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Ibrutinib for Refractory Melanoma
Study Summary
This trial is studying whether ibrutinib can help treat patients with stage IV melanoma that has not responded to previous treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- Your AST and ALT levels in your blood are not too high. If you have cancer that has spread to your liver, the levels can be a little higher but still within a certain limit.My melanoma diagnosis was confirmed by tissue examination.My side effects from previous cancer treatments have mostly gone away.My melanoma originated in a mucous membrane or my eye.You have had serious allergic reactions to drugs similar to ibrutinib in the past, with symptoms like difficulty breathing, lip swelling, itching, or rash.I need regular blood transfusions due to low platelet counts.You have an active hepatitis B or C infection. If you are hepatitis B core antibody positive but antigen negative, you need a negative polymerase chain reaction (PCR) test before joining the study. If you are hepatitis B antigen or PCR positive, you cannot participate.Women who can become pregnant need to have a negative pregnancy test within 7 days before starting treatment with ibrutinib.I haven't had chemotherapy, immunotherapy, or radiotherapy in the specified time before starting this trial.I am not currently on any other cancer treatments.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I am HIV-positive but on antiretroviral therapy with a normal CD4+ count.I do not have serious heart problems or a recent heart attack.I haven't taken warfarin or similar blood thinners in the last 28 days and don't have a bleeding disorder.My liver function is not normal, as measured by the Child-Pugh score.I haven't taken strong CYP3A inhibitors in the last 7 days.I have a tumor that can be measured and is at least 1 cm in size.I can swallow pills.Your hemoglobin level is at least 9.0 grams per deciliter.Your platelet count is higher than 100,000 per microliter.I haven't taken high doses of corticosteroids daily for the last 28 days.I have been treated with ibrutinib or similar medications before.I have not had worsening anemia or low platelets due to autoimmune conditions in the last 4 weeks.I had cancer before, but it's either been treated, is a non-threatening type, or I've been cancer-free for 2+ years.I cannot swallow pills or have a condition that affects my gut's ability to absorb nutrients.I've had radiation before, but my current cancer spots haven't been treated with it.I can take care of myself but might not be able to do heavy physical work.My bilirubin levels are normal or slightly elevated, unless due to Gilbert's syndrome or liver disease.My kidney function, measured by creatinine clearance, is adequate.My cancer did not respond to treatment with PD1/PD-L1 inhibitors after at least two doses.I agree to use effective birth control during and for 90 days after the study.I have an autoimmune disease but take 20 mg or less of corticosteroids daily.I am willing to undergo a biopsy for my metastatic melanoma if needed.I had severe side effects from BRAF or MEK inhibitors that didn't improve even after changing medications.My brain cancer is under control, and I'm on a low or decreasing dose of steroids.I am not pregnant or breastfeeding.I have not had a stroke or brain bleed in the last 6 months.You are expected to live for more than 3 months.Your absolute neutrophil count is higher than 1,500 per microliter.My condition is at stage IV.I will stop taking Ibrutinib 3-7 days before and after surgery, based on bleeding risk.My cancer has not responded to specific treatments for the BRAFV600 mutation.
- Group 1: Treatment (ibrutinib)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Does this research endeavor still have an intake period for participants?
"The trial has ended, having been posted on August 17 2016 and last modified September 20 2022. However, those looking for other studies could consider the 827 clinical trials requiring participants with stage IV cutaneous melanoma AJCC V6 and V7 or the 155 trials involving Ibrutinib therapy that are still open to patient enrolment."
What precedent exists for research regarding Ibrutinib?
"First discovered in 2011 at the NIH Clinical Center, ibrutinib has been studied extensively since then. There are 687 completed trials related to this drug and currently 155 active ones taking place, with a predominant concentration of studies located in St. Louis, Missouri."
What perils have been associated with Ibrutinib usage?
"With evidence of safety from a Phase 2 trial, Ibrutinib is estimated to be two on the scale of 1-3. Unfortunately there are no data yet which would support its efficacy."
What is the current enrollment rate of this research project?
"This particular medical study is no longer actively looking for candidates. The initial post was made on August 17th 2016 and the last update happened on September 20th 2022. If you are still searching, 827 trials for stage iv cutaneous melanoma ajcc v6 and v7 as well as 155 Ibrutinib-related experiments are currently accepting applicants."
How many geographical areas are participants able to access this trial?
"Currently, 14 medical facilities are taking part in this trial. These locations can be found in Saint Louis, Los Angeles and Columbus as well as 11 other cities. To reduce any potential commute requirements, participants should select the closest site to them when signing up for the study."
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