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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (Phase I)
Tumor response (dose expansion cohort)
Secondary outcome measures
Overall survival
Progression-free survival
Neoplasms
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
Pembrolizumab
2017
Completed Phase 2
~2010
Ibrutinib
2014
Completed Phase 4
~1890
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,227 Previous Clinical Trials
3,771,648 Total Patients Enrolled
40 Trials studying Melanoma
2,503 Patients Enrolled for Melanoma
National Cancer Institute (NCI)NIH
13,687 Previous Clinical Trials
40,930,351 Total Patients Enrolled
557 Trials studying Melanoma
193,170 Patients Enrolled for Melanoma
Matthew S BlockPrincipal InvestigatorMayo Clinic in Rochester
4 Previous Clinical Trials
183 Total Patients Enrolled
2 Trials studying Melanoma
103 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I am not willing to use birth control during the study.My cancer has spread to my brain or its coverings.I do not have any severe illnesses besides my current condition.I haven't had serious heart problems in the last 6 months.I have not had any other cancer within the last 3 years.I have a known bleeding disorder.My melanoma cannot be surgically removed and has spread beyond its original site.My liver function tests are within the required range.I finished antibiotics for an infection less than 14 days ago.I haven't taken any immunosuppressant drugs in the last 21 days.I can take care of myself and am up and about more than half of my waking hours.My melanoma cannot be removed by surgery and has spread beyond its original site.Your hemoglobin level is at least 9.0 grams per deciliter.Your bilirubin levels in your blood are not too high.I have not had a stroke or brain bleed in the last 6 months.I have a serious liver condition right now.I have no lasting side effects from previous cancer treatments.I haven't had cancer treatment in the last 28 days.I haven't taken strong CYP3A inhibitors in the last week.I have taken a pregnancy test within the last week and it was negative.I have not received any live vaccines in the last 28 days.I have a stomach or intestine condition that could affect medication absorption.My kidney function tests are within the required range.I have been diagnosed with uveal melanoma.I am currently taking warfarin or similar blood thinners.I have at least one tumor or malignant lymph node that can be measured.Your absolute neutrophil count is at least 1000 per cubic millimeter.I need ongoing treatment with a strong medication that affects liver enzymes.My melanoma cannot be removed by surgery and has spread.Your platelet count is at least 75,000 per cubic millimeter.I do not have HIV, hepatitis B or C, or any uncontrolled infections.You have had a serious autoimmune disease or an organ transplant in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ibrutinib, pembrolizumab)
Awards:
This trial has 1 awards, including:- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the customary application of Ibrutinib?
"Ibrutinib is mainly prescribed to aid in the treatment of cancerous tumours. However, it has been known to also be beneficial for individuals with unresectable melanoma, a microsatellite instability high, and those who experience disease progression following chemotherapy."
Answered by AI
How many participants are partaking in this trial?
"Affirmative. The information on clinicaltrials.gov reveals that this research is currently recruiting participants, with the first post dating back to January 31st 2017 and the most recent edits registered as of March 11th 2022. 23 patients need to be enrolled at 1 medical centre for successful completion of this trial."
Answered by AI
Has the FDA issued authorization for Ibrutinib?
"Due to the fact that Ibrutinib is still in its first phase of clinical trials, our team at Power rated its safety a 1 on a scale from 1-3. This implies there is limited evidence for efficacy and protection available."
Answered by AI
Are researchers currently seeking participants for this experiment?
"Per the information available through clinicaltrials.gov, this trial is currently onboarding participants. It was initially announced on January 31st 2017 and has since been renewed as of March 11th 2022."
Answered by AI
Are there any other reports that have concentrated on the effects of Ibrutinib?
"Currently, 1111 Ibrutinib studies are underway. Of those trials, 145 have progressed to Phase 3. A bulk of the research is being conducted in Houston, Texas yet there exists a network of over 42 thousand sites running related investigations into this drug's effectiveness."
Answered by AI
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