- An open-label, phase 2 trial suggests that nivolumab combined with ipilimumab is associated with a 57% intracranial clinical benefit rate in patients with melanoma with untreated brain metastases.
Why this matters
- Combined nivolumab and ipilimumab may represent a future treatment for patients with melanoma with brain metastases, a common cause of neurologic complications and death.
- Intracranial clinical benefit rate was 57% (95% CI, 47%-68%).
- Extracranial clinical benefit rate was 56% (95% CI, 46%-67%).
- Intracranial complete and partial response rates were 26% and 30%, respectively.
- Proportion with stable intracranial disease for ≥6 months was 2%.
- Clinical benefit rate was higher among patients with lactate dehydrogenase levels above the upper limit of normal (ULN) and patients with tumor programmed death ligand 1 (PD-L1) expression ≥5%.
- 55% of patients experienced grade 3-4 treatment-related adverse events (7% affecting the central nervous system).
- 94 patients with melanoma from 28 centers with ≥1 nonirradiated brain metastasis and no neurologic symptoms were treated with nivolumab and ipilimumab until progression or unacceptable toxic effects.
- Funding: Bristol-Myers Squibb; National Cancer Institute.
- Phase 2 study with small patient sample size and without control patients.