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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 belowSelect...
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
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 moreTrial 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
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,866 Previous Clinical Trials
4,199,192 Total Patients Enrolled
51 Trials studying Melanoma
30,769 Patients Enrolled for Melanoma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have unstable brain tumors or symptoms from brain metastases.I am 12 years old or older.My melanoma cannot be removed with surgery and has spread.I have NRAS mutation melanoma and have had up to 2 treatments with specific immune therapies.I haven't had cancer treatments like radiation, chemotherapy, or immunotherapy in the specified time before starting this study.I have or am at risk for blocked blood vessels in my eye due to conditions like uncontrolled glaucoma.I have melanoma with a specific mutation and have had certain treatments, including targeted therapy as my last treatment.I am between 12 and 17 years old and weigh more than 40kg.
Research Study Groups:
This trial has the following groups:- Group 1: LXH254 + LTT462
- Group 2: LXH254 + trametinib
- Group 3: LXH254 + ribociclib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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