Actively Recruiting
Bevacizumab and ICIs + hSRT in Symptomatic Melanoma Brain Metastases
Led by Melanoma and Skin Cancer Trials Limited · Updated on 2025-05-13
46
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Bevacizumab and ICIs + hSRT in Symptomatic Melanoma Brain Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed metastatic melanoma with brain metastases seen on scans
- Symptomatic brain metastases or requiring corticosteroids for neurological symptoms
- Brain lesions suitable for hypofractionated stereotactic radiotherapy (≥5 mm, symptomatic, or in sensitive brain areas)
- World Health Organisation performance status of 0 to 2
- At least one brain metastasis causing symptoms
- Blood tests meeting specified levels for hemoglobin, neutrophils, platelets, liver enzymes, bilirubin, and kidney function
- Age 18 years or older
- Able to give written informed consent, attend study visits, and cooperate with treatment and follow-up
You will not qualify if you...
- Previous radiotherapy to the brain
- Active cancer requiring systemic treatment within last 2 years (except cured cancers with no disease)
- Prior melanoma systemic treatment unless completed >6 months ago without brain metastases
- Unable to have an MRI of the brain
- Definite leptomeningeal disease (uncertain cases may be included after discussion)
- Pregnant or breastfeeding women; women of childbearing potential must have negative pregnancy test and use two forms of contraception or abstinence
- Men with partners of childbearing potential must use contraception or abstinence during and after treatment
- Hemorrhage involving >50% of lesions >10 mm in diameter
- Brain metastases larger than 5 cm
- Increasing corticosteroid dose within 48 hours before treatment or daily dose >8 mg dexamethasone equivalent
- Major thoracic or abdominal surgery within 28 days before treatment
- Neurosurgery within 14 days before treatment
- Severe autoimmune disease requiring systemic therapy (well-controlled autoimmune diseases may be included after consultation)
- History of inflammatory bowel disease
- Need for ongoing systemic immunosuppressive therapy other than corticosteroids
- History of recent intra-abdominal inflammation, gastrointestinal perforation, abscess, or fistula within 6 months
- History of intestinal obstruction or related symptoms requiring special feeding or hydration within 6 months
- Grade 3 or higher bleeding within 28 days before treatment (except treated hemorrhagic brain metastases)
- Current full-dose anticoagulation or thrombolytic therapy within 10 days before treatment
- Bleeding disorders or significant clotting problems
- Poorly controlled high blood pressure or history of hypertensive crises
- Heart failure, serious heart disease, or arrhythmias
- Participation in another interventional clinical trial or intention to do so
- Any other condition making participation unsuitable in the investigator's opinion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Alfred Health
Melbourne, Victoria, Australia, 3004
Actively Recruiting
Research Team
K
Katja Loewe
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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