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IRAK-4 Inhibitor
CA-4948 + Pembrolizumab for Melanoma
Phase 1 & 2
Waitlist Available
Led By Bently Doonan, MD, MS
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have radiographic or histologically confirmed melanoma brain metastases (MBM) and be planning to undergo SRS for treatment
Patients must have peripheral disease amenable to biopsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will study the potential benefits of combining a novel oral medicine with aPD1 therapy for treating melanoma brain metastases, potentially reducing the need for radiation and improving patients' quality of life.
Who is the study for?
Adults with melanoma brain metastases planning to undergo stereotactic radiosurgery, who have good organ function and performance status. They must be able to tolerate MRIs, not be pregnant or breastfeeding, agree to use contraception, and can't have had certain treatments or vaccines recently. Those with controlled HIV or hepatitis are eligible.Check my eligibility
What is being tested?
The trial is testing a new oral drug called CA-4948 combined with Pembrolizumab after targeted brain radiation therapy in patients with melanoma that has spread to the brain. It aims to see if this combination reduces further brain tumors and improves quality of life.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions from Pembrolizumab, liver enzyme changes due to CA-4948, fatigue, skin rash and potential increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have melanoma that has spread to my brain and will undergo SRS treatment.
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I can have a biopsy on my disease that's not in my central body.
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I am 18 years old or older.
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I am fully active and can carry on all my pre-disease activities without restriction.
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I can undergo MRI scans and am not allergic to gadolinium contrast.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Reduction in need for repeated intercranial intervention 1 year after initial stereotactic radiosurgery (SRS)
Secondary outcome measures
Intracranial objective response rate
Overall survival
Radiation necrosis-free survival at 1 year
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: CA-4948 and PembrolizumabExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
University of FloridaLead Sponsor
1,340 Previous Clinical Trials
715,676 Total Patients Enrolled
4 Trials studying Melanoma
115 Patients Enrolled for Melanoma
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,524 Total Patients Enrolled
120 Trials studying Melanoma
21,654 Patients Enrolled for Melanoma
Bently Doonan, MD, MSPrincipal InvestigatorUniversity of Florida
1 Previous Clinical Trials
18 Total Patients Enrolled
1 Trials studying Melanoma
18 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I have received an organ or tissue transplant from another person.I am 18 years old or older.You must have a disease that can be measured.I am currently being treated for an infection.I cannot stop taking medication that would interfere with the trial drugs.I am fully active and can carry on all my pre-disease activities without restriction.I have melanoma that has spread to my brain and will undergo SRS treatment.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I do not have any unmanaged ongoing illnesses.I have or had lung inflammation not caused by infection, treated with steroids.I haven't had radiotherapy in the last 2 weeks and have no ongoing side effects needing high-dose steroids.I can have a biopsy on my disease that's not in my central body.I have brain metastases and my cancer elsewhere is stable or I haven't started treatment yet.I can undergo MRI scans and am not allergic to gadolinium contrast.I have tested positive for pregnancy within the last 3 days before treatment.I haven't had any cancer treatments or been part of a cancer study in the last 4 weeks.I have fully recovered from any major surgery before starting the study.I haven't had a live vaccine in the last 30 days, but I may have had the COVID-19 vaccine or a killed vaccine.You have a severe allergic reaction (Grade 3 or higher) to pembrolizumab or CA-4948, or any of the ingredients in these medications.I have not had active treatment for another cancer, except for certain skin cancers or in situ cancers, in the last 3 years.
Research Study Groups:
This trial has the following groups:- Group 1: CA-4948 and 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 criteria must be met to partake in this investigation?
"A minimum age of 18 and a maximum age of 99 are the requirements to apply for this experiment. The estimated number of participants is 29 individuals that have melanoma metastatic in the brain."
Answered by AI
Do any individuals younger than 20 qualify for this research trial?
"This clinical trial's entry parameters indicate that applicants must be between 18 and 99 years of age. There are, however, 150 different trials for minors under the legal age of consent and 1461 studies available for seniors over 65."
Answered by AI
Is the recruitment of participants for this trial still on-going?
"The clinical trial listing on Clinicaltrials.gov reflects that this research project is no longer seeking participants, with the original posting being published on August 1st 2023 and its last update occurring December 20th 2022. Despite these facts, there are still a plethora of other medical studies actively enrolling patients at present; 1543 trials to be exact."
Answered by AI
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