Ibrutinib + Pembrolizumab for Leukemia and Lymphoma
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you have had certain treatments like chemotherapy or radiation therapy within 2 weeks before starting the trial, or if you are on systemic steroid therapy or other immunosuppressive treatments within 7 days before the trial.
What data supports the effectiveness of the drug combination Ibrutinib and Pembrolizumab for Leukemia and Lymphoma?
Research shows that Ibrutinib, when used alone or with other drugs, is effective in treating certain types of blood cancers like chronic lymphocytic leukemia and mantle cell lymphoma, with good response rates and survival benefits. Additionally, Ibrutinib has shown promising results when combined with immune therapies like nivolumab, suggesting potential benefits when combined with Pembrolizumab.12345
Is the combination of Ibrutinib and Pembrolizumab safe for humans?
Ibrutinib (Imbruvica) has been shown to have an acceptable safety profile in treating certain types of leukemia and lymphoma, with less than 10% of patients stopping treatment due to side effects. However, there have been rare cases of serious bleeding events. While specific safety data for the combination with Pembrolizumab (KEYTRUDA) is not provided, Ibrutinib alone is generally considered tolerable.12467
How is the drug combination of Ibrutinib and Pembrolizumab unique for treating leukemia and lymphoma?
The combination of Ibrutinib and Pembrolizumab is unique because it pairs Ibrutinib, an oral drug that blocks signals in cancer cells to stop their growth, with Pembrolizumab, an immune therapy that helps the body's immune system attack cancer cells. This dual approach targets cancer in two different ways, potentially offering a more effective treatment option for leukemia and lymphoma compared to traditional therapies.468910
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 \[MCL\].
Research Team
Joshua Brody
Principal Investigator
Icahn School of Medicine at Mount Sinai
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Lead-in Treatment
Participants receive a 28-day lead-in of ibrutinib
Treatment
Participants receive a 21-day cycle of pembrolizumab and daily ibrutinib
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Ibrutinib
- Pembrolizumab
Ibrutinib is already approved in European Union, United States, Canada, Japan for the following indications:
- Chronic lymphocytic leukemia
- Mantle cell lymphoma
- Waldenström's macroglobulinemia
- Marginal zone lymphoma
- Graft-versus-host disease
- Chronic lymphocytic leukemia/small lymphocytic lymphoma
- Mantle cell lymphoma
- Waldenström's macroglobulinemia
- Marginal zone lymphoma
- Graft-versus-host disease
- Chronic lymphocytic leukemia
- Mantle cell lymphoma
- Waldenström's macroglobulinemia
- Marginal zone lymphoma
- Chronic lymphocytic leukemia
- Mantle cell lymphoma
- Waldenström's macroglobulinemia
Find a Clinic Near You
Who Is Running the Clinical Trial?
Joshua Brody
Lead Sponsor
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University