What side effects are associated with this type of intervention?

Common treatments for melanoma, particularly those targeting the MAPK pathway such as BRAF and MEK inhibitors, often have side effects including fatigue, rash, diarrhea, and liver enzyme abnormalities. Other potential adverse effects include fever, joint pain, and photosensitivity. In some cases, more severe side effects like cardiotoxicity and ocular toxicity can occur. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved several drugs targeting the MAPK pathway for the treatment of melanoma, particularly those with BRAF mutations. Key drugs include vemurafenib and dabrafenib, both BRAF inhibitors, and trametinib and cobimetinib, which are MEK inhibitors. Vemurafenib was one of the first BRAF inhibitors approved in 2011, followed by dabrafenib in 2013. Trametinib, a MEK inhibitor, was also approved in 2013, and cobimetinib received approval in 2015. These drugs are often used in combination to improve efficacy and manage resistance, providing significant advancements in the treatment of metastatic melanoma.

What other types of research exist?

Promising novel alternatives to LXH254 for melanoma patients in 2024 include: 1) Pembrolizumab (anti-PD-1) combined with Axitinib (VEGFR inhibitor), 2) Nivolumab (anti-PD-1) with or without Ipilimumab (anti-CTLA-4), 3) Abemaciclib (CDK4 inhibitor), and 4) Pembrolizumab (anti-PD-1) combined with other targeted therapies like BRAF and MEK inhibitors.

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Kinase Inhibitor

LXH254 Combinations for Melanoma

Phase 2

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed unresectable or metastatic cutaneous melanoma

Must not have

All primary central nervous system (CNS) tumors or symptomatic CNS metastases that are neurologically unstable

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new medication called LXH254, used in combination with other treatments, for people with a type of skin cancer that can't be removed by surgery and has spread. These patients have already tried other treatments. LXH254 works by blocking signals in the cancer cells to slow or stop their growth.

Who is the study for?

This trial is for adults and adolescents (12+) with a body weight over 40kg who have unresectable or metastatic melanoma. Participants must have tried certain therapies before, like checkpoint inhibitors or targeted therapy, depending on their mutation type (NRAS or BRAFV600). They should not have received recent cancer treatments that could interfere with the study.

What is being tested?

The study tests combinations of LXH254 with other drugs (LTT462, Trametinib, Ribociclib) in patients who've had previous treatments for advanced melanoma. It aims to find out how effective these drug combos are in treating this condition.

What are the potential side effects?

While specific side effects aren't listed here, common ones from cancer drugs may include nausea, fatigue, skin reactions, increased risk of infections and possibly unique side effects related to each drug's mechanism of action.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My melanoma cannot be removed with surgery and has spread.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have unstable brain tumors or symptoms from brain metastases.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Response Rate

Secondary study objectives

Disease Control Rate (DCR)

Dose Interruptions

Dose reductions

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: LXH254 + trametinibExperimental Treatment1 Intervention

Group II: LXH254 + ribociclibExperimental Treatment1 Intervention

Group III: LXH254 + LTT462Experimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ribociclib

2018

Completed Phase 3

~2420

Trametinib

2014

Completed Phase 2

~1630

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for melanoma include MAPK pathway inhibitors and immune checkpoint inhibitors. MAPK pathway inhibitors, such as BRAF and MEK inhibitors, target mutations in the BRAF gene, which are present in about half of melanomas. These inhibitors block the signaling pathway that promotes tumor cell growth and survival. Immune checkpoint inhibitors, like nivolumab and ipilimumab, work by blocking proteins that prevent the immune system from attacking cancer cells, thereby enhancing the body's immune response against the tumor. These treatments are crucial for melanoma patients as they offer targeted and effective options, especially for those with specific genetic mutations or advanced disease stages.