Actively Recruiting
Anti-PD 1 Brain Collaboration + Radiotherapy Extension (ABC-X Study)
Led by Melanoma Institute Australia · Updated on 2026-02-02
218
Participants Needed
9
Research Sites
520 weeks
Total Duration
On this page
Sponsors
M
Melanoma Institute Australia
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a phase II, open label, randomised trial of ipilimumab and nivolumab with concurrent intracranial stereotactic radiotherapy versus ipilimumab and nivolumab alone in patients with asymptomatic, untreated melanoma brain metastases.
CONDITIONS
Official Title
Anti-PD 1 Brain Collaboration + Radiotherapy Extension (ABC-X Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years or older of any gender
- Signed informed consent
- Histologically confirmed unresectable melanoma with at least one measurable brain metastasis between 5mm and 40mm
- Available BRAF mutation status before randomisation
- Brain metastases suitable for stereotactic radiotherapy, without immediate need for whole brain radiotherapy
- Brain metastases untreated by radiotherapy or systemic treatment; prior surgery allowed if complete resection
- No prior systemic treatment for brain metastases except neoadjuvant or adjuvant therapy for extracranial disease completed at least 6 months prior
- Asymptomatic from brain metastases without corticosteroids or other neurological symptom treatments (antiepileptics allowed if asymptomatic)
- ECOG performance status 0 to 2
- Life expectancy greater than 30 days
- Able to undergo MRI with gadolinium contrast
- Adequate blood, liver, and kidney function as defined by specific laboratory values
- Women of childbearing potential must have a negative pregnancy test and agree to effective contraception during and after treatment
You will not qualify if you...
- Change in intracranial disease making stereotactic radiotherapy unsuitable between diagnostic and planning MRI
- Brain metastasis larger than 40mm
- Evidence of leptomeningeal disease except prior isolated findings with no current evidence
- History or current ocular melanoma
- Neurological symptoms from brain metastases at baseline (unless fully resolved for at least 7 days)
- Prior brain radiotherapy (surgery allowed)
- Prior systemic drug therapy for melanoma unless neoadjuvant/adjuvant and completed 6 months ago
- Active, known or suspected autoimmune disease, except certain controlled conditions
- Current systemic corticosteroid use within 7 days, except low-dose prednisone or specific allowed circumstances
- Active infection needing treatment
- History of interstitial lung disease
- Concurrent malignancy requiring treatment or history of another malignancy unless disease-free for 3 years
- Serious or unstable medical conditions interfering with safety or compliance
- Pregnant or breastfeeding females
- Live vaccine within 30 days prior or during trial; caution with other vaccines
- Hypersensitivity to study treatments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Westmead Hospital
Sydney, New South Wales, Australia, 2145
Actively Recruiting
2
Calvary Mater NewcastleHospital
Waratah, New South Wales, Australia, 2298
Actively Recruiting
3
Melanoma Institute Australia
Wollstonecraft, New South Wales, Australia, 2065
Actively Recruiting
4
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Actively Recruiting
5
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Actively Recruiting
6
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia, 3002
Actively Recruiting
7
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Actively Recruiting
8
Sir Charles Gairdner Hosptial
Perth, Western Australia, Australia, 6009
Actively Recruiting
9
Oslo Univesity Hospital Radiumhospitalet
Oslo, Oslo, Norway, 0379
Terminated
Research Team
G
Georgina V Long, MBBS PhD
CONTACT
M
Maria Gonzalez, RN MHSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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