ASCO 2017 - Melanoma brain mets: nivolumab+ipilimumab deliver promising phase 2 results

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  • At a maximum tolerated dose of nivolumab (Opdivo) 3 mg/kg or 1 mg/kg+ipilimumab (Yervoy) 3 mg/kg, 42% of patients in the combined group achieved best intracranial response vs 20% in the single groups of this phase 2 trial.

Why this matters

  • Previous trials excluded patients with untreated brain metastases but found compounds active.
  • This examines the antitumour activity and safety in patients with no prior therapy.

Study design

  • Phase 2, open-label trial (n=76) of patients naive to anti-PD1/PDL1/PDL2/CTLA4.
  • Patients randomly assigned to:
  • —A: nivolumab 1 mg/kg+ipilimumab 3 mg/kg, every 3 wk×4 cycles, and then nivolumab 3 mg/kg every 2 wk.
  • —B: nivolumab 3 mg/kg every 2 wk.
  • —C: nivolumab 3 mg/kg every 2 wk had brain metastases that failed therapy, were symptomatic, or pat...