NCT03340129 Anti-PD 1 Brain Collaboration + Radiotherapy Extension (ABC-X Study)
| NCT ID | NCT03340129 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Melanoma Institute Australia |
| Condition | Melanoma Stage Iv |
| Study Type | INTERVENTIONAL |
| Enrollment | 218 participants |
| Start Date | 2019-08-14 |
| Primary Completion | 2026-08 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Female or male patients, ≥18 years of age. 2. Signed, written, informed consent. 3. AJCC Stage IV \[any T, any N, M1d (0) or M1D(1)\] histologically confirmed cutaneous, acral or mucosal unresectable melanoma or unknown primary melanoma and at least 1 radiological definitive brain metastasis that is ≥ 5mm and ≤40mm, measurable per RECIST version 1.1 guidelines (modified for brain metastases, enabling up to 5 target lesions in the brain as well as up to 5 extracranial target lesions). There is no upper limit restriction in the number of brain metastases, provided the remaining eligibility criteria are met. 4. The BRAF mutation status must be available prior to randomisation. 5. The treating clinician(s) should consider the intracranial disease amenable to stereotactic radiotherapy over whole brain radiotherapy. Patients for whom there is a definite and immediate indication for radiotherapy (e.g. rapidly progressing disease with associated clinical signs and /or sy
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