Pembrolizumab + Ibrutinib for Melanoma

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Mayo Clinic

Must not be taking: Warfarin, Strong CYP3A inhibitors

Disqualifiers: Pregnancy, Uveal melanoma, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 7

Duration: 28 days for cycle 1, 21 days for subsequent cycles

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase I trial studies the best dose of ibrutinib when given together with pembrolizumab in treating patients with stage III-IV melanoma that cannot be removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and ibrutinib may work better in treating patients with melanoma.

Research Team

Matthew S. Block, MD, PhD

Principal Investigator

Mayo Clinic in Rochester

Eligibility Criteria

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.

Inclusion Criteria

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

My liver function tests are within the required range.

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

Exclusion Criteria

I have not had any major surgery in the last 28 days.

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

I am currently breastfeeding.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive ibrutinib orally daily and pembrolizumab intravenously as part of a dose-escalation study

28 days for cycle 1, 21 days for subsequent cycles

Cycle 1: 1 visit (in-person), Subsequent cycles: 1 visit every 21 days (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Every 6 months for 5 years

Follow-up visits every 6 months

Treatment Details

Interventions

• Ibrutinib
• Pembrolizumab

Trial Overview 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.

Participant Groups

Group I: Treatment (ibrutinib, pembrolizumab) Experimental Treatment 3 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.

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

Approved in European Union as Imbruvica for:

• Chronic lymphocytic leukemia
• Mantle cell lymphoma
• Waldenström's macroglobulinemia
• Marginal zone lymphoma
• Graft-versus-host disease

Approved in United States as Imbruvica for:

• Chronic lymphocytic leukemia/small lymphocytic lymphoma
• Mantle cell lymphoma
• Waldenström's macroglobulinemia
• Marginal zone lymphoma
• Graft-versus-host disease

Approved in Canada as Imbruvica for:

• Chronic lymphocytic leukemia
• Mantle cell lymphoma
• Waldenström's macroglobulinemia
• Marginal zone lymphoma

Approved in Japan as Imbruvica for:

• Chronic lymphocytic leukemia
• Mantle cell lymphoma
• Waldenström's macroglobulinemia

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+