Ibrutinib for Refractory Melanoma

Recruiting in Palo Alto (17 mi)

+16 other locations

Overseen byStergios J Moschos

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well ibrutinib works in treating patients with stage IV melanoma of the skin that has not responded to previous treatment. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Eligibility Criteria

This trial is for adults with stage IV cutaneous melanoma that hasn't improved after treatment. They must have measurable disease, normal organ function, and a life expectancy over 3 months. Participants need to be able to swallow pills, agree to use contraception if applicable, and provide tissue samples if needed. Excluded are those with certain allergies, uncontrolled illnesses, recent other cancer treatments or high-dose steroids.

Inclusion Criteria

Your AST and ALT levels in your blood are not too high. If you have cancer that has spread to your liver, the levels can be a little higher but still within a certain limit.

My melanoma diagnosis was confirmed by tissue examination.

My side effects from previous cancer treatments have mostly gone away.

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Exclusion Criteria

My melanoma originated in a mucous membrane or my eye.

You have had serious allergic reactions to drugs similar to ibrutinib in the past, with symptoms like difficulty breathing, lip swelling, itching, or rash.

I need regular blood transfusions due to low platelet counts.

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Treatment Details

Interventions

Ibrutinib (Kinase Inhibitor)

Trial OverviewThe trial tests Ibrutinib's effectiveness in treating advanced skin melanoma resistant to prior therapies by inhibiting enzymes that promote tumor cell growth. It includes laboratory biomarker analysis and pharmacological studies to understand how the drug interacts with the body.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (ibrutinib)Experimental Treatment4 Interventions

Patients receive ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Ibrutinib is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Imbruvica for: