Table 3

Intracranial response rate to ipilimumab–nivolumab (I–N)

Intracranial response, no. (%)First-line I–N (n=16)Second-line and third-line I–N (n=21)P value
Complete response5 (31.3)0 (0.0)
Partial response7 (43.8)1 (4.8)
Stable disease0 (0.0)0 (0.0)
Progressive disease4 (25.0)20 (96.2)
Disease control rate13 (81.2)1 (4.8)<0.0001
Objective response rate12 (75.0)1 (4.8)
  • Assessments as per modified intracranial RECIST using gadolinium enhanced thin slice MRI for patients with at least one non-irradiated melanoma brain metastasis (MBM). For the first-line ipilimumab-nivolumab (I-N) group, 9 out of 25 patients were excluded from response evaluation as they had a solitary MBM that was treated with stereotactic radiosurgery within 12 weeks of commencement of I–N (n=5), whole brain radiotherapy within 12 weeks of commencement I–N (n=3) and did not have measurable intracranial lesions (n=1). In the second/third line I–N group, 9 out of 30 patients were excluded from response evaluation as they received whole brain radiotherapy within 12 weeks of commencement of I–N (n=5) and non-measurable MBMs (n=2), stereotactic radiosurgery to solitary MBM within 12 weeks of commencement of ipilimumab–nivolumab (n=2). Patients who were excluded for objective response assessment were included in the intracranial progression-free survival analysis.

  • RECIST, Response Evaluation Criteria in Solid Tumours.