A Study of Oral IRAK-4 Inhibitor CA-4948 in Combination With Pembrolizumab and Stereotactic Radiosurgery in Patients With Melanoma Brain Metastases

Conditions

• Melanoma Metastatic in the Brain

Eligibility Criteria

Sex

ALL

Age

18 Years - 99 Years

Healthy Volunteers

Not accepted

Interventions

• CA-4948 — DRUG
  Subjects on both the phase I and phase II portions will take 200 mg CA-4948 orally two times daily.
• Pembrolizumab — DRUG
  Subjects on both the phase I and phase II portions will receive 400 mg pembrolizumab intravenously once every six weeks.

Study Details

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 (SRS) in patients with melanoma brain metastases (MBM). The investigators hypothesize that the addition of CA-4948 will reduce the rate of distant intracranial failure and reduce the need for subsequent radiation therapy. The investigators 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.

Key Dates

First listed

Dec 30, 2022

Start date

Apr 30, 2025

Status verified

Mar 2025

Primary completion

Aug 31, 2026

Completion

Aug 31, 2027

Study Design

Enrollment

29 participants (estimated)

Allocation

NA

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: CA-4948 and Pembrolizumab

Primary Outcome Measure

Reduction in need for repeated intercranial intervention 1 year after initial stereotactic radiosurgery (SRS) [ Time Frame: 1 year ]

Locations (1)

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