combination with a MEKi (+/- CPI allowed) as the last prior therapy.
•A maximum of two prior lines of systemic CPI-containing immunotherapy for unresectable or metastatic melanoma are allowed. Additional agents with CPI are permitted.
•A maximum of one line of targeted therapy is allowed, and it must be the most recent line of therapy.
+1 more criteria

Exclusion Criteria

•Treatment with any of the following anti-cancer therapies prior to the first dose of study treatment within the stated timeframes:
•≤ 4 weeks for radiation therapy or ≤ 2 weeks for limited field radiation for palliation prior to the first dose of study treatment.
•≤ 2 weeks for small molecule therapeutics.
•≤ 4 weeks for any immunotherapy treatment including immune checkpoint inhibitors.
•≤ 4 weeks for chemotherapy agents, locally directed anti-neoplastic agents, or other investigational agents.
•≤ 6 weeks for cytotoxic agents with major delayed toxicities, such as nitrosourea and mitomycin c.
•Participants participating in additional parallel investigational drug or medical device studies.
•All primary central nervous system (CNS) tumors or symptomatic CNS metastases that are neurologically unstable History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO (e.g. uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes).
•Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.

Locations (36)

The Angeles Clinic and Research Institute

Los Angeles, California, United States

UCSF Medical Center

San Francisco, California, United States

Florida Cancer Specialists

Fort Myers, Florida, United States

H Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Mayo Clinic Mayo Rochester

Rochester, Minnesota, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

NYU Laura and Isaac Perlmutter Cancer Center

New York, New York, United States

Memorial Sloan Kettering

New York, New York, United States

Key Dates

Start Date

October 30, 2020

Primary Completion Date

February 2, 2027

Completion Date

February 2, 2027

Last Updated

March 12, 2026

Enrollment

134

ACTUAL participants

Conditions

Melanoma

Interventions

LXH254

DRUG

LTT462

DRUG

Trametinib

DRUG

Ribociclib

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of Efficacy and Safety of LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma

Inclusion Criteria

Exclusion Criteria

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