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Bruton's Tyrosine Kinase (BTK) Inhibitor

Pembrolizumab + Ibrutinib for Melanoma

Phase 1

Waitlist Available

Led By Matthew S Block

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

Diagnosis of unresectable stage III or metastatic melanoma (stage IV) not amenable to local therapy

Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN OR =< 5 X ULN for patients with liver metastases

Must not have

Prior treatment with ibrutinib or prior exposure to BTK inhibitors

Nursing women

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing ibrutinib + pembrolizumab to see if it's more effective than pembrolizumab alone in treating patients with stage III-IV melanoma.

Who is the study for?

This trial is for adults with advanced melanoma (stage III-IV) that can't be surgically removed. They should have a certain level of physical fitness, adequate organ function, and no recent treatments or severe illnesses that could interfere with the study. Pregnant women and those not using contraception are excluded.

What is being tested?

The trial is testing the combination of two drugs: Pembrolizumab, an antibody that may boost the immune system's attack on cancer, and Ibrutinib, which might stop tumor growth by blocking specific enzymes. The goal is to find the best dose of Ibrutinib to use alongside Pembrolizumab.

What are the potential side effects?

Possible side effects include immune-related reactions like inflammation in various organs, infusion reactions from receiving drugs through a vein, fatigue, liver issues due to enzyme inhibition by Ibrutinib, increased risk of bleeding or infection.

Eligibility Criteria

Inclusion Criteria

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

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My melanoma cannot be surgically removed and has spread beyond its original site.

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My liver function tests are within the required range.

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My kidney function tests are within the required range.

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I can take care of myself and am up and about more than half of my waking hours.

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My melanoma cannot be removed by surgery and has spread beyond its original site.

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I have at least one tumor or malignant lymph node that can be measured.

Exclusion Criteria

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

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I have been treated with ibrutinib or other BTK inhibitors before.

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I am currently breastfeeding.

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I am not willing to use birth control during the study.

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I have a stomach or intestine condition that could affect medication absorption.

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My cancer has spread to my brain or its coverings.

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I do not have any severe illnesses besides my current condition.

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I have a known bleeding disorder.

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I have a serious liver condition right now.

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I have no lasting side effects from previous cancer treatments.

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I haven't taken strong CYP3A inhibitors in the last week.

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I am currently taking warfarin or similar blood thinners.

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I need ongoing treatment with a strong medication that affects liver enzymes.

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My melanoma cannot be removed by surgery and has spread.

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I do not have HIV, hepatitis B or C, or any uncontrolled infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Maximum tolerated dose (Phase I)

Tumor response (dose expansion cohort)

Secondary study objectives

Overall survival

Progression-free survival

Neoplasms

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (ibrutinib, pembrolizumab)Experimental Treatment3 Interventions

Patients receive ibrutinib PO daily on days 1-28 of cycle 1 and days 1-21 of cycle 2 and subsequent cycles. Patients also receive pembrolizumab IV over 30 minutes on day 8 of cycle 1 and day 1 of cycle 2 and subsequent cycles. Cycle 1 continues for 28 days and subsequent cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ibrutinib

2014

Completed Phase 4

~2060

Pembrolizumab

2017

Completed Phase 3

~3150