Bevacizumab and ICIs + hSRT in Symptomatic Melanoma Brain Metastases

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

May 31, 2025

Primary Completion Date

January 30, 2026

Study Completion Date

January 30, 2026

Conditions
Melanoma Brain Metastases
Interventions
DRUG

Bevacizumab

Bevacizumab is a humanised monoclonal antibody with molecular weight 167kD that inhibits all isoforms of the vascular endothelial growth factor (VEGF) and is produced from a Chinese hamster ovary mammalian system. It has high specificity for isoform-A and has a half-life of \~21 days.

DRUG

Ipilimumab

Ipilimumab is an immune checkpoint inhibitor (ICI) that targets anti-tumour immunity. Ipilimumab is a recombinant human immunoglobulin monoclonal antibody that binds CTLA4 and blocks the interaction between CD80/86 and CTLA4.

DRUG

Nivolumab

Nivolumab ia an immune checkpoint inhibitor (ICI) that targets anti-tumour immunity. Nivolumab is a fully human monoclonal IgG4 antibody targeting PD-1 which demonstrates activity across a range of tumours.

RADIATION

Hypofractionated stereotactic radiotherapy

Hypofractionated stereotactic radiotherapy (hSRT) will be delivered to previously untreated brain metastases in eligible participants. hSRT will be delivered to all symptomatic brain metastases, all brain metastases \>1 cm and all brain metastases located in eloquent areas of the brain. hSRT will be commenced after the first cycle of nivolumab plus ipilimumab and completed before the second cycle of nivolumab plus ipilimumab. hSRT should be commenced within 1 week from the planning MRI.

Trial Locations (1)

3004

RECRUITING

Alfred Health, Melbourne

All Listed Sponsors
lead

Melanoma and Skin Cancer Trials Limited

OTHER