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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

Study Summary

This trial will test how well different combinations of the drug LXH254 work against unresectable or metastatic melanoma that has come back or does not respond to other treatments.

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.Check my eligibility

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.See study design

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

Select...

My melanoma cannot be removed with surgery and has spread.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Response Rate

Secondary outcome measures

Derived PK parameter (AUC) for LXH254 & LTT462

Derived PK parameter (AUC) for LXH254 & ribociclib

Derived PK parameter (AUC) for LXH254 & trametinib

+10 more

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

Trametinib

2014

Completed Phase 2

~1550

Ribociclib

2018

Completed Phase 3

~2330

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,855 Previous Clinical Trials

4,197,216 Total Patients Enrolled

51 Trials studying Melanoma

30,769 Patients Enrolled for Melanoma

Media Library

LXH254 (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04417621 — Phase 2

Melanoma Research Study Groups: LXH254 + LTT462, LXH254 + trametinib, LXH254 + ribociclib

Melanoma Clinical Trial 2023: LXH254 Highlights & Side Effects. Trial Name: NCT04417621 — Phase 2

LXH254 (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04417621 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How is LXH254 most often utilized?

"LXH254 can ameliorate the negative effects of malignant neoplasms, postmenopause, and metastatic melanoma."

Answered by AI

How many study subjects are included in this research?

"Right now, this clinical trial isn't looking for new patients. The date range for the posting is from 10/30/2020 to 10/10/2022. For other options, there are 783 trials concerning melanoma and 143 involving LXH254 that are currently open to enrolment."

Answered by AI

Are individuals with the required qualifications still able to enroll in this trial?

"Currently, this study is not recruiting patients. Although, it is important to note that the trial was first posted on October 30th 2020 and was most recently updated on October 10th 2022. For individuals who are interested in other studies, there are 783 clinical trials actively searching for participants with melanoma and 143 LXH254 trials admitting patients."

Answered by AI

What are the potential risks associated with taking LXH254?

"LXH254 has been evaluated for safety in Phase 2 trials. While there is some data supporting its safety, LXH254 has not yet been proven effective."

Answered by AI

Does this clinical trial break new ground?

"According to our research, there are 143 active clinical trials for LXH254 across the globe. The first study was held 8 years ago in 2012 and completed Phase 1 & 2 drug approval. Sponsored by Pfizer, the initial trial had 189 participants. In the years since 2012, 100 more trials have been conducted."

Answered by AI

What is the LXH254 success rate in other medical studies?

"LXH254 was first researched in 2012 at Azienda Ospedaliera Universitaria Federico II. As of now, there have been one hundred completed studies and 143 active trials-- a large majority of which are based in Miami, Florida."

Answered by AI

How many medical facilities are participating in this clinical trial?

"The study has sites at University of Miami, Mayo Clinic Rochester, Memorial Sloan Kettering Dept. of MSKCC, and 10 other locations."

Answered by AI

Will this research be accessible to patients that are middle-aged?

"Based on the age restrictions set by this study, any person between 12 and 120 years old may participate."

Answered by AI

Would I be able to help out with this medical research?

"This trial is looking for 134 participants that have melanoma and meet the following age criteria: being aged between 12 and 120. The most crucial aspect is that potential patients must also have received prior systemic therapy, as detailed below.Other protocol-defined inclusion criteria may apply., 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"

Answered by AI

Recent research and studies

nrasJournal

War Against <i>nras</i>-mutant Melanoma Using Targeted Therapies Remains Challenging

Moschos, Stergios J.. 2022. “War Against nras-mutant Melanoma Using Targeted Therapies Remains Challenging”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-22-1256.

clinicaltrials.govStudy

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

2020. "Study of Efficacy and Safety of LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04417621.

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