Nivolumab and ipilimumab in metastatic uveal melanoma: results from a single-arm phase II study
MS Pelster, SK Gruschkus, R Bassett… - Journal of Clinical …, 2021 - ascopubs.org
MS Pelster, SK Gruschkus, R Bassett, DS Gombos, M Shephard, L Posada, MS Glover…
Journal of Clinical Oncology, 2021•ascopubs.orgPURPOSE Metastatic 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 METHODS We 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 …
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 METHODS We 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 …
PURPOSE
Metastatic 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 METHODS
We 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.
RESULTS
Thirty-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.
CONCLUSION
The combination regimen of nivolumab plus ipilimumab demonstrates activity in metastatic uveal melanoma, with deep and sustained confirmed responses.
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