A Contemporary Report of Clinical Outcomes in Patients with Melanoma Brain Metastases.
William J Phillips, Tabassom Baghai, Michael Ong...
https://pubmed.ncbi.nlm.nih.gov/33450821Actively Recruiting
Phase 2
Age: 18Years - 120Years
All Genders
ID03340129
A Phase II, Open Label, Randomised Trial of Ipilimumab and Nivolumab With or Without Concurrent Intracranial Stereotactic Radiotherapy in Patients With Melanoma Brain Metastases
Led by Melanoma Institute Australia · Updated on 2026-02-02
218
Participants Needed
9
Research Sites
156 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
Researchers are evaluating treatments for patients with asymptomatic, untreated melanoma brain metastases in this phase II randomized trial. The study compares a combination of immunotherapy drugs, ipilimumab and nivolumab, given with or without stereotactic radiotherapy to the brain. This approach builds on earlier findings suggesting that combining these therapies may enhance the immune response against melanoma brain tumors and improve outcomes. Participants will receive combination treatment with ipilimumab and nivolumab according to approved dosing schedules. One group will also receive stereotactic radiotherapy to the brain within 7 days of a baseline MRI scan, while the other group will receive immunotherapy alone. Salvage therapies like surgery or radiotherapy may be used if brain disease progresses. The study aims to assess the effects of these treatments on survival, tumor response, neurocognitive function, quality of life, and side effects. During the study, participants will undergo brain MRIs, neurological and cognitive assessments, and complete quality of life questionnaires regularly. Blood, tissue, stool, and urine samples will be collected to study biomarkers related to treatment response and toxicity. Safety will be monitored through adverse event reporting. Participants will be followed for up to 10 years to evaluate neurological death rates, tumor response, survival, cognitive changes, and quality of life.
CONDITIONS
Brief Title
Anti-PD 1 Brain Collaboration + Radiotherapy Extension (ABC-X Study)
Who Can Participate
Age: 18Years - 120Years
All Genders
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 years or older
- Signed informed consent
- Histologically confirmed unresectable melanoma with at least one measurable brain metastasis between 5mm and 40mm
- Available BRAF mutation status prior to randomisation
- Brain metastases suitable for stereotactic radiotherapy
- No prior radiotherapy or systemic treatment for brain metastases except certain prior surgeries
- Asymptomatic from brain metastases without corticosteroids or other neurological symptom treatments
- ECOG performance status of 0 to 2
- Life expectancy greater than 30 days
- Ability to undergo MRI with gadolinium contrast
- Adequate blood, liver, and kidney function
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception
You will not qualify if you...
- Intracranial disease unsuitable for stereotactic radiotherapy or requiring alternative treatment
- Brain metastasis larger than 40mm
- Evidence of leptomeningeal disease except certain prior resections
- History or current ocular melanoma
- Neurological symptoms from brain metastases present at baseline
- Prior brain radiotherapy
- Prior systemic drug therapy for melanoma unless given in neoadjuvant or adjuvant setting completed 6 months before
- Active or suspected autoimmune disease except specified conditions
- Current systemic corticosteroid treatment above allowed doses
- Active infection requiring treatment
- History of interstitial lung disease
- Concurrent malignancy requiring treatment or recent history within 3 years
- Serious unstable medical conditions
- Pregnant or breastfeeding females
- Recent live vaccine administration
- Hypersensitivity to study treatments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for baseline MRI brain with contrast and clinical assessments
Treatment
Duration - Up to 2 years or until disease progression or discontinuation
Participants receive combination immunotherapy with ipilimumab and nivolumab, with or without concurrent stereotactic radiotherapy to brain metastases.
Infusions every 3 weeks for 4 doses, then nivolumab every 4 weeks; stereotactic radiotherapy given as one or hypofractionated doses within 14 days of first immunotherapy dose in the radiotherapy group
Follow-up
Duration - Up to 10 years
Participants are monitored for disease progression, neurocognitive function, quality of life, adverse events, and biomarker assessments after treatment ends or during continued immunotherapy for progression.
Neurocognitive and quality of life assessments every 6 to 12 weeks; periodic imaging and blood, stool, urine sample collections as per protocol
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
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Research Team
G
Georgina V Long, MBBS PhD
M
Maria Gonzalez, RN MHSc
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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