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New treatment option for Melanoma Brain Metastases
Official title Bevacizumab and ICIs + hSRT in Symptomatic Melanoma Brain Metastases
ClinicalTrials.gov ID: NCT06163820
What this study is testing
What is Bevacizumab?
Bevacizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for melanoma brain metastases.
Also referred to as Avastin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 1\. Histologically (or cytologically) proven metastatic melanoma, with radiologically confirmed brain metastases.
- 2\. Symptomatic from brain metastases at the time of study enrolment, or brain metastases that requires corticosteroids for the management of...
- 3\. Intracranial lesions amenable to hypofractionated stereotactic radiotherapy. These are defined as all intracranial melanoma lesions greater or...
- 4\. World Health Organisation (WHO) performance status of 0 - 2
- 5\. At least one brain metastasis has to be symptomatic.
You likely can't join if
- 1\. Prior radiotherapy to the brain
- 2\. Active concurrent malignancy requiring systemic anti-cancer therapy within the last 2 years. Patients with any malignancy treated with curative...
- 3\. Prior systemic therapy for melanoma, unless given in the neoadjuvant or adjuvant setting for extracranial disease only, completed more than \>6...
- 4\. Inability to undergo MRI of the brain
- 5\. Definitive leptomeningeal disease. Patients with equivocal leptomeningeal disease may be included on the trial after discussion with CPI.
- 6\. Female patients who are pregnant or lactating. Patients who are able to become pregnant, must return a negative serum or urine pregnancy test...
See the full eligibility criteria
Who can join
- 1\. Histologically (or cytologically) proven metastatic melanoma, with radiologically confirmed brain metastases.
- 2\. Symptomatic from brain metastases at the time of study enrolment, or brain metastases that requires corticosteroids for the management of neurological symptoms.
- 3\. Intracranial lesions amenable to hypofractionated stereotactic radiotherapy. These are defined as all intracranial melanoma lesions greater or equal to 5 mm in diameter, all intracranial lesions that are causing...
- 4\. World Health Organisation (WHO) performance status of 0 - 2
- 5\. At least one brain metastasis has to be symptomatic.
- 6\. Laboratory tests required: Haemoglobin (Hb) ≥ 9.0 g/dL Absolute neutrophil count ≥ 1 x 109/L Platelet count ≥ 100 x 109/L Either: Serum bilirubin ≤ 1.5 x upper limit of normal (ULN) (Patients with isolated...
- 7\. Age ≥ 18 years
- 8\. Able to provide informed written consent (signed and dated), attend trial site for study visits and be capable of co-operating with treatment and follow-up
What rules you out
- 1\. Prior radiotherapy to the brain
- 2\. Active concurrent malignancy requiring systemic anti-cancer therapy within the last 2 years. Patients with any malignancy treated with curative intent and no evidence of disease will be eligible for this trial.
- 3\. Prior systemic therapy for melanoma, unless given in the neoadjuvant or adjuvant setting for extracranial disease only, completed more than \>6 months prior to enrolment in this trial and if administered with...
- 4\. Inability to undergo MRI of the brain
- 5\. Definitive leptomeningeal disease. Patients with equivocal leptomeningeal disease may be included on the trial after discussion with CPI.
- 6\. Female patients who are pregnant or lactating. Patients who are able to become pregnant, must return a negative serum or urine pregnancy test before enrolment and agree to use two forms of contraception (one...
- 7\. Male patients with partners of child-bearing potential (unless they agree to take measures not to father children by using a barrier method of contraception or to sexual abstinence effective from the first...
- 8\. Haemorrhage encompassing \>50% of any lesion that is \>10 mm in diameter (excluding surrounding oedema). A modern susceptibility-sensitive MRI sequence such as SWI is mandatory.
- 9\. Brain metastases greater than 5 cm in maximal diameter
- 10\. Increasing corticosteroid dose for 48 hours prior to initiation of study therapy OR current dexamethasone-equivalent dose of \>8 mg per day
- 11\. Major thoracic or abdominal surgery within 28 days prior to initiation of trial treatment
- 12\. Neurosurgery within 14 days prior to initiation of trial treatment
- 13\. Active or history of severe auto-immune disease requiring systemic anti-inflammatory therapy. Patients with well-controlled auto-immune diseases not requiring systemic anti-inflammatory therapy may be included...
- 14\. History of inflammatory bowel disease
- 15\. Requirement for ongoing concurrent systemic immunosuppressive therapy (other than corticosteroids).
- 16\. History of intra-abdominal inflammatory process within 6 months prior to initiation of trial treatment, including but not limited to peptic ulcer disease, diverticular disease or colitis.
- 17\. History of abdominal or trachea-oesophageal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to initiation of trial treatment
- 18\. History of intestinal obstruction and/or clinical signs or symptoms of gastrointestinal obstruction including sub-occlusive disease related to the underlying disease or requirement for routine parenteral hydration...
- 19\. Any Grade ≥3 haemorrhage or bleeding event within 28 days of trial treatment initiation. Patients presenting with haemorrhagic brain metastases that have been adequately treated with neurosurgery are not excluded...
- 20\. Current use of full-dose anticoagulation or thrombolytic therapy within 10 days of initiation of trial treatment
- 21\. Evidence of bleeding diatheses or significant coagulopathy
- 22\. History of inadequately controlled arterial hypertension (systolic BP ≥160 mm Hg or diastolic BP ≥100 mm Hg despite maximal medical therapy); prior history of hypertensive crises or hypertensive encephalopathy
- 23\. Concurrent congestive heart failure, prior history of NYHA class III/ IV cardiac disease, prior history of cardiac ischaemia or prior history of cardiac arrhythmia
- 24\. Concurrent participation in another treatment clinical trial or intention to do so. Concurrent participation in an observational trial is acceptable.
- 25\. Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Melbourne, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Melbourne, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.