Study on Oral IRAK-4 Inhibitor CA-4948 with Pembrolizumab After Brain Radiation in Melanoma Patients

Sponsor: University of Florida

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05669352

Provider View

This clinical trial is exploring a new treatment approach for patients with melanoma that has spread to the brain. It combines an oral drug, CA-4948, with pembrolizumab after targeted brain radiation to see if it can better control the cancer and improve quality of life.

Patient Parameters

Program Overview

This study is testing a new treatment for melanoma that has spread to the brain. It involves using an oral drug called CA-4948 along with pembrolizumab after patients receive a type of precise brain radiation called stereotactic radiosurgery. Researchers hope this combination will help control the cancer more effectively, reduce the need for further radiation, and improve symptoms and quality of life for patients. This is the first time CA-4948 is being used with pembrolizumab in this way, and the study aims to provide valuable insights into its potential benefits.

Eligibility Criteria

Inclusion Criteria

  • Have confirmed melanoma that has spread to the brain and are planning to undergo precise brain radiation (SRS).
  • Have measurable cancer that can be tracked.
  • May be new to treatment or currently receiving treatment for cancer control. If on treatment, the cancer must be stable.
  • Have cancer outside the brain that can be biopsied.
  • Can undergo MRI scans and are not allergic to the contrast dye used.
  • Be 18 years or older.
  • Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in strenuous activity but ambulatory.
  • Have adequate blood cell counts and organ function as determined by specific tests.
  • HIV-positive patients on effective treatment with undetectable viral load are eligible.
  • Hepatitis B patients must have undetectable viral load on treatment.
  • Hepatitis C patients must be treated and cured, or have undetectable viral load if on treatment.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after the study.
  • Men must agree to use contraception and not donate sperm during and after the study.
  • Can have other cancers if they do not interfere with the study treatment.
  • Must have recovered from previous treatments to a certain level.
  • Must provide a tumor sample for analysis.
  • Must understand and agree to the study requirements.

Exclusion Criteria

  • Women who are pregnant or have a positive pregnancy test before treatment.
  • Have received other cancer treatments or investigational drugs recently.
  • Have had major surgery recently and not fully recovered.
  • Have had recent radiation therapy and not fully recovered.
  • Have received a live vaccine recently.
  • Have an immune deficiency or are on high-dose steroids or other immune-suppressing drugs.
  • Have another active cancer that needs treatment.
  • Have severe allergies to the study drugs.
  • Have active autoimmune diseases needing treatment.
  • Have lung diseases needing steroids or current lung issues.
  • Have active infections needing treatment.
  • Have conditions that could interfere with the study.
  • Have psychiatric or substance abuse issues affecting study participation.
  • Are pregnant, breastfeeding, or planning to have children soon.
  • Have had a tissue or organ transplant.
  • Cannot stop medications that conflict with the study drugs.
  • Have uncontrolled health issues.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.