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BTK Inhibitor
Ibrutinib + Pembrolizumab for Leukemia and Lymphoma
Phase 1 & 2
Recruiting
Led By Joshua Brody, MD
Research Sponsored by Joshua Brody
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male subjects of childbearing potential must agree to use adequate contraception from the first dose of study therapy through 120 days after the last dose
Have a performance status of 0 or 1 on the ECOG Performance Scale
Must not have
Received prior anti-cancer monoclonal antibody within 4 weeks prior to study Day 1 or not recovered from adverse events
Received prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or not recovered from adverse events
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Summary
This trial will help determine the best dose of ibrutinib in combination with pembrolizumab for patients with CLL or MCL that has relapsed or progressed after prior therapy. The safety of this combination will also be studied.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system attacking normal organs (autoimmune reactions), infusion-related reactions from receiving the drug into a vein, fatigue, infections due to lowered immunity, liver problems, and possibly others as it's an experimental treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man who can father a child and will use birth control during and for 4 months after the study.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am 18 years old or older.
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My recent tests show my organs are functioning well.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't had cancer treatment with antibodies in the last 4 weeks or still have side effects.
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I haven't had chemotherapy, targeted therapy, or radiation in the last 2 weeks.
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I have another cancer besides skin cancer that is getting worse or needs treatment.
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I have active brain metastases or cancer in the lining of my brain.
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I have a history of or currently have non-infectious lung inflammation.
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I am currently being treated for an infection.
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I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.
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My condition worsened despite being on a BTK inhibitor treatment.
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I have a history of HIV or active Hepatitis B or C.
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I have an immune system disorder or have been on steroids or immune-suppressing drugs recently.
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I have an active TB infection.
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I am not allergic to ibrutinib, pembrolizumab, or their ingredients.
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I have been treated for an autoimmune disease in the last year.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose Limiting Toxicity (DLT)
Secondary outcome measures
Complete Response (CR) rate
Overall Survival Rate
Progression-free Survival Rate
Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
FDA approved
Pembrolizumab
FDA approved
Find a Location
Who is running the clinical trial?
Joshua BrodyLead Sponsor
1 Previous Clinical Trials
21 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,919 Previous Clinical Trials
5,068,242 Total Patients Enrolled
Joshua Brody, MD5.03 ReviewsPrincipal Investigator - Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai
3 Previous Clinical Trials
83 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a man who can father a child and will use birth control during and for 4 months after the study.I haven't had cancer treatment with antibodies in the last 4 weeks or still have side effects.I have not received a live vaccine in the last 30 days.I am 18 years old or older.I agree to provide a recent biopsy sample of my tumor.I have taken a pregnancy test within the last 3 days and it was negative.I will use birth control during and for 4 months after the study.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 a history of HIV or active Hepatitis B or C.I have a history of or currently have non-infectious lung inflammation.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 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 am fully active or restricted in physically strenuous activity but can do light work.My recent tests show my organs are functioning well.I have been treated for an autoimmune disease in the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Participants with MCL
- Group 2: Participants with CLL
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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