Bevacizumab and ICIs + hSRT in Symptomatic Melanoma Brain Metastases

Sponsor
Melanoma and Skin Cancer Trials Limited
Study ID
NCT06163820
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Melanoma Brain Metastases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    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.
  • Ipilimumab — DRUG
    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.
  • Nivolumab — DRUG
    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.
  • Hypofractionated stereotactic radiotherapy — RADIATION
    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.

Study Details

Single arm phase I/II trial to evaluate the safety and efficacy of the combination of bevacizumab, with ipilimumab plus nivolumab, and hypofractionated stereotactic radiotherapy (hSRT) in patients with symptomatic melanoma brain metastases (MBM).

Key Dates

Start date
May 31, 2025
Status verified
May 2025
Primary completion
Jan 30, 2026
Completion
Jan 30, 2026

Study Design

Enrollment
46 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention
    Patients will receive the following: 1. Bevacizumab 7.5 mg/kg every 3 weeks for 4 cycles 2. Nivolumab 1 mg /kg + ipilimumab 3 mg/kg every 3 weeks for 4 cycles (induction phase) followed by nivolumab monotherapy at 480mg every 4 weeks (maintenance phase) 3. hSRT (24-27Gy/3# or 25-30Gy/5#)

Primary Outcome Measure

To determine the safety of bevacizumab, in combination with ipilimumab, nivolumab and hSRT [ Time Frame: 5 years ]

Central Contacts