Nivolumab and Ipilimumab in Metastatic Uveal Melanoma: Results from a Single-Arm Phase II Study

Meredith S. Pelster, Stephen K. Gruschkus, Roland Bassett, Dan S. Gombos, Michael Shephard, Liberty Posada, Maura S. Glover, Rinata Simien, Adi Diab, Patrick Hwu, Brett W. Carter, Sapna P. Patel

Research output: Contribution to journalArticlepeer-review

172 Scopus citations


PURPOSEMetastatic uveal melanoma has poor overall survival (OS) and no approved systemic therapy options. Studies of single-agent immunotherapy regimens have shown minimal benefit. There is the potential for improved responses with the use of combination immunotherapy.PATIENTS AND METHODSWe conducted a phase II study of nivolumab with ipilimumab in patients with metastatic uveal melanoma. Any number of prior treatments was permitted. Patients received nivolumab 1 mg/kg and ipilimumab 3 mg/kg for four cycles, followed by nivolumab maintenance therapy for up to 2 years. The primary outcome of the study was overall response rate (ORR) as determined by RECIST 1.1 criteria. Progression-free survival (PFS), OS, and adverse events were also assessed.RESULTSThirty-five patients were enrolled, and 33 patients were evaluable for efficacy. The ORR was 18%, including one confirmed complete response and five confirmed partial responses. The median PFS was 5.5 months (95% CI, 3.4 to 9.5 months), and the median OS was 19.1 months (95% CI, 9.6 months to NR). Forty percent of patients experienced a grade 3-4 treatment-related adverse event.CONCLUSIONThe combination regimen of nivolumab plus ipilimumab demonstrates activity in metastatic uveal melanoma, with deep and sustained confirmed responses.

Original languageEnglish (US)
Pages (from-to)599-607
Number of pages9
JournalJournal of Clinical Oncology
Issue number6
StatePublished - Feb 20 2021

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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