LXH254 Combinations for Melanoma

Recruiting in Palo Alto (17 mi)

+59 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Novartis Pharmaceuticals

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

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.

Inclusion Criteria

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.

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Exclusion Criteria

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.

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

Participants participating in additional parallel investigational drug or medical device studies.

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Treatment Details

Interventions

LXH254 (Kinase Inhibitor)
Ribociclib (Kinase Inhibitor)
Trametinib (Kinase Inhibitor)

Trial OverviewThe 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.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: LXH254 + trametinibExperimental Treatment1 Intervention

Group II: LXH254 + ribociclibExperimental Treatment1 Intervention

Group III: LXH254 + LTT462Experimental Treatment2 Interventions