OncoMatch/Clinical Trials/NCT03340129
Anti-PD 1 Brain Collaboration + Radiotherapy Extension (ABC-X Study)
Is NCT03340129 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Ipilimumab and Nivolumab for melanoma stage iv.
Treatment: Ipilimumab · Nivolumab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Cancer type
Melanoma
Biomarker criteria
Required: BRAF mutation status available
The BRAF mutation status must be available prior to randomisation.
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Cannot have received: systemic drug therapy for melanoma (anti-PD1, anti-PD-L1, anti-CTLA-4, BRAF inhibitor, MEK inhibitor)
Exception: neoadjuvant or adjuvant setting only, completed ≥6 months before enrolment, and no brain metastases at time of therapy
No prior systemic treatment for brain metastases is permitted unless given in the neoadjuvant or adjuvant settings for systemic drug the treatment for extracranial disease only. At the time of neoadjuvant or adjuvant systemic therapy for extracranial disease, there should be radiological evidence of the absence of brain metastases. The presenting diagnosis of brain metastases at the time of enrolment in this study must have occurred a minimum of 6 months after stopping neoadjuvant or adjuvant 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)
Cannot have received: radiotherapy to the brain
Brain metastases must be untreated with any modality of radiotherapy or systemic treatment. Previous surgery for melanoma brain metastases is permitted if it resulted in gross total resection and no radiotherapeutic cavity boost was required.
Lab requirements
Blood counts
White cell count ≥ 2.0 × 10x9/L; Neutrophil count ≥ 1.5 × 10x9/L; Haemoglobin ≥ 90 g/L; Platelet count ≥ 100 x 10x9/L
Kidney function
Serum creatinine ≤ 1.5 x ULN. If >1.5 x ULN, creatinine clearance must be ≥ 40 ml/min
Liver function
Total bilirubin ≤ 1.5 x ULN; Alanine transaminase ≤ 3.0 x ULN; Aspartate aminotransferase ≤ 3.0 x ULN
Adequate haematological, hepatic and renal organ function as defined by: White cell count ≥ 2.0 × 10x9/L; Neutrophil count ≥ 1.5 × 10x9/L; Haemoglobin ≥ 90 g/L; Platelet count ≥ 100 x 10x9/L; Total bilirubin ≤ 1.5 x ULN; Alanine transaminase ≤ 3.0 x ULN; Aspartate aminotransferase ≤ 3.0 x ULN; Serum creatinine ≤ 1.5 x ULN. If serum creatinine is > 1.5 x ULN, creatinine clearance must be 40ml/min to be eligible.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT03340129 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic drug therapy for melanoma, radiotherapy to the brain disqualifies patients from enrollment.
Does this trial require BRAF?
Yes, BRAF mutation status available is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Is there an age limit?
Yes. Patients must be 120 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages