Ibrutinib + Pembrolizumab for Leukemia and Lymphoma

Recruiting in Palo Alto (17 mi)

Overseen ByJoshua Brody

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Joshua Brody

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The purpose of this study is to determine the most appropriate dose for the combination of ibrutinib and pembrolizumab and to see if the combination is active for the disease. The study will monitor for any side effects and if the combination of ibrutinib and pembrolizumab works in the cancers being studied. There will be 2 experimental drugs given to the subject in this study. One experimental drug used in this study is called ibrutinib and the second is called pembrolizumab. This is the first time that ibrutinib will be used in combination with pembrolizumab. This combination is considered experimental. Experimental means that it is still being tested to see if it is safe and effective. Ibrutinib is a new drug known as a 'Bruton's Tyrosine Kinase (BTK) inhibitor'. Ibrutinib blocks an enzyme (protein) that affects how certain types of blood cancer cells grow and survive. Blocking this enzyme is a very important mechanism in killing blood cancer cells. Ibrutinib has been approved in the United States, Israel, and the European Union for use in adult patients with mantle cell lymphoma (MCL) and adult patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. Pembrolizumab is an antibody (a type of human protein) that is being tested to see if it will allow the body's immune system to work against tumor cells. Pembrolizumab is approved for use by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with melanoma (skin cancer) who have received prior treatments. Pembrolizumab is not FDA approved to treat patients with chronic lymphocytic leukemia \[CLL\] and mantle cell lymphoma \[MCL\].

Eligibility Criteria

Adults over 18 with chronic lymphocytic leukemia (CLL) or mantle cell lymphoma (MCL) who can provide consent and have measurable disease. They must be in good health otherwise, not pregnant, agree to use contraception, and haven't used certain other treatments recently like immunosuppressives or live vaccines.

Inclusion Criteria

I am a man who can father a child and will use birth control during and for 4 months after the study.

I am fully active or restricted in physically strenuous activity but can do light work.

I am 18 years old or older.

My recent tests show my organs are functioning well.

Exclusion Criteria

I haven't had cancer treatment with antibodies in the last 4 weeks or still have side effects.

I haven't had chemotherapy, targeted therapy, or radiation in the last 2 weeks.

I have another cancer besides skin cancer that is getting worse or needs treatment.

I have active brain metastases or cancer in the lining of my brain.

I have a history of or currently have non-infectious lung inflammation.

I am currently being treated for an infection.

I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.

My condition worsened despite being on a BTK inhibitor treatment.

I have a history of HIV or active Hepatitis B or C.

I have an immune system disorder or have been on steroids or immune-suppressing drugs recently.

I have an active TB infection.

I am not allergic to ibrutinib, pembrolizumab, or their ingredients.

I have been treated for an autoimmune disease in the last year.

Participant Groups

The trial is testing a combination of two drugs: Ibrutinib, which blocks an enzyme that helps blood cancer cells grow; and Pembrolizumab, an antibody designed to help the immune system fight tumor cells. This study aims to find the right dose and see if this experimental combo works for CLL/MCL.

2Treatment groups

Experimental Treatment

Group I: Participants with MCLExperimental Treatment2 Interventions

Participants with relapsed/ refractory Mantle Cell Lymphoma (MCL)

Group II: Participants with CLLExperimental Treatment2 Interventions

Participants with relapsed/ refractory Chronic Lymphocytic Leukemia (CLL) or 17p- CLL

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

🇪🇺 Approved in European Union as Imbruvica for: