Overview

A Phase 1/2 Study of Oral IRAK-4 Inhibitor CA-4948 in Combination With Pembrolizumab Following Stereotactic Radiosurgery in Patients With Melanoma Brain Metastases

Status:
Not yet recruiting

Trial end date:
2027-08-01

Target enrollment:

Participant gender:

Summary

This phase I/II trial will investigate the use of the novel oral IRAK-4 inhibitor CA-4948 in combination with pembrolizumab therapy following stereotactic radiosurgery in patients with melanoma brain metastases (MBM). We hypothesize that the addition of CA-4948 will reduce the rate of distant intracranial failure and reduce the need for subsequent radiation therapy. We also propose that it will have a significant reduction in radiation necrosis and improve patient-reported symptoms and quality of life. This trial represents the first time an oral IRAK-4 inhibitor has been used in combination with aPD1 therapy in MBM and will yield valuable insight into its synergistic potential both in MBM and additional sites of metastases.

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

University of Florida

Collaborator:

Merck Sharp & Dohme LLC

Treatments:

Pembrolizumab