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IRAK-4 Inhibitor

CA-4948 + Pembrolizumab for Melanoma

Phase 1 & 2
Recruiting
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
Must not have
Has a history of non-infectious pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids over ≤ 10mg of oral prednisone daily or equivalent, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have or had lung inflammation not caused by infection, treated with steroids.
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I haven't had radiotherapy in the last 2 weeks and have no ongoing side effects needing high-dose steroids.
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I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.
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I have received an organ or tissue transplant from another person.
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I am currently being treated for an infection.
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I cannot stop taking medication that would interfere with the trial drugs.
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I do not have any unmanaged ongoing illnesses.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Reduction in need for repeated intercranial intervention 1 year after initial stereotactic radiosurgery (SRS)
Secondary study objectives
Intracranial objective response rate
Overall survival
Systemic objective response rate

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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 3
~3130

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,409 Previous Clinical Trials
767,430 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,032 Previous Clinical Trials
5,189,771 Total Patients Enrolled
Bently Doonan, MD, MSPrincipal InvestigatorUniversity of Florida
2 Previous Clinical Trials
50 Total Patients Enrolled

Media Library

CA-4948 (IRAK-4 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05669352 — Phase 1 & 2
Brain metastasis Research Study Groups: CA-4948 and Pembrolizumab
Brain metastasis Clinical Trial 2023: CA-4948 Highlights & Side Effects. Trial Name: NCT05669352 — Phase 1 & 2
CA-4948 (IRAK-4 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05669352 — Phase 1 & 2
~19 spots leftby Aug 2026
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