BridgeMD
Anti-PD 1 Brain Collaboration + Radiotherapy Extension: The ABC-X Study
EU CTIS ID: 2024-518545-13-00
What this study is testing
Neurological-specific death rate at 1 year
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- ≥18 years of age
- Life expectancy of > 30 days
- Able to undergo MRI with Gadolinium contrast agent
- Adequate haematological, hepatic and renal organ function
- Women of childbearing potential with a negative pregnancy test, effective contraception
- Men with female partner of childbearing potential use effective contraception and refrain from donating sperm during the study and for 31 weeks from end of treatment
You likely can't join if
- Patients whose intracranial disease changes between the eligibility MRI scan and the SRS planning MRI rendering the patient unsuitable for randomised treatment on trial, or requires a specific alternative treatment
- Active infection requiring therapy
- History of interstitial lung disease
- Any concurrent malignancy (excluding successful resection or curative treatment of in situ disease, superficial bladder cancer or non-melanoma skin cancer) requiring any treatment or a history of another malignancy, unless the patient has been disease-free for 1 year
- Serious or unstable pre-existing medical conditions or other conditions that could interfere with the patient’s safety, consent, or compliance
- Pregnant or breastfeeding females
See the full eligibility criteria
Who can join
- ≥18 years of age
- Life expectancy of > 30 days
- Able to undergo MRI with Gadolinium contrast agent
- Adequate haematological, hepatic and renal organ function
- Women of childbearing potential with a negative pregnancy test, effective contraception
- Men with female partner of childbearing potential use effective contraception and refrain from donating sperm during the study and for 31 weeks from end of treatment
- Written informed consent
- AJCC Stage IV (any T, any N, M1d) histologically confirmed cutaneous, acral or mucosal melanoma, or unknown primary melanoma, with metastases to the brain that are considered unresectable. Patients must have a minimum of one radiological definitive brain metastasis that is ≥ 5mm and ≤40mm, measurable per bm RECIST guidelines. There is no upper limit restriction to the number of brain metastases
- Known BRAF mutation status prior to randomisation
- The treating clinician(s) should consider all intracranial lesions (target and non-target) amenable to stereotactic radiotherapy over whole brain radiotherapy. This includes brain metastases ≤5mm diameter
- No prior radiotherapy for brain metastases (previous surgery for melanoma brain metastases is permitted). Prior radiotherapy for extracranial disease is permitted
- No prior systemic drug therapy for melanoma, unless given in the neoadjuvant or adjuvant setting and for the treatment of extracranial disease only. Radiological confirmation of the absence of brain metastases throughout prior systemic treatment should be documented. The presenting diagnosis of brain metastases must have occurred ≥ 6 months after stopping systemic therapy (prior anti PD1, anti PD-L1, anti CTLA-4, BRAF/MEK inhibitors or clinical trial agents are acceptable in the setting of neoadjuvant or adjuvant treatment)
- Asymptomatic from brain metastases at the time of study enrolment without corticosteroids, analgesia or any other treatment for the management of active neurological symptoms. Resolved neurological symptoms are permitted if complete resolution has been sustained for a minimum of 7 days prior to randomisation. Antiepileptics are permitted regardless of the indication, provided the patient is asymptomatic at the time of randomisation
- ECOG performance status of 0-2
What rules you out
- Patients whose intracranial disease changes between the eligibility MRI scan and the SRS planning MRI rendering the patient unsuitable for randomised treatment on trial, or requires a specific alternative treatment
- Active infection requiring therapy
- History of interstitial lung disease
- Any concurrent malignancy (excluding successful resection or curative treatment of in situ disease, superficial bladder cancer or non-melanoma skin cancer) requiring any treatment or a history of another malignancy, unless the patient has been disease-free for 1 year
- Serious or unstable pre-existing medical conditions or other conditions that could interfere with the patient’s safety, consent, or compliance
- Pregnant or breastfeeding females
- Administration of any form of live vaccine within 30 days of starting the trial and during trial. Other vaccine use is cautionary within 30 days of starting trial and during treatment phase of trial
- Hypersensitivity to study treatment or to any of the excipients listed in the corresponding Investigator's Brochure
- Any melanoma brain metastasis >40mm
- Evidence of leptomeningeal disease, with the exception of pathological findings seen at previous resection of brain disease, but no evidence of leptomeningeal disease elsewhere at the time of resection or at study entry
- Ocular (both uveal and conjunctival) melanoma (mucosal and acral melanoma are eligible)
- Current neurological symptoms from brain metastases or a requirement for corticosteroids, analgesia or other treatment for the management of symptoms
- Prior radiotherapy to the brain (prior surgery for melanoma brain metastases permitted)
- Prior systemic drug therapy for melanoma, unless given in the neoadjuvant or adjuvant setting, prior to the development of any brain metastases and completed ≥ 6 months before enrolment in this study
- Patients with significant active, known or suspected autoimmune disease requiring past or current immunosuppression
- Current systemic treatment with corticosteroids, or within 7 days of randomisation, except prednisone at non-immunosuppressive doses of ≤ 10 mg/day (or equivalent)
The study team makes the final eligibility decision.
Where it's taking place
- 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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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 EU CTIS; the study team decides eligibility.